brexpiprazole
Brand names: Rexulti
Rexulti is a medication used to treat certain mental health conditions. It can help with depression, schizophrenia, and agitation related to Alzheimer's disease.
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.
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.
How to Take It
Take Rexulti once a day by mouth. You can take it with or without food. Your doctor will tell you what dose to start with. They may change your dose over time based on how you respond to the medicine.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Babies born to mothers who take Rexulti in the last 3 months of pregnancy may have withdrawal symptoms or other problems after birth. There is a pregnancy registry to monitor outcomes in women exposed to Rexulti during pregnancy. You can contact the registry at 1-866-961-2388.
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.
Storage
Store Rexulti tablets at room temperature, between 68°F and 77°F.
Side Effects (from patient reports)
Based on 8,742 FDA adverse event reports.
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
Death-Related Reports
856
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 |
| 2 | PRODUCT USE IN UNAPPROVED INDICATION | 1,277 |
| 3 | OFF LABEL USE | 1,092 |
| 4 | DRUG INEFFECTIVE | 929 |
| 5 | AKATHISIA | 854 |
| 6 | TREMOR | 630 |
| 7 | ANXIETY | 591 |
| 8 | TARDIVE DYSKINESIA | 590 |
| 9 | DEPRESSION | 568 |
| 10 | SUICIDAL IDEATION | 538 |
| 11 | PRODUCT USE ISSUE | 492 |
| 12 | FATIGUE | 485 |
| 13 | INSOMNIA | 477 |
| 14 | FEELING ABNORMAL | 471 |
| 15 | DEATH | 428 |
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
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.
What to do: No changes to your medication dose are needed when taking these two drugs together.
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.
What to do: You can take these medications together without needing to adjust your doses.
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.
What to do: No dose adjustments are necessary when these two medications are used at the same time.
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.
What to do: Your doctor does not need to change your dose of brexpiprazole when you are also taking fluoxetine.
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.
What to do: No dose adjustment is needed when these drugs are used together for the treatment of depression.
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?
Is brexpiprazole safe during pregnancy?
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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
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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 8,742 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 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: June 18, 2025
Read our methodology — how this data is sourced, computed, and verified.
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