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Insomnia (14)
Swelling (6)
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Itching (4)
Bradycardia (3)
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Showing 1-25 of 1807 

Off Label Use, Oesophageal Pain, Regurgitation (8448651-1)
on Jun 05, 2012 Female from UNITED STATES , 52 years of age, weighting 170.0 lb, was diagnosed with
  • arthralgia
  • barrett's oesophagus
  • blood cholesterol increased
  • sleep disorder
and was treated with Hydrocodone. Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: off label use, oesophageal pain, regurgitation. Hydrocodone dosage: N/A.
Associated medications used:
  • Nexium
  • Pravastatin
  • Seroquel
  • Meclizine
  • Xanax


Plantar Erythema, Rash, Skin Exfoliation, Dry Skin (8448354-3)
Patient was taking Hydrocodone. Patient felt the following Hydrocodone side effects: plantar erythema, rash, skin exfoliation, dry skin on Jun 15, 2012 from UNITED STATES Additional patient health information: Female , weighting 99.98 lb, was diagnosed with
  • pain in extremity
  • anxiety
and. Hydrocodone dosage: 10 Mg, 4x/day.
Multiple prescriptions taken:
  • Paxil (20 Mg, Daily)
  • Gabapentin (300 Mg, 3x/day)
  • Gabapentin (150 Mg, Unk)


Influenza Like Illness, Pyrexia, Abdominal Discomfort (8448347-6)
Adverse event was reported on Jun 12, 2012 by a Male taking Hydrocodone (Dosage: Unk) . Location: UNITED STATES , weighting 240.3 lb, After Hydrocodone was administered, patient encountered several Hydrocodone side effects: influenza like illness, pyrexia, abdominal discomfort.
Multiple concurrent drugs taken:
  • Penicillin G Potassium (Unk)
  • Demerol (Unk)


Aggression, Suicidal Ideation (8445116-8)
on Jun 12, 2012 Female from UNITED STATES , weighting 180.0 lb, was treated with Hydrocodone. Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: aggression, suicidal ideation. Hydrocodone dosage: Unk, 1x/day.
Associated medications used:
  • Chantix (1 Mg, 2x/day)
  • Xanax (1 Mg, 4x/day)
  • Chantix (0.5 Mg, 1x/day)



Cholecystitis, Biliary Dyskinesia, Cholelithiasis, Injury (8443915-X)
on Jun 08, 2012 Female from UNITED STATES , 19 years of age, weighting 125.0 lb, was treated with Hydrocodone Bitartrate. Patient felt the following Hydrocodone side effects: cholecystitis, biliary dyskinesia, cholelithiasis, injury. Hydrocodone Bitartrate dosage: N/A.
Multiple prescriptions taken:
  • Yaz (Unk)
  • Ranitidine
  • Phenergan
Patient was hospitalized.

Extraocular Muscle Disorder, Chorioretinopathy (8442584-2)
Patient was taking Hydrocodone Bitartrate + Acetaminophen. After Hydrocodone was administered, patient encountered several Hydrocodone side effects: extraocular muscle disorder, chorioretinopathy on Jun 02, 2012 from INDIA Additional patient health information: Male , 56 years of age, weighting 194.0 lb, was diagnosed with
  • pain
and. Hydrocodone Bitartrate + Acetaminophen dosage: 1df=7.5-325mg.
Multiple concurrent drugs taken:
  • Lexapro (Tabs At Bedtime)
  • Miralax (Powder)
  • Ipilimumab (No Of Courses: 04)
  • Prilosec


Incorrect Dose Administered, Arthropathy (8441344-6)
Adverse event was reported on Jun 05, 2012 by a Male taking Hydrocodone (Dosage: N/A) . Location: UNITED STATES , 84 years of age, Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: incorrect dose administered, arthropathy.
Associated medications used:
  • Levothyroxine Sodium
  • Lisinopril
  • Vicodin
  • Omeprazole
  • Excedrin Extra Strength Tablets
  • Rosuvastatin


Product Quality Issue, Off Label Use, Infectious Mononucleosis (8441153-8)
on Jul 11, 2011 Female from UNITED STATES , weighting 250.0 lb, was diagnosed with
  • scoliosis
  • attention deficit/hyperactivity disorder
and was treated with Hydrocodone. Patient felt the following Hydrocodone side effects: product quality issue, off label use, infectious mononucleosis. Hydrocodone dosage: As Needed.
Multiple prescriptions taken:
  • Daytrana (10 Mg, Qd Monday Through Friday, Off On Weekends)


