Drug · FAERS side-effect profile with label screen
Asenapine side effects: what 8,612 FDA adverse event reports show
Who reports
8,612 reports · 48% serious · 415 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Asenapine is indicated for: • Bipolar I disorder • Acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults Asenapine is an atypical.
FDA label, Indications and Usage
What it is
Asenapine sublingual tablet contains asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles.
FDA label, Description section
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1, 5.2)].
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 2Labeled adverse reaction 4Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 22
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 882 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anosognosia | 426 | 3,044.0 2,642.6–3,506.5ROR 3,202.3 · χ² 570,105 / p <1e-300 | 1,265.7 EB05 1,168.0 · IC025 +8.9 3/3 methods agree | Not in label — unassessed | serious n=421 | no trial data cached |
| Blood prolactin abnormal | 415 | 2,234.1 1,957.8–2,549.3ROR 2,347.1 · χ² 478,691 / p <1e-300 | 1,098.5 EB05 1,012.7 · IC025 +8.8 3/3 methods agree | Lab value / disease marker | serious n=409 | no trial data cached |
| Antipsychotic drug level below therapeutic | 151 | 677.6 566.4–810.8ROR 689.7 · χ² 79,042 / p <1e-300 | 495.4 EB05 432.5 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious n=151 · ♀ 0% (drug 63%) · 90% clinician | no trial data cached |
| Personality change due to a general medical condition | 25 | 606.3 391.2–939.7ROR 608.1 · χ² 11,583 / p <1e-300 | 353.1 EB05 251.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 63%) · 100% clinician | no trial data cached |
| Disturbance in social behaviour | 413 | 515.4 464.4–572.0ROR 541.3 · χ² 174,152 / p <1e-300 | 416.3 EB05 383.6 · IC025 +8.0 3/3 methods agree | Reporting / coding artifact | serious n=411 | no trial data cached |
| Disinhibition | 151 | 251.8 213.2–297.3ROR 256.2 · χ² 33,912 / p <1e-300 | 221.6 EB05 193.5 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=151 · ♀ 0% (drug 63%) · 90% clinician | no trial data cached |
| Thermal burns of eye | 15 | 190.6 112.7–322.2ROR 190.9 · χ² 2,448 / p <1e-300 | 144.5 EB05 93.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Metabolic disorder | 416 | 188.0 170.5–207.2ROR 197.5 · χ² 71,602 / p <1e-300 | 173.0 EB05 159.5 · IC025 +7.0 3/3 methods agree | Labeled (related wording) related wording | serious n=413 | no trial data cached |
| Personality change | 387 | 105.1 95.1–116.1ROR 110.0 · χ² 38,146 / p <1e-300 | 100.2 EB05 92.1 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 161.3 | no trial data cached |
| Therapeutic product effect variable | 143 | 94.7 80.2–111.8ROR 96.3 · χ² 12,669 / p <1e-300 | 90.1 EB05 78.4 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=143 · ♀ 0% (drug 63%) · 90% clinician | no trial data cached |
| Sexual dysfunction | 437 | 94.6 86.2–103.9ROR 99.6 · χ² 38,882 / p <1e-300 | 90.7 EB05 83.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 159.8 | no trial data cached |
| Emotional poverty | 58 | 83.2 64.1–108.1ROR 83.8 · χ² 4,476 / p <1e-300 | 78.5 EB05 62.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=58 · ♀ 4% (drug 63%) | no trial data cached |
| Akathisia (inner restlessness) | 415 | 76.3 69.4–84.0ROR 80.1 · χ² 29,845 / p <1e-300 | 73.8 EB05 68.0 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 96.4 · ♀ 37% (drug 63%) | no trial data cached |
| Sedation | 705 | 67.6 63.0–72.7ROR 73.6 · χ² 45,012 / p <1e-300 | 65.7 EB05 61.7 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 84.5 | no trial data cached |
| Schizophrenia | 328 | 67.5 60.6–75.1ROR 70.1 · χ² 20,834 / p <1e-300 | 65.4 EB05 59.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 79.2 | no trial data cached |
| Dystonia | 522 | 67.1 61.6–73.0ROR 71.3 · χ² 33,016 / p <1e-300 | 65.1 EB05 60.6 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 81.1 | no trial data cached |
