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side effects patient, weighting 130.0 lb, was diagnosed with pain in extremity and took Fentanyl-50 1 Patch Q 3 Days (used Only 3 Patches) Patient was hospitalized. View more Serious Adverse Events reported to FDA.

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List of Fentanyl-50 Adverse Effects reported to US Food and Drug Administration (FDA)

Showing 1-25 of 74 

Application Site Pain, Cardio-respiratory Arrest, Hyperhidrosis, Overdose, Resuscitation (7023430-0)
on Sep 20, 2010 Female patient from UNITED STATES , weighting 130.0 lb, was diagnosed with
  • pain in extremity
and was treated with Fentanyl-50. Patient experienced the following unwanted or unexpected effects: application site pain, cardio-respiratory arrest, hyperhidrosis, overdose, resuscitation. Fentanyl-50 dosage: 1 Patch Q 3 Days (used Only 3 Patches). Patient was hospitalized.

Abasia, Asthenia, Blood Pressure Increased, Consciousness Fluctuating, Headache, Incoherent, Miosis, Nausea, Sensation Of Heaviness (7003473-3)
Patient was taking Fentanyl-50. Patient had the following side effects: abasia, asthenia, blood pressure increased, consciousness fluctuating, headache, incoherent, miosis, nausea, sensation of heaviness on Sep 09, 2010 from UNITED STATES Additional patient health information: Female patient , weighting 246.9 lb, was diagnosed with
  • cancer pain
  • hypertension
and. Fentanyl-50 dosage: 1 Patch Q 72hrs.
Patient also using the following medications:
  • Benicar (Unk)
  • Coreg (Unk)
Patient was hospitalized.

Convulsion, Respiratory Depression, Unresponsive To Stimuli (6963782-0)
Adverse event was reported on Aug 25, 2010 by a Male patient taking Fentanyl-50 (Dosage: 1 Patch Q 3 Days) was diagnosed with
  • pain
and. Location: UNITED STATES , weighting 170.0 lb, After Fentanyl-50 was administered, patient had the following side effects: convulsion, respiratory depression, unresponsive to stimuli. Patient was hospitalized.

Atelectasis, Bronchopneumonia, Coronary Artery Disease, Cyanosis, Dilatation Ventricular, Feeling Cold, Hepatic Steatosis (6931033-9)
on Aug 09, 2010 Male patient from UNITED STATES , weighting 191.0 lb, was diagnosed with
  • pain
and was treated with Fentanyl-50. Patient experienced the following unwanted or unexpected effects: atelectasis, bronchopneumonia, coronary artery disease, cyanosis, dilatation ventricular, feeling cold, hepatic steatosis. Fentanyl-50 dosage: Prescribed To Be Changed Every 72 Hours (every Three Hours Place On Left Shoulder).
Patient also using the following medications:
  • Hydrocodone Bitartrate And Acetaminophen (Unk)
  • Cyclobenzaprine Hydrochloride (10 Mg, Tid)
  • Ketorolac (30 Mg, Q6h)



Narcotic Intoxication (6857344-3)
on Jul 07, 2010 Male patient from UNITED STATES , 29 years of age, was treated with Fentanyl-50. Patient had the following side effects: narcotic intoxication. Fentanyl-50 dosage: Unk.

Gastric Ulcer, Nausea (6810102-8)
Patient was taking Fentanyl-50. After Fentanyl-50 was administered, patient had the following side effects: gastric ulcer, nausea on Jun 22, 2010 from UNITED STATES Additional patient health information: Male patient , 57 years of age, was diagnosed with
  • pain
and. Fentanyl-50 dosage: 1 Patch, Q 3 Days. Patient was hospitalized.

Convulsion, Dyskinesia, Dyspnoea, Feeling Jittery, Headache, Hyperhidrosis, Pain, Pain In Extremity (6809886-4)
Adverse event was reported on Jun 21, 2010 by a Female patient taking Fentanyl-50 (Dosage: Unk) was diagnosed with
  • neuropathy peripheral
  • restless legs syndrome
and. Location: UNITED STATES , weighting 166.0 lb, Patient experienced the following unwanted or unexpected effects: convulsion, dyskinesia, dyspnoea, feeling jittery, headache, hyperhidrosis, pain, pain in extremity.