Blood Pressure Increased, Lower Limb Fracture, Road Traffic Accident, Rotator Cuff Syndrome, Stress, Pain (8441125-3)
on Jun 05, 2012 Male from UNITED STATES , 54 years of age, was treated with Hydrocodone. After Hydrocodone was administered, patient encountered several Hydrocodone side effects: blood pressure increased, lower limb fracture, road traffic accident, rotator cuff syndrome, stress, pain. Hydrocodone dosage: N/A.
Multiple concurrent drugs taken:
  • Cymbalta (60 Mg, Bid)
  • Lyrica
  • Lasix
  • Ativan
  • Clonidine
  • Cymbalta (60 Mg, Qd)
  • Cymbalta (60 Mg, Qd)
  • Trazodone Hcl
Patient was hospitalized.

Intentional Overdose, Completed Suicide (8433339-3)
Patient was taking Hydrocodone Bitartrate + Acetaminophen. Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: intentional overdose, completed suicide on Jun 13, 2012 from UNITED STATES Additional patient health information: Male , 56 years of age, . Hydrocodone Bitartrate + Acetaminophen dosage: Unk.
Associated medications used:
  • Calan (Unk)
  • Citalopram Hydrobromide (Unk)


Electrocardiogram Abnormal, Troponin Increased, Hypertension (8433169-2)
Adverse event was reported on Jun 06, 2012 by a Male taking Hydrocodone Bitartrate + Acetaminophen (Dosage: N/A) . Location: UNITED STATES , 65 years of age, weighting 151.0 lb, Patient felt the following Hydrocodone side effects: electrocardiogram abnormal, troponin increased, hypertension.
Multiple prescriptions taken:
  • Norvasc (10mg Per Day)
  • Cialis (20mg Per Day)
  • Benazepril Hydrochloride (40mg Twice Per Day)
  • Terazosin Hcl (1mg Per Day)
  • Hydrochlorothiazide (25mg Per Day)
  • Catapres (.4mg Twice Per Day)
  • Metoprolol Tartrate (50mg Per Day)
  • Pazopanib (800mg Per Day)
Patient was hospitalized.

Hypoxia, Hypotension, Completed Suicide, Bradycardia (8432415-9)
on Jun 13, 2012 Patient from UNITED STATES , 56 years of age, was treated with Hydrocodone Bitartrate + Acetaminophen. After Hydrocodone was administered, patient encountered several Hydrocodone side effects: hypoxia, hypotension, completed suicide, bradycardia. Hydrocodone Bitartrate + Acetaminophen dosage: N/A.
Multiple concurrent drugs taken:
  • Citalopram
  • Verapamil Hcl


Chest Discomfort, Chest Pain, Fear, Feeling Abnormal (8431462-0)
on Jun 07, 2012 Female from UNITED STATES , weighting 136.0 lb, was diagnosed with
  • herpes zoster
and was treated with Hydrocodone Bitartrate + Acetaminophen. Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: chest discomfort, chest pain, fear, feeling abnormal. Hydrocodone Bitartrate + Acetaminophen dosage: 1 Tablet Every 4 Hrs Oral.

Dyspnoea, Hyponatraemia (8429870-7)
Patient was taking Hydrocodone. Patient felt the following Hydrocodone side effects: dyspnoea, hyponatraemia on Jun 01, 2012 from UNITED STATES Additional patient health information: Female , 63 years of age, weighting 229.3 lb, . Hydrocodone dosage: 1df:5/500mg , Every 4 Hours Prn.
Multiple prescriptions taken:
  • Lorazepam
  • Prochlorperazine
  • Amlodipine
  • Zolpidem
  • Aspirin
  • Ipilimumab (Last Dose:02may2011)
  • Furosemide
  • Docusate Sodium
Patient was hospitalized.

Lower Limb Fracture, Off Label Use (8428124-2)
Adverse event was reported on Jun 04, 2012 by a Female taking Hydrocodone (Dosage: N/A) was diagnosed with
  • lower limb fracture
  • upper limb fracture
  • pain
and. Location: UNITED STATES , weighting 150.1 lb, After Hydrocodone was administered, patient encountered several Hydrocodone side effects: lower limb fracture, off label use.

