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From simple mix-ups to fatal overdoses, medication mistakes happen, on average, once a day to every hospital patient, a new report says. Nationwide, at least 1.5 million people annually are harmed from drug errors, more than half of them in nursing homes.
Many Unfavorable Drug Studies Aren’t Published. Nearly a third of antidepressant drug studies are never published in the medical literature, and nearly all of those happen to show that the drug being tests failed to work.
Only Drugs That are Safe Should be put on the Market. Drug developers are just beginning to come to grips with recent FDA oversight reforms and how they will affect drug safety. But, it appears that industry and consumer advocates are not together on how well the overhaul will be able to prevent future drug safety scandals.

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Review Fentanyl Safety Reports submitted to FDA

Total Fentanyl reports: 908.
Fentanyl FDA safety alerts: 2002 2004 2005 2007 2008 .
Reported deaths: 178    Reported hospitalizations: 355.
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FDA Reported Fentanyl Side Effects: overdose, nausea, loss of consciousness, vomiting, hyperhidrosis, inadequate analgesia, dizziness, confusional state, incorrect dose administered, somnolence, weight decreased.
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Fentanyl Side Effects Report #5278845-8
Health Professional from JAPAN reported FENTANYL problem on Mar 19, 2007. Male patient, 64 years of age, was diagnosed with pain management, pulmonary tuberculosis and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased. FENTANYL dosage: unknown. During the same period patient was treated with RIFAMPICIN, ISONIAZID, ETHAMBUTOL HYDROCHLORIDE, LOXOPROFEN. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5279687-X
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 09, 2007. Female patient, 59 years of age, weighting 160.0 lb, was diagnosed with complex regional pain syndrome and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, constipation, dehydration, electrolyte imbalance, gingival bleeding, gingival swelling, hypokalaemia, nausea, vomiting. FENTANYL dosage: unknown. During the same period patient was treated with ADVAIR DISKUS, INTAL, ZELNORM, XANAX, MAXZIDE, ACIPHEX, PREMARIN, ALLERGY SHOTS. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5281346-4
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 22, 2007. Male patient, 30 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: loss of consciousness. FENTANYL dosage: unknown. During the same period patient was treated with XANAX. Patient recovered.

Fentanyl Side Effects Report #5281915-1
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 23, 2007. Male patient, weighting 235.0 lb, was diagnosed with back pain, depression, hypertension and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, dysuria, heart rate increased, hyperhidrosis, loss of consciousness, malaise, oxygen saturation decreased, renal failure, urine analysis abnormal. FENTANYL dosage: unknown. During the same period patient was treated with CELEBREX, ADVIL, EFFEXOR, ALTACE, METOPROLOL SUCCINATE. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5283880-X
Pharmacist from UNITED STATES reported FENTANYL problem on Mar 19, 2007. Female patient, 19 years of age, was treated with FENTANYL. FENTANYL dosage: unknown. During the same period patient was treated with CYCLOBENZAPRINE, METHADONE. Patient died.

Fentanyl Side Effects Report #5285452-X
FENTANYL problem was reported by a Health Professional from UNITED STATES on Mar 14, 2007. Female patient, 29 years of age, weighting 144.0 lb, was diagnosed with breakthrough pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: unintended pregnancy. FENTANYL dosage: unknown. During the same period patient was treated with OXYCODONE, ZOLPIDEM, HYDROCODONE, NUVARING. Patient died.

Fentanyl Side Effects Report #5285888-7
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 18, 2007. Female patient, 53 years of age, was diagnosed with neuropathy and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: migraine, nausea, vomiting. FENTANYL dosage: unknown. During the same period patient was treated with CYCLOBENZAPRINE, MONTELUKAST, FLUTICASONE PROPIONATE, DULOXETINE HYDROCHLORIDE, ESTROGENS CONJUGATED, OMEPRAZOLE. Patient recovered.

Fentanyl Side Effects Report #5285889-9
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 14, 2007. Male patient was diagnosed with back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, convulsion, nausea, pain, vomiting, weight decreased. FENTANYL dosage: unknown. During the same period patient was treated with PERCOCET, GABAPENTIN. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5284151-8
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 26, 2007. Female patient, weighting 140.0 lb, was diagnosed with nerve injury, pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dental caries. FENTANYL dosage: unknown. During the same period patient was treated with DURAGESIC, ZANAFLEX, MORPHINE. Patient recovered.

Fentanyl Side Effects Report #5284610-8
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 27, 2007. Female patient, weighting 119.0 lb, was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: constipation, gastric disorder, hyperhidrosis, tremor, weight decreased. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5286458-7
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 28, 2007. Female patient, weighting 130.0 lb, was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: bone neoplasm malignant, faecal vomiting, heart rate increased, oedema peripheral, pneumonia aspiration. FENTANYL dosage: unknown. Patient was hospitalized. Patient died on 03/23/2007.

Fentanyl Side Effects Report #5287897-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 23, 2007. Female patient, weighting 196.0 lb, was diagnosed with fibromyalgia, osteoarthritis, depression, gastrointestinal disorder, blood pressure, blood cholesterol and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: fall, osteoporosis, rib fracture, scoliosis. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, FENTANYL TRANSDERMAL SYSTEM, CYMBALTA, PROTONIX, LISINOPRIL, TRICOR, WELLBUTRIN. Patient recovered.

