IBUPROFEN AND DIPHENHYDRAMINE CITRATE

N/A

Manufactured by Kenvue Brands LLC

50,486 FDA adverse event reports analyzed

Last updated: 2026-04-14

About IBUPROFEN AND DIPHENHYDRAMINE CITRATE

IBUPROFEN AND DIPHENHYDRAMINE CITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. The most commonly reported adverse reactions for IBUPROFEN AND DIPHENHYDRAMINE CITRATE include DRUG INEFFECTIVE, PAIN, NAUSEA, HEADACHE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IBUPROFEN AND DIPHENHYDRAMINE CITRATE.

Top Adverse Reactions

DRUG INEFFECTIVE2,792 reports
PAIN1,945 reports
NAUSEA1,783 reports
HEADACHE1,714 reports
FATIGUE1,399 reports
DIZZINESS1,215 reports
VOMITING1,082 reports
ANXIETY1,063 reports
DRUG HYPERSENSITIVITY1,043 reports
DIARRHOEA922 reports
DYSPNOEA876 reports
ARTHRALGIA872 reports
INSOMNIA829 reports
OFF LABEL USE797 reports
SOMNOLENCE755 reports
PAIN IN EXTREMITY752 reports
INJURY704 reports
DEPRESSION699 reports
ABDOMINAL DISCOMFORT669 reports
FEELING ABNORMAL663 reports
BACK PAIN652 reports
ABDOMINAL PAIN UPPER649 reports
RASH642 reports
MALAISE625 reports
WEIGHT DECREASED624 reports
PYREXIA606 reports
ASTHENIA601 reports
ABDOMINAL PAIN595 reports
PULMONARY EMBOLISM587 reports
DECREASED APPETITE581 reports
CHEST PAIN569 reports
PRODUCT USE IN UNAPPROVED INDICATION568 reports
DEEP VEIN THROMBOSIS565 reports
FALL551 reports
EMOTIONAL DISTRESS511 reports
HYPERTENSION451 reports
PRURITUS431 reports
OVERDOSE422 reports
CONSTIPATION418 reports
GAIT DISTURBANCE409 reports
CONDITION AGGRAVATED391 reports
ERYTHEMA390 reports
HYPOAESTHESIA390 reports
COUGH388 reports
MUSCLE SPASMS375 reports
HYPERSENSITIVITY360 reports
ALOPECIA344 reports
OEDEMA PERIPHERAL339 reports
WEIGHT INCREASED338 reports
PARAESTHESIA334 reports
URTICARIA334 reports
PERIPHERAL SWELLING326 reports
GENERAL PHYSICAL HEALTH DETERIORATION325 reports
PRODUCT USE ISSUE323 reports
URINARY TRACT INFECTION322 reports
PNEUMONIA319 reports
DYSPEPSIA307 reports
INCORRECT DOSE ADMINISTERED304 reports
TREMOR300 reports
ANAEMIA298 reports
MYALGIA293 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION287 reports
CHOLECYSTITIS CHRONIC285 reports
EAR INFECTION282 reports
JOINT SWELLING278 reports
MUSCULOSKELETAL STIFFNESS277 reports
CHOLELITHIASIS273 reports
VISION BLURRED272 reports
CEREBROVASCULAR ACCIDENT270 reports
ARTHROPATHY268 reports
DEHYDRATION268 reports
BLOOD PRESSURE INCREASED263 reports
CONFUSIONAL STATE262 reports
GASTROOESOPHAGEAL REFLUX DISEASE262 reports
INJECTION SITE PAIN262 reports
MIGRAINE260 reports
RENAL FAILURE258 reports
MYOCARDIAL INFARCTION256 reports
PALPITATIONS256 reports
DRUG INTOLERANCE255 reports
PHARYNGITIS255 reports
ASPARTATE AMINOTRANSFERASE INCREASED252 reports
DEATH252 reports
GASTROINTESTINAL HAEMORRHAGE252 reports
RHEUMATOID ARTHRITIS247 reports
HYPERHIDROSIS246 reports
ALANINE AMINOTRANSFERASE INCREASED243 reports
DYSPHAGIA241 reports
CHILLS236 reports
PRODUCT QUALITY ISSUE234 reports
NASOPHARYNGITIS232 reports
INTENTIONAL PRODUCT MISUSE228 reports
GASTROINTESTINAL DISORDER227 reports
ARTHRITIS226 reports
HEART RATE INCREASED224 reports
MEMORY IMPAIRMENT222 reports
CHRONIC KIDNEY DISEASE215 reports
INFECTION211 reports
MUSCULAR WEAKNESS209 reports
NECK PAIN209 reports

Report Outcomes

Out of 22,913 classified reports for IBUPROFEN AND DIPHENHYDRAMINE CITRATE:

Serious 49.4%Non-Serious 50.6%

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

Female14,743 (71.4%)
Male5,796 (28.1%)
Unknown112 (0.5%)

Reports by Age

Age 58308 reports
Age 57302 reports
Age 60288 reports
Age 54285 reports
Age 41282 reports
Age 55278 reports
Age 50272 reports
Age 56272 reports
Age 62256 reports
Age 51254 reports
Age 46246 reports
Age 53246 reports
Age 52241 reports
Age 49240 reports
Age 63240 reports
Age 61237 reports
Age 48230 reports
Age 64229 reports
Age 45228 reports
Age 65223 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 IBUPROFEN AND DIPHENHYDRAMINE CITRATE?

This profile reflects 50,486 FDA FAERS reports that mention IBUPROFEN AND DIPHENHYDRAMINE CITRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IBUPROFEN AND DIPHENHYDRAMINE CITRATE?

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

Who manufactures IBUPROFEN AND DIPHENHYDRAMINE CITRATE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with IBUPROFEN AND DIPHENHYDRAMINE CITRATE. 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.