ACETAMINOPHEN AND IBUPROFEN

N/A

Manufactured by AFT Pharmaceuticals US, Inc.

299 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN AND IBUPROFEN

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

Top Adverse Reactions

DRUG INEFFECTIVE44 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION29 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE27 reports
DRUG EFFECT LESS THAN EXPECTED15 reports
UNDERDOSE11 reports
OVERDOSE10 reports
INCORRECT DOSE ADMINISTERED9 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION8 reports
HYPERSENSITIVITY8 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION6 reports
OFF LABEL USE6 reports
DRUG HYPERSENSITIVITY5 reports
MALAISE4 reports
DIARRHOEA3 reports
FATIGUE3 reports
OROPHARYNGEAL PAIN3 reports
SOMNOLENCE3 reports
ABDOMINAL DISCOMFORT2 reports
ABDOMINAL PAIN UPPER2 reports
ANXIETY2 reports
ASTHENIA2 reports
CARDIAC FAILURE2 reports
CONSTIPATION2 reports
DEFAECATION URGENCY2 reports
DEPRESSION2 reports
DRUG DEPENDENCE2 reports
DYSPNOEA2 reports
EXTRA DOSE ADMINISTERED2 reports
FEELING ABNORMAL2 reports
HEADACHE2 reports
INCORRECT PRODUCT ADMINISTRATION DURATION2 reports
INJECTION SITE BRUISING2 reports
PRODUCT USE IN UNAPPROVED INDICATION2 reports
SINUSITIS2 reports
THERAPEUTIC PRODUCT EFFECT DECREASED2 reports
THERAPEUTIC PRODUCT EFFECT VARIABLE2 reports
THROAT IRRITATION2 reports
VOMITING2 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS2 reports
ABDOMINAL PAIN1 reports
ABNORMAL BEHAVIOUR1 reports
ABNORMAL DREAMS1 reports
ACUTE KIDNEY INJURY1 reports
ARTHRALGIA1 reports
BLOOD GLUCOSE INCREASED1 reports
BRAIN OEDEMA1 reports
CARDIAC DISORDER1 reports
CHRONIC RESPIRATORY FAILURE1 reports
CONDITION AGGRAVATED1 reports
CORNEAL PERFORATION1 reports
COUGH1 reports
COVID 191 reports
DIAPHRAGMATIC PARALYSIS1 reports
DISEASE RECURRENCE1 reports
DIZZINESS1 reports
DRUG SCREEN POSITIVE1 reports
DYSBIOSIS1 reports
DYSGEUSIA1 reports
DYSPEPSIA1 reports
EXPIRED PRODUCT ADMINISTERED1 reports
FEAR1 reports
FEELING DRUNK1 reports
FLATULENCE1 reports
GASTRITIS1 reports
GASTROENTERITIS VIRAL1 reports
GASTROINTESTINAL DISORDER1 reports
HAEMATOCHEZIA1 reports
HAEMORRHAGE1 reports
HALLUCINATION1 reports
HEPATIC FAILURE1 reports
HOSPITALISATION1 reports
INCREASED NEED FOR SLEEP1 reports
INFLUENZA LIKE ILLNESS1 reports
INJECTION SITE ERYTHEMA1 reports
INJECTION SITE PRURITUS1 reports
INJECTION SITE SWELLING1 reports
INJECTION SITE WARMTH1 reports
INSOMNIA1 reports
INTENTIONAL DOSE OMISSION1 reports
INTENTIONAL PRODUCT USE ISSUE1 reports
INTENTIONAL SELF INJURY1 reports
KERATITIS1 reports
LIVER DISORDER1 reports
LIVER INJURY1 reports
MOBILITY DECREASED1 reports
MOOD SWINGS1 reports
MUSCULOSKELETAL DISCOMFORT1 reports
NASAL CONGESTION1 reports
NASOPHARYNGITIS1 reports
NAUSEA1 reports
OBLITERATIVE BRONCHIOLITIS1 reports
PAIN1 reports
PALPITATIONS1 reports
PARAESTHESIA1 reports
PERICARDITIS1 reports
PNEUMOMEDIASTINUM1 reports
PNEUMONIA1 reports
PNEUMOTHORAX1 reports
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE1 reports
PRODUCT AFTER TASTE1 reports

Report Outcomes

Out of 208 classified reports for ACETAMINOPHEN AND IBUPROFEN:

Serious 7.7%Non-Serious 92.3%

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

Female39 (72.2%)
Male15 (27.8%)

Reports by Age

Age 322 reports
Age 582 reports
Age 782 reports
Age 41 reports
Age 111 reports
Age 121 reports
Age 161 reports
Age 181 reports
Age 241 reports
Age 301 reports
Age 351 reports
Age 371 reports
Age 391 reports
Age 521 reports
Age 551 reports
Age 611 reports
Age 631 reports
Age 681 reports
Age 691 reports
Age 751 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 IBUPROFEN?

This profile reflects 299 FDA FAERS reports that mention ACETAMINOPHEN AND IBUPROFEN. Reporting is voluntary and does not prove that the drug caused any listed event.

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

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

Who manufactures ACETAMINOPHEN AND IBUPROFEN?

Labeling and FAERS entries often list AFT Pharmaceuticals US, Inc. in connection with ACETAMINOPHEN AND 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.