Fentanyl Side Effects Report #5287952-5
Health Professional from TAIWAN, PROVINCE OF CHINA reported FENTANYL problem on Mar 29, 2007. Female patient, 81 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dizziness, hypotension, nausea, vomiting. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5287954-9
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 28, 2007. Female patient, weighting 96.01 lb, was diagnosed with pain, depression, breast cancer, thyroid disorder, anxiety, sleep disorder and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: application site dryness, application site erythema, knee deformity. FENTANYL dosage: unknown. During the same period patient was treated with OXYCODONE, DILAUDID, REMERON, FEMARA, SYNTHROID, XANAX, AMBIEN. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5287955-0
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 28, 2007. Female patient, weighting 190.0 lb, was diagnosed with pain, depression, hypothyroidism, blood cholesterol increased, cardiac disorder, tachycardia, nausea, vomiting, oesophagitis and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: chest discomfort, endotracheal intubation complication, hypertension, pneumonia aspiration, respiratory arrest, ventricular extrasystoles. FENTANYL dosage: unknown. During the same period patient was treated with WELLBUTRIN, LEVOTHYROXINE, LIPITOR, PLAVIX, ATENOLOL, PHENERGAN, ACIPHEX. Patient recovered.

Fentanyl Side Effects Report #5288180-X
FENTANYL problem was reported by a Pharmacist from UNITED STATES on Apr 02, 2007. Female patient, 91 years of age, weighting 141.1 lb, was diagnosed with back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: loss of consciousness. FENTANYL dosage: unknown. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5289307-6
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 02, 2007. Female patient, weighting 202.0 lb, was diagnosed with pain, bipolar disorder, anxiety, gastrooesophageal reflux disease and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dysgeusia, fatigue, inadequate analgesia, lethargy, mental disorder. FENTANYL dosage: unknown. During the same period patient was treated with REQUIP, SYNTHROID, CYMBALTA, POTASSIUM CHLORIDE, CLONAZEPAM, GEODON, ACIPHEX, SEROQUEL. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5290323-9
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 30, 2007. Male patient, weighting 184.0 lb, was diagnosed with pain in extremity, back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: appetite disorder, body temperature decreased, cold sweat, dizziness, feeling of body temperature change, gait disturbance, headache, heart rate decreased, initial insomnia. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM. Patient recovered.

Fentanyl Side Effects Report #5291775-0
Physician from UNITED STATES reported FENTANYL problem on Apr 06, 2007. Female patient, weighting 200.0 lb, was diagnosed with arthralgia, back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: abasia, constipation. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5291776-2
FENTANYL problem was reported by a Health Professional from UNITED STATES on Apr 06, 2007. Female patient, 48 years of age, weighting 220.0 lb, was diagnosed with back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: vomiting. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5292672-7
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 22, 2007. Female patient, 47 years of age, weighting 215.0 lb, was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dehydration, diarrhoea, pilonidal cyst, pyrexia, rash, vomiting. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, GABAPENTIN, OXYCOCET, ACETYLSALICYLIC ACID SRT. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5294517-8
FENTANYL problem was reported by a Pharmacist from UNITED STATES on Apr 09, 2007. Male patient, weighting 216.7 lb, was diagnosed with sedation and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest. FENTANYL dosage: unknown. During the same period patient was treated with MIDAZOLAM IV. Patient was hospitalized. Patient died on 12/13/2006.

Fentanyl Side Effects Report #5294519-1
Pharmacist from UNITED STATES reported FENTANYL problem on Apr 09, 2007. Male patient, weighting 147.7 lb, was diagnosed with sedation and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: anaemia, blood glucose increased, haemorrhage, hypoxia, post procedural complication, respiratory arrest. FENTANYL dosage: unknown. During the same period patient was treated with MIDAZOLAM IV. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5294653-6
FENTANYL problem was reported by a Pharmacist from UNITED STATES on Apr 09, 2007. Male patient, weighting 244.1 lb, was diagnosed with sedation and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: blood creatinine abnormal, blood glucose increased, blood urea increased, body temperature decreased, haemoglobin decreased, respiratory arrest. FENTANYL dosage: unknown. During the same period patient was treated with MIDAZOLAM IV. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5297261-6
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 06, 2007. Female patient, weighting 145.0 lb, was diagnosed with arthralgia, back pain, tremor, anxiety, nervousness, depression, hypertension, blood cholesterol increased and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: pain, spinal nerve stimulator implantation. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, INDERAL, KLONOPIN, NEURONTIN, EFFEXOR, AVALIDE, CELEBREX, LIPITOR. Patient recovered.

Fentanyl Side Effects Report #5297510-4
FENTANYL problem was reported by a Health Professional from UNITED STATES on Apr 06, 2007. Male patient, 50 years of age, was treated with FENTANYL. FENTANYL dosage: unknown. During the same period patient was treated with OXYCODONE AND ACETAMINOPHEN. Patient died.

Fentanyl Side Effects Report #5298521-5
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 31, 2007. Female patient, 18 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: loss of consciousness. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5300395-0
FENTANYL problem was reported by a Physician from UNITED STATES on Apr 13, 2007. Female patient was diagnosed with tooth extraction and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: procedural complication. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL CITRATE, MIDAZOLAM. Patient recovered.

Fentanyl Side Effects Report #5300431-1
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 28, 2007. Female patient, 37 years of age, weighting 84.00 lb, was diagnosed with brain neoplasm, pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dehydration, device failure, gastroenteritis viral. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, DICYCLOMINE, DIAZEPAM, TRAMADOL, PETHIDINE HYDROCHLORIDE, ESCITALOPRAM, NITROQUICK. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5301494-X
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 28, 2007. Female patient was diagnosed with back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: overdose. FENTANYL dosage: unknown. Patient died on 03/23/2005.

Fentanyl Side Effects Report #5301721-9
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 09, 2007. Female patient, weighting 200.0 lb, was diagnosed with pain, hypertension and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dizziness, feeling abnormal, hypothyroidism. FENTANYL dosage: unknown. During the same period patient was treated with VERAPAMIL, TYLENOL EXTRA STRENGHT. Patient recovered.

