OXYCODONE AND ACETAMINOPHEN

N/A

Manufactured by Par Health USA, LLC

80,165 FDA adverse event reports analyzed

Last updated: 2026-04-14

About OXYCODONE AND ACETAMINOPHEN

OXYCODONE AND ACETAMINOPHEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Par Health USA, LLC. The most commonly reported adverse reactions for OXYCODONE AND ACETAMINOPHEN include DEPENDENCE, OVERDOSE, ILL-DEFINED DISORDER, DRUG INEFFECTIVE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OXYCODONE AND ACETAMINOPHEN.

Top Adverse Reactions

DEPENDENCE8,730 reports
OVERDOSE4,104 reports
ILL DEFINED DISORDER3,102 reports
DRUG INEFFECTIVE1,827 reports
PAIN1,770 reports
DEATH1,651 reports
FATIGUE1,594 reports
NAUSEA1,320 reports
WITHDRAWAL SYNDROME1,148 reports
DYSPNOEA1,140 reports
DRUG DEPENDENCE1,125 reports
ARTHRALGIA1,074 reports
ANXIETY1,040 reports
HEADACHE1,031 reports
DEPRESSION964 reports
OFF LABEL USE964 reports
RASH921 reports
PRURITUS886 reports
DIARRHOEA875 reports
PYREXIA858 reports
PERIPHERAL SWELLING848 reports
NASOPHARYNGITIS819 reports
INFECTION818 reports
JOINT SWELLING817 reports
CONFUSIONAL STATE803 reports
WEIGHT INCREASED795 reports
SINUSITIS773 reports
HYPERSENSITIVITY771 reports
ABDOMINAL DISCOMFORT767 reports
VOMITING755 reports
GASTROINTESTINAL DISORDER749 reports
ALOPECIA723 reports
SWELLING712 reports
CONTUSION670 reports
LOWER RESPIRATORY TRACT INFECTION663 reports
STOMATITIS660 reports
BLISTER651 reports
FOETAL EXPOSURE DURING PREGNANCY651 reports
IRRITABLE BOWEL SYNDROME650 reports
RHEUMATOID ARTHRITIS648 reports
IMPAIRED HEALING647 reports
INFUSION RELATED REACTION647 reports
DIZZINESS638 reports
FOLLICULITIS637 reports
HEPATIC ENZYME INCREASED618 reports
MUSCLE INJURY617 reports
DRUG WITHDRAWAL SYNDROME NEONATAL616 reports
ASTHENIA605 reports
ARTHROPATHY594 reports
MALAISE586 reports
DISCOMFORT577 reports
GLOSSODYNIA569 reports
HAND DEFORMITY565 reports
SYSTEMIC LUPUS ERYTHEMATOSUS565 reports
PEMPHIGUS557 reports
HELICOBACTER INFECTION556 reports
INSOMNIA556 reports
DRUG INTOLERANCE554 reports
PERICARDITIS553 reports
CONDITION AGGRAVATED548 reports
CHRONIC KIDNEY DISEASE544 reports
DUODENAL ULCER PERFORATION540 reports
PNEUMONIA537 reports
SYNOVITIS533 reports
HYPERTENSION527 reports
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE525 reports
WOUND523 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE521 reports
HYPERHIDROSIS520 reports
WEIGHT DECREASED519 reports
PAIN IN EXTREMITY500 reports
DECREASED APPETITE498 reports
THERAPEUTIC PRODUCT EFFECT DECREASED498 reports
FALL493 reports
BACK PAIN490 reports
DRUG HYPERSENSITIVITY472 reports
MATERNAL EXPOSURE DURING PREGNANCY465 reports
PRODUCT USE IN UNAPPROVED INDICATION465 reports
ABDOMINAL PAIN UPPER457 reports
CHEST PAIN457 reports
SLEEP DISORDER428 reports
CONSTIPATION427 reports
CONTRAINDICATED PRODUCT ADMINISTERED404 reports
DEVELOPMENTAL DELAY391 reports
ACUTE KIDNEY INJURY382 reports
EMOTIONAL DISTRESS376 reports
INJURY376 reports
MUSCULOSKELETAL STIFFNESS375 reports
HYPOAESTHESIA374 reports
GAIT DISTURBANCE373 reports
MUSCLE SPASMS372 reports
RENAL FAILURE370 reports
URTICARIA361 reports
LEARNING DISABILITY357 reports
SEDATION356 reports
GENERAL PHYSICAL HEALTH DETERIORATION354 reports
ASTHMA352 reports
PRODUCT USE ISSUE331 reports
NIGHTMARE328 reports
ABDOMINAL PAIN322 reports

Report Outcomes

Out of 22,681 classified reports for OXYCODONE AND ACETAMINOPHEN:

Serious 82.3%Non-Serious 17.7%

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

Female9,995 (54.8%)
Male8,242 (45.2%)
Unknown11 (0.1%)

Reports by Age

Age 44474 reports
Age 53376 reports
Age 58220 reports
Age 57212 reports
Age 66205 reports
Age 61201 reports
Age 54197 reports
Age 59197 reports
Age 64193 reports
Age 60191 reports
Age 50188 reports
Age 65184 reports
Age 62180 reports
Age 55177 reports
Age 63173 reports
Age 52167 reports
Age 70160 reports
Age 56159 reports
Age 69159 reports
Age 71159 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 AND ACETAMINOPHEN?

This profile reflects 80,165 FDA FAERS reports that mention OXYCODONE AND ACETAMINOPHEN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OXYCODONE AND ACETAMINOPHEN?

Frequently reported terms in FAERS include DEPENDENCE, OVERDOSE, ILL-DEFINED DISORDER, DRUG INEFFECTIVE, PAIN, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures OXYCODONE AND ACETAMINOPHEN?

Labeling and FAERS entries often list Par Health USA, LLC in connection with OXYCODONE AND ACETAMINOPHEN. 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.