This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Oxycodone and Acetaminophen (Oxycodone / Acetaminophen) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (72)
Death (14)
Life Threatening Events (2)
Disability (4)
Reports by Reaction Type
Drug Ineffective (24),
Toxicity To Various Agents (8),
Multiple Drug Overdose (7),
Drug Administration Error (6),
Overdose (5),
Hypotension (5),
Product Quality Issue (4),
Withdrawal Syndrome (4),
Confusional State (3),
Pain (3),
Coma (3),
Intentional Drug Misuse (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Oxycodone and Acetaminophen (Oxycodone / Acetaminophen). For a complete list or a specific selection of reports, please use the links above.
Possible Oxycodone and Acetaminophen side effects in 49 year old male
Reported by a physician from United States on 2012-08-24
Patient: 49 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: Hypothermia, Hypotension, Coma, Respiratory Depression, Self Injurious Behaviour, Multiple Drug Overdose
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Acetaminophen and Hydrocodone Bitartrate
Indication: Product Used FOR Unknown Indication
Alcohol
Indication: Product Used FOR Unknown Indication
Apap TAB
Indication: Product Used FOR Unknown Indication
Apap TAB
Cyclobenzaprine
Indication: Product Used FOR Unknown Indication
Oxycodone and Acetaminophen
Indication: Product Used FOR Unknown Indication
Tramadol HCL
Indication: Product Used FOR Unknown Indication
Possible Oxycodone and Acetaminophen side effects in 28 year old male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 28 year old male, weighing 82.6 kg (181.6 pounds)
Reactions: Overdose, Toxicity To Various Agents, Somnambulism
Adverse event resulted in: death
Drug(s) suspected as cause:
Fentanyl-100
Dosage: q3d
Indication: Neck Pain
Fentanyl-100
Dosage: q3d
Oxycodone and Acetaminophen
Dosage: 1-2 tabs po q6 hours prn
Administration route: Oral
Indication: Neck Pain
Other drugs received by patient: Amitriptyline Hydrochloride; Gabapentin; Topamax; Hydroxyzine Pamoate; Lyrica
Possible Oxycodone and Acetaminophen side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: male
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Indication: Back Injury
Oxycodone and Acetaminophen
Dosage: 40/1300 mg
Administration route: Oral
Indication: Back Pain
Possible Oxycodone and Acetaminophen side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: female
Reactions: Anaphylactic Shock
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in 4 year old female
Reported by a physician from United States on 2012-08-09
Patient: 4 year old female
Reactions: Brain Death, Respiratory Rate Decreased, Mydriasis, Brain Herniation, Breath Sounds Abnormal, Hypotension, Brain Oedema, Convulsion
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Alprazolam
Dosage: po
Administration route: Oral
Kadian
Dosage: po
Administration route: Oral
Oxycodone and Acetaminophen
Dosage: po
Administration route: Oral
Possible Oxycodone and Acetaminophen side effects in 17 year old male
Reported by a physician from United States on 2012-08-09
Patient: 17 year old male
Reactions: Brain Herniation, Alanine Aminotransferase Increased, Unresponsive To Stimuli, Hypotension, Drug Abuse, Haemodialysis, Cardiomegaly, Loss of Consciousness, Cerebellar Infarction, Renal Failure
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Clonazepam
Dosage: po
Administration route: Oral
Indication: Intentional Drug Misuse
Kadian
Indication: Sedation
Oxycodone and Acetaminophen
Dosage: po
Administration route: Oral
Indication: Intentional Drug Misuse
Zolpidem Tartrate
Dosage: po
Administration route: Oral
Indication: Intentional Drug Misuse
Possible Oxycodone and Acetaminophen side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: male
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Other drugs received by patient: Oxycodone / Acetaminophen
Possible Oxycodone and Acetaminophen side effects in female
Reported by a individual with unspecified qualification from United States on 2012-07-27
Patient: female
Reactions: Pruritus Generalised, Vomiting
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in female
Reported by a pharmacist from United States on 2012-07-26
Patient: female, weighing 77.2 kg (169.8 pounds)
Reactions: Drug Ineffective, Withdrawal Syndrome
