LOW-VOLUME · SEX-BALANCED
tasimelteon Side Effects
tasimelteon (also sold as Hetlioz) is a LOW-VOLUME FAERS extract #385 of 524 by FAERS report count. Still opens on SEX-BALANCED: 57% of sex-coded reports are female (3,267 F / 2,465 M).
Data updated 2026-05-15
- 5,762
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
tasimelteon reporting skew - 57% of sex-coded reports are female (3,267 F / 2,465 M). Volume band LOW-VOLUME #385 of 524 by FAERS report count; caseload WATCHLIST.
Thinner FAERS extract for tasimelteon (Hetlioz) (5,762 reports #385 of 524 by FAERS report count). 57% of sex-coded reports are female (3,267 F / 2,465 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2014–2025). Stamps WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
INSOMNIA leads 727 of 5,762 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (1,272 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 166 reports (2.9% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 129 |
| CARDIAC ARREST | 4 |
| PNEUMONIA | 4 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 3 |
| COMPLETED SUICIDE | 3 |
| SEPSIS | 3 |
| ACCIDENT | 2 |
| CARDIAC FAILURE | 2 |
| CARDIOVASCULAR DISORDER | 2 |
| DYSPHAGIA | 2 |
| HYPOTENSION | 2 |
| MYOCARDIAL INFARCTION | 2 |
| PNEUMONIA ASPIRATION | 2 |
| PULMONARY EMBOLISM | 2 |
| TOXICITY TO VARIOUS AGENTS | 2 |
| ACCIDENTAL DEATH | 1 |
| ACUTE MYOCARDIAL INFARCTION | 1 |
| AORTIC ANEURYSM | 1 |
| ARTERIOSCLEROSIS CORONARY ARTERY | 1 |
Reactions in Hospitalization Reports
Hospitalization is lighter here (281). Reactions in that subset:
| Reaction | Reports |
|---|---|
| FALL | 28 |
| PRODUCT DOSE OMISSION | 23 |
| PNEUMONIA | 18 |
| DRUG DOSE OMISSION | 13 |
| INSOMNIA | 12 |
| CARDIAC DISORDER | 10 |
| SOMNOLENCE | 10 |
| URINARY TRACT INFECTION | 10 |
| MALAISE | 9 |
| SEIZURE | 9 |
| MIDDLE INSOMNIA | 8 |
| DIZZINESS | 7 |
| NIGHTMARE | 7 |
| SEPSIS | 7 |
| THROMBOSIS | 7 |
| VOMITING | 7 |
| CEREBROVASCULAR ACCIDENT | 6 |
| CHEST PAIN | 6 |
How to read tasimelteon FAERS figures (WATCHLIST · DEATH-MARKED · HOSP-LIGHT)
FAERS holds 5,762 voluntary reports linked to tasimelteon (Hetlioz), 2014-2025. Death is listed on 166 (2.9%). Hospitalization appears on 281 (4.9%). Top co-reported indication: Non-24-Hour Sleep-Wake Disorder.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with tasimelteon
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-LIGHT stamps.
ABS(total_reports) peer at 5,766 FAERS cases (Δ 4 heavier vs tasimelteon); DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 5,825 FAERS cases (Δ 63 heavier vs tasimelteon); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 5,840 FAERS cases (Δ 78 heavier vs tasimelteon); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 5,878 FAERS cases (Δ 116 heavier vs tasimelteon); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 59.2 pp vs tasimelteon's DEATH-MARKED): CASELOAD · HOSP-MID.
tasimelteon stamps WATCHLIST · SEX-BALANCED; class peers and methodology beat restating the same FAERS caveats on every effects URL.