| Schizoaffective disorder | 41 | 56.9 41.8–77.5ROR 57.2 · χ² 2,147 / p <1e-300 | 54.3 EB05 41.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 8% (drug 63%) | no trial data cached |
| Cogwheel rigidity | 24 | 56.7 37.9–85.0ROR 56.9 · χ² 1,229 / p 1e-269 | 53.2 EB05 37.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 63%) | no trial data cached |
| Hypoaesthesia oral | 338 | 55.9 50.3–62.1ROR 58.1 · χ² 17,759 / p <1e-300 | 54.5 EB05 49.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 21.7 | no trial data cached |
| Obsessive-compulsive disorder | 181 | 55.8 48.3–64.6ROR 57.0 · χ² 9,475 / p <1e-300 | 54.3 EB05 48.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=180 · ♀ 8% (drug 63%) | no trial data cached |
| Orthostatic hypertension | 13 | 55.2 31.9–95.7ROR 55.3 · χ² 625 / p 3e-138 | 50.3 EB05 31.3 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Pharyngeal hypoaesthesia | 20 | 53.5 34.3–83.2ROR 53.6 · χ² 957 / p 2e-210 | 50.0 EB05 34.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Vascular dementia | 16 | 45.5 27.7–74.5ROR 45.5 · χ² 640 / p 2e-141 | 42.5 EB05 27.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Head titubation | 25 | 44.8 30.2–66.5ROR 44.9 · χ² 1,008 / p 1e-221 | 42.7 EB05 30.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 63%) | no trial data cached |
| Dyslipidaemia | 85 | 41.4 33.4–51.2ROR 41.8 · χ² 3,254 / p <1e-300 | 40.4 EB05 33.7 · IC025 +4.7 3/3 methods agree | Labeled — boxed warning exact term | serious n=85 · ♀ 0% (drug 63%) · 90% clinician | no trial data cached |
| Euphoric mood | 172 | 41.3 35.6–48.0ROR 42.1 · χ² 6,614 / p <1e-300 | 40.5 EB05 35.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=156 · ♀ 8% (drug 63%) | no trial data cached |
| Selective eating disorder | 15 | 40.7 24.5–67.8ROR 40.8 · χ² 533 / p 3e-118 | 38.3 EB05 24.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Social anxiety disorder | 10 | 37.5 20.1–70.0ROR 37.6 · χ² 315 / p 9e-71 | 34.7 EB05 20.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Tongue blistering | 32 | 35.2 24.9–49.9ROR 35.4 · χ² 1,016 / p 3e-223 | 34.1 EB05 25.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Sedation complication | 35 | 34.5 24.8–48.2ROR 34.7 · χ² 1,091 / p 1e-239 | 33.5 EB05 25.2 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=35 · ♀ 15% (drug 63%) | no trial data cached |
| Soliloquy | 12 | 34.5 19.5–60.9ROR 34.5 · χ² 352 / p 7e-79 | 32.4 EB05 19.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Tooth discolouration | 41 | 34.1 25.1–46.4ROR 34.3 · χ² 1,268 / p 4e-278 | 33.2 EB05 25.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product blister packaging issue | 14 | 33.6 19.8–56.9ROR 33.6 · χ² 405 / p 2e-90 | 31.8 EB05 20.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Oropharyngeal blistering | 22 | 33.0 21.7–50.2ROR 33.1 · χ² 642 / p 7e-142 | 31.7 EB05 22.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=3 · 91% clinician | no trial data cached |
| Dyskinesia (involuntary movements) | 534 | 32.5 29.9–35.3ROR 34.5 · χ² 16,067 / p <1e-300 | 32.0 EB05 29.8 · IC025 +4.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 47.4 | no trial data cached |
| Bipolar i disorder | 26 | 29.2 19.9–43.0ROR 29.3 · χ² 673 / p 1e-148 | 28.4 EB05 20.3 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=23 | no trial data cached |
| Anxiety disorder | 39 | 28.6 20.9–39.2ROR 28.7 · χ² 999 / p 2e-219 | 27.9 EB05 21.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 5% (drug 63%) · 85% consumer | no trial data cached |
| Anticholinergic syndrome | 18 | 27.8 17.5–44.2ROR 27.8 · χ² 434 / p 1e-96 | 26.8 EB05 17.9 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Suicide attempt | 665 | 26.9 25.0–29.0ROR 29.1 · χ² 16,437 / p <1e-300 | 26.6 EB05 25.0 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 32.1 | no trial data cached |
