OXYCODONE HCL

N/A

Manufactured by Amneal Pharmaceuticals NY LLC

32,776 FDA adverse event reports analyzed

Last updated: 2026-04-14

About OXYCODONE HCL

OXYCODONE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. The most commonly reported adverse reactions for OXYCODONE HCL include NAUSEA, PAIN, VOMITING, FATIGUE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYCODONE HCL.

Top Adverse Reactions

NAUSEA1,132 reports
PAIN924 reports
VOMITING875 reports
FATIGUE697 reports
DYSPNOEA691 reports
CARDIAC ARREST683 reports
DIARRHOEA680 reports
RESPIRATORY ARREST666 reports
COMPLETED SUICIDE649 reports
DRUG INEFFECTIVE644 reports
DEATH637 reports
ASTHENIA561 reports
PYREXIA557 reports
HEADACHE542 reports
PNEUMONIA530 reports
CONFUSIONAL STATE509 reports
MULTIPLE DRUG OVERDOSE461 reports
DIZZINESS459 reports
ANXIETY442 reports
SOMNOLENCE441 reports
FALL436 reports
BACK PAIN430 reports
DEHYDRATION425 reports
CONSTIPATION417 reports
OEDEMA PERIPHERAL412 reports
CARDIO RESPIRATORY ARREST407 reports
DEPRESSION404 reports
ABDOMINAL PAIN400 reports
ARTHRALGIA385 reports
HYPOTENSION374 reports
OVERDOSE365 reports
PAIN IN EXTREMITY364 reports
WEIGHT DECREASED351 reports
ACCIDENTAL OVERDOSE350 reports
INSOMNIA348 reports
DRUG ABUSE339 reports
ANAEMIA331 reports
CHEST PAIN326 reports
MALAISE317 reports
DRUG TOXICITY310 reports
DRUG INTERACTION306 reports
TOXICITY TO VARIOUS AGENTS294 reports
DRUG ABUSER280 reports
RASH279 reports
HYPERHIDROSIS278 reports
DECREASED APPETITE277 reports
DRUG DEPENDENCE266 reports
RENAL FAILURE ACUTE265 reports
FEELING ABNORMAL259 reports
LOSS OF CONSCIOUSNESS256 reports
DRUG WITHDRAWAL SYNDROME251 reports
PULMONARY EMBOLISM251 reports
TREMOR248 reports
HYPERTENSION245 reports
MENTAL STATUS CHANGES244 reports
POISONING242 reports
CONDITION AGGRAVATED239 reports
PLEURAL EFFUSION238 reports
DEEP VEIN THROMBOSIS231 reports
RENAL FAILURE226 reports
HAEMOGLOBIN DECREASED223 reports
HYPOAESTHESIA221 reports
GAIT DISTURBANCE219 reports
URINARY TRACT INFECTION218 reports
MUSCLE SPASMS216 reports
CONVULSION211 reports
COUGH207 reports
DISEASE PROGRESSION207 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS207 reports
CHILLS202 reports
PRURITUS201 reports
INTENTIONAL DRUG MISUSE198 reports
AGITATION193 reports
SEPSIS193 reports
LETHARGY192 reports
WEIGHT INCREASED192 reports
ABDOMINAL PAIN UPPER191 reports
INJURY188 reports
BLOOD GLUCOSE INCREASED187 reports
SUICIDAL IDEATION181 reports
THROMBOCYTOPENIA179 reports
RESPIRATORY FAILURE178 reports
TACHYCARDIA177 reports
GENERAL PHYSICAL HEALTH DETERIORATION175 reports
COMA174 reports
MYALGIA171 reports
PARAESTHESIA170 reports
MALIGNANT NEOPLASM PROGRESSION169 reports
ATRIAL FIBRILLATION164 reports
ERYTHEMA164 reports
MUSCULAR WEAKNESS164 reports
BLOOD CREATININE INCREASED161 reports
NEUTROPENIA160 reports
BLOOD PRESSURE INCREASED156 reports
PULMONARY OEDEMA156 reports
PLATELET COUNT DECREASED155 reports
CARDIAC FAILURE CONGESTIVE154 reports
DRUG EFFECT DECREASED152 reports
DYSPHAGIA152 reports
HEART RATE INCREASED152 reports

Report Outcomes

Out of 14,564 classified reports for OXYCODONE HCL:

Serious 84.0%Non-Serious 16.0%

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

Female6,999 (50.5%)
Male6,768 (48.9%)
Unknown84 (0.6%)

Reports by Age

Age 52251 reports
Age 57250 reports
Age 51238 reports
Age 46228 reports
Age 56225 reports
Age 50220 reports
Age 53220 reports
Age 54212 reports
Age 55206 reports
Age 61206 reports
Age 47203 reports
Age 48202 reports
Age 49202 reports
Age 60190 reports
Age 45188 reports
Age 58182 reports
Age 59178 reports
Age 62178 reports
Age 42175 reports
Age 65175 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 OXYCODONE HCL?

This profile reflects 32,776 FDA FAERS reports that mention OXYCODONE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OXYCODONE HCL?

Frequently reported terms in FAERS include NAUSEA, PAIN, VOMITING, FATIGUE, DYSPNOEA, CARDIAC ARREST. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OXYCODONE HCL?

Labeling and FAERS entries often list Amneal Pharmaceuticals NY LLC in connection with OXYCODONE HCL. 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.