Fentanyl Side Effects Report #5301722-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 09, 2007. Male patient, weighting 105.0 lb, was diagnosed with fibromyalgia, hypertension, pain, anxiety, emphysema and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: hypertension, oxygen saturation decreased, rash. FENTANYL dosage: unknown. During the same period patient was treated with NORVASC, PERCOCET, XANAX, LISINOPRIL, COMBIVENT. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5302985-8
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 09, 2007. Female patient, weighting 140.0 lb, was diagnosed with pain, depression, fluid retention, hypertension, nervousness, nausea and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: depression, hip fracture, infection, post procedural complication. FENTANYL dosage: unknown. During the same period patient was treated with DURAGESIC, EFFEXOR, LASIX, NORVASC, TOPRAL, LORAZEPAM, PHENERGAN, POTASSIUM ACETATE. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5302988-3
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 10, 2007. Male patient, weighting 120.0 lb, was diagnosed with cancer pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: hepatic neoplasm malignant. FENTANYL dosage: unknown. Patient died on 04/05/2007.

Fentanyl Side Effects Report #5303368-7
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 10, 2007. Male patient, weighting 214.0 lb, was diagnosed with back pain, constipation, hypertension, diabetes mellitus non-insulin-dependent, benign prostatic hyperplasia, fluid retention, anxiety, gastric disorder and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: application site reaction, spinal cord compression. FENTANYL dosage: unknown. During the same period patient was treated with GLYCOLAX, ALTACE, ACTOS, FLOMAX, FUROSEMIDE, HYDROCODONE, LORAZEPAM, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5303374-2
FENTANYL problem was reported by a Physician from UNITED STATES on Apr 10, 2007. Female patient, weighting 148.0 lb, was diagnosed with arthritis and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: asthenia, circulatory collapse, confusional state, dizziness, feeling abnormal, kidney infection, speech disorder. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5305499-4
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 13, 2007. Female patient, weighting 220.0 lb, was diagnosed with fibromyalgia, blood cholesterol, muscle spasms and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: coronary artery occlusion, device failure, restless legs syndrome. FENTANYL dosage: unknown. During the same period patient was treated with ZETIA, HYDROCHLOROTHIAZIDE, BACLOFEN. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5305563-X
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 12, 2007. Male patient, weighting 235.0 lb, was diagnosed with osteoarthritis, gout, hypertension, pain, breakthrough pain, iron deficiency, depression and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dyspnoea, hyperhidrosis, interstitial lung disease, osteomyelitis, staphylococcal infection. FENTANYL dosage: unknown. During the same period patient was treated with COLCHICINE, ALLOPURINOL, ATENOLOL, OXYCODONE, DILAUDID, NORVASC, FERROUS SULPHATE, CITALOPRAM HYDROBROMIDE. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5306436-9
Consumer or non-health professional from UNITED KINGDOM reported FENTANYL problem on Apr 16, 2007. Male patient, 82 years of age, weighting 132.3 lb, was diagnosed with anaesthesia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. FENTANYL dosage: unknown. During the same period patient was treated with PROPOFOL. Patient recovered.

Fentanyl Side Effects Report #5306866-5
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 20, 2007. Male patient, 72 years of age, weighting 143.3 lb, was diagnosed with pain, chronic obstructive pulmonary disease, sedation, hypertension and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: accidental overdose, bradycardia, disease progression. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL CITRATE, ALBUTEROL, MIDAZOLAM, MOMETASONE FUROATE, PIPERACILLIN, LASIX, PHOSPHATES, LISINOPRIL. Patient died on 03/29/2007.

Fentanyl Side Effects Report #5306969-5
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 18, 2007. Male patient, weighting 219.0 lb, was diagnosed with pain, blood pressure, multiple allergies, intestinal functional disorder, muscle spasms, blood cholesterol and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, device leakage. FENTANYL dosage: unknown. During the same period patient was treated with ATENOLOL, HYDROCHLOROTHIAZIDE, LORATADINE, DICYCLOMINE, ZANAFLEX, LYRICA, FLUVASTATIN, LIDODERM. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5308057-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 16, 2007. Female patient, weighting 134.0 lb, was diagnosed with pain, pneumonia, anxiety, hypertension and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, haemoglobin decreased, oedema peripheral, pneumonia, swelling face, transient ischaemic attack. FENTANYL dosage: unknown. During the same period patient was treated with PREDNISONE, KLONOPIN, LISINOPRIL, ASPIRIN, VOLTAREN, PROZAC. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5309588-X
Health Professional from UNITED STATES reported FENTANYL problem on Apr 25, 2007. Female patient, weighting 138.0 lb, was diagnosed with back injury, back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: rash pruritic. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5310980-8
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 18, 2007. Female patient was diagnosed with pain, hypertension, neuralgia, gastrooesophageal reflux disease, depression and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: alopecia, back pain, blood potassium increased, blood pressure increased, blood urine present, bronchitis, decreased activity, depression, dyspnoea. FENTANYL dosage: unknown. During the same period patient was treated with DURAGESIC, SPIRONOLACTONE, POTASSIUM ACETATE, MOBIC, NEURONTIN, PRILOSEC, PAXIL. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5310981-X
Physician from UNITED STATES reported FENTANYL problem on Apr 19, 2007. Male patient, weighting 209.4 lb, was diagnosed with cluster headache, cardiac disorder, depression, sleep disorder, dizziness, parkinson's disease and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: confusional state, disorientation, fall, feeding disorder, muscular weakness, somnolence. FENTANYL dosage: unknown. During the same period patient was treated with PLAVIX, ZOLOFT, CORDARONE, TEMAZEPAM, ASPIRIN, DEPAKOTE ER, ANTIVERT, SINEMET. Patient recovered.

