Prescription medicine
Lurasidone Brand names: Latuda
Lurasidone (Latuda) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.142 per lurasidone HCl 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the lurasidone FDA label on DailyMed (effective January 31, 2025, Sumitomo Pharma America, Inc.); the NDA 200603 record on Drugs@FDA; every lurasidone label on DailyMed.
Highlights of the record
FDA label of January 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
and SUICIDAL THOUGHTS AND BEHAVIORS WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis ( 5.1 ). Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.2 ). Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.2 )].
Used for
From the label: indications and usageLATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )].
Forms and strengths
- 20 mg
- 40 mg
- 60 mg
- 80 mg
- 120 mg
Film-coated tablet; coated tablet; tablet.
On the market
- Earliest approval on file
- October 28, 2010 Latuda, Sunovion Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first January 3, 2019; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 29 of which 28 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 23, 2031 Latuda tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.142 per tablet Lurasidone HCl 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest January 18, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 20,803 through July 30, 2026
What is lurasidone used for?
From the label: indications and usageLATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )]. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )]. Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )]. […]
Conditions named in the indications of lurasidone's FDA labels, with every medicine labeled for each:
From other lurasidone labelsDepression: Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy (1,14.2) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as …
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (Latuda), NDA200603 (Sunovion Pharms Inc), as published by Sumitomo Pharma America, Inc., effective January 31, 2025 (SPL set afad3051-9df2-4c54-9684-e8262a133af8), via openFDA; the full label on DailyMed
What does the patient leaflet for lurasidone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LATUDA?LATUDA may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. Medicines like LATUDA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). LATUDA is not approved for the treatment of people with dementia-related psychosis. Increased risk of suicidal thoughts or actions in children and young adults. Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or a history of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. […]
From the patient leaflet: What should I avoid while taking LATUDA?Do not drive, operate heavy machinery, or do other dangerous activities until you know how LATUDA affects you. LATUDA may make you drowsy. Avoid eating grapefruit or drinking grapefruit juice during treatment with LATUDA. Grapefruit and grapefruit juice may affect the amount of LATUDA in your blood. Do not become too hot or dehydrated during treatment with LATUDA. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
From the patient leaflet: How should I store LATUDA?Store LATUDA tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep LATUDA and all medicines out of the reach of children.
Source: FDA drug label (Latuda), NDA200603 (Sunovion Pharms Inc), as published by Sumitomo Pharma America, Inc., effective January 31, 2025 (SPL set afad3051-9df2-4c54-9684-e8262a133af8), via openFDA; the full label on DailyMed
Is there a generic for lurasidone (Latuda)?
The FDA approved the first generic lurasidone on January 3, 2019. 19 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists lurasidone from 28 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Latuda tablets, the last expiring on November 23, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2019 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lurasidone (Latuda)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.142 per Lurasidone HCl 20 mg tablet, down 28% from $0.196 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lurasidone HCl 20 mg tablet (generic)
- Latuda 80 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lurasidone HCl 120 mg tablet | Generic | $0.487 per tablet | $14.60 | -29% |
| Lurasidone HCl 20 mg tablet | Generic | $0.142 per tablet | $4.25 | -28% |
| Lurasidone HCl 40 mg tablet | Generic | $0.210 per tablet | $6.29 | -24% |
| Lurasidone HCl 60 mg tablet | Generic | $0.291 per tablet | $8.74 | -27% |
| Lurasidone HCl 80 mg tablet | Generic | $0.328 per tablet | $9.83 | -29% |
| Latuda 120 mg tablet | Brand | $69.28 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $2,078.39 | +3% |
| Latuda 20 mg tablet | Brand | $46.46 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,393.70 | +3% |
| Latuda 40 mg tablet | Brand | $47.11 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,413.39 | +4% |
| Latuda 60 mg tablet | Brand | $46.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,404.33 | +3% |
| Latuda 80 mg tablet | Brand | $46.37 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,391.08 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lurasidone been recalled?
The FDA's Enforcement Report lists 3 recalls naming lurasidone since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of lurasidone and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 18, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003486 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lurasidone label say about other medicines?
