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 →
NADAC price trail: LURASIDONE HCL 120 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -11.9% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| October 23, 2024 | $0.7174/EA | - | 1 |
| December 18, 2024 | $0.6322/EA | -11.9% | 15 |
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.
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
- Anxiety
Anxiety
1,223 reports
- Feeling Abnormal
Feeling Abnormal
1,166 reports
- Depression
Depression
1,120 reports
- Weight Increased
Weight Increased
1,077 reports
- Somnolence
Somnolence
1,066 reports
- Nausea
Nausea
1,037 reports
- Insomnia
Insomnia
1,002 reports
- Suicidal Ideation
Suicidal Ideation
957 reports
- Fatigue
Fatigue
942 reports
- Dyskinesia
Dyskinesia
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for lurasidone?
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.
Compare with lurasidone →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with lurasidone →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with lurasidone →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with lurasidone →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with lurasidone →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for lurasidone: 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: 20,544.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 2.75%.
- fexofenadine Δ 0.02 pts · 19,831 reports · Second-Generation Antihistamine 2.77%death share
- inclisiran Δ 0.03 pts · 6,989 reports · PCSK9 siRNA 2.72%death share
- bimatoprost Δ 0.04 pts · 28,128 reports · Prostaglandin Analog (Ophthalmic) 2.71%death share
- etanercept Δ 0.04 pts · 591,578 reports · TNF-Alpha Inhibitor (Biologic) 2.79%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 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 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: February 6, 2026
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