IBUPROFEN, DIPHENHYDRAMINE HCL

N/A

Manufactured by CVS Pharmacy

180 FDA adverse event reports analyzed

Last updated: 2026-04-15

About IBUPROFEN, DIPHENHYDRAMINE HCL

IBUPROFEN, DIPHENHYDRAMINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS Pharmacy. The most commonly reported adverse reactions for IBUPROFEN, DIPHENHYDRAMINE HCL include FATIGUE, NAUSEA, ABDOMINAL DISTENSION, CONSTIPATION, HYPOAESTHESIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IBUPROFEN, DIPHENHYDRAMINE HCL.

Top Adverse Reactions

FATIGUE9 reports
NAUSEA9 reports
ABDOMINAL DISTENSION5 reports
CONSTIPATION4 reports
HYPOAESTHESIA4 reports
INSOMNIA4 reports
JOINT SWELLING4 reports
PAIN4 reports
ABDOMINAL PAIN3 reports
ARTHRITIS3 reports
ARTHROPATHY3 reports
COLD SWEAT3 reports
DIARRHOEA3 reports
DIZZINESS3 reports
HEADACHE3 reports
HOT FLUSH3 reports
MALAISE3 reports
PARAESTHESIA3 reports
PERIPHERAL SWELLING3 reports
PRURITUS3 reports
VOMITING3 reports
ALOPECIA2 reports
ARTHRALGIA2 reports
CEREBROVASCULAR ACCIDENT2 reports
CHEST DISCOMFORT2 reports
DRUG EFFECT DECREASED2 reports
DRY MOUTH2 reports
FEELING ABNORMAL2 reports
FLUSHING2 reports
HERPES ZOSTER2 reports
HYPERSENSITIVITY2 reports
IMPAIRED WORK ABILITY2 reports
OFF LABEL USE2 reports
PAIN IN EXTREMITY2 reports
PALLOR2 reports
PRODUCT DOSE OMISSION2 reports
SEIZURE2 reports
SOMNOLENCE2 reports
UPPER RESPIRATORY TRACT INFECTION2 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS2 reports
ABDOMINAL DISCOMFORT1 reports
ACCIDENTAL EXPOSURE TO PRODUCT1 reports
ACNE1 reports
ACUTE KIDNEY INJURY1 reports
ANAEMIA1 reports
ASCITES1 reports
BACK DISORDER1 reports
BACK INJURY1 reports
BALANCE DISORDER1 reports
BLINDNESS UNILATERAL1 reports
BLOOD GLUCOSE INCREASED1 reports
BLOOD PRESSURE ABNORMAL1 reports
BONE PAIN1 reports
BRONCHITIS1 reports
BURNING SENSATION1 reports
CERVICAL RADICULOPATHY1 reports
CHEST PAIN1 reports
CHILLS1 reports
CHRONIC KIDNEY DISEASE1 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR1 reports
COGNITIVE DISORDER1 reports
COLITIS1 reports
COMMUNICATION DISORDER1 reports
CONDITION AGGRAVATED1 reports
CONFUSIONAL STATE1 reports
COVID 191 reports
CRYING1 reports
CYSTITIS1 reports
DEVICE DISLOCATION1 reports
DEVICE LEAKAGE1 reports
DISEASE PROGRESSION1 reports
DISORIENTATION1 reports
DISTURBANCE IN ATTENTION1 reports
DRUG ABUSE1 reports
DRUG EFFECT PROLONGED1 reports
DRUG INEFFECTIVE1 reports
DRY SKIN1 reports
DUODENAL ULCER1 reports
DYSGEUSIA1 reports
ENDODONTIC PROCEDURE1 reports
EYE DISORDER1 reports
FALL1 reports
FOETAL EXPOSURE DURING PREGNANCY1 reports
GAIT DISTURBANCE1 reports
GAIT INABILITY1 reports
GASTRIC ULCER1 reports
GASTRIC ULCER HAEMORRHAGE1 reports
GASTRITIS1 reports
GASTROINTESTINAL HAEMORRHAGE1 reports
GASTROOESOPHAGEAL REFLUX DISEASE1 reports
HAEMORRHAGIC ANAEMIA1 reports
HALLUCINATION1 reports
HEART RATE INCREASED1 reports
HERNIA1 reports
HIATUS HERNIA1 reports
HYPERTHYROIDISM1 reports
HYPOAESTHESIA ORAL1 reports
IMPAIRED GASTRIC EMPTYING1 reports
IMPLANT SITE PAIN1 reports
INJECTION SITE BRUISING1 reports

Report Outcomes

Out of 69 classified reports for IBUPROFEN, DIPHENHYDRAMINE HCL:

Serious 43.5%Non-Serious 56.5%

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

Female40 (62.5%)
Male23 (35.9%)
Unknown1 (1.6%)

Reports by Age

Age 604 reports
Age 654 reports
Age 553 reports
Age 593 reports
Age 683 reports
Age 412 reports
Age 572 reports
Age 582 reports
Age 321 reports
Age 331 reports
Age 341 reports
Age 351 reports
Age 391 reports
Age 491 reports
Age 511 reports
Age 611 reports
Age 621 reports
Age 631 reports
Age 641 reports
Age 661 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, DIPHENHYDRAMINE HCL?

This profile reflects 180 FDA FAERS reports that mention IBUPROFEN, DIPHENHYDRAMINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IBUPROFEN, DIPHENHYDRAMINE HCL?

Frequently reported terms in FAERS include FATIGUE, NAUSEA, ABDOMINAL DISTENSION, CONSTIPATION, HYPOAESTHESIA, INSOMNIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures IBUPROFEN, DIPHENHYDRAMINE HCL?

Labeling and FAERS entries often list CVS Pharmacy in connection with IBUPROFEN, DIPHENHYDRAMINE HCL. 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.