DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE

N/A

Manufactured by Kenvue Brands LLC

251 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE

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

Top Adverse Reactions

PRURITUS11 reports
RASH10 reports
FATIGUE8 reports
HEADACHE8 reports
VOMITING8 reports
DIZZINESS7 reports
PRODUCT USE IN UNAPPROVED INDICATION7 reports
URTICARIA6 reports
CONDITION AGGRAVATED5 reports
DRUG INEFFECTIVE5 reports
DRY SKIN5 reports
SOMNOLENCE5 reports
WEIGHT DECREASED5 reports
ARTHRALGIA4 reports
DIARRHOEA4 reports
ERYTHEMA4 reports
PNEUMONIA4 reports
SKIN HAEMORRHAGE4 reports
ABDOMINAL DISCOMFORT3 reports
ABDOMINAL PAIN UPPER3 reports
ANXIETY3 reports
BACK PAIN3 reports
DERMATITIS ATOPIC3 reports
ECZEMA3 reports
EXPIRED PRODUCT ADMINISTERED3 reports
NAUSEA3 reports
NECK PAIN3 reports
OFF LABEL USE3 reports
PRESYNCOPE3 reports
ANAEMIA2 reports
APPLICATION SITE PRURITUS2 reports
BLOOD ALBUMIN DECREASED2 reports
BLOOD PRESSURE DECREASED2 reports
CELLULITIS2 reports
CEREBROVASCULAR ACCIDENT2 reports
CHILLS2 reports
COUGH2 reports
DRUG HYPERSENSITIVITY2 reports
DYSPNOEA2 reports
DYSURIA2 reports
EPISTAXIS2 reports
GAIT DISTURBANCE2 reports
HAEMOGLOBIN INCREASED2 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION2 reports
INCORRECT DOSE ADMINISTERED2 reports
INJECTION SITE PAIN2 reports
INTENTIONAL PRODUCT MISUSE2 reports
LABORATORY TEST ABNORMAL2 reports
MALAISE2 reports
MEMORY IMPAIRMENT2 reports
MUSCULAR WEAKNESS2 reports
NASOPHARYNGITIS2 reports
NEUTROPHIL COUNT INCREASED2 reports
PAIN2 reports
PAIN IN JAW2 reports
PERIPHERAL SWELLING2 reports
PLATELET COUNT DECREASED2 reports
PRODUCT DOSE OMISSION ISSUE2 reports
RED BLOOD CELL COUNT DECREASED2 reports
SCRATCH2 reports
SKIN EXFOLIATION2 reports
SLEEP APNOEA SYNDROME2 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION2 reports
THERAPEUTIC RESPONSE UNEXPECTED2 reports
TREMOR2 reports
WHITE BLOOD CELL COUNT INCREASED2 reports
ABDOMINAL DISTENSION1 reports
ACCIDENTAL EXPOSURE TO PRODUCT1 reports
ACCIDENTAL POISONING1 reports
ACNE1 reports
ACUTE RESPIRATORY FAILURE1 reports
ADRENAL INSUFFICIENCY1 reports
ADVERSE DRUG REACTION1 reports
AMNESIA1 reports
ANISOCORIA1 reports
APPLICATION SITE BURN1 reports
APPLICATION SITE ERYTHEMA1 reports
APPLICATION SITE EXFOLIATION1 reports
APPLICATION SITE PAIN1 reports
APPLICATION SITE RASH1 reports
APPLICATION SITE SWELLING1 reports
APPLICATION SITE VESICLES1 reports
APPLICATION SITE WARMTH1 reports
ARTERIOSCLEROSIS1 reports
ARTHRITIS1 reports
ARTHROPATHY1 reports
ARTHROPOD BITE1 reports
ASPHYXIA1 reports
ASTHENIA1 reports
ATRIAL FIBRILLATION1 reports
AUTOIMMUNE DISORDER1 reports
BACK DISORDER1 reports
BALANCE DISORDER1 reports
BAND NEUTROPHIL COUNT INCREASED1 reports
BIOPSY COLON1 reports
BIOPSY LIVER1 reports
BIPOLAR DISORDER1 reports
BLOOD ALBUMIN INCREASED1 reports
BLOOD ALKALINE PHOSPHATASE INCREASED1 reports
BLOOD CHLORIDE DECREASED1 reports

Report Outcomes

Out of 71 classified reports for DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE:

Serious 47.9%Non-Serious 52.1%

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

Female41 (63.1%)
Male24 (36.9%)

Reports by Age

Age 573 reports
Age 823 reports
Age 462 reports
Age 502 reports
Age 602 reports
Age 722 reports
Age 782 reports
Age 832 reports
Age 21 reports
Age 71 reports
Age 101 reports
Age 241 reports
Age 291 reports
Age 301 reports
Age 361 reports
Age 371 reports
Age 401 reports
Age 431 reports
Age 481 reports
Age 521 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 DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE?

This profile reflects 251 FDA FAERS reports that mention DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE?

Frequently reported terms in FAERS include PRURITUS, RASH, FATIGUE, HEADACHE, VOMITING, DIZZINESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE. 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.