Fentanyl Side Effects Report #5311079-7
FENTANYL problem was reported by a Physician from UNITED STATES on Apr 27, 2007. Male patient, 47 years of age, weighting 180.0 lb, was diagnosed with paraesthesia, polyneuropathy and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dizziness, nausea, vertigo. FENTANYL dosage: unknown. Patient was hospitalized. Patient died on 03/07/2007.

Fentanyl Side Effects Report #5311374-1
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 23, 2007. Female patient, 50 years of age, was diagnosed with irritable bowel syndrome and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: catheterisation cardiac, dyspepsia, myocardial infarction, stent placement. FENTANYL dosage: unknown. During the same period patient was treated with MARINOL, NEURONTIN, PROVERA, PROTONIX, PROMETHAZINE, ZELNORM. Patient recovered.

Fentanyl Side Effects Report #5311425-4
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 23, 2007. Male patient, 19 years of age, was treated with FENTANYL. FENTANYL dosage: unknown. Patient died on 04/10/2007.

Fentanyl Side Effects Report #5311457-6
Pharmacist from UNITED STATES reported FENTANYL problem on Apr 26, 2007. Male patient, 52 years of age, weighting 134.0 lb, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dizziness, nausea, vomiting. FENTANYL dosage: unknown. During the same period patient was treated with BACLOFEN, CITALOPRAM HYDROBROMIDE, HYDROCHLOROTHIAZIDE, LISINOPRIL, CAPSAICIN, GABAPENTIN, OMEPRAZOLE. Patient recovered.

Fentanyl Side Effects Report #5313129-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 13, 2007. Male patient, 49 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: accidental overdose, incorrect dose administered. FENTANYL dosage: unknown. Patient died on 04/13/2007.

Fentanyl Side Effects Report #5313131-9
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 13, 2007. Female patient, 22 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: accidental overdose, incorrect dose administered. FENTANYL dosage: unknown. Patient died on 04/13/2007.

Fentanyl Side Effects Report #5313132-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 11, 2007. Female patient, 54 years of age, weighting 170.0 lb, was diagnosed with back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: anxiety, tremor. FENTANYL dosage: unknown. During the same period patient was treated with OXYCODONE. Patient recovered.

Fentanyl Side Effects Report #5314269-2
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 11, 2007. Male patient, 73 years of age, weighting 172.0 lb, was diagnosed with arthralgia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: agitation, middle insomnia, myalgia, no therapeutic response, tinnitus, urinary retention. FENTANYL dosage: unknown. During the same period patient was treated with SERETIDE, TAMSULOSIN, DUTASTERIDE, OMEPRAZOLE, HYZAAR, DILTIAZEM, CLOPIDOGREL, EZETIMIBE. Patient recovered.

Fentanyl Side Effects Report #5314291-6
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 11, 2007. Male patient, 72 years of age, weighting 172.0 lb, was diagnosed with arthralgia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: myalgia, tinnitus. FENTANYL dosage: unknown. During the same period patient was treated with SERETIDE, TAMSULOSIN, DUTASTERIDE, OMEPRAZOLE, HYZAAR, DILTIAZEM, CLOPIDOGREL, EZETIMIBE. Patient recovered.

Fentanyl Side Effects Report #5314436-8
Physician from UNITED STATES reported FENTANYL problem on Apr 30, 2007. Female patient, weighting 107.0 lb, was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: rash. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5316303-2
FENTANYL problem was reported by a Physician from UNITED STATES on Apr 20, 2007. Female patient, 65 years of age, was diagnosed with back pain, depression and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: aggression, gait disturbance, serotonin syndrome, tremor. FENTANYL dosage: unknown. During the same period patient was treated with CITALOPRAM HYDROBROMIDE, RABEPRAZOLE, TOLTERODINE TARTRATE, HYDROCODONE. Patient recovered.

Fentanyl Side Effects Report #5336090-1
Health Professional from UNITED STATES reported FENTANYL problem on June 26, 2006. Female patient was diagnosed with anaesthesia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: apnoea. FENTANYL dosage: unknown. During the same period patient was treated with VERSED, PROMETHAZINE, DECADRON. Patient recovered.

Fentanyl Side Effects Report #5336091-3
FENTANYL problem was reported by a Health Professional from UNITED STATES on June 26, 2006. Female patient was diagnosed with anaesthesia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: apnoea. FENTANYL dosage: unknown. During the same period patient was treated with VERSED, PROMETHAZINE, DECADRON. Patient recovered.

Fentanyl Side Effects Report #5336092-5
Health Professional from UNITED STATES reported FENTANYL problem on June 26, 2006. Female patient was diagnosed with anaesthesia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: apnoea. FENTANYL dosage: unknown. During the same period patient was treated with VERSED, PROMETHAZINE, DECADRON. Patient recovered.

Fentanyl Side Effects Report #5336093-7
FENTANYL problem was reported by a Health Professional from UNITED STATES on June 26, 2006. Male patient was diagnosed with anaesthesia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: apnoea. FENTANYL dosage: unknown. During the same period patient was treated with VERSED, PROMETHAZINE, DECADRON. Patient recovered.

Fentanyl Side Effects Report #5336094-9
Health Professional from UNITED STATES reported FENTANYL problem on Oct 11, 2006. Female patient was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dizziness, hypotension. FENTANYL dosage: 1 MILLIGRAM/MILLILITERS, EPIDURAL. During the same period patient was treated with ROPAVICAINE. Patient recovered.

