Prescription medication · Atypical Antipsychotic
lurasidone
Also sold as Latuda. Lurasidone is used to treat schizophrenia in adults and teens ages 13-17.
Data updated 2026-05-15
- 20,544
- FDA reportsModerately reported
- 15
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- $67.41
- Brand price (NADAC)
What the data shows
lurasidone (Latuda) is a prescription Atypical Antipsychotic, reported at a middle-of-the-pack volume (20,544 FDA reports), whose generic costs a fraction of the brand (about 99% 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.
lurasidone (Latuda) is a prescription Atypical Antipsychotic. Lurasidone is used to treat schizophrenia in adults and teens ages 13-17.
Lurasidone (Latuda) is a medicine used to treat schizophrenia and bipolar depression. It helps to balance chemicals in the brain.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$67.41/unit
Generic Price
$0.63/unit
Generic Savings
99%
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Lurasidone is used to treat schizophrenia in adults and teens ages 13-17.
Common side effects
Feeling sleepy, Feeling restless and needing to move, Nausea
Key warnings
This medicine has two important warnings: * **Increased risk of death in elderly people with dementia:** If you are an older adult with dementia-related psychosis, this medicine may increase your chance of death.
The sections below are summarized in plain English from lurasidone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Lurasidone is an atypical antipsychotic. It works by affecting certain chemicals in the brain, such as dopamine and serotonin. This helps to improve mood, thinking, and behavior.
How to Take It
Take lurasidone tablets with food (at least 350 calories). Food helps your body absorb the medicine better. The usual starting dose is between 20 mg to 40 mg per day. Your doctor may change your dose as needed, up to a maximum of 80 mg to 160 mg per day depending on your condition.
This is a plain-language summary of lurasidone'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 take this medicine in the last 3 months of pregnancy may have withdrawal symptoms or other problems after birth. Talk to your doctor about the risks and benefits of taking lurasidone during pregnancy.
This is a plain-language summary of lurasidone'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 take your next dose at the regular time.
This is a plain-language summary of lurasidone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store lurasidone tablets at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 20,544 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for lurasidone, by number of reports
- Feeling worried or nervous
Feeling worried or nervous
1,223 reports
- Feeling strange or not like yourself
Feeling strange or not like yourself
1,166 reports
- Feeling sad or hopeless
Feeling sad or hopeless
1,120 reports
- Gaining weight
Gaining weight
1,077 reports
- Feeling sleepy
Feeling sleepy
1,066 reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,037 reports
- Trouble sleeping
Trouble sleeping
1,002 reports
- Thinking about suicide
Thinking about suicide
957 reports
- Feeling tired
Feeling tired
942 reports
- Uncontrolled muscle movements
Uncontrolled muscle movements
818 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 lurasidone 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 lurasidone sits
lurasidone has more FDA adverse-event reports than 56% 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 lurasidone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 20,544 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2009–2025.
Total Reports
20,544
Reports Mentioning Death
564
2.7% of reports — not proof of cause
Hospitalization Reports
2,956
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | ANXIETY | 1,223 |
| 4 | FEELING ABNORMAL | 1,166 |
| 5 | DEPRESSION | 1,120 |
| 6 | WEIGHT INCREASED | 1,077 |
| 7 | SOMNOLENCE | 1,066 |
| 8 | NAUSEA | 1,037 |
| 9 | INSOMNIA | 1,002 |
| 10 | SUICIDAL IDEATION | 957 |
| 11 | FATIGUE | 942 |
| 12 | DYSKINESIA | 818 |
| 13 | SUICIDE ATTEMPT | 751 |
| 14 | TREMOR | 705 |
| 15 | VOMITING | 665 |
| 16 | MALAISE | 659 |
| 17 | SEDATION | 613 |
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
This medicine has two important warnings: * **Increased risk of death in elderly people with dementia:** If you are an older adult with dementia-related psychosis, this medicine may increase your chance of death. Lurasidone is not approved for this condition. * **Increased risk of suicidal thoughts and behaviors:** Antidepressants may increase the risk of suicidal thoughts and behaviors in children, teens, and young adults. Your doctor will need to watch you closely for worsening mood or suicidal thoughts.
