Index of reports
> Cases with Product Quality Issue (18)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Percocet (Oxycodone / Acetaminophen) where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Percocet side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Product Quality Issue, Overdose, Drug Administration Error, Acute Hepatic Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butalbital / Acetaminophen
Indication: Product Used FOR Unknown Indication
Extra Strength Tylenol
Administration route: Oral
Indication: Headache
Start date: 2009-12-28
Extra Strength Tylenol
Administration route: Oral
Percocet
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Prednisone TAB; Pristiq
Possible Percocet side effects in female
Reported by a physician from United States on 2012-08-23
Patient: female, weighing 49.9 kg (109.8 pounds)
Reactions: Product Quality Issue, Product Substitution Issue, Restless Legs Syndrome, Heart Rate Increased, Pain, Drug Withdrawal Syndrome
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Percocet
Possible Percocet side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-25
Patient:
Reactions: Product Quality Issue, Malaise, Insomnia, Nervous System Disorder, Headache, Ill-Defined Disorder, Tremor
Drug(s) suspected as cause:
Percocet
Possible Percocet side effects in female
Reported by a lawyer from United States on 2012-07-19
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Product Quality Issue, Overdose, Drug Administration Error, Acute Hepatic Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butalbital / Acetaminophen
Indication: Ill-Defined Disorder
Extra Strength Tylenol
Indication: Headache
Start date: 2009-12-28
Extra Strength Tylenol
Percocet
Indication: Ill-Defined Disorder
Other drugs received by patient: Prednisone; Pristiq
Possible Percocet side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Product Quality Issue, Overdose, Acute Hepatic Failure, Drug Administration Error
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butalbital / Acetaminophen
Indication: Ill-Defined Disorder
Extra Strength Tylenol
Extra Strength Tylenol
Indication: Headache
Start date: 2009-12-28
Percocet
Indication: Ill-Defined Disorder
Other drugs received by patient: Pristiq; Prednisone
Possible Percocet side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Weight Decreased, Product Quality Issue, Concussion, Hypothalamo-Pituitary Disorder, Wrong Technique in Drug Usage Process, Drug Ineffective, Dysuria, Drug Administration Error, Memory Impairment, Fall
Drug(s) suspected as cause:
Duragesic-100
Indication: Nerve Injury
Start date: 2006-03-01
Percocet
Administration route: Oral
Indication: Pain
Other drugs received by patient: Valium; Synthroid; Norditropin
Possible Percocet side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: male, weighing 113.0 kg (248.5 pounds)
Reactions: Product Quality Issue, Dyspnoea, Wrong Technique in Drug Usage Process, Pain, Sensory Disturbance, Presyncope, Paraesthesia
Drug(s) suspected as cause:
Duragesic-100
Indication: Pain
Start date: 2012-03-26
Duragesic-100
Start date: 2012-01-01
End date: 2012-03-01
Percocet
Dosage: as needed
Administration route: Oral
Indication: Pain
Start date: 2012-03-23
End date: 2012-03-26
Other drugs received by patient: Lipitor; Asthma Inhaler; Blood Pressure Medication NOS
Possible Percocet side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-08
Patient: female
Reactions: Death, Product Quality Issue, Unresponsive To Stimuli, Snoring, Pulse Absent, Cardiomegaly
Adverse event resulted in: death
Drug(s) suspected as cause:
Excedrin (Acetaminophen / Aspirin / Caffeine)
Administration route: Oral
Indication: Migraine
Start date: 2011-11-04
Excedrin PM Caplets
Administration route: Oral
Indication: Sleep Disorder
Excedrin PM Caplets
Administration route: Oral
Indication: Pain
Percocet
Administration route: Oral
Indication: Intervertebral Disc Protrusion
Topamax
Administration route: Oral
Indication: Migraine Prophylaxis
Start date: 2011-11-04
End date: 2011-11-01
Other drugs received by patient: Xanax
Possible Percocet side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-08
Patient: male
Reactions: Product Quality Issue, Drug Ineffective
Drug(s) suspected as cause:
Opana ER
Dosage: 40 mg, 2 in 1 d, oral
Administration route: Oral
Indication: Back Pain
End date: 2012-02-01
Percocet
Dosage: oral
Administration route: Oral
Indication: Back Pain
Possible Percocet side effects in 52 year old female
Reported by a individual with unspecified qualification from United States on 2012-02-21
Patient: 52 year old female
Reactions: Product Quality Issue, Drug Effect Decreased
Drug(s) suspected as cause:
