LOW-VOLUME · HOSP-HEAVY
asenapine Side Effects
asenapine (also sold as Saphris) is a LOW-VOLUME FAERS extract #494 of 524 by FAERS report count. Still opens on HOSP-HEAVY: 36.6% mention hospitalization (316 reports).
Data updated 2026-05-15
- 863
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
asenapine: 36.6% mention hospitalization (316 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #494 of 524 by FAERS report count.
Thinner FAERS extract for asenapine (Saphris) (863 reports #494 of 524 by FAERS report count). 36.6% mention hospitalization (316 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2010–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DRUG INTERACTION leads 78 of 863 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (295 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (125 reports, 14.5%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 61 |
| TOXICITY TO VARIOUS AGENTS | 46 |
| DEATH | 17 |
| CARDIAC ARREST | 12 |
| ASPIRATION | 8 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 8 |
| EMBOLIC STROKE | 8 |
| RESPIRATION ABNORMAL | 8 |
| SEIZURE | 8 |
| PULMONARY OEDEMA | 7 |
| CARDIO-RESPIRATORY ARREST | 6 |
| HYPONATRAEMIA | 6 |
| INTENTIONAL OVERDOSE | 6 |
| PULMONARY CONGESTION | 6 |
| ACCIDENTAL OVERDOSE | 5 |
| ASPHYXIA | 5 |
| CEREBROVASCULAR ACCIDENT | 5 |
| POLYDIPSIA | 5 |
| UNRESPONSIVE TO STIMULI | 5 |
| OVERDOSE | 4 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (316, 36.6% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 46 |
| MYOCARDITIS | 27 |
| TOXICITY TO VARIOUS AGENTS | 25 |
| DEPRESSION | 22 |
| SEDATION | 20 |
| SOMNOLENCE | 19 |
| HYPOTENSION | 18 |
| SEROTONIN SYNDROME | 18 |
| ACUTE KIDNEY INJURY | 17 |
| SUICIDAL IDEATION | 17 |
| DEPRESSED MOOD | 16 |
| VOMITING | 16 |
| EXTRAPYRAMIDAL DISORDER | 15 |
| HALLUCINATION, AUDITORY | 15 |
| WEIGHT DECREASED | 15 |
| DECREASED APPETITE | 14 |
| NEUROLEPTIC MALIGNANT SYNDROME | 14 |
| PSYCHOTIC DISORDER | 14 |
How to read asenapine FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 863 voluntary reports linked to asenapine (Saphris), 2010-2025. Death is listed on 125 (14.5%). Hospitalization appears on 316 (36.6%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with asenapine
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 834 FAERS cases (Δ 29 lighter vs asenapine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 896 FAERS cases (Δ 33 heavier vs asenapine); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 826 FAERS cases (Δ 37 lighter vs asenapine); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 905 FAERS cases (Δ 42 heavier vs asenapine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 47.6 pp vs asenapine's DEATH-HEAVY): CASELOAD · HOSP-MID.
asenapine stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.