Fentanyl Side Effects Report #5313246-5
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 23, 2007. Female patient was diagnosed with pain, blood cholesterol increased, anaemia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: application site rash, blood creatinine increased, circulatory collapse, gait disturbance, rhabdomyolysis. FENTANYL dosage: unknown. During the same period patient was treated with VIOXX, LIPITOR, CLONIDINE, EFFEXOR, PREMARIN, IMMUNE GLOBULIN INTRAVENOUS, FOLIC ACID, ACTIQ. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5313249-0
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 23, 2007. Female patient, weighting 146.0 lb, was diagnosed with pain, nervousness, blood pressure, gastric disorder, lung disorder and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: pain, phenylketonuria. FENTANYL dosage: unknown. During the same period patient was treated with AMITRIPTYLINE, NORVASC, TOPROL, DIOVAN, PROTONIX, SINGULAIR, SPIRIVA, ADVAIR DISKUS. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5313592-5
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 18, 2007. Male patient, weighting 201.0 lb, was diagnosed with pain, neuralgia, diabetes mellitus, hypertension and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: application site erythema, hypertension, neuralgia. FENTANYL dosage: unknown. During the same period patient was treated with NEURONTIN, VICODIN, METFORMIN, GLIPIZIDE, ENALIPRIL. Patient recovered.

Fentanyl Side Effects Report #5313594-9
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Mar 16, 2007. Male patient, 46 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: colectomy, colon cancer, impaired work ability. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5313595-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 23, 2007. Female patient, weighting 245.0 lb, was diagnosed with pain in extremity, back pain, diabetes mellitus insulin-dependent, hypertension and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: fall, impaired healing, joint injury, oedema. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, VICODIN, MORPHINE, GLUCOPHAGE. Patient recovered.

Fentanyl Side Effects Report #5313598-6
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 25, 2007. Female patient, weighting 164.0 lb, was diagnosed with pain, anxiety, sleep disorder, thyroid disorder and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: thyroid disorder. FENTANYL dosage: unknown. During the same period patient was treated with KLONOPIN, LYRICA, ARMOUR. Patient recovered.

Fentanyl Side Effects Report #5313599-8
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 25, 2007. Female patient, weighting 130.0 lb, was diagnosed with pain, depression, migraine and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: hot flush, hypothyroidism, insomnia, pain. FENTANYL dosage: unknown. During the same period patient was treated with DURAGESIC, WELLBUTRIN, MAXALT. Patient recovered.

Fentanyl Side Effects Report #5314646-X
Health Professional from TAIWAN, PROVINCE OF CHINA reported FENTANYL problem on Mar 28, 2007. Female patient, 81 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dizziness, hypotension, nausea, vomiting. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5314651-3
FENTANYL problem was reported by a Health Professional from UNITED KINGDOM on Apr 26, 2007. Female patient, 78 years of age, was diagnosed with analgesic effect, hypertension, anaesthesia, intubation and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: delayed recovery from anaesthesia, miosis, respiratory depression. FENTANYL dosage: unknown. During the same period patient was treated with MORPHINE, ATENOLOL, CYCLIZINE, MIDAZOLAM, PROPOFOL, ROCURONIUM BROMIDE, SIMVASTATIN, SEVOFLURANE. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5315442-X
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 26, 2007. Male patient, weighting 190.0 lb, was diagnosed with arthritis, pain, gout, blood pressure, nervousness, multiple allergies, depression and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: asthenia, cystitis, eating disorder, oral intake reduced, salivary hypersecretion, weight decreased. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, FENTANYL TRANSDERMAL SYSTEM, ALLOPURINOL, NIFEDIPINE, ALPRAZOLAM, ZYRTEC, HYDROXYZINE, LEXAPRO. Patient recovered.

Fentanyl Side Effects Report #5315852-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 26, 2007. Male patient, weighting 135.0 lb, was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: faeces discoloured. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, VICODIN. Patient recovered.

Fentanyl Side Effects Report #5317632-9
Health Professional from UNITED KINGDOM reported FENTANYL problem on Apr 26, 2007. Female patient, 78 years of age, was diagnosed with analgesic effect, hypertension, anaesthesia, intubation and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: delayed recovery from anaesthesia, miosis, respiratory depression. FENTANYL dosage: unknown. During the same period patient was treated with MORPHINE, ATENOLOL, CYCLIZINE, MIDAZOLAM, PROPOFOL, ROCURONIUM BROMIDE, SIMVASTATIN, SEVOFLURANE. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5319681-3
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 16, 2007. Female patient, 53 years of age, was diagnosed with muscle spasms, neuropathy, pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: migraine, nausea, vomiting. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, FENTANYL TRANSDERMAL SYSTEM, CYCLOBENZAPRINE, MONTELUKAST, FLUTICASONE PROPIONATE, DULOXETINE HYDROCHLORIDE, ESTROGENS CONJUGATED, OMEPRAZOLE. Patient recovered.

Fentanyl Side Effects Report #5319897-6
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 18, 2007. Female patient, 48 years of age, was diagnosed with back pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: abdominal pain lower, anxiety, back pain, chills, confusional state, hyperhidrosis, incorrect dose administered, nephrolithiasis, red blood cells urine positive. FENTANYL dosage: unknown. During the same period patient was treated with METHYLPHENIDATE, LEVOTHYROXINE, SPIRONOLACTONE, QUETIAPINE FUMARATE, ESTRADIOL, PROGESTERONE, ACETAMINOPHEN AND OXYCODONE, HYDROXYZINE HYDROCHLORIDE. Patient recovered.

Fentanyl Side Effects Report #5319922-2
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 09, 2007. Female patient, weighting 200.0 lb, was diagnosed with pain, hypertension and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dizziness, feeling abnormal, hypothyroidism. FENTANYL dosage: unknown. During the same period patient was treated with VERAPAMIL, TYLENOL EXTRA STRENGHT. Patient recovered.

Fentanyl Side Effects Report #5321082-9
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 20, 2007. Female patient, 29 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: body temperature decreased, overdose. FENTANYL dosage: unknown. Patient died on 01/04/2007.

