ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE

N/A

Manufactured by Kenvue Brands LLC

9,511 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE

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

Top Adverse Reactions

FATIGUE409 reports
NAUSEA335 reports
DIARRHOEA274 reports
DIZZINESS255 reports
HEADACHE239 reports
INSOMNIA239 reports
DRUG INEFFECTIVE226 reports
PAIN219 reports
ASTHENIA207 reports
DYSPNOEA200 reports
VOMITING187 reports
OFF LABEL USE182 reports
FALL175 reports
CEREBROVASCULAR ACCIDENT158 reports
ARTHRALGIA153 reports
CONSTIPATION142 reports
MALAISE130 reports
WEIGHT DECREASED127 reports
DECREASED APPETITE118 reports
OVERDOSE118 reports
INTENTIONAL OVERDOSE115 reports
PAIN IN EXTREMITY115 reports
ANXIETY113 reports
PRURITUS112 reports
DEATH109 reports
RASH102 reports
FEELING ABNORMAL101 reports
SOMNOLENCE100 reports
ABDOMINAL PAIN UPPER99 reports
PNEUMONIA99 reports
COUGH97 reports
DEPRESSION97 reports
MUSCLE SPASMS96 reports
BACK PAIN94 reports
INCORRECT DOSE ADMINISTERED94 reports
GAIT DISTURBANCE92 reports
PRODUCT USE IN UNAPPROVED INDICATION91 reports
DRUG ADMINISTRATION ERROR89 reports
HYPERTENSION87 reports
ACUTE HEPATIC FAILURE86 reports
BLOOD PRESSURE INCREASED84 reports
PYREXIA80 reports
URINARY TRACT INFECTION78 reports
ANAEMIA76 reports
SUICIDE ATTEMPT75 reports
WEIGHT INCREASED75 reports
ACUTE KIDNEY INJURY73 reports
PERIPHERAL SWELLING73 reports
HYPOTENSION71 reports
ABDOMINAL PAIN70 reports
DEHYDRATION70 reports
ABDOMINAL DISCOMFORT68 reports
NASOPHARYNGITIS67 reports
CONDITION AGGRAVATED66 reports
CHEST PAIN65 reports
HYPOAESTHESIA64 reports
PRODUCT USE ISSUE64 reports
TREMOR63 reports
CONFUSIONAL STATE61 reports
DRUG DOSE OMISSION61 reports
PARAESTHESIA61 reports
TOXICITY TO VARIOUS AGENTS61 reports
LOSS OF CONSCIOUSNESS59 reports
MUSCULAR WEAKNESS59 reports
WHITE BLOOD CELL COUNT DECREASED59 reports
MEMORY IMPAIRMENT58 reports
PRODUCT DOSE OMISSION ISSUE58 reports
DRUG HYPERSENSITIVITY56 reports
DYSPEPSIA56 reports
HAEMOGLOBIN DECREASED56 reports
ALOPECIA55 reports
INJECTION SITE PAIN55 reports
GASTROOESOPHAGEAL REFLUX DISEASE54 reports
RENAL FAILURE54 reports
ERYTHEMA52 reports
MYALGIA52 reports
VISION BLURRED52 reports
DRY MOUTH50 reports
OEDEMA PERIPHERAL50 reports
BLOOD GLUCOSE INCREASED49 reports
GASTROINTESTINAL HAEMORRHAGE49 reports
JOINT SWELLING49 reports
ARTHRITIS48 reports
CHRONIC KIDNEY DISEASE48 reports
CONTUSION48 reports
HEART RATE INCREASED48 reports
NEUROPATHY PERIPHERAL48 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION47 reports
BALANCE DISORDER46 reports
INJURY46 reports
PRODUCT ADMINISTRATION ERROR46 reports
SLEEP DISORDER46 reports
AMNESIA45 reports
CHILLS45 reports
PLATELET COUNT DECREASED45 reports
VISUAL IMPAIRMENT44 reports
FLUSHING43 reports
FOETAL EXPOSURE DURING PREGNANCY43 reports
INTENTIONAL PRODUCT MISUSE43 reports
PULMONARY EMBOLISM43 reports

Report Outcomes

Out of 4,472 classified reports for ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE:

Serious 58.5%Non-Serious 41.5%

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

Female2,746 (65.5%)
Male1,438 (34.3%)
Unknown8 (0.2%)

Reports by Age

Age 7478 reports
Age 7174 reports
Age 7070 reports
Age 7370 reports
Age 7869 reports
Age 6867 reports
Age 7567 reports
Age 6666 reports
Age 6465 reports
Age 6360 reports
Age 6760 reports
Age 7660 reports
Age 7758 reports
Age 6957 reports
Age 5754 reports
Age 7253 reports
Age 5850 reports
Age 6547 reports
Age 7947 reports
Age 5646 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, DIPHENHYDRAMINE HYDROCHLORIDE?

This profile reflects 9,511 FDA FAERS reports that mention ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE?

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

Who manufactures ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE. 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.