The lurasidone label names 22 other medicines in its interaction, contraindication or warning sections. The labels of 22 other medicines name lurasidone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aripiprazole | warnings and precautions | Stroke in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities … |
| Atazanavir | drug interactions | Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone. … inhibitors of CYP3A4 [see Dosage and Administration ()]. Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil |
| Bosentan | drug interactions | Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone. Intervention: LATUDA dose should be increased when used concomitantly with moderate inducers of CYP3A4 [see Dosage and Administration ()]. Examples: Bosentan, efavirenz, etravirine, modafinil, nafcillin |
| Carbamazepine | contraindications | Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) [see Drug Interactions ( 7.1 )]. |
| Clarithromycin | contraindications | Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ( 7.1 )]. |
| Diltiazem | drug interactions | Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone. … moderate inhibitors of CYP3A4 [see Dosage and Administration ()]. Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil |
| Efavirenz | drug interactions | Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone. Intervention: LATUDA dose should be increased when used concomitantly with moderate inducers of CYP3A4 [see Dosage and Administration ()]. Examples: Bosentan, efavirenz, etravirine, modafinil, nafcillin |
| Erythromycin | drug interactions | Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone. … CYP3A4 [see Dosage and Administration ()]. Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil |
| Etravirine | drug interactions | Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone. Intervention: LATUDA dose should be increased when used concomitantly with moderate inducers of CYP3A4 [see Dosage and Administration ()]. Examples: Bosentan, efavirenz, etravirine, modafinil, nafcillin |
| Fluconazole | drug interactions | Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone. … Dosage and Administration ()]. Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil |
| Ketoconazole | contraindications | Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ( 7.1 )]. |
| Lithium | drug interactions | Interactions with LATUDA Based on pharmacokinetic studies, no dosage adjustment of LATUDA is required when administered concomitantly with lithium, valproate, or substrates of P-gp or CYP3A4 [see Clinical Pharmacology ( 12.3 )]. |
| Modafinil | drug interactions | Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone. Intervention: LATUDA dose should be increased when used concomitantly with moderate inducers of CYP3A4 [see Dosage and Administration ()]. Examples: Bosentan, efavirenz, etravirine, modafinil, nafcillin |
| Nafcillin | drug interactions | Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone. Intervention: LATUDA dose should be increased when used concomitantly with moderate inducers of CYP3A4 [see Dosage and Administration ()]. Examples: Bosentan, efavirenz, etravirine, modafinil, nafcillin |
Every other medicine the lurasidone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Olanzapine | warnings and precautions | Stroke in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence … |
| Phenytoin | contraindications | Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) [see Drug Interactions ( 7.1 )]. |
| Quetiapine | warnings and precautions | Change in weight from baseline for olanzapine was +4.15 kg and for quetiapine extended-release was +2.09 kg in Studies 3 and 5 [see Clinical Studies ( 14.1 )], respectively. |
| Rifampin | contraindications | Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) [see Drug Interactions ( 7.1 )]. |
| Risperidone | warnings and precautions | Stroke in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence … |
| Ritonavir | contraindications | Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ( 7.1 )]. |
| Verapamil | drug interactions | Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone. … Administration ()]. Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil |
| Voriconazole | contraindications | Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ( 7.1 )]. |
Other labels that name lurasidone
Source: FDA drug label (Latuda), NDA200603 (Sunovion Pharms Inc), as published by Sumitomo Pharma America, Inc., effective January 31, 2025 (SPL set afad3051-9df2-4c54-9684-e8262a133af8), via openFDA; the full label on DailyMed
What do FAERS reports show for lurasidone?
The FDA Adverse Event Reporting System holds 20,803 reports that list lurasidone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 576 are coded as a death and 3,029 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lurasidone?
21 other medicines are given the same way (oral) and in the same FDA class as lurasidone or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Quetiapine | Depression, Bipolar disorder, Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Depression, Bipolar disorder, Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Depression, Bipolar disorder, Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Bipolar disorder, Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder, Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
| Iloperidone | Bipolar disorder, Schizophrenia | 1 labeler | $60.01 per tablet 12 mg tablet | No current entry |
Every medicine labeled for the same conditions as lurasidone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lurasidone compare with medicines for the same use?
7 side-by-side pages set lurasidone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lurasidone
- 21 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Lurasidone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other