What the label lists and what reports show
Asenapine side effects
Asenapine's FDA label: “The most common adverse reactions (≥5% and at least twice the rate of placebo) reported with acute treatment in adults with schizophrenia were akathisia, oral hypoesthesia, and somnolence.” FAERS holds 8,667 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is sedation (706 reports).
- Generic listed
- Boxed warning
Check it at the source: the asenapine FDA label on DailyMed (effective January 31, 2025, Allergan, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥5% and at least twice the rate of placebo) reported with acute treatment in adults with schizophrenia were akathisia, oral hypoesthesia, and somnolence.
Table 10: Adverse Reactions Reported in 2% or More of Pediatric Patients (Ages 10 to 17 Years) in Any SAPHRIS Dose Group and Which Occurred at Greater Incidence Than in the Placebo Group in a 3-Week Bipolar Mania Trial
| System Organ Class/ AE Preferred Term | Placebo N=101 % | SAPHRIS 2.5 mg twice daily N=104 % | SAPHRIS 5 mg twice daily N=99 % | SAPHRIS 10 mg twice daily N=99 % | All SAPHRIS 2.5, 5, and 10 mg N=302 % |
|---|---|---|---|---|---|
| Tachycardia 1 | 0 | 3 | 0 | 1 | 1 |
| Oral hypoesthesia 2 | 4 | 25 | 25 | 30 | 27 |
| Nausea | 3 | 6 | 6 | 6 | 6 |
| Vomiting | 3 | 4 | 4 | 4 | 4 |
| Abdominal pain 3 | 7 | 9 | 3 | 5 | 6 |
| Glossodynia | 0 | 0 | 2 | 0 | 1 |
| Fatigue 4 | 5 | 4 | 8 | 14 | 9 |
| Irritability | 1 | 1 | 1 | 2 | 1 |
| Muscle strain | 0 | 0 | 0 | 2 | 1 |
| Increased weight | 0 | 6 | 2 | 2 | 3 |
| Hyperinsulinemia 5 | 0 | 1 | 3 | 1 | 2 |
| ALT increased | 0 | 0 | 0 | 2 | 1 |
| AST increased | 0 | 0 | 0 | 2 | 1 |
| Increased appetite | 2 | 10 | 9 | 6 | 8 |
| Dehydration | 1 | 0 | 2 | 0 | 1 |
| Myalgia | 0 | 0 | 2 | 1 | 1 |
| Somnolence 6 | 12 | 46 | 53 | 49 | 49 |
| Headache | 6 | 8 | 11 | 9 | 9 |
| Dizziness | 3 | 6 | 10 | 5 | 7 |
| Dysgeusia | 2 | 4 | 5 | 9 | 6 |
| Akathisia | 0 | 2 | 2 | 1 | 2 |
| Parkinsonism | 0 | 1 | 0 | 2 | 1 |
| Insomnia | 3 | 3 | 4 | 3 | 3 |
| Suicidal ideation | 1 | 4 | 1 | 3 | 3 |
| Anger | 0 | 0 | 0 | 2 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in other sections of the labeling: Use in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 and 5.2 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.3 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.4 )] Metabolic Changes [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Contraindications, Warnings and Precautions ( 5.6 )] Orthostatic Hypotension, Syncope, and other Hemodynamic Effects [see Warnings and Precautions ( 5.7 )] Falls [see Warnings and Precautions ( 5.8 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.9 )] QT Interval Prolongation [see Warnings and Precautions ( 5.10 )] Hyperprolactinemia [see Warnings and Precautions ( 5.11 )] Seizures [see Warnings and Precautions ( 5.12 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.13 )] Body Temperature Regulation [see Warnings and Precautions ( 5.14 )] Dysphagia [see Warnings and Precautions ( 5.15 )] The most common adverse reactions (≥5% and at least twice the rate of placebo) reported with acute treatment in adults with schizophrenia were akathisia, oral hypoesthesia, and somnolence. …
Source: FDA drug label, NDA022117 (Abbvie), as published by Allergan, Inc., effective January 31, 2025 (SPL set 5429f134-839f-4ffc-9944-55f51238def8), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,667 reports list asenapine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 415 are coded as a death and 1,460 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Asenapine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions