HIGH-VOLUME · HOSP-HEAVY
diphenhydramine Side Effects
diphenhydramine (also sold as Benadryl) is HIGH-VOLUME in this FAERS book #121 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 32.3% mention hospitalization (19,529 reports).
Data updated 2026-05-15
- 60,533
- FAERS reports
FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
diphenhydramine: 32.3% mention hospitalization (19,529 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #121 of 524 by FAERS report count.
High-report extract for diphenhydramine (Benadryl): 60,533 FAERS rows (2003-2025). Top named reactions: HEADACHE, FATIGUE, NAUSEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2003–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
HEADACHE leads 5,138 of 60,533 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (13,785 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (11,360 reports, 18.8%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 2,805 |
| TOXICITY TO VARIOUS AGENTS | 2,776 |
| DEATH | 2,291 |
| DRUG ABUSE | 1,610 |
| CARDIO-RESPIRATORY ARREST | 781 |
| CARDIAC ARREST | 677 |
| OVERDOSE | 550 |
| RESPIRATORY ARREST | 472 |
| PNEUMONIA | 452 |
| FATIGUE | 444 |
| DYSPNOEA | 358 |
| PAIN | 356 |
| PYREXIA | 355 |
| HEADACHE | 334 |
| HYPERTENSION | 321 |
| NAUSEA | 300 |
| INTENTIONAL PRODUCT MISUSE | 297 |
| INFUSION RELATED REACTION | 289 |
| VOMITING | 282 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (19,529, 32.3% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| PNEUMONIA | 2,033 |
| NAUSEA | 1,772 |
| FATIGUE | 1,710 |
| PYREXIA | 1,663 |
| HEADACHE | 1,627 |
| PAIN | 1,539 |
| DYSPNOEA | 1,534 |
| MALAISE | 1,283 |
| VOMITING | 1,224 |
| ARTHRALGIA | 1,223 |
| FEBRILE NEUTROPENIA | 1,211 |
| DIARRHOEA | 1,199 |
| WEIGHT DECREASED | 1,191 |
| COVID-19 | 1,159 |
| INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 1,153 |
| FALL | 1,148 |
| SINUSITIS | 1,098 |
| CONDITION AGGRAVATED | 1,061 |
How to read diphenhydramine FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 60,533 voluntary reports linked to diphenhydramine (Benadryl), 2003-2025. Death is listed on 11,360 (18.8%). Hospitalization appears on 19,529 (32.3%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with diphenhydramine
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 59,560 FAERS cases (Δ 973 lighter vs diphenhydramine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 61,536 FAERS cases (Δ 1,003 heavier vs diphenhydramine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 61,560 FAERS cases (Δ 1,027 heavier vs diphenhydramine); DEATH-MARKED · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 59,013 FAERS cases (Δ 1,520 lighter vs diphenhydramine); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 43.3 pp vs diphenhydramine's DEATH-HEAVY): CASELOAD · HOSP-MID.
diphenhydramine stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.