Prescription medication · Atypical Antipsychotic
asenapine
Also sold as Saphris. Asenapine is used to treat bipolar I disorder.
Data updated 2026-05-15
- 863
- FDA reportsRarely reported
- 8
- InteractionsFew interactions
- 88% less
- Generic vs brandHuge savings
- $19.25
- Brand price (NADAC)
What the data shows
asenapine (Saphris) is a prescription Atypical Antipsychotic, among the least-reported drugs the FDA tracks (863 FDA reports), whose generic runs roughly half the brand price or less (88% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
asenapine (Saphris) is a prescription Atypical Antipsychotic. Asenapine is used to treat bipolar I disorder.
Asenapine (Saphris) is an antipsychotic medicine. It is used to treat bipolar I disorder in adults and children ages 10-17.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$19.25/unit
Generic Price
$2.28/unit
Generic Savings
88%
Generic Available
Yes (3 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Asenapine is used to treat bipolar I disorder.
Common side effects
Sleepiness, Numbness in the mouth, Dizziness
Key warnings
Asenapine may increase the risk of death in elderly patients who have psychosis related to dementia.
The sections below are summarized in plain English from asenapine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Asenapine affects certain chemicals in the brain. These chemicals are called neurotransmitters. By changing the balance of these chemicals, asenapine can help reduce symptoms of bipolar disorder.
How to Take It
Take asenapine exactly as your doctor tells you. Place the tablet under your tongue and let it dissolve completely. Do not chew, crush, or swallow the tablet. Do not eat or drink anything for 10 minutes after taking the medicine.
This is a plain-language summary of asenapine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Babies born to mothers who use antipsychotics in the last 3 months of pregnancy may have withdrawal symptoms after birth. There is a pregnancy registry, call 1-866-961-2388.
This is a plain-language summary of asenapine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of asenapine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store asenapine tablets at room temperature (77°F).
Side Effects (from patient reports)
Based on 863 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for asenapine, by number of reports
- Interaction with another medicine
Interaction with another medicine
78 reports
- Poisoning from different substances
Poisoning from different substances
64 reports
- Death by suicide
Death by suicide
61 reports
- Inflammation of the heart muscle
Inflammation of the heart muscle
53 reports
- Feeling very sleepy
Feeling very sleepy
39 reports
- Feeling sad and hopeless
Feeling sad and hopeless
36 reports
- Thinking about suicide
Thinking about suicide
32 reports
- Gaining weight
Gaining weight
32 reports
- Sleepiness 31
Sleepiness
31 reports
- Problem with getting the correct medicine 30
Problem with getting the correct medicine
30 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for asenapine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where asenapine sits
asenapine has more FDA adverse-event reports than 6% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is asenapine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 863 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2010–2025.
Total Reports
863
Reports Mentioning Death
125
14.5% of reports — not proof of cause
Hospitalization Reports
316
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | DRUG INTERACTION | 78 |
| 4 | TOXICITY TO VARIOUS AGENTS | 64 |
| 5 | COMPLETED SUICIDE | 61 |
| 6 | MYOCARDITIS | 53 |
| 7 | SEDATION | 39 |
| 8 | DEPRESSION | 36 |
| 9 | SUICIDAL IDEATION | 32 |
| 10 | WEIGHT INCREASED | 32 |
| 11 | SOMNOLENCE | 31 |
| 12 | PRODUCT SUBSTITUTION ISSUE | 30 |
| 13 | ANXIETY | 29 |
| 14 | INSOMNIA | 28 |
| 15 | CONDITION AGGRAVATED | 26 |
| 16 | DYSTONIA | 26 |
| 17 | HYPOTENSION | 26 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Asenapine may increase the risk of death in elderly patients who have psychosis related to dementia. Asenapine is not approved to treat this condition.
Known Drug Interactions
( 5.7 , 7.1 , 12.3 ) • Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine by half when used in combination with asenapine. CYP2D6 substrates and inhibitors (e.g., paroxetine) Asenapine may enhance the inhibitory effects of paroxetine on its own metabolism. Concomitant use of paroxetine with asenapine increased the paroxetine exposure by 2-fold as compared to use paroxetine alone [see Clinical Pharmacology (12.3)].
Mechanism: Asenapine slows down the process your body uses to get rid of paroxetine, which can double the amount of paroxetine in your blood.
What to do: Your doctor should reduce your paroxetine dose by half when you are also taking asenapine.
7.2 Drugs Having No Clinically Important Interactions with Asenapine No dosage adjustment of asenapine is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions (7.1) for paroxetine dosage adjustment), imipramine, cimetidine, valporate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin).
Mechanism: Carbamazepine does not significantly change the levels of asenapine in your body.
What to do: No changes to your asenapine dose are necessary when taking these two drugs together.
7.2 Drugs Having No Clinically Important Interactions with Asenapine No dosage adjustment of asenapine is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions (7.1) for paroxetine dosage adjustment), imipramine, cimetidine, valporate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin). In addition, valproic acid and lithium pre-dose serum concentrations collected from an adjunctive therapy study were comparable between asenapine-treated patients and placebo-treated patients indicating a lack of effect of asenapine on valproic and...
Mechanism: These two drugs do not have a meaningful effect on each other's levels in the blood.
What to do: No dosage changes are needed when taking these medicines together.
7.2 Drugs Having No Clinically Important Interactions with Asenapine No dosage adjustment of asenapine is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions (7.1) for paroxetine dosage adjustment), imipramine, cimetidine, valporate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin).
Mechanism: Rifampin speeds up certain liver enzymes, but it does not change the levels of asenapine enough to cause a problem.
What to do: You can take these two drugs together without needing to adjust your dose.
7.2 Drugs Having No Clinically Important Interactions with Asenapine No dosage adjustment of asenapine is necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions (7.1) for paroxetine dosage adjustment), imipramine, cimetidine, valporate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin).
Mechanism: These medications do not significantly change how the body processes or reacts to one another.
What to do: No dose adjustment is required when using these medications at the same time.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I swallow the tablet?
Can I eat or drink right after taking asenapine?
What should I do if I feel dizzy?
Can asenapine be used for dementia?
Will asenapine make me gain weight?
Can I stop taking asenapine suddenly?
Does asenapine interact with other medications?
What is the starting dose for adults?
What is the starting dose for children?
Can asenapine cause diabetes?
What are the common side effects of asenapine?
Does asenapine interact with other medications?
What drug class is asenapine?
Is there a generic version of asenapine?
Is asenapine safe during pregnancy?
Related Medications in Atypical Antipsychotic
Other drugs grouped near asenapine - same-class peers and common alternatives.
acamprosate
Campral
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alprazolam
Xanax
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amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on asenapine
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What the FDA Data Shows for asenapine
The FDA label for asenapine (sold under brand names such as Saphris) classifies it as a prescription-only medication in the Atypical Antipsychotic class. Asenapine is used to treat bipolar I disorder. Official labeling lists 8 commonly reported side effects, including Sleepiness, Numbness in the mouth, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 863 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $2.28 versus $19.25 for the brand - a 88% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: February 25, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages