DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

 
 



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 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 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 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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017