Abasia, Device Malfunction, No Therapeutic Response, Pain, Product Quality Issue (6752314-8)
on Jun 01, 2010 Male patient from UNITED STATES , 49 years of age, weighting 170.0 lb, was diagnosed with
  • back pain
  • intervertebral disc disorder
  • nervous system disorder
and was treated with Fentanyl-50. Patient had the following side effects: abasia, device malfunction, no therapeutic response, pain, product quality issue. Fentanyl-50 dosage: 1 Patch Q48 Hours Transdermal.

Abnormal Behaviour, Accidental Overdose, Agitation, Bipolar Disorder, Confusional State, Delirium, Depersonalisation, Disorientation (6732893-7)
on May 06, 2010 Female patient from UNITED STATES , 49 years of age, weighting 118.0 lb, was diagnosed with
  • pain
and was treated with Fentanyl-50. After Fentanyl-50 was administered, patient had the following side effects: abnormal behaviour, accidental overdose, agitation, bipolar disorder, confusional state, delirium, depersonalisation, disorientation. Fentanyl-50 dosage: 1 Patch, Q72h (had 2 Patches On At The Time Of Er). Patient was hospitalized.

Abdominal Pain, Accidental Overdose, Asthenia, Asthma, Back Pain, Brain Hypoxia, Brain Oedema, Chills, Cough (6723899-2)
Patient was taking Fentanyl-50. Patient experienced the following unwanted or unexpected effects: abdominal pain, accidental overdose, asthenia, asthma, back pain, brain hypoxia, brain oedema, chills, cough on May 05, 2010 from UNITED STATES Additional patient health information: Male patient , weighting 304.2 lb, . Fentanyl-50 dosage: Unk.
Patient also using the following medications:
  • Penicillin /00000901/ (500 Mg, Tid)
  • Avapro (150 Mg, Daily)
  • Effexor (225 Mg, Bid)
  • Oxycodone Hcl And Acetaminophen (10/325 Mg, 3 Times Daily)
  • Glipizide (10 Mg, Bid)
  • Glucophage (1000 Mg, Bid)
  • Humalog (70/30 Units, Sliding Scale)
  • Pravachol (80 Mg, Qhs)


Lung Disorder, Overdose (6703991-9)
Adverse event was reported on Apr 19, 2010 by a Male patient taking Fentanyl-50 (Dosage: Unk) . Location: UNITED STATES , 26 years of age, Patient had the following side effects: lung disorder, overdose.

Altered Visual Depth Perception, Convulsion, Muscle Contractions Involuntary, Pain In Jaw, Tremor (6687120-6)
on Apr 08, 2010 Female patient from UNITED STATES , 61 years of age, was diagnosed with
  • neuralgia
  • pain
and was treated with Fentanyl-50. After Fentanyl-50 was administered, patient had the following side effects: altered visual depth perception, convulsion, muscle contractions involuntary, pain in jaw, tremor. Fentanyl-50 dosage: 1 Patch, Q 3 Days.
Patient also using the following medications:
  • Fentanyl-25 (Unk)


Bipolar Disorder, Confusional State, Depersonalisation, Incoherent, Memory Impairment, Nightmare, Overdose (6680103-1)
on Apr 06, 2010 Female patient from UNITED STATES , 49 years of age, was diagnosed with
  • pain
and was treated with Fentanyl-50. Patient experienced the following unwanted or unexpected effects: bipolar disorder, confusional state, depersonalisation, incoherent, memory impairment, nightmare, overdose. Fentanyl-50 dosage: 1 Patch, Q72h (had 2 Patches On At The Time Of Er). Patient was hospitalized.

