MID-VOLUME · SEX-BALANCED
doxepin Side Effects
doxepin (also sold as Sinequan, Silenor) sits MID-VOLUME #323 of 524 by FAERS report count. Lead signal: SEX-BALANCED - 69% of sex-coded reports are female (6,137 F / 2,822 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 9,780
- FAERS reports
FDA Adverse Event Reporting System extract for doxepin. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-MID. How figures are compiled.
doxepin reporting skew - 69% of sex-coded reports are female (6,137 F / 2,822 M). Volume band MID-VOLUME #323 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for doxepin (Sinequan) (9,780 reports). Signature SEX-BALANCED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (1998–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
TOXICITY TO VARIOUS AGENTS leads 801 of 9,780 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (2,890 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (1,746 reports, 17.9%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 613 |
| TOXICITY TO VARIOUS AGENTS | 591 |
| DEATH | 363 |
| DRUG ABUSE | 201 |
| CARDIO-RESPIRATORY ARREST | 156 |
| OVERDOSE | 79 |
| PULMONARY OEDEMA | 70 |
| CARDIAC ARREST | 67 |
| BRAIN OEDEMA | 54 |
| DRUG INTERACTION | 52 |
| NAUSEA | 50 |
| RESPIRATORY ARREST | 48 |
| FATIGUE | 47 |
| RESPIRATORY DEPRESSION | 46 |
| INTENTIONAL OVERDOSE | 42 |
| ACUTE KIDNEY INJURY | 40 |
| SUSPECTED SUICIDE | 38 |
| HYPOTENSION | 37 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 36 |
| PAIN | 36 |
Reactions in Hospitalization Reports
Hospitalization mid-share (2,865, 29.3%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| TOXICITY TO VARIOUS AGENTS | 278 |
| FALL | 216 |
| NAUSEA | 211 |
| DYSPNOEA | 208 |
| FATIGUE | 193 |
| PAIN | 176 |
| DIARRHOEA | 171 |
| ASTHENIA | 169 |
| DRUG INTERACTION | 164 |
| HEADACHE | 163 |
| DIZZINESS | 159 |
| VOMITING | 152 |
| PNEUMONIA | 151 |
| COMPLETED SUICIDE | 140 |
| WEIGHT DECREASED | 136 |
| DEPRESSION | 133 |
| INSOMNIA | 127 |
| PAIN IN EXTREMITY | 125 |
How to read doxepin FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 9,780 voluntary reports linked to doxepin (Sinequan, Silenor), 1998-2025. Death is listed on 1,746 (17.9%). Hospitalization appears on 2,865 (29.3%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 69% of sex-coded reports are female (6,137 F / 2,822 M).
Read with doxepin
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 9,782 FAERS cases (Δ 2 heavier vs doxepin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 9,764 FAERS cases (Δ 16 lighter vs doxepin); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 9,877 FAERS cases (Δ 97 heavier vs doxepin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 9,899 FAERS cases (Δ 119 heavier vs doxepin); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 44.3 pp vs doxepin's DEATH-HEAVY): CASELOAD · HOSP-MID.
doxepin stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.