| Increased appetite | 205 | 26.8 23.4–30.7ROR 27.5 · χ² 5,020 / p <1e-300 | 26.5 EB05 23.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 68.0 · ♀ 19% (drug 63%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 912 | 1.7 1.6–1.8ROR 1.8 · χ² 271 / p 3e-61 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| Sedation | 705 | 67.6 63.0–72.7ROR 73.6 · χ² 45,012 / p <1e-300 | 65.7 EB05 61.7 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 84.5 | no trial data cached |
| Suicide attempt | 665 | 26.9 25.0–29.0ROR 29.1 · χ² 16,437 / p <1e-300 | 26.6 EB05 25.0 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 32.1 | no trial data cached |
| Inappropriate schedule of drug administration | 565 | 19.2 17.7–20.8ROR 20.5 · χ² 9,686 / p <1e-300 | 19.0 EB05 17.8 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 17.6 | no trial data cached |
| Weight increased (weight gain) | 564 | 6.2 5.7–6.7ROR 6.5 · χ² 2,461 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.3 | no trial data cached |
| Dyskinesia (involuntary movements) | 534 | 32.5 29.9–35.3ROR 34.5 · χ² 16,067 / p <1e-300 | 32.0 EB05 29.8 · IC025 +4.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 47.4 | no trial data cached |
| Dystonia | 522 | 67.1 61.6–73.0ROR 71.3 · χ² 33,016 / p <1e-300 | 65.1 EB05 60.6 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 81.1 | no trial data cached |
| Blood glucose increased | 485 | 6.3 5.7–6.8ROR 6.6 · χ² 2,149 / p <1e-300 | 6.2 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 17.0 | no trial data cached |
| Sexual dysfunction | 437 | 94.6 86.2–103.9ROR 99.6 · χ² 38,882 / p <1e-300 | 90.7 EB05 83.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 159.8 | no trial data cached |
| Anosognosia | 426 | 3,044.0 2,642.6–3,506.5ROR 3,202.3 · χ² 570,105 / p <1e-300 | 1,265.7 EB05 1,168.0 · IC025 +8.9 3/3 methods agree | Not in label — unassessed | serious n=421 | no trial data cached |
| Off label use (used outside approved label) | 422 | 1.2 1.1–1.3ROR 1.2 · χ² 12 / p 2e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Metabolic disorder | 416 | 188.0 170.5–207.2ROR 197.5 · χ² 71,602 / p <1e-300 | 173.0 EB05 159.5 · IC025 +7.0 3/3 methods agree | Labeled (related wording) related wording | serious n=413 | no trial data cached |
| Akathisia (inner restlessness) | 415 | 76.3 69.4–84.0ROR 80.1 · χ² 29,845 / p <1e-300 | 73.8 EB05 68.0 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 96.4 · ♀ 37% (drug 63%) | no trial data cached |
| Blood prolactin abnormal | 415 | 2,234.1 1,957.8–2,549.3ROR 2,347.1 · χ² 478,691 / p <1e-300 | 1,098.5 EB05 1,012.7 · IC025 +8.8 3/3 methods agree | Lab value / disease marker | serious n=409 | no trial data cached |
| Disturbance in social behaviour | 413 | 515.4 464.4–572.0ROR 541.3 · χ² 174,152 / p <1e-300 | 416.3 EB05 383.6 · IC025 +8.0 3/3 methods agree | Reporting / coding artifact | serious n=411 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Anosognosia — n=426, PRR 3,044.0
- Personality change due to a general medical condition — n=25, PRR 606.3
- Disinhibition — n=151, PRR 251.8
- Personality change — n=387, PRR 105.1
- Sexual dysfunction — n=437, PRR 94.6
- Emotional poverty — n=58, PRR 83.2
- Schizophrenia — n=328, PRR 67.5
- Schizoaffective disorder — n=41, PRR 56.9
- Cogwheel rigidity — n=24, PRR 56.7
- Hypoaesthesia oral — n=338, PRR 55.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Asenapine?
In FDA FAERS, the most frequently co-reported reaction terms for Asenapine are sedation, suicide attempt, weight increased, dyskinesia, dystonia, blood glucose increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Asenapine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1, 5.2)].
Do FAERS signals prove that Asenapine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID cf587c48-9cd2-4dc5-b0e9-21783c5633a6, effective 20230120; matched on
openfda.generic_name.exact:"ASENAPINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 922 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.