MID-VOLUME · FEMALE-LED
promethazine Side Effects
promethazine (also sold as Phenergan) sits MID-VOLUME #249 of 524 by FAERS report count. Lead signal: FEMALE-LED - 75% of sex-coded reports are female (12,671 F / 4,129 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 17,969
- FAERS reports
FDA Adverse Event Reporting System extract for promethazine. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
promethazine reporting skew - 75% of sex-coded reports are female (12,671 F / 4,129 M). Volume band MID-VOLUME #249 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for promethazine (Phenergan) (17,969 reports). Signature FEMALE-LED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (1996–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
NAUSEA leads 2,530 of 17,969 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (75% of sex-coded rows)
Age peak 45-64 (5,108 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,754 reports, 9.8%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 521 |
| NAUSEA | 213 |
| TOXICITY TO VARIOUS AGENTS | 204 |
| VOMITING | 172 |
| PNEUMONIA | 152 |
| FATIGUE | 140 |
| DYSPNOEA | 135 |
| ASTHENIA | 120 |
| CARDIAC ARREST | 116 |
| DIARRHOEA | 113 |
| SEPSIS | 112 |
| RENAL FAILURE | 111 |
| PAIN | 110 |
| HYPOTENSION | 106 |
| RESPIRATORY FAILURE | 94 |
| ANAEMIA | 91 |
| ABDOMINAL PAIN | 90 |
| PYREXIA | 85 |
| DECREASED APPETITE | 81 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (7,143, 39.8% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| NAUSEA | 1,057 |
| VOMITING | 903 |
| PAIN | 777 |
| DIARRHOEA | 615 |
| PNEUMONIA | 608 |
| DYSPNOEA | 602 |
| FATIGUE | 576 |
| ABDOMINAL PAIN | 506 |
| HEADACHE | 486 |
| PYREXIA | 484 |
| ANXIETY | 458 |
| DEHYDRATION | 451 |
| ASTHENIA | 442 |
| FALL | 379 |
| WEIGHT DECREASED | 355 |
| ANAEMIA | 350 |
| CHEST PAIN | 349 |
| DIZZINESS | 343 |
| URINARY TRACT INFECTION | 331 |
| MALAISE | 316 |
How to read promethazine FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 17,969 voluntary reports linked to promethazine (Phenergan), 1996-2025. Death is listed on 1,754 (9.8%). Hospitalization appears on 7,143 (39.8%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 75% of sex-coded reports are female (12,671 F / 4,129 M).
Read with promethazine
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 17,976 FAERS cases (Δ 7 heavier vs promethazine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 18,056 FAERS cases (Δ 87 heavier vs promethazine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 18,159 FAERS cases (Δ 190 heavier vs promethazine); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 17,740 FAERS cases (Δ 229 lighter vs promethazine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.3 pp vs promethazine's DEATH-HEAVY): CASELOAD · HOSP-MID.
promethazine stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.