OXYMORPHONE HYDROCHLORIDE

N/A

Manufactured by Amneal Pharmaceuticals LLC

20,768 FDA adverse event reports analyzed

Last updated: 2026-04-14

About OXYMORPHONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for OXYMORPHONE HYDROCHLORIDE include DEPENDENCE, DEATH, TOXICITY TO VARIOUS AGENTS, OVERDOSE, DRUG DEPENDENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYMORPHONE HYDROCHLORIDE.

Top Adverse Reactions

DEPENDENCE4,902 reports
DEATH3,323 reports
TOXICITY TO VARIOUS AGENTS2,758 reports
OVERDOSE2,308 reports
DRUG DEPENDENCE583 reports
DRUG ABUSE550 reports
BACK PAIN432 reports
DRUG WITHDRAWAL SYNDROME NEONATAL350 reports
FOETAL EXPOSURE DURING PREGNANCY331 reports
PAIN306 reports
BACK INJURY243 reports
INTENTIONAL PRODUCT MISUSE220 reports
ILL DEFINED DISORDER203 reports
DEPRESSION201 reports
DEVELOPMENTAL DELAY174 reports
WITHDRAWAL SYNDROME167 reports
ANXIETY163 reports
DRUG DIVERSION150 reports
ARTHRALGIA135 reports
DYSPHAGIA130 reports
ACCIDENTAL OVERDOSE116 reports
GASTROINTESTINAL DISORDER112 reports
ROAD TRAFFIC ACCIDENT97 reports
ASTHMA95 reports
GASTROOESOPHAGEAL REFLUX DISEASE94 reports
SPEECH DISORDER DEVELOPMENTAL94 reports
LEARNING DISORDER90 reports
EMOTIONAL DISTRESS88 reports
SPINAL OPERATION79 reports
LEARNING DISABILITY74 reports
MATERNAL EXPOSURE DURING PREGNANCY74 reports
NECK PAIN73 reports
CARDIAC DISORDER66 reports
VISUAL IMPAIRMENT64 reports
PAIN IN EXTREMITY61 reports
PREMATURE BABY59 reports
DISABILITY55 reports
ATTENTION DEFICIT HYPERACTIVITY DISORDER52 reports
DISTURBANCE IN ATTENTION51 reports
HEADACHE51 reports
INTERVERTEBRAL DISC PROTRUSION49 reports
JOINT INJURY49 reports
CONSTIPATION48 reports
DRUG INEFFECTIVE48 reports
HYPOACUSIS48 reports
NAUSEA47 reports
DRUG WITHDRAWAL SYNDROME40 reports
ARTHRITIS39 reports
VOMITING39 reports
LIMB INJURY38 reports
DYSPNOEA37 reports
GAIT DISTURBANCE37 reports
GAIT INABILITY37 reports
COMPLETED SUICIDE36 reports
INJURY35 reports
KNEE OPERATION35 reports
NECK INJURY35 reports
SPINAL CORD INJURY33 reports
MIGRAINE32 reports
FATIGUE31 reports
AMNESIA30 reports
POST TRAUMATIC STRESS DISORDER30 reports
INTERVERTEBRAL DISC DEGENERATION28 reports
PRODUCT PRESCRIBING ISSUE28 reports
ABDOMINAL PAIN UPPER27 reports
FIBROMYALGIA27 reports
DIZZINESS25 reports
FALL25 reports
INSOMNIA25 reports
SEIZURE25 reports
AUTISM SPECTRUM DISORDER24 reports
MALAISE24 reports
CEREBROVASCULAR ACCIDENT23 reports
VISION ABNORMAL NEONATAL22 reports
CONFUSIONAL STATE21 reports
SPINAL FRACTURE21 reports
SUICIDE ATTEMPT21 reports
SURGERY21 reports
ABDOMINAL DISCOMFORT20 reports
BRAIN INJURY18 reports
COGNITIVE DISORDER18 reports
NEOPLASM MALIGNANT17 reports
TOOTH DISORDER17 reports
DRUG INTERACTION16 reports
HYPOTENSION16 reports
MULTIPLE DRUG OVERDOSE ACCIDENTAL16 reports
OFF LABEL USE16 reports
PRODUCT DOSE OMISSION ISSUE16 reports
SOMNOLENCE16 reports
TOOTHACHE16 reports
VISION BLURRED16 reports
WEIGHT DECREASED16 reports
COMA15 reports
DEPRESSED LEVEL OF CONSCIOUSNESS15 reports
EXPOSURE VIA BREAST MILK15 reports
KNEE ARTHROPLASTY15 reports
LIVER INJURY15 reports
MENTAL DISORDER15 reports
MULTIPLE DRUG OVERDOSE15 reports
RENAL DISORDER15 reports

Report Outcomes

Out of 11,590 classified reports for OXYMORPHONE HYDROCHLORIDE:

Serious 98.4%Non-Serious 1.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male2,412 (56.2%)
Female1,877 (43.8%)

Reports by Age

Age 7716 reports
Age 3413 reports
Age 4012 reports
Age 4712 reports
Age 5512 reports
Age 5810 reports
Age 329 reports
Age 419 reports
Age 429 reports
Age 529 reports
Age 218 reports
Age 487 reports
Age 497 reports
Age 276 reports
Age 356 reports
Age 446 reports
Age 516 reports
Age 576 reports
Age 255 reports
Age 295 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with OXYMORPHONE HYDROCHLORIDE?

This profile reflects 20,768 FDA FAERS reports that mention OXYMORPHONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OXYMORPHONE HYDROCHLORIDE?

Frequently reported terms in FAERS include DEPENDENCE, DEATH, TOXICITY TO VARIOUS AGENTS, OVERDOSE, DRUG DEPENDENCE, DRUG ABUSE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OXYMORPHONE HYDROCHLORIDE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with OXYMORPHONE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.