Known Drug Interactions
Colchicine (in patients with normal renal and hepatic function) Use With Caution Antipsychotics: Pimozide Contraindicated Pimozide: [See Contraindications ( 4.2 )] Quetiapine Lurasidone Quetiapine: Quetiapine is a substrate for CYP3A4, which is inhibited by clarithromycin. Lurasidone: [See Contraindications ( 4.7 )] Antispasmodics: Tolterodine (patients deficient in CYP2D6 activity) Use With Caution Tolterodine: The primary route of metabolism for tolterodine is via CYP2D6.
Mechanism: Clarithromycin stops the body from clearing lurasidone by blocking a specific enzyme, which can lead to toxic levels of the medication.
What to do: Avoid taking these two drugs together as this combination is not recommended by the FDA.
Antipsychotics: lurasidone ↑ lurasidone Co-administration is contraindicated due to potential for serious and/or life-threatening reactions.
Mechanism: Darunavir causes lurasidone to build up in the body to unsafe levels.
What to do: This combination should not be used because it can cause life-threatening reactions.
Lurasidone Midazolam (oral) a Pimozide Triazolam a Contraindicated during and 2 weeks after itraconazole treatment.
Mechanism: Itraconazole stops the enzymes that process lurasidone, leading to a buildup of the medication in your blood.
What to do: Avoid taking these two drugs together and for at least two weeks after your itraconazole treatment ends.
Antipsychotics lurasidone, pimozide ↑ lurasidone ↑ pimozide Co-administration contraindicated due to serious and/or life-threatening reactions such as cardiac arrhythmias [see Contraindications (4) ] .
Mechanism: Nirmatrelvir/ritonavir slows down the body's ability to clear lurasidone, causing it to build up to dangerous levels. This increase can lead to serious or life-threatening heart rhythm problems.
What to do: This combination should be avoided because it is unsafe.
Ergot Alkaloids (CYP450 Inhibition) Not Studied In Vivo or In Vitro , but Drug Plasma Exposure Likely to be Increased Contraindicated Naloxegol (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Drug Plasma Exposure Likely to be Increased which may Increase the Risk of Adverse Reactions Contraindicated Tolvaptan (CYP3A4 Inhibition) Although Not Studied Clinically, Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Tolvaptan Contraindicated Lurasidone (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Voriconazole is Likely to Significantly Increase...
Mechanism: Voriconazole blocks the enzyme that normally clears lurasidone from your system. This can cause lurasidone to build up to unsafe levels in your body, increasing the risk of toxic effects.
What to do: This combination is considered unsafe and should be avoided. Talk to your healthcare provider about using a different medication.
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 take this medication without food?
What should I do if I feel worse after starting this medication?
Can I drink alcohol while taking this medication?
Will this medication make me gain weight?
How long does it take for this medication to start working?
Can I stop taking this medication suddenly?
What if I have kidney problems?
What if I have liver problems?
Can I take this with my other medications?
What are the symptoms of Neuroleptic Malignant Syndrome?
What are the common side effects of lurasidone?
Does lurasidone interact with other medications?
What drug class is lurasidone?
Is there a generic version of lurasidone?
Is lurasidone safe during pregnancy?
Related Medications in Atypical Antipsychotic
Other drugs grouped near lurasidone - 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.
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alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
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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.
Compare with lurasidone →
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 lurasidone
The FDA label for lurasidone (sold under brand names such as Latuda) classifies it as a prescription-only medication in the Atypical Antipsychotic class. Lurasidone is used to treat schizophrenia in adults and teens ages 13-17. Official labeling lists 5 commonly reported side effects, including Feeling sleepy, Feeling restless and needing to move, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 20,544 voluntary reports. The database also lists 15 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.63 versus $67.41 for the brand - a 99% 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 6, 2026
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