Fentanyl Side Effects Report #5321361-5
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on May 02, 2007. Male patient, weighting 220.0 lb, was diagnosed with pain, migraine and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: application site erythema, blood cholesterol increased, hypertension, somnolence. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, FENTANYL TRANSDERMAL SYSTEM, LORTAB, FLEXERIL, INDOMETHACIN. Patient recovered.

Fentanyl Side Effects Report #5321364-0
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on May 03, 2007. Female patient, weighting 124.0 lb, was diagnosed with pain, breakthrough pain, muscle spasms, cardiac disorder, osteoporosis, anxiety and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: convulsion, electrocardiogram change, pain. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, DILAUDID, BACLOFEN, ASPIRIN, CALCIUM CHLORIDE, XANAX. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5322635-4
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on May 02, 2007. Male patient, weighting 320.0 lb, was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: dizziness, euphoric mood, hypoaesthesia, intervertebral disc protrusion, oedema peripheral, vomiting. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, FENTANYL TRANSDERMAL SYSTEM, FENTANYL TRANSDERMAL SYSTEM, PERCOCET. Patient recovered.

Fentanyl Side Effects Report #5323995-0
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on May 04, 2007. Female patient, weighting 174.0 lb, was diagnosed with pain, gastric disorder and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: abdominal distension, asthma, ear infection, eye infection, rib fracture, upper respiratory tract infection. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, BACLOFEN, TRAMADOL, PRILOSEC. Patient recovered.

Fentanyl Side Effects Report #5324830-7
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on May 10, 2007. Male patient, 46 years of age, weighting 200.0 lb, was diagnosed with pain management and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: disorientation, fall, fatigue, hallucination, visual, hyperhidrosis, somnolence, vision blurred. FENTANYL dosage: 50 MCG./HR 5.10 MG FOR 72 HOURS TRANSDERMAL. Patient was hospitalized and became disabled. Patient recovered.

Fentanyl Side Effects Report #5325018-6
Health Professional from UNITED STATES reported FENTANYL problem on May 11, 2007. Female patient, 42 years of age, weighting 214.0 lb, was diagnosed with back pain, pelvic pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: application site rash, pruritus, skin reaction, urticaria. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5325372-5
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on May 10, 2007. Female patient, weighting 150.0 lb, was diagnosed with fibromyalgia, back pain, gastrooesophageal reflux disease and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: blood cholesterol increased, cerebrovascular accident, convulsion, seasonal allergy, spinal column stenosis. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, DURAGESIC, LORA, PRILOSEC, LEVATHYROXINE. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5325760-7
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 26, 2007. Female patient, 64 years of age, weighting 193.0 lb, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: abasia, anxiety, pain, panic reaction, tremor. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5326561-6
FENTANYL problem was reported by a Physician from UNITED STATES on Apr 24, 2007. Male patient, 29 years of age, weighting 132.3 lb, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: acute psychosis, hallucinations, mixed, insomnia. FENTANYL dosage: unknown. During the same period patient was treated with NALTREXONE. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5327418-7
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on Apr 26, 2007. Female patient, 76 years of age, was diagnosed with back pain, pain in extremity and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: road traffic accident. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM. Patient died on 01/01/2007.

Fentanyl Side Effects Report #5327424-2
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 26, 2007. Male patient, 49 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: accidental overdose. FENTANYL dosage: unknown. During the same period patient was treated with TRAMADOL, ALPRAZOLAM, VICODIN. Patient died on 04/13/2007.

Fentanyl Side Effects Report #5327810-0
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on May 07, 2007. Female patient, weighting 165.0 lb, was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: amnesia, apnoea, blood test abnormal, cardiac disorder, fall, liver function test abnormal, loss of consciousness, mass, overdose. FENTANYL dosage: unknown. During the same period patient was treated with ACTIQ. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5328339-6
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on May 09, 2007. Male patient, weighting 230.0 lb, was diagnosed with pain, gastric disorder and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: blood pressure increased. FENTANYL dosage: unknown. During the same period patient was treated with PRILOSEC. Patient recovered.

Fentanyl Side Effects Report #5329907-8
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on May 10, 2007. Female patient, weighting 125.0 lb, was diagnosed with pain, migraine, breakthrough pain, depression, anxiety, sleep disorder and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: multiple fractures, road traffic accident. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, FENTANYL TRANSDERMAL SYSTEM, RELPAX, SKELAXIN, XODOL, WELLBUTRIN, CLONOPIN, AMBIEN. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5330779-6
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 16, 2007. Male patient, 46 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: colectomy, colon cancer, impaired work ability. FENTANYL dosage: unknown. Patient recovered.

Fentanyl Side Effects Report #5330804-2
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on May 01, 2007. Male patient, 19 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: overdose. FENTANYL dosage: unknown. Patient died on 07/22/2006.

Fentanyl Side Effects Report #5330923-0
FENTANYL problem was reported by a Physician from CANADA on May 08, 2007. Female patient, 65 years of age, was diagnosed with perioperative analgesia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: pneumonia aspiration. FENTANYL dosage: unknown. During the same period patient was treated with FENTANYL CITRATE, PROPOFOL. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5331149-7
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on May 10, 2007. Female patient, weighting 135.0 lb, was diagnosed with pain, neuralgia and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: anxiety, confusional state, depression, eating disorder, feeling abnormal, pyrexia. FENTANYL dosage: unknown. During the same period patient was treated with LEVOXYL, NEURONTIN, PREMARIN, MOTRIN. Patient recovered.

Fentanyl Side Effects Report #5331418-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on May 01, 2007. Female patient, 50 years of age, was diagnosed with sciatica and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: inadequate analgesia, migraine. FENTANYL dosage: unknown. During the same period patient was treated with CELECOXIB, ESCITALOPRAM OXALATE, FUROSEMIDE, BUTENAFINE HYDROCHLORIDE, ATORVASTATIN CALCIUM, POTASSIUM CHLORIDE, LEVOTHYROXINE, ESTRATEST H. Patient recovered.