Arteriospasm Coronary, Hypotension, Prinzmetal Angina (6680038-4)
Patient was taking Fentanyl-50. Patient had the following side effects: arteriospasm coronary, hypotension, prinzmetal angina on Apr 01, 2010 from UNITED KINGDOM Additional patient health information: Female patient , 68 years of age, . Fentanyl-50 dosage: 50 Mcg, Single.
Patient also using the following medications:
  • Vecuronium Bromide (watson Laboratories) (7 Mg, Single)
  • Propofol (140 Mg, Single)
Patient was hospitalized.

Accidental Overdose, Brain Hypoxia, Brain Oedema, Pulmonary Oedema, Swelling Face (6673258-6)
Adverse event was reported on Mar 29, 2010 by a Male patient taking Fentanyl-50 (Dosage: Unk) . Location: UNITED STATES , weighting 304.2 lb, After Fentanyl-50 was administered, patient had the following side effects: accidental overdose, brain hypoxia, brain oedema, pulmonary oedema, swelling face.

Application Site Bleeding, Application Site Erythema, Application Site Scar, Blood Pressure Decreased, Body Temperature Fluctuation, Cardiac Flutter, Cerebrovascular Accident, Chest Pain, Dizziness (6652404-4)
on Mar 10, 2010 Female patient from UNITED STATES , 44 years of age, weighting 120.0 lb, was diagnosed with
  • pain
and was treated with Fentanyl-50. Patient experienced the following unwanted or unexpected effects: application site bleeding, application site erythema, application site scar, blood pressure decreased, body temperature fluctuation, cardiac flutter, cerebrovascular accident, chest pain, dizziness. Fentanyl-50 dosage: 100 Mg/hr, Q 3 Days, Transdermal.
Patient also using the following medications:
  • Percocet
  • Valium
  • Miralax


Apnoea (6595320-9)
on Feb 19, 2010 Female patient from UNITED STATES , 80 years of age, weighting 139.0 lb, was diagnosed with
  • pain
and was treated with Fentanyl-50. Patient had the following side effects: apnoea. Fentanyl-50 dosage: 50mcg Q 2 Hours Prn Iv Bolus.

Anaemia, Application Site Erythema, Application Site Vesicles, Device Leakage, Pulmonary Embolism (6575639-8)
Patient was taking Fentanyl-50. After Fentanyl-50 was administered, patient had the following side effects: anaemia, application site erythema, application site vesicles, device leakage, pulmonary embolism on Jan 21, 2010 from UNITED STATES Additional patient health information: Female patient , 72 years of age, was diagnosed with
  • back pain
and. Fentanyl-50 dosage: 50 Mcg/hr Every 72 Hr, Transdermal. Patient was hospitalized.

Application Site Vesicles, Device Leakage, Pulmonary Thrombosis, Skin Exfoliation (6551892-1)
Adverse event was reported on Jan 06, 2010 by a Female patient taking Fentanyl-50 (Dosage: 50 Mcg/hr Every 72 Hr, Transdermal) was diagnosed with
  • back pain
and. Location: UNITED STATES , 72 years of age, Patient experienced the following unwanted or unexpected effects: application site vesicles, device leakage, pulmonary thrombosis, skin exfoliation. Patient was hospitalized.

Blood Glucose Increased, Condition Aggravated, Pain, Sarcoidosis, Weight Increased (6545540-4)
on Jan 04, 2010 Female patient from UNITED STATES , 41 years of age, weighting 150.0 lb, was diagnosed with
  • pain
  • sarcoidosis
and was treated with Fentanyl-50. Patient had the following side effects: blood glucose increased, condition aggravated, pain, sarcoidosis, weight increased. Fentanyl-50 dosage: 50 Mcg/hr Every 72 Hr, Transdermal. Patient was hospitalized.

Fall, Mydriasis, Sedation (6491876-5)
on Nov 25, 2009 Female patient from UNITED KINGDOM , 78 years of age, was diagnosed with
  • pain
and was treated with Fentanyl-50. After Fentanyl-50 was administered, patient had the following side effects: fall, mydriasis, sedation. Fentanyl-50 dosage: 50 Mcg/hr Every 72 Hr, Transdermal. Patient was hospitalized.