Chronic Hepatic Failure, Neuropathy Peripheral, Type 2 Diabetes Mellitus (8427352-X)
on Jun 04, 2012 Female from UNITED STATES , weighting 184.0 lb, was diagnosed with
  • pain
  • chronic hepatic failure
and was treated with Hydrocodone. Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: chronic hepatic failure, neuropathy peripheral, type 2 diabetes mellitus. Hydrocodone dosage: Unk.
Associated medications used:
  • Lactulose (2 Tablespoon Daily)
  • Neurontin (1200 Mg, 3x/day)
  • Neurontin (Unk)
  • Venlafaxine (75 Mg, Daily)
  • Norvasc (10 Mg, Daily)
  • Lisinopril (40 Mg, Daily)
  • Humulin R (Unk, 4x/day)
  • Lasix (40 Mg, Daily)


Gastrointestinal Disorder (8419688-3)
on Jun 04, 2012 Female from UNITED STATES , weighting 200.0 lb, was treated with Hydrocodone Bitartrate And Acetaminophen. Patient felt the following Hydrocodone side effects: gastrointestinal disorder. Hydrocodone Bitartrate And Acetaminophen dosage: N/A.

Uterine Prolapse, Gastric Disorder, Dysuria, Lip Pain, Myocardial Infarction (8419378-7)
Patient was taking Hydrocodone Bitartrate + Acetaminophen. After Hydrocodone was administered, patient encountered several Hydrocodone side effects: uterine prolapse, gastric disorder, dysuria, lip pain, myocardial infarction on May 29, 2012 from UNITED STATES Additional patient health information: Female , 77 years of age, . Hydrocodone Bitartrate + Acetaminophen dosage: 5/325 Every 4 Hrs Or As Needed.
Multiple concurrent drugs taken:
  • Prilosec
  • Hydrochlorothiazde Tab
  • Metformin Hcl
  • Glipizide
  • Toprol-xl
  • Amlodipine Besylate
  • Nexium
Patient was hospitalized.

Spinal Fracture, Rib Fracture, Influenza, Spinal Compression Fracture, Skull Fracture, Cerebrovascular Accident, Arthritis, Spinal Osteoarthritis (8418302-0)
Adverse event was reported on May 30, 2012 by a Female taking Hydrocodone Bitartrate (Dosage: N/A) was diagnosed with
  • pain
  • gastrooesophageal reflux disease
  • sleep apnoea syndrome
and. Location: UNITED STATES , 64 years of age, Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: spinal fracture, rib fracture, influenza, spinal compression fracture, skull fracture, cerebrovascular accident, arthritis, spinal osteoarthritis.
Associated medications used:
  • Nexium (Two Times A Day)
  • Proigil
  • Celebrex
  • Ascorbic Acid
  • Nexium
  • Glyburide
  • Vitamin D
  • Aspirin
Patient was hospitalized.

Deep Vein Thrombosis, Anxiety, Injury, Anhedonia, Pain, Oedema Peripheral (8418158-6)
on May 30, 2012 Female from UNITED STATES , 20 years of age, weighting 114.6 lb, was treated with Hydrocodone Bitartrate And Acetaminophen. Patient felt the following Hydrocodone side effects: deep vein thrombosis, anxiety, injury, anhedonia, pain, oedema peripheral. Hydrocodone Bitartrate And Acetaminophen dosage: 10/650.
Multiple prescriptions taken:
  • Yasmin (Unk)
  • Spectracef (200 Mg, Unk)
Patient was hospitalized.

Body Temperature Increased, Pain, Blood Pressure Increased, Hepatic Enzyme Increased, Pulmonary Oedema, Breath Sounds Abnormal, Rash Macular, Dyspnoea, Flushing (8418116-1)
on Jun 04, 2012 Female from UNITED STATES , 23 years of age, weighting 164.0 lb, was diagnosed with
  • cholecystectomy
and was treated with Hydrocodone Bitartrate + Acetaminophen. After Hydrocodone was administered, patient encountered several Hydrocodone side effects: body temperature increased, pain, blood pressure increased, hepatic enzyme increased, pulmonary oedema, breath sounds abnormal, rash macular, dyspnoea, flushing. Hydrocodone Bitartrate + Acetaminophen dosage: 7.5-750 1every 4-6hours Po.

