DIPHENHYDRAMINE HCL

N/A

Manufactured by Meijer Distribution Inc

24,504 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DIPHENHYDRAMINE HCL

DIPHENHYDRAMINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Meijer Distribution Inc. The most commonly reported adverse reactions for DIPHENHYDRAMINE HCL include COMPLETED SUICIDE, DEATH, FATIGUE, NAUSEA, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DIPHENHYDRAMINE HCL.

Top Adverse Reactions

COMPLETED SUICIDE768 reports
DEATH678 reports
FATIGUE643 reports
NAUSEA631 reports
PAIN554 reports
DIARRHOEA519 reports
DYSPNOEA517 reports
HEADACHE500 reports
DRUG INEFFECTIVE492 reports
INFUSION RELATED REACTION475 reports
ARTHRALGIA467 reports
VOMITING424 reports
RASH402 reports
PYREXIA398 reports
TOXICITY TO VARIOUS AGENTS392 reports
BLOOD PRESSURE INCREASED381 reports
PNEUMONIA367 reports
HYPOTENSION366 reports
CARDIAC ARREST362 reports
OFF LABEL USE336 reports
DIZZINESS335 reports
ASTHENIA331 reports
WEIGHT DECREASED324 reports
DRUG HYPERSENSITIVITY316 reports
COUGH307 reports
WEIGHT INCREASED307 reports
PRURITUS304 reports
FALL299 reports
ANXIETY294 reports
RESPIRATORY ARREST291 reports
CARDIO RESPIRATORY ARREST286 reports
OXYGEN SATURATION DECREASED281 reports
PAIN IN EXTREMITY281 reports
MALAISE278 reports
DRUG TOXICITY270 reports
BACK PAIN250 reports
INSOMNIA250 reports
HYPERTENSION248 reports
NASOPHARYNGITIS246 reports
OVERDOSE246 reports
RHEUMATOID ARTHRITIS245 reports
SOMNOLENCE230 reports
HEART RATE INCREASED220 reports
ABDOMINAL PAIN211 reports
CHEST PAIN198 reports
DEPRESSION198 reports
TACHYCARDIA197 reports
DRUG ABUSE195 reports
ANAEMIA187 reports
URINARY TRACT INFECTION185 reports
DECREASED APPETITE182 reports
ERYTHEMA181 reports
CONSTIPATION175 reports
CHILLS173 reports
SEPSIS165 reports
RENAL FAILURE164 reports
TREMOR164 reports
NEUTROPENIA163 reports
WHITE BLOOD CELL COUNT DECREASED163 reports
JOINT SWELLING162 reports
HYPERSENSITIVITY160 reports
LOSS OF CONSCIOUSNESS160 reports
ABDOMINAL PAIN UPPER158 reports
CONFUSIONAL STATE158 reports
DEHYDRATION158 reports
SINUSITIS157 reports
MUSCLE SPASMS149 reports
GAIT DISTURBANCE148 reports
URTICARIA147 reports
DRUG INTERACTION146 reports
FEELING ABNORMAL145 reports
FLUSHING144 reports
PLATELET COUNT DECREASED144 reports
HAEMOGLOBIN DECREASED140 reports
PULMONARY OEDEMA138 reports
THROMBOCYTOPENIA138 reports
BRONCHITIS137 reports
BLOOD PRESSURE FLUCTUATION135 reports
INFECTION134 reports
FEBRILE NEUTROPENIA133 reports
DIABETES MELLITUS129 reports
BLOOD PRESSURE SYSTOLIC INCREASED127 reports
CONDITION AGGRAVATED127 reports
INTENTIONAL OVERDOSE127 reports
OEDEMA PERIPHERAL127 reports
INFLUENZA126 reports
AGITATION125 reports
MULTIPLE DRUG OVERDOSE121 reports
CONVULSION120 reports
PERIPHERAL SWELLING120 reports
ALOPECIA118 reports
BLOOD GLUCOSE INCREASED118 reports
PARAESTHESIA118 reports
HYPERHIDROSIS117 reports
HYPOAESTHESIA117 reports
MUSCULOSKELETAL STIFFNESS117 reports
ACCIDENTAL OVERDOSE114 reports
HEART RATE DECREASED114 reports
MYALGIA111 reports
CHEST DISCOMFORT108 reports

Report Outcomes

Out of 10,769 classified reports for DIPHENHYDRAMINE HCL:

Serious 79.3%Non-Serious 20.7%

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

Female5,964 (59.9%)
Male3,912 (39.3%)
Unknown85 (0.9%)

Reports by Age

Age 61197 reports
Age 60185 reports
Age 59172 reports
Age 55163 reports
Age 51162 reports
Age 58162 reports
Age 64158 reports
Age 44157 reports
Age 49156 reports
Age 57155 reports
Age 62155 reports
Age 56154 reports
Age 50151 reports
Age 45149 reports
Age 65147 reports
Age 67143 reports
Age 48141 reports
Age 53137 reports
Age 54136 reports
Age 66135 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 HCL?

This profile reflects 24,504 FDA FAERS reports that mention DIPHENHYDRAMINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DIPHENHYDRAMINE HCL?

Frequently reported terms in FAERS include COMPLETED SUICIDE, DEATH, FATIGUE, NAUSEA, PAIN, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DIPHENHYDRAMINE HCL?

Labeling and FAERS entries often list Meijer Distribution Inc in connection with 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.