Cold Sweat, Headache, Hyperhidrosis, Malaise, Muscle Contractions Involuntary, Oedema Peripheral, Product Substitution Issue, Renal Disorder, Vomiting (6480376-4)
Patient was taking Fentanyl-50. Patient experienced the following unwanted or unexpected effects: cold sweat, headache, hyperhidrosis, malaise, muscle contractions involuntary, oedema peripheral, product substitution issue, renal disorder, vomiting on Nov 19, 2009 from UNITED STATES Additional patient health information: Female patient , 47 years of age, was diagnosed with
  • back pain
  • nephrolithiasis
and. Fentanyl-50 dosage: 50 Mcg/hr, Transdermal.

Convulsion, Dyskinesia, Dyspnoea, Headache, Hyperhidrosis, Pain, Pain In Extremity, Paraesthesia (6474927-3)
Adverse event was reported on Nov 23, 2009 by a Female patient taking Fentanyl-50 (Dosage: Unk) was diagnosed with
  • neuropathy peripheral
  • restless legs syndrome
and. Location: UNITED STATES , weighting 166.0 lb, Patient had the following side effects: convulsion, dyskinesia, dyspnoea, headache, hyperhidrosis, pain, pain in extremity, paraesthesia.

Altered State Of Consciousness, Blood Pressure Increased, Gout, Heart Rate Increased, Hepatic Function Abnormal, Hypoaesthesia, Loss Of Consciousness, Oedema Peripheral, Overdose (6474918-2)
on Nov 25, 2009 Male patient from UNITED STATES , weighting 180.0 lb, was diagnosed with
  • intervertebral disc protrusion
and was treated with Fentanyl-50. After Fentanyl-50 was administered, patient had the following side effects: altered state of consciousness, blood pressure increased, gout, heart rate increased, hepatic function abnormal, hypoaesthesia, loss of consciousness, oedema peripheral, overdose. Fentanyl-50 dosage: 50 Mcg, Single. Patient was hospitalized.

Constipation, Incorrect Dose Administered, Miosis, Overdose, Product Quality Issue, Product Substitution Issue, Somnolence, Vision Blurred (6443962-3)
on Nov 17, 2009 Female patient from UNITED STATES , 51 years of age, weighting 200.0 lb, was diagnosed with
  • neuralgia
and was treated with Fentanyl-50. Patient experienced the following unwanted or unexpected effects: constipation, incorrect dose administered, miosis, overdose, product quality issue, product substitution issue, somnolence, vision blurred. Fentanyl-50 dosage: 1 Patch Every 36 Hours Transdermal.

Showing 1-25 of 74 

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Side Effects reported to FDA: 74. View FDA Adverse Reports

Fentanyl-50 safety alerts: No

Reported deaths: 18

Reported hospitalizations: 35

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Fentanyl-50 Adverse Reactions

Overdose ( 10 Reports)

Convulsion ( 9 Reports)

Pain ( 8 Reports)

Headache ( 7 Reports)

Product Substitution Issue ( 7 Reports)

Application Site Erythema ( 6 Reports)

Asthenia ( 6 Reports)

Cold Sweat ( 6 Reports)

Confusional State ( 6 Reports)

Hyperhidrosis ( 6 Reports)

Accidental Overdose ( 5 Reports)

Blood Pressure Increased ( 5 Reports)

Chills ( 5 Reports)

Dyspnoea ( 5 Reports)

Feeling Abnormal ( 5 Reports)

Loss Of Consciousness ( 5 Reports)

Nausea ( 5 Reports)

Amnesia ( 4 Reports)

Apnoea ( 4 Reports)

Constipation ( 4 Reports)

Cyanosis ( 4 Reports)

Fall ( 4 Reports)

Unresponsive To Stimuli ( 4 Reports)

Vomiting ( 4 Reports)

Abasia ( 3 Reports)

Application Site Pruritus ( 3 Reports)

Application Site Rash ( 3 Reports)

Back Pain ( 3 Reports)

Chest Pain ( 3 Reports)

Death ( 3 Reports)

side effects
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