Fentanyl Side Effects Report #5331937-7
Physician from CANADA reported FENTANYL problem on May 11, 2007. Female patient, weighting 160.0 lb, was diagnosed with pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: diarrhoea, dizziness, hypoaesthesia, initial insomnia, malaise, muscle spasms, overdose, pain. FENTANYL dosage: unknown. During the same period patient was treated with DURAGESIC, OXYCONTIN, PREMARIN, RHOVANE. Patient recovered.

Fentanyl Side Effects Report #5332036-0
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on May 04, 2007. Female patient, 29 years of age, was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: overdose. FENTANYL dosage: unknown. Patient died on 12/11/2006.

Fentanyl Side Effects Report #5333748-5
Consumer or non-health professional from UNITED STATES reported FENTANYL problem on May 11, 2007. Female patient, weighting 177.0 lb, was diagnosed with systemic lupus erythematosus, pain, pulmonary hypertension, pulmonary fibrosis, cardiac disorder and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: unevaluable event. FENTANYL dosage: unknown. During the same period patient was treated with OXYCODONE, TRACLEER, PREDNISONE, ASPIRIN, NEURONTIN, COUMADIN, NORVASC, ATENOLOL. Patient was hospitalized. Patient recovered.

Fentanyl Side Effects Report #5334576-7
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on May 15, 2007. Female patient, weighting 115.0 lb, was diagnosed with pain, blood oestrogen and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: anxiety, blood cholesterol increased, chest pain, dyspnoea. FENTANYL dosage: unknown. During the same period patient was treated with TRAMADOL, CLIMARA. Patient recovered.

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Drug Information: Fentanyl Buccal (Transmucosal)

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605043.html

fen' ta nil

IMPORTANT WARNING:

Buccal fentanyl should be used only to treat breakthrough cancer pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. This medication should not be used to treat pain other than chronic cancer pain, especially short-term pain such as pain from an injury or pain after a medical or dental procedure. Buccal fentanyl should only be prescribed by doctors who are experienced in treating pain in cancer patients. Buccal fentanyl may cause serious breathing problems or death if it is used by people who are not being treated with other narcotic medications or who are not tolerant to narcotic medications.Buccal fentanyl comes as two different products, a lozenge and a tablet. The medication in fentanyl lozenges is absorbed differently by the body than the medication in fentanyl buccal tablets, so one product cannot be substituted for the other. If you are switching from one product to the other, your doctor will prescribe a dose that is best for you.Buccal fentanyl may cause serious harm or death if taken accidentally by a child or by an adult who has not been prescribed the medication. Even partially used fentanyl buccal lozenges and tablets may contain enough medication to cause serious harm or death to children or other adults. Always keep fentanyl buccal lozenges and tablets in a locked storage space that is out of the reach of children. The manufacturer of the lozenges supplies child resistant locks and other items to help you store your medication safely. Ask your doctor how you can obtain these items. Dispose of partially used buccal lozenges or tablets according to the manufacturer's directions immediately after you remove them from your mouth.Tell your doctor if you are taking any of the following medications: certain antibiotics such as clarithromycin (Biaxin), erythromycin (Erythocin), and troleandomycin (TAO) (not available in the United States); certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); aprepitant (Emend); certain medications for human immunodeficiency virus (HIV) such as amprenavir (Agenerase), fosamprenavir (Lexiva), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); nefazodone; or verapamil (Calan, Covera, Verelan). Taking these medications with fentanyl buccal lozenges or tablets may increase the risk that you will develop serious or life-threatening breathing problems. Your doctor may need to change the dosages of your medications and will monitor you carefully.Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fentanyl and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.Talk to your doctor about the risks of using this medication.

Why is this medication prescribed?

Buccal fentanyl is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called narcotic (opiate) analgesics. It works by changing the way the brain and nervous system respond to pain.

How should this medicine be used?

Buccal fentanyl comes as a lozenge on a handle (Actiq) and a tablet (Fentora) to dissolve in the mouth. Fentanyl buccal lozenges and tablets are used as needed to treat breakthrough pain, but not more often than four times a day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand.

Your doctor will probably start you on a low dose of fentanyl buccal lozenges or tablets and gradually increase your dose until you find the dose that will relieve your breakthrough pain. When you start using buccal fentanyl and are still trying to reach the correct dose, if you still have pain after using one buccal lozenge or tablet, your doctor may tell you to use a second lozenge or tablet. You may use the second lozenge 15 minutes after you finish the first lozenge, or use the second tablet 30 minutes after you started using the first tablet. Do not use a second lozenge or tablet to treat the same episode of pain unless your doctor tells you that you should. Talk to your doctor about how well the medication is working and whether you are experiencing any side effects so that your doctor can decide whether your dose should be adjusted.

Do not use fentanyl buccal lozenges or tablets more than four times a day. Call your doctor if you experience more than four episodes of breakthrough pain per day. Your doctor may need to adjust the dose of your other pain medication to better control your pain.

Fentanyl buccal lozenges and tablets should be used along with your other pain medication(s). Do not stop taking your other pain medication(s) when you begin your treatment with fentanyl buccal lozenges or tablets.

Buccal fentanyl may be habit-forming. Do not use a larger dose of buccal fentanyl, use the medication more often, or use it for a longer period of time than prescribed by your doctor. Do not stop using fentanyl buccal lozenges or tablets without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop using fentanyl buccal lozenges or tablets, you may experience unpleasant withdrawal symptoms.