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Other drugs received by patient: Amlodipine Besylate; Metoprolol Tartrate; Gabapentin
Possible Oxycodone and Acetaminophen side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient: female
Reactions: Mental Impairment, Panic Attack, Feeling Abnormal
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Dosage: 20mg/650mg
Administration route: Oral
Start date: 2012-07-01
Oxycodone and Acetaminophen
Dosage: 40mg/1300mg
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-05
End date: 2012-07-01
Possible Oxycodone and Acetaminophen side effects in 46 year old female
Reported by a physician from United States on 2012-07-20
Patient: 46 year old female, weighing 53.0 kg (116.6 pounds)
Reactions: Hypotension, Aspartate Aminotransferase Increased, Tachycardia, Miosis, Alanine Aminotransferase Increased, Coma, Multiple Drug Overdose
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Acetaminophen
Indication: Product Used FOR Unknown Indication
Diphenhydramine HCL
Indication: Product Used FOR Unknown Indication
Oxycodone and Acetaminophen
Indication: Product Used FOR Unknown Indication
Oxycodone HCL
Indication: Product Used FOR Unknown Indication
Paracetamol / Diphenhydramine
Indication: Product Used FOR Unknown Indication
Quetiapine
Indication: Product Used FOR Unknown Indication
Possible Oxycodone and Acetaminophen side effects in 37 year old male
Reported by a physician from United States on 2012-07-20
Patient: 37 year old male, weighing 93.0 kg (204.6 pounds)
Reactions: Abdominal Pain, Vomiting, Diarrhoea, Drug-Induced Liver Injury, Drug Administration Error, Multiple Drug Overdose
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apap TAB
Indication: Product Used FOR Unknown Indication
Apap TAB
Apap / Diphenhydramine
Indication: Product Used FOR Unknown Indication
Oxycodone and Acetaminophen
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Ambien; Lorazepam
Possible Oxycodone and Acetaminophen side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: male
Reactions: Product Quality Issue, Drug Ineffective
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Dosage: 10/325 mg
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-01
Oxycodone and Acetaminophen
Dosage: 10/325 mg
Administration route: Oral
Possible Oxycodone and Acetaminophen side effects in female
Reported by a physician from United States on 2012-07-18
Patient: female, weighing 117.9 kg (259.5 pounds)
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in 78 year old male
Reported by a physician from United States on 2012-07-10
Patient: 78 year old male, weighing 85.0 kg (187.0 pounds)
Reactions: Confusional State, Agitation, Urinary Tract Infection, Drug Administration Error, Delirium
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ceftriaxone
Indication: Urinary Tract Infection
Ciprofloxacin
Indication: Urinary Tract Infection
Desipramine HCL
Diphenhydramine HCL
Furosemide
Gabapentin
Insulin
Metformin HCL
Morphine
Indication: Pain
Oxycodone and Acetaminophen
Indication: Pain
Oxycodone and Acetaminophen
Other drugs received by patient: Capsaicin Cream; Desipramine HCL; Ferrous Sulfate TAB; Docusate; Furosemide; Metformin HCL; Ranitidine; Acetaminophen; Allopurinol; Cinacalcet Hydrochloride; Clonidine; Ergocalciferol; Naproxen; Omeprazole; Colchicine; Lisinopril; Vardenafil Hydrochloride (Levitra); Vitamin E; Aspirin; Baclofen; Finasteride; Gabapentin; Hydrocodone Bitartrate + Acetaminophen; Simvastatin; Terazosin HCL
Possible Oxycodone and Acetaminophen side effects in 31 year old female
Reported by a physician from United States on 2012-07-09
Patient: 31 year old female, weighing 90.9 kg (200.0 pounds)
Reactions: Dyskinesia, Multiple Drug Overdose, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Indication: Product Used FOR Unknown Indication
Acetaminophen
Butalbital and Acetaminophen
Indication: Product Used FOR Unknown Indication
Carisoprodol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Oxycodone and Acetaminophen
Indication: Product Used FOR Unknown Indication
Oxycodone HCL
Indication: Product Used FOR Unknown Indication
Paracetamol / Dextromethorphan
Indication: Product Used FOR Unknown Indication
Zolpidem
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Paroxetine; Lamotrigine; Promethazine
