MID-VOLUME · FEMALE-LED
amitriptyline Side Effects
amitriptyline (also sold as Elavil) sits MID-VOLUME #258 of 524 by FAERS report count. Lead signal: FEMALE-LED - 71% of sex-coded reports are female (10,711 F / 4,363 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 16,403
- FAERS reports
FDA Adverse Event Reporting System extract for amitriptyline. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
amitriptyline reporting skew - 71% of sex-coded reports are female (10,711 F / 4,363 M). Volume band MID-VOLUME #258 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for amitriptyline (Elavil) (16,403 reports). Signature FEMALE-LED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
PAIN leads 1,565 of 16,403 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (71% of sex-coded rows)
Age peak 45-64 (4,766 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,235 reports, 7.5%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 264 |
| DEATH | 210 |
| TOXICITY TO VARIOUS AGENTS | 155 |
| CARDIO-RESPIRATORY ARREST | 104 |
| PNEUMONIA | 58 |
| DRUG ABUSE | 55 |
| CARDIAC ARREST | 54 |
| FATIGUE | 54 |
| PYREXIA | 50 |
| DYSPNOEA | 49 |
| OVERDOSE | 48 |
| CONFUSIONAL STATE | 46 |
| VOMITING | 46 |
| NAUSEA | 45 |
| PAIN | 44 |
| DRUG INTERACTION | 43 |
| MALAISE | 40 |
| DIARRHOEA | 39 |
| HYPOTENSION | 38 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (5,471, 33.4% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| FALL | 787 |
| PAIN | 781 |
| HYPOTENSION | 649 |
| COGNITIVE DISORDER | 591 |
| CONSTIPATION | 576 |
| DYSPNOEA | 542 |
| TOXICITY TO VARIOUS AGENTS | 542 |
| BALANCE DISORDER | 537 |
| ORTHOSTATIC HYPOTENSION | 498 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 474 |
| FATIGUE | 472 |
| MOBILITY DECREASED | 450 |
| SEDATION | 450 |
| BLOOD CALCIUM DECREASED | 428 |
| CREATININE RENAL CLEARANCE DECREASED | 427 |
| NAUSEA | 424 |
| SEDATION COMPLICATION | 417 |
| HEADACHE | 404 |
| DIZZINESS | 376 |
How to read amitriptyline FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 16,403 voluntary reports linked to amitriptyline (Elavil), 2004-2025. Death is listed on 1,235 (7.5%). Hospitalization appears on 5,471 (33.4%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 71% of sex-coded reports are female (10,711 F / 4,363 M).
Read with amitriptyline
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 16,243 FAERS cases (Δ 160 lighter vs amitriptyline); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 16,238 FAERS cases (Δ 165 lighter vs amitriptyline); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 16,231 FAERS cases (Δ 172 lighter vs amitriptyline); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 16,672 FAERS cases (Δ 269 heavier vs amitriptyline); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.6 pp vs amitriptyline's DEATH-HEAVY): CASELOAD · HOSP-MID.
amitriptyline stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.