ACETAMINOPHEN AND CODEINE

N/A

Manufactured by Amneal Pharmaceuticals LLC

113,152 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ACETAMINOPHEN AND CODEINE

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

Top Adverse Reactions

DEPENDENCE3,690 reports
OVERDOSE2,108 reports
PAIN1,956 reports
DRUG INEFFECTIVE1,889 reports
FATIGUE1,856 reports
ARTHRALGIA1,667 reports
RHEUMATOID ARTHRITIS1,566 reports
RASH1,545 reports
OFF LABEL USE1,537 reports
JOINT SWELLING1,500 reports
CONFUSIONAL STATE1,484 reports
PERIPHERAL SWELLING1,415 reports
ARTHROPATHY1,408 reports
ABDOMINAL DISCOMFORT1,399 reports
HEPATIC ENZYME INCREASED1,399 reports
BLISTER1,390 reports
ALOPECIA1,389 reports
NASOPHARYNGITIS1,386 reports
SWELLING1,376 reports
DRUG INTOLERANCE1,367 reports
INFUSION RELATED REACTION1,364 reports
DUODENAL ULCER PERFORATION1,362 reports
HELICOBACTER INFECTION1,356 reports
DYSPNOEA1,355 reports
STOMATITIS1,353 reports
SYSTEMIC LUPUS ERYTHEMATOSUS1,350 reports
FOLLICULITIS1,340 reports
HYPERSENSITIVITY1,340 reports
PERICARDITIS1,330 reports
PEMPHIGUS1,322 reports
SYNOVITIS1,318 reports
HAND DEFORMITY1,305 reports
WEIGHT INCREASED1,304 reports
LOWER RESPIRATORY TRACT INFECTION1,296 reports
IMPAIRED HEALING1,291 reports
GLOSSODYNIA1,279 reports
IRRITABLE BOWEL SYNDROME1,279 reports
MUSCLE INJURY1,251 reports
ANTI CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE1,246 reports
CONDITION AGGRAVATED1,212 reports
PYREXIA1,204 reports
WOUND1,195 reports
HEADACHE1,165 reports
GASTROINTESTINAL DISORDER1,155 reports
DIARRHOEA1,144 reports
NAUSEA1,133 reports
ILL DEFINED DISORDER1,122 reports
INFECTION1,103 reports
DISCOMFORT1,099 reports
VOMITING1,070 reports
CONTRAINDICATED PRODUCT ADMINISTERED1,056 reports
MATERNAL EXPOSURE DURING PREGNANCY1,046 reports
GENERAL PHYSICAL HEALTH DETERIORATION1,045 reports
PRURITUS1,037 reports
DEPRESSION1,014 reports
HYPERTENSION1,009 reports
DIZZINESS1,006 reports
ABDOMINAL PAIN UPPER993 reports
CONTUSION979 reports
THERAPEUTIC PRODUCT EFFECT DECREASED977 reports
SINUSITIS968 reports
DRUG HYPERSENSITIVITY960 reports
ASTHENIA955 reports
FIBROMYALGIA950 reports
MALAISE937 reports
BLOOD CHOLESTEROL INCREASED934 reports
HYPOAESTHESIA920 reports
MUSCULOSKELETAL STIFFNESS893 reports
PSORIATIC ARTHROPATHY892 reports
MOBILITY DECREASED874 reports
URTICARIA869 reports
DEATH866 reports
TREATMENT FAILURE866 reports
BURSITIS855 reports
INJURY847 reports
TYPE 2 DIABETES MELLITUS829 reports
JOINT RANGE OF MOTION DECREASED818 reports
PNEUMONIA813 reports
SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE806 reports
WHEEZING806 reports
SLEEP DISORDER799 reports
LIVER INJURY772 reports
INTENTIONAL PRODUCT USE ISSUE764 reports
PAIN IN EXTREMITY763 reports
DRY MOUTH755 reports
PRODUCT USE IN UNAPPROVED INDICATION755 reports
OSTEOARTHRITIS747 reports
RHEUMATIC FEVER743 reports
PRODUCT USE ISSUE738 reports
INSOMNIA709 reports
MUSCULOSKELETAL PAIN703 reports
INFLAMMATION695 reports
FACET JOINT SYNDROME692 reports
PARAESTHESIA690 reports
DECREASED APPETITE686 reports
MUSCLE SPASMS680 reports
MEMORY IMPAIRMENT679 reports
ANXIETY674 reports
GAIT INABILITY662 reports
WOUND INFECTION656 reports

Report Outcomes

Out of 11,712 classified reports for ACETAMINOPHEN AND CODEINE:

Serious 92.4%Non-Serious 7.6%

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

Female7,121 (67.2%)
Male3,475 (32.8%)
Unknown1 (0.0%)

Reports by Age

Age 44723 reports
Age 43603 reports
Age 40396 reports
Age 45137 reports
Age 59124 reports
Age 53121 reports
Age 54119 reports
Age 55119 reports
Age 65107 reports
Age 77102 reports
Age 5889 reports
Age 5088 reports
Age 5282 reports
Age 5782 reports
Age 6482 reports
Age 7178 reports
Age 7478 reports
Age 5175 reports
Age 6374 reports
Age 5673 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 ACETAMINOPHEN AND CODEINE?

This profile reflects 113,152 FDA FAERS reports that mention ACETAMINOPHEN AND CODEINE. Reporting is voluntary and does not prove that the drug caused any listed event.

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

Frequently reported terms in FAERS include DEPENDENCE, OVERDOSE, PAIN, DRUG INEFFECTIVE, FATIGUE, ARTHRALGIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN AND CODEINE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with ACETAMINOPHEN AND CODEINE. 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.