ACETAMINOPHEN, DIPHENHYDRAMINE HCL

N/A

Manufactured by United Natural Foods, Inc. dba UNFI

782 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DIPHENHYDRAMINE HCL

ACETAMINOPHEN, DIPHENHYDRAMINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by United Natural Foods, Inc. dba UNFI. The most commonly reported adverse reactions for ACETAMINOPHEN, DIPHENHYDRAMINE HCL include FATIGUE, DRUG INEFFECTIVE, PAIN, HEADACHE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DIPHENHYDRAMINE HCL.

Top Adverse Reactions

FATIGUE31 reports
DRUG INEFFECTIVE27 reports
PAIN24 reports
HEADACHE20 reports
NAUSEA20 reports
MALAISE17 reports
DIZZINESS16 reports
INSOMNIA14 reports
WEIGHT DECREASED14 reports
ANXIETY13 reports
DIARRHOEA13 reports
PNEUMONIA13 reports
DEATH12 reports
DYSPNOEA12 reports
FALL12 reports
VOMITING12 reports
ANAEMIA11 reports
ARTHRALGIA11 reports
ASTHENIA11 reports
FEELING ABNORMAL10 reports
MUSCLE SPASMS10 reports
OFF LABEL USE10 reports
PYREXIA10 reports
BACK PAIN9 reports
BRONCHITIS9 reports
CYSTITIS9 reports
INFLUENZA9 reports
RENAL FAILURE9 reports
URINARY TRACT INFECTION9 reports
AMNESIA8 reports
BLOOD GLUCOSE INCREASED8 reports
CHRONIC KIDNEY DISEASE8 reports
CONSTIPATION8 reports
COUGH8 reports
DECREASED APPETITE8 reports
PAIN IN EXTREMITY8 reports
WEIGHT INCREASED8 reports
ABDOMINAL PAIN UPPER7 reports
ALOPECIA7 reports
BURNING SENSATION7 reports
CHEST PAIN7 reports
DEHYDRATION7 reports
DRUG DOSE OMISSION7 reports
HYPERTENSION7 reports
HYPOAESTHESIA7 reports
MYALGIA7 reports
NASOPHARYNGITIS7 reports
OVERDOSE7 reports
PARAESTHESIA7 reports
TREMOR7 reports
ACUTE KIDNEY INJURY6 reports
CHILLS6 reports
GASTROOESOPHAGEAL REFLUX DISEASE6 reports
HYPERSENSITIVITY6 reports
INJURY6 reports
SOMNOLENCE6 reports
STRESS6 reports
WHITE BLOOD CELL COUNT DECREASED6 reports
ABDOMINAL DISCOMFORT5 reports
ARTHROPATHY5 reports
ASTHMA5 reports
CONDITION AGGRAVATED5 reports
DRY MOUTH5 reports
EMOTIONAL DISTRESS5 reports
GASTROENTERITIS VIRAL5 reports
HALLUCINATION5 reports
INJECTION SITE PAIN5 reports
MYOCARDIAL INFARCTION5 reports
NEUROPATHY PERIPHERAL5 reports
OEDEMA PERIPHERAL5 reports
PRODUCT DOSE OMISSION ISSUE5 reports
PRODUCT USE IN UNAPPROVED INDICATION5 reports
SINUSITIS5 reports
SLEEP DISORDER5 reports
SPINAL FRACTURE5 reports
SWELLING5 reports
AGITATION4 reports
BLOOD PRESSURE INCREASED4 reports
CANDIDA INFECTION4 reports
COVID 194 reports
DISEASE PROGRESSION4 reports
DRUG ADMINISTRATION ERROR4 reports
ERYTHEMA4 reports
HAEMORRHAGE4 reports
HEART RATE INCREASED4 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION4 reports
INFECTION4 reports
LETHARGY4 reports
LIMB DISCOMFORT4 reports
MENTAL STATUS CHANGES4 reports
PERIPHERAL SWELLING4 reports
RASH4 reports
RHEUMATOID ARTHRITIS4 reports
SEPSIS4 reports
UPPER RESPIRATORY TRACT INFECTION4 reports
URINARY RETENTION4 reports
ABDOMINAL PAIN3 reports
ACUTE HEPATIC FAILURE3 reports
ARTHRITIS3 reports
ATAXIA3 reports

Report Outcomes

Out of 294 classified reports for ACETAMINOPHEN, DIPHENHYDRAMINE HCL:

Serious 51.7%Non-Serious 48.3%

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

Female184 (68.7%)
Male80 (29.9%)
Unknown4 (1.5%)

Reports by Age

Age 497 reports
Age 587 reports
Age 687 reports
Age 536 reports
Age 616 reports
Age 626 reports
Age 646 reports
Age 676 reports
Age 756 reports
Age 816 reports
Age 425 reports
Age 515 reports
Age 525 reports
Age 705 reports
Age 765 reports
Age 274 reports
Age 454 reports
Age 654 reports
Age 714 reports
Age 724 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 HCL?

This profile reflects 782 FDA FAERS reports that mention ACETAMINOPHEN, DIPHENHYDRAMINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

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

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

Who manufactures ACETAMINOPHEN, DIPHENHYDRAMINE HCL?

Labeling and FAERS entries often list United Natural Foods, Inc. dba UNFI in connection with ACETAMINOPHEN, 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.