Cough, Joint Injury, Post-traumatic Stress Disorder, Emotional Distress, Depression, Pain, Hypovitaminosis, Infection, Tooth Abscess (8417695-8)
Patient was taking Hydrocodone Bitartrate. Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: cough, joint injury, post-traumatic stress disorder, emotional distress, depression, pain, hypovitaminosis, infection, tooth abscess on May 17, 2012 from UNITED STATES Additional patient health information: Female , 63 years of age, . Hydrocodone Bitartrate dosage: 5-500 Mg.
Associated medications used:
  • Lisinopril
  • Aspirin (81 Mg)
  • Losarta


Tongue Carcinoma Stage Iv, Off Label Use (8410789-2)
Adverse event was reported on May 24, 2012 by a Male taking Hydrocodone (Dosage: 5/325 Elixir 1 In 4 Hrs) was diagnosed with
  • pain
  • urinary tract infection
  • diarrhoea
  • head and neck cancer stage iv
and. Location: UNITED STATES , weighting 149.9 lb, Patient felt the following Hydrocodone side effects: tongue carcinoma stage iv, off label use.
Multiple prescriptions taken:
  • Biaxin Xl (1000 Mg, Uid/qd)
  • Lomotil (25 Mg, Q 4hrs)
  • Tarceva (150 Mg, Uid/qd)
  • Duragesic-100 (150 Ug, Q3d)
  • Phenergan (25 Mg, Q6 Hours)
  • Keppra (750 Mg, Q12 Hours)
  • Prednisone (15 Mg, Uid/qd)
  • Bactrim Ds (1000 Mg, Uid/qd)


Pain, Hearing Impaired, Bone Fragmentation, Multiple Fractures, Dysstasia, Intervertebral Disc Protrusion, Intervertebral Disc Disorder, Activities Of Daily Living Impaired (8408119-5)
on May 25, 2012 Female from UNITED STATES , 56 years of age, was diagnosed with
  • back pain
  • restless legs syndrome
  • osteoporosis
  • blood cholesterol increased
and was treated with Hydrocodone. After Hydrocodone was administered, patient encountered several Hydrocodone side effects: pain, hearing impaired, bone fragmentation, multiple fractures, dysstasia, intervertebral disc protrusion, intervertebral disc disorder, activities of daily living impaired. Hydrocodone dosage: 10/325 Mgs.
Multiple concurrent drugs taken:
  • Requip
  • Prolia
  • Lipitor
  • Celexa
  • Calcium With Vitamin D
  • Depakote
  • Rhinocort
  • Lamictal


Retinal Pigmentation (8407812-8)
on May 23, 2012 Male from INDIA , 56 years of age, was diagnosed with
  • pain
and was treated with Hydrocodone Bitartrate + Acetaminophen. Directly after, patient experienced the unwanted or unexpected Hydrocodone side effects: retinal pigmentation. Hydrocodone Bitartrate + Acetaminophen dosage: 1df=7.5-325mg.
Associated medications used:
  • Prednisone (Tabs)
  • Lexapro (Tabs At Bedtime)
  • Miralax (Powder)
  • Prilosec
  • Ipilimumab (No Of Courses: 04)
  • Steroids


Showing 1-25 of 1807 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Hydrocodone Information

Alternative HYDROCODONE Names:HYDROCODO YDROCODON

Active Ingredient: ACETAMINO CHLORPHEN HOMATROPI HYDROCODO

More About Hydrocodone

Side Effects reported to FDA: 1807. View Hydrocodone Adverse Reports

Hydrocodone safety alerts: 2012 2011 2008 2007

Reported deaths: 500

Reported hospitalizations: 121

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Watson Laboratories): Recall - Potential for Oversized and Superpotent Tablets

 

[Posted 09/24/2012]

AUDIENCE: Pharmacy

ISSUE: Watson Laboratories, Inc. notified the public of a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg (Lot Numbers 519406A and 521759A, both with the expiry date April 2014, distributed between 6/27/2012 and 7/18/2012 to wholesale distributors and retail pharmacies nationwide).

A complaint was received for tablets that were thicker and darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A exceed the weight specification and may contain higher than indicated amounts of the ingredients Hydrocodone Bitartrate and/or Acetaminophen.

Unintentional ingestion of excessive amounts of acetaminophen may potentially result in an adverse event, including liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death. Unintentional ingestion of excessive amounts of hydrocodone may result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, such as sedating medications or certain antidepressants.

BACKGROUND: Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

RECOMMENDATION: Pharmacists and wholesalers are asked to check their inventories for lots 519406A or 521759A segregate any material from the lots, and to contact GENCO Pharmaceutical Services at 1-800-950-5479 for instructions on product return.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[09/20/2012 - Press Release - Watson Laboratories, Inc.]

Related MedWatch Alert:

[09/11/2012 - Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg]

 

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