ACETAMINOPHEN, IBUPROFEN

N/A

Manufactured by WALGREENS

567 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, IBUPROFEN

ACETAMINOPHEN, IBUPROFEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by WALGREENS. The most commonly reported adverse reactions for ACETAMINOPHEN, IBUPROFEN include DRUG INEFFECTIVE, DRUG EFFECTIVE FOR UNAPPROVED INDICATION, THERAPEUTIC PRODUCT EFFECT INCOMPLETE, DRUG EFFECT LESS THAN EXPECTED, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, IBUPROFEN.

Top Adverse Reactions

DRUG INEFFECTIVE56 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION29 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE29 reports
DRUG EFFECT LESS THAN EXPECTED15 reports
DIARRHOEA14 reports
OFF LABEL USE14 reports
FATIGUE13 reports
MALAISE13 reports
CONSTIPATION12 reports
OVERDOSE11 reports
UNDERDOSE11 reports
PAIN10 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION9 reports
HEADACHE9 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION9 reports
INCORRECT DOSE ADMINISTERED9 reports
DRUG HYPERSENSITIVITY8 reports
GAIT DISTURBANCE8 reports
HYPERSENSITIVITY8 reports
PRODUCT DOSE OMISSION ISSUE8 reports
BACK PAIN7 reports
COVID 197 reports
NAUSEA7 reports
SOMNOLENCE7 reports
VOMITING7 reports
ARTHRALGIA6 reports
CONDITION AGGRAVATED6 reports
COUGH6 reports
DYSPNOEA6 reports
MOBILITY DECREASED6 reports
URINARY TRACT INFECTION6 reports
ASTHENIA5 reports
DIZZINESS5 reports
MUSCULOSKELETAL STIFFNESS5 reports
PAIN IN EXTREMITY5 reports
PNEUMONIA5 reports
PRURITUS5 reports
WEIGHT DECREASED5 reports
ABDOMINAL DISCOMFORT4 reports
ABDOMINAL PAIN4 reports
BALANCE DISORDER4 reports
DEATH4 reports
DEPRESSION4 reports
DISEASE RECURRENCE4 reports
FALL4 reports
FEELING ABNORMAL4 reports
INSOMNIA4 reports
MYALGIA4 reports
PARAESTHESIA4 reports
RASH4 reports
SLEEP DISORDER4 reports
ALOPECIA3 reports
CARDIAC FAILURE3 reports
DECREASED APPETITE3 reports
DRUG DEPENDENCE3 reports
DYSPEPSIA3 reports
EXTRA DOSE ADMINISTERED3 reports
HALLUCINATION3 reports
INFECTION3 reports
MEMORY IMPAIRMENT3 reports
MUSCULAR WEAKNESS3 reports
OROPHARYNGEAL PAIN3 reports
PRODUCT ADHESION ISSUE3 reports
PRODUCT QUALITY ISSUE3 reports
PYREXIA3 reports
SURGERY3 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS3 reports
ABDOMINAL PAIN UPPER2 reports
ANAEMIA2 reports
ANXIETY2 reports
ARRHYTHMIA2 reports
ARTHRITIS2 reports
BLOOD URINE PRESENT2 reports
BRONCHITIS2 reports
CENTRAL NERVOUS SYSTEM LESION2 reports
CHEST PAIN2 reports
CHILLS2 reports
CYSTITIS2 reports
DEFAECATION URGENCY2 reports
DEHYDRATION2 reports
DISCOMFORT2 reports
DISORIENTATION2 reports
DRUG ABUSE2 reports
DRY EYE2 reports
DYSGEUSIA2 reports
DYSURIA2 reports
EXPIRED PRODUCT ADMINISTERED2 reports
FAECES HARD2 reports
FLATULENCE2 reports
GASTRIC DISORDER2 reports
GASTROINTESTINAL HAEMORRHAGE2 reports
HERPES ZOSTER2 reports
HIATUS HERNIA2 reports
HIP FRACTURE2 reports
HOSPITALISATION2 reports
HOT FLUSH2 reports
HYPERTENSION2 reports
HYPOTENSION2 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION2 reports
INCORRECT PRODUCT ADMINISTRATION DURATION2 reports

Report Outcomes

Out of 347 classified reports for ACETAMINOPHEN, IBUPROFEN:

Serious 25.1%Non-Serious 74.9%

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

Female131 (72.0%)
Male51 (28.0%)

Reports by Age

Age 606 reports
Age 686 reports
Age 695 reports
Age 785 reports
Age 444 reports
Age 524 reports
Age 674 reports
Age 794 reports
Age 223 reports
Age 513 reports
Age 573 reports
Age 583 reports
Age 723 reports
Age 813 reports
Age 182 reports
Age 292 reports
Age 302 reports
Age 322 reports
Age 352 reports
Age 372 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, IBUPROFEN?

This profile reflects 567 FDA FAERS reports that mention ACETAMINOPHEN, IBUPROFEN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, IBUPROFEN?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRUG EFFECTIVE FOR UNAPPROVED INDICATION, THERAPEUTIC PRODUCT EFFECT INCOMPLETE, DRUG EFFECT LESS THAN EXPECTED, DIARRHOEA, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, IBUPROFEN?

Labeling and FAERS entries often list WALGREENS in connection with ACETAMINOPHEN, IBUPROFEN. 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.