Percocet
Possible Percocet side effects in 59 year old male
Reported by a consumer/non-health professional from United States on 2012-02-17
Patient: 59 year old male, weighing 90.7 kg (199.6 pounds)
Reactions: Product Quality Issue, Drug Ineffective, Dependence, Insomnia
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Dosage: 5/325 mg, 10 in 1 m, oral
Administration route: Oral
Indication: Pain
Percocet
Dosage: 5/325 mg, 10 in 1 m, oral
Administration route: Oral
Indication: Pain
Start date: 2007-01-01
Other drugs received by patient: Enalapril / Hydrochlorothiazide (Hydrochlorothiazie, Enalapril Maleate); Nifediac CC (Nifedipine); ASA (Acetylsalicylic Acid) (Salicylic Acid); Diazepam; Lescol XL; Viagra
Possible Percocet side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-02-10
Patient: 59 year old female
Reactions: Product Quality Issue, Product Measured Potency Issue, Fatigue, Product Colour Issue, Dizziness
Drug(s) suspected as cause:
Percocet
Possible Percocet side effects in female
Reported by a consumer/non-health professional from Puerto Rico on 2011-12-19
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Product Quality Issue, Overdose, Drug Administration Error, Acute Hepatic Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butalbital / Acetaminophen
Indication: Ill-Defined Disorder
Extra Strength Tylenol
Extra Strength Tylenol
Indication: Headache
Start date: 2009-12-28
Percocet
Indication: Ill-Defined Disorder
Other drugs received by patient: Prednisone TAB; Pristiq
Possible Percocet side effects in female
Reported by a consumer/non-health professional from Puerto Rico on 2011-11-11
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Product Quality Issue, Overdose, Acute Hepatic Failure, Drug Administration Error
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butalbital / Acetaminophen
Indication: Ill-Defined Disorder
Extra Strength Tylenol
Indication: Headache
Start date: 2009-12-28
Extra Strength Tylenol
Percocet
Indication: Ill-Defined Disorder
Other drugs received by patient: Prednisone TAB; Pristiq
Possible Percocet side effects in female
Reported by a consumer/non-health professional from Puerto Rico on 2011-11-09
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Gastritis, Liver Transplant, Abdominal Discomfort, Overdose, Drug Administration Error, Pleural Effusion, Splenomegaly, Cholangitis Acute, Product Quality Issue, Vomiting, Nausea, International Normalised Ratio Increased, Hyperglycaemia, Urinary Tract Infection, General Physical Health Deterioration, Livedo Reticularis, Ascites, Sepsis, Acute Hepatic Failure, Hepatic Artery Stenosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butalbital / Acetaminophen
Indication: Ill-Defined Disorder
Extra Strength Tylenol
Indication: Headache
Start date: 2009-12-28
Extra Strength Tylenol
Percocet
Indication: Ill-Defined Disorder
Other drugs received by patient: Prednisone; Pristiq
Possible Percocet side effects in female
Reported by a health professional (non-physician/pharmacist) from Puerto Rico on 2011-11-07
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Product Quality Issue, Overdose, Drug Administration Error, Acute Hepatic Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butalbital / Acetaminophen
Indication: Ill-Defined Disorder
Extra Strength Tylenol
Extra Strength Tylenol
Indication: Headache
Start date: 2009-12-28
Percocet
Indication: Ill-Defined Disorder
Other drugs received by patient: Prednisone; Pristiq
Possible Percocet side effects in female
Reported by a consumer/non-health professional from Puerto Rico on 2011-10-18
Patient: female, weighing 64.0 kg (140.7 pounds)
Reactions: Product Quality Issue, Overdose, Drug Administration Error, Acute Hepatic Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Butalbital / Acetaminophen
Indication: Ill-Defined Disorder
Extra Strength Tylenol
Indication: Headache
Start date: 2009-12-28
Extra Strength Tylenol
Percocet
Indication: Ill-Defined Disorder
Other drugs received by patient: Pristiq; Prednisone
Possible Percocet side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-03
Patient: female, weighing 88.9 kg (195.6 pounds)
Reactions: Drug Dose Omission, Product Quality Issue, Back Pain, Drug Ineffective, Dermatitis, Nervous System Disorder, Spinal Disorder, Gait Disturbance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Duragesic-100
Indication: Back Pain
End date: 2010-10-01
Duragesic-100
Start date: 2011-09-01
Duragesic-100
Start date: 2011-09-06
End date: 2011-09-01
Duragesic-100
Start date: 2011-08-01
End date: 2011-09-06
Percocet
Indication: Product Used FOR Unknown Indication
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