ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

N/A

Manufactured by Kenvue Brands LLC

10,191 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

ACETAMINOPHEN AND 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 AND DIPHENHYDRAMINE HYDROCHLORIDE include FATIGUE, NAUSEA, DIARRHOEA, DIZZINESS, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE.

Top Adverse Reactions

FATIGUE449 reports
NAUSEA355 reports
DIARRHOEA284 reports
DIZZINESS259 reports
DRUG INEFFECTIVE252 reports
INSOMNIA244 reports
PAIN244 reports
HEADACHE237 reports
ASTHENIA207 reports
OFF LABEL USE205 reports
VOMITING205 reports
DYSPNOEA204 reports
TOXICITY TO VARIOUS AGENTS185 reports
FALL183 reports
ARTHRALGIA174 reports
COMPLETED SUICIDE168 reports
MALAISE148 reports
CONSTIPATION146 reports
WEIGHT DECREASED137 reports
DEATH136 reports
PAIN IN EXTREMITY132 reports
OVERDOSE128 reports
INTENTIONAL OVERDOSE123 reports
DECREASED APPETITE121 reports
SOMNOLENCE119 reports
PNEUMONIA118 reports
ANXIETY117 reports
PRURITUS113 reports
RASH106 reports
MUSCLE SPASMS102 reports
ABDOMINAL PAIN UPPER101 reports
COUGH101 reports
FEELING ABNORMAL101 reports
GAIT DISTURBANCE101 reports
BACK PAIN98 reports
DEPRESSION95 reports
PRODUCT USE IN UNAPPROVED INDICATION94 reports
INCORRECT DOSE ADMINISTERED93 reports
DRUG ADMINISTRATION ERROR90 reports
PERIPHERAL SWELLING89 reports
ACUTE HEPATIC FAILURE88 reports
CONDITION AGGRAVATED87 reports
BLOOD PRESSURE INCREASED86 reports
PYREXIA86 reports
SUICIDE ATTEMPT85 reports
URINARY TRACT INFECTION80 reports
WEIGHT INCREASED80 reports
ANAEMIA79 reports
HYPERTENSION78 reports
ABDOMINAL PAIN74 reports
HYPOTENSION72 reports
ABDOMINAL DISCOMFORT71 reports
DEHYDRATION71 reports
ACUTE KIDNEY INJURY70 reports
JOINT SWELLING70 reports
INTENTIONAL PRODUCT MISUSE69 reports
NASOPHARYNGITIS68 reports
DRUG DOSE OMISSION66 reports
PRODUCT USE ISSUE66 reports
PARAESTHESIA65 reports
TREMOR64 reports
CHEST PAIN63 reports
HYPOAESTHESIA63 reports
CONFUSIONAL STATE62 reports
WHITE BLOOD CELL COUNT DECREASED62 reports
PRODUCT DOSE OMISSION ISSUE61 reports
GASTROOESOPHAGEAL REFLUX DISEASE60 reports
MEMORY IMPAIRMENT60 reports
DYSPEPSIA59 reports
MUSCULAR WEAKNESS59 reports
OEDEMA PERIPHERAL59 reports
VISUAL IMPAIRMENT58 reports
ALOPECIA56 reports
INJECTION SITE PAIN56 reports
RENAL FAILURE56 reports
HAEMOGLOBIN DECREASED55 reports
MYALGIA55 reports
BLOOD GLUCOSE INCREASED54 reports
DRY MOUTH52 reports
GASTROINTESTINAL HAEMORRHAGE51 reports
SLEEP DISORDER51 reports
ARTHRITIS50 reports
HEART RATE INCREASED50 reports
LOSS OF CONSCIOUSNESS50 reports
NEUROPATHY PERIPHERAL50 reports
VISION BLURRED50 reports
ERYTHEMA49 reports
CHRONIC KIDNEY DISEASE48 reports
CONTUSION48 reports
PRODUCT ADMINISTRATION ERROR48 reports
DRUG HYPERSENSITIVITY47 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION47 reports
BALANCE DISORDER46 reports
CHILLS46 reports
HOT FLUSH46 reports
INFECTION46 reports
PLATELET COUNT DECREASED46 reports
HEPATIC ENZYME INCREASED45 reports
FLUSHING44 reports
FOETAL EXPOSURE DURING PREGNANCY44 reports

Report Outcomes

Out of 4,657 classified reports for ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE:

Serious 59.6%Non-Serious 40.4%

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

Female2,865 (65.7%)
Male1,491 (34.2%)
Unknown7 (0.2%)

Reports by Age

Age 7081 reports
Age 7479 reports
Age 6873 reports
Age 7173 reports
Age 7569 reports
Age 7869 reports
Age 6668 reports
Age 7368 reports
Age 6466 reports
Age 6265 reports
Age 7665 reports
Age 6764 reports
Age 5763 reports
Age 6363 reports
Age 7263 reports
Age 6961 reports
Age 7759 reports
Age 5554 reports
Age 5854 reports
Age 5352 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 DIPHENHYDRAMINE HYDROCHLORIDE?

This profile reflects 10,191 FDA FAERS reports that mention ACETAMINOPHEN AND 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 AND DIPHENHYDRAMINE HYDROCHLORIDE?

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

Who manufactures ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with ACETAMINOPHEN AND 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.