To use fentanyl buccal lozenges, follow these steps:

  • Check the blister package and the handle of the lozenge to make sure the lozenge contains the dose of medication you have been prescribed.
  • Use scissors to cut open the blister package, and remove the lozenge. Do not open the blister package until you are ready to use the medication.
  • Place the lozenge in your mouth, between your cheek and gum. Actively suck on the lozenge, but do not chew or bite it. Move the lozenge around in your mouth, from one side to the other, using the handle. Twirl the handle often.
  • Do not eat or drink anything while the lozenge is in your mouth.
  • Finish the lozenge in about 15 minutes.
  • If you begin to feel dizzy, very sleepy, or nauseous before you have finished the lozenge, remove it from your mouth. Dispose of it immediately as described below or put it in the temporary storage bottle for later disposal.
  • If you finished the entire lozenge, throw the handle away in a garbage can that is out of the reach of children. If you did not finish the entire lozenge, hold the handle under hot running water to dissolve all the medication, and then throw the handle away in a garbage can that is out of the reach of children and pets.

To use fentanyl buccal tablets, follow these steps:

  • Separate one blister unit from the blister card by tearing along the perforations. Peel back the foil to open the blister unit. Do not try to push the tablet through the foil. Do not open the blister unit until you are ready to use the tablet.
  • Place the tablet in your mouth between one of your upper back teeth and your gum.
  • Leave the tablet in place until it dissolves completely. You may notice a gentle bubbling feeling between your cheek and gum as the tablet dissolves. It may take 14 to 25 minutes for the tablet to dissolve. Do not split, chew, bite, or suck the tablet.
  • If any of the tablet is left in your mouth after 30 minutes, swallow it with a drink of water.
  • If you begin to feel dizzy, very sleepy, or nauseous before the tablet dissolves, rinse your mouth with water and spit the remaining pieces of tablet into the sink or toilet. Flush the toilet or rinse the sink to wash away the tablet pieces.

Other uses for this medicine

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using fentanyl buccal lozenges or tablets,

  • tell your doctor and pharmacist if you are allergic to fentanyl or any other medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following medications: antihistamines; buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); carbamazepine (Carbatrol, Epitol, Tegretol); medications for mental illness and nausea; muscle relaxants; other pain medications; nalbuphine (Nubain); naloxone (Narcan); nalmefene (Revex); pentazocine (Talwin); phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; and tranquilizers. Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol or uses or has ever used street drugs or excessive amounts of prescription medications. Also tell your doctor if you have or have ever had a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; seizures; slowed heartbeat or other heart problems; low blood pressure; mental problems such as depression or hallucinations (seeing things or hearing voices that do not exist); lung disease such as asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); or kidney or liver disease.
  • tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using fentanyl buccal lozenges or tablets, call your doctor. Do not breastfeed while using fentanyl buccal lozenges or tablets.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using buccal fentanyl.
  • you should know that buccal fentanyl may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
  • do not drink alcohol while you are using buccal fentanyl. Alcohol increases the chance that you will experience serious side effects of the medication.
  • you should know that buccal fentanyl may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using buccal fentanyl. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • if you have diabetes, you should know that each fentanyl buccal lozenge contains about 2 grams of sugar.
  • if you will be using the lozenges, talk to your dentist about the best way to care for your teeth during your treatment. The lozenges contain sugar and may cause tooth decay and other dental problems.
  • you should know that buccal fentanyl may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

What special dietary instructions should I follow?

Avoid eating grapefruit and drinking grapefruit juice while using this medication.

What should I do if I forget a dose?

This medication is usually used as needed.

What side effects can this medication cause?

Buccal fentanyl may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness
  • nausea
  • stomach pain
  • vomiting
  • constipation
  • diarrhea
  • gas
  • heartburn
  • loss of appetite
  • weight loss
  • difficulty urinating
  • weakness
  • headache
  • changes in vision
  • anxiety
  • depression
  • hallucinations (seeing things or hearing voices that do not exist)
  • unusual thinking
  • unusual dreams
  • difficulty falling asleep or staying asleep
  • dry mouth
  • sweating
  • flushing
  • uncontrollable shaking of a part of the body
  • back pain
  • chest pain
  • pain, sores, or irritation in the mouth in the area where you placed the buccal tablet
  • rash
  • itching
  • swelling of the hands, arms, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • slow, shallow breathing
  • extreme drowsiness
  • dizziness
  • confusion
  • fainting
  • heartbeat that is slower or faster than normal
  • seizures

Buccal fentanyl may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the blister package it came in, tightly closed, and out of reach of children. Store fentanyl buccal lozenges and tablets in a safe place so that no one else can take them accidentally or on purpose. Use the child-resistant locks and other supplies provided by the manufacturer to keep children away from the lozenges. Keep track of how many lozenges or tablets are left so you will know if any are missing. Store fentanyl buccal lozenges and tablets at room temperature and away from excess heat and moisture (not in the bathroom).

You must immediately dispose of any medication that is outdated or no longer needed. Dispose of unneeded lozenges by removing each lozenge from the blister package, holding the lozenge over the toilet, and cutting off the medicine end with wire cutters so that it falls into the toilet. Throw away the remaining handles in a place that is out of the reach of children and pets, and flush the toilet twice when it contains up to five lozenges. Dispose of unneeded buccal tablets by removing the tablets from the blister package and flushing them down the toilet. Call your pharmacist or the manufacturer if you have questions or need help disposing of unneeded medication.

In case of emergency/overdose

In case of overdose, remove the lozenge or tablet from the victim's mouth and call local emergency services at 911.

Symptoms of overdose may include:

  • drowsiness
  • dizziness
  • confusion
  • slow, shallow breathing or stopped breathing

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication, even if he or she has the same symptoms that you have. Selling or giving away this medication may cause severe harm or death to others and is against the law.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

  • Actiq®
  • Fentora®

Ask Our Patient Community about Fentanyl

PatientsVille.com does not provide medical advice, diagnosis or treatment. The information contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments.


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