Possible Oxycodone and Acetaminophen side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-25
Patient: female
Reactions: Product Quality Issue, Dizziness
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Dosage: 5/325mg once a day po
Administration route: Oral
Indication: Back Pain
Oxycodone and Acetaminophen
Dosage: 5/325mg once a day po once
Administration route: Oral
Indication: Back Pain
Possible Oxycodone and Acetaminophen side effects in 37 year old male
Reported by a physician from United States on 2012-06-22
Patient: 37 year old male, weighing 93.0 kg (204.6 pounds)
Reactions: Abdominal Pain, Vomiting, Diarrhoea, Drug-Induced Liver Injury, Drug Administration Error, Multiple Drug Overdose
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Apap TAB
Apap TAB
Indication: Product Used FOR Unknown Indication
Apap / Diphenhydramine
Indication: Product Used FOR Unknown Indication
Oxycodone and Acetaminophen
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Ambien; Lorazepam
Possible Oxycodone and Acetaminophen side effects in female
Reported by a pharmacist from United States on 2012-06-07
Patient: female
Reactions: Drug Ineffective, Withdrawal Syndrome
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient: male
Reactions: Malaise, Drug Ineffective
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-06
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Other drugs received by patient: Sleeping Pill
Possible Oxycodone and Acetaminophen side effects in 46 year old female
Reported by a physician from United States on 2012-06-05
Patient: 46 year old female, weighing 53.0 kg (116.6 pounds)
Reactions: Aspartate Aminotransferase Increased, Miosis, Alanine Aminotransferase Increased, Tachycardia, Hypotension, Coma, Multiple Drug Overdose
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Acetaminophen
Indication: Product Used FOR Unknown Indication
Diphenhydramine HCL
Indication: Product Used FOR Unknown Indication
Oxycodone and Acetaminophen
Indication: Product Used FOR Unknown Indication
Oxycodone Hydrochloride
Indication: Product Used FOR Unknown Indication
Paracetamol / Diphenhydramine
Indication: Product Used FOR Unknown Indication
Quetiapine
Indication: Product Used FOR Unknown Indication
Possible Oxycodone and Acetaminophen side effects in
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient:
Reactions: Personality Change, Aggression
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: male
Reactions: Malaise, Drug Ineffective
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in 35 year old male
Reported by a physician from United States on 2012-05-18
Patient: 35 year old male, weighing 94.0 kg (206.8 pounds)
Reactions: Pulse Absent, Drug Administration Error, Respiratory Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Hydromorphone HCL
Dosage: 3 mg;q4h,prn;iv, 3 mg;q3hx6;im
Indication: Abdominal Pain Lower
Oxycodone and Acetaminophen
Dosage: 5/325 mg; prn; up to qid
Indication: Headache
Possible Oxycodone and Acetaminophen side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: female, weighing 63.6 kg (139.8 pounds)
Reactions: Drug Effect Decreased, Drug Screen Negative
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Possible Oxycodone and Acetaminophen side effects in 34 year old female
Reported by a physician from United States on 2012-04-30
Patient: 34 year old female
Reactions: Autonomic Nervous System Imbalance, Quadriparesis, Necrosis, Cervical Myelopathy, Skin Lesion, Suicide Attempt
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Chloral Hydrate
Oxycodone and Acetaminophen
Quetiapine Fumarate
Possible Oxycodone and Acetaminophen side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: female
Reactions: Drug Ineffective, Intentional Drug Misuse
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
Dosage: 40/1300 mg
Administration route: Oral
Indication: Pain
Start date: 2012-01-01
End date: 2012-01-01
Oxycodone and Acetaminophen
Dosage: 50/1625 mg
Administration route: Oral
Start date: 2012-01-01
Other drugs received by patient: Opana
Possible Oxycodone and Acetaminophen side effects in 33 year old female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: 33 year old female, weighing 83.9 kg (184.6 pounds)
Reactions: Drug Dispensing Error
Drug(s) suspected as cause:
Oxycodone and Acetaminophen
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