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Oxycodone and Acetaminophen (Oxycodone / Acetaminophen) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (72)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Oxycodone and Acetaminophen (Oxycodone / Acetaminophen) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 72   Next >>

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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