Prescription medication · Atypical Antipsychotic
brexpiprazole
Also sold as Rexulti. Rexulti can be used with antidepressants to treat major depressive disorder in adults.
Data updated 2026-05-15
- 15,755
- FDA reportsModerately reported
- 9
- InteractionsFew interactions
- $47.03
- Brand price (NADAC)
What the data shows
brexpiprazole (Rexulti) is a prescription Atypical Antipsychotic, reported less often than most tracked drugs (15,755 FDA reports), with 9 documented drug interactions.
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.
brexpiprazole (Rexulti) is a prescription Atypical Antipsychotic. Rexulti can be used with antidepressants to treat major depressive disorder in adults.
Rexulti is a medication used to treat certain mental health conditions. It can help with depression, schizophrenia, and agitation related to Alzheimer's disease.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$47.03/unit
Generic Available
Yes (1 manufacturer)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Rexulti can be used with antidepressants to treat major depressive disorder in adults.
Common side effects
Weight gain, Feeling sleepy, Restlessness or feeling like you need to move
Key warnings
Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
The sections below are summarized in plain English from brexpiprazole's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Rexulti affects the balance of certain natural chemicals in the brain. These chemicals, called neurotransmitters, include dopamine and serotonin. By affecting these chemicals, Rexulti can help improve mood, thinking, and behavior.
Side Effects (from patient reports)
Based on 15,755 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for brexpiprazole, by number of reports
- Weight Increased
Weight Increased
1,673 reports
- Akathisia
Akathisia
854 reports
- Tremor 630
Tremor
630 reports
- Anxiety 591
Anxiety
591 reports
- Tardive Dyskinesia 590
Tardive Dyskinesia
590 reports
- Depression 568
Depression
568 reports
- Suicidal Ideation 538
Suicidal Ideation
538 reports
- Fatigue 485
Fatigue
485 reports
- Insomnia 477
Insomnia
477 reports
- Feeling Abnormal 471
Feeling Abnormal
471 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 brexpiprazole 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 brexpiprazole sits
brexpiprazole has more FDA adverse-event reports than 49% 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 brexpiprazole; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 15,755 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2012–2025.
Total Reports
15,755
Reports Mentioning Death
856
5.4% of reports — not proof of cause
Hospitalization Reports
1,926
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | WEIGHT INCREASED | 1,673 |
| 5 | AKATHISIA | 854 |
| 6 | TREMOR | 630 |
| 7 | ANXIETY | 591 |
| 8 | TARDIVE DYSKINESIA | 590 |
| 9 | DEPRESSION | 568 |
| 10 | SUICIDAL IDEATION | 538 |
| 12 | FATIGUE | 485 |
| 13 | INSOMNIA | 477 |
| 14 | FEELING ABNORMAL | 471 |
| 15 | DEATH | 428 |
| 16 | SOMNOLENCE | 401 |
| 17 | NAUSEA | 400 |
| 18 | DIZZINESS | 380 |
| 19 | HEADACHE | 359 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death. Rexulti is not approved to treat dementia-related psychosis unless it is related to agitation from Alzheimer's disease. Antidepressants may increase the risk of suicidal thoughts and behaviors in young adults and children. Tell your doctor right away if you have thoughts of harming yourself.
Known Drug Interactions
7.2 Drugs Having No Clinically Important Interactions with REXULTI Based on pharmacokinetic studies, no dosage adjustment of REXULTI is required when administered concomitantly with CYP2B6 inhibitors (e.g., ticlopidine) or gastric pH modifiers (e.g., omeprazole).
Mechanism: Omeprazole changes the acid levels in the stomach, but this does not affect how the body absorbs or processes brexpiprazole.
Additionally, no dosage adjustment for substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI.
Mechanism: Brexpiprazole does not interfere with the specific proteins the body uses to move and process rosuvastatin.
Additionally, no dosage adjustment for substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI.
Mechanism: Brexpiprazole does not change how the liver enzymes break down bupropion in the body.
7 DRUG INTERACTIONS Factors Dosage Adjustments for REXULTI ( 2.7 ) Strong CYP2D6 REXULTI may be administered without dosage adjustment in patients with MDD when administered with strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). Strong CYP2D6 Inhibitors In the clinical studies examining the adjunctive use of REXULTI in the treatment of MDD, dosage was not adjusted for strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine).
Mechanism: Fluoxetine blocks an enzyme that breaks down brexpiprazole, but the effect is not strong enough to require a change in dose for patients with depression.
7 DRUG INTERACTIONS Factors Dosage Adjustments for REXULTI ( 2.7 ) Strong CYP2D6 REXULTI may be administered without dosage adjustment in patients with MDD when administered with strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). Strong CYP2D6 Inhibitors In the clinical studies examining the adjunctive use of REXULTI in the treatment of MDD, dosage was not adjusted for strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine).
Mechanism: Paroxetine blocks the liver enzyme that breaks down brexpiprazole, which can lead to higher levels of the drug in your body.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I stop taking Rexulti suddenly?
Will Rexulti make me gain weight?
Can I drink alcohol while taking Rexulti?
How long does it take for Rexulti to start working?
Can I drive while taking Rexulti?
What should I do if I experience side effects?
Does Rexulti interact with other medications?
How often will I see my doctor while taking Rexulti?
Is Rexulti addictive?
What if Rexulti doesn't seem to be working for me?
What are the common side effects of brexpiprazole?
Does brexpiprazole interact with other medications?
What drug class is brexpiprazole?
What pregnancy or breastfeeding source fields are listed for brexpiprazole?
Related Medications in Atypical Antipsychotic
Other drugs grouped near brexpiprazole - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with brexpiprazole →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with brexpiprazole →
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.
Compare with brexpiprazole →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for brexpiprazole: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 15,755.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 5.43%.
- insulin degludec Δ 0.01 pts · 22,011 reports · Ultra-Long-Acting Insulin 5.42%death share
- suvorexant Δ 0.03 pts · 12,687 reports · Orexin Receptor Antagonist 5.41%death share
- brivaracetam Δ 0.07 pts · 4,286 reports · Anticonvulsant (SV2A Ligand) 5.51%death share
- ustekinumab Δ 0.09 pts · 98,899 reports · Anti-IL-12/23 Monoclonal Antibody 5.53%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for brexpiprazole
The FDA label for brexpiprazole (sold under brand names such as Rexulti) classifies it as a prescription-only medication in the Atypical Antipsychotic class. Rexulti can be used with antidepressants to treat major depressive disorder in adults. Official labeling lists 3 commonly reported side effects, including Weight gain, Feeling sleepy, Restlessness or feeling like you need to move.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 15,755 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS.
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: June 18, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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