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Lurasidone

Lurasidone is an atypical antipsychotic tablet used to treat schizophrenia and bipolar depression in adults and certain children and adolescents.

Brand name Latuda
Drug class Atypical Antipsychotic
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 42 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Lurasidone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Lurasidone (Latuda) is an atypical antipsychotic that calms dopamine and serotonin signaling, used for schizophrenia from age 13 and bipolar depression from age 10; on the market since about 2010 and available generically, it is a familiar choice, often favored for bipolar depression. Most people tolerate it well, and it is easier on weight and blood sugar than many antipsychotics, though sleepiness, nausea and akathisia (a restless, can't-sit-still feeling) are common early on. Its boxed warning flags a higher risk of death in older adults with dementia-related psychosis and of suicidal thoughts in children, teens and young adults, so watch closely for mood changes early in treatment.

Clinical pearls

  • Take it with a meal of at least 350 calories, since food greatly increases how much of the dose your body absorbs.
  • Clarithromycin, ketoconazole, rifampin, carbamazepine and St. John's wort must not be combined with it, so mention lurasidone before any new antibiotic or antifungal.
  • Diltiazem, verapamil, erythromycin and fluconazole can be used but call for a lower lurasidone dose, so every prescriber needs your full list.
  • Expect blood sugar, cholesterol and weight checks, and report new tongue, face or limb movements, which can signal tardive dyskinesia.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Two serious risks are highlighted in a black box warning on this medication.

Elderly patients with dementia-related psychosis: Older adults with dementia who take antipsychotic medications have a higher risk of death. Lurasidone is not approved for treating psychosis related to dementia and should not be used for this purpose.

Suicidal thoughts and behaviors in young people: Antidepressant medications, including lurasidone when used for bipolar depression, have been linked to a higher risk of suicidal thoughts and behaviors in children, teenagers, and young adults. Watch closely for any new or worsening thoughts of self-harm, especially in the first few months of treatment or after a dose change. Family members and caregivers should also monitor for sudden changes in mood or behavior and contact the prescriber right away if these occur.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2010
Companies listing it with the FDA29
FDA label last updatedJan 31, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Lurasidone, written from its FDA label.

What Lurasidone is used for

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Lurasidone is an atypical antipsychotic available as an oral tablet under brand names including Latuda, Lurasidone HCL, and Lurasidone Hydrochloride. It is approved to treat the following conditions:

  • Schizophrenia in adults and adolescents aged 13 to 17
  • Depressive episodes associated with bipolar I disorder (bipolar depression) in adults — as monotherapy or combined with lithium or valproate
  • Bipolar depression in pediatric patients aged 10 to 17 — as monotherapy only (the adjunctive use with lithium or valproate is approved in adults only)

How Lurasidone works

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Lurasidone works by blocking specific receptors in the brain that respond to dopamine and serotonin — two key chemical messengers involved in mood, perception, and thought. It strongly blocks dopamine D2 receptors and serotonin 5-HT2A and 5-HT7 receptors, and partially activates serotonin 5-HT1A receptors. This combination of actions is believed to reduce the symptoms of schizophrenia and bipolar depression, though the exact mechanism is not fully understood.

Notably, lurasidone has little effect on histamine H1 or muscarinic M1 receptors — receptors often linked to sedation and weight gain with other antipsychotics.

Lurasidone dosage

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Lurasidone tablets are taken once daily by mouth with food — a meal of at least 350 calories is needed because food significantly increases how much lurasidone your body absorbs. The size or fat content of the meal does not matter, as long as it meets the calorie threshold. Steady, consistent blood levels are typically reached within about 7 days of starting.

  • No gradual dose titration (stepping up slowly) is required when starting
  • Doses may differ based on whether you are treating schizophrenia or bipolar depression, your age, kidney or liver function, and any other medications you take
  • Always follow your prescriber's specific instructions — do not adjust your dose on your own

Dosing details from the FDA-approved label

From the Lurasidone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Schizophrenia – adults
    • Starting dose 40 mg once daily
    • Initial dose titration is not required
    • Effective in a dose range of 40 mg per day to 160 mg per day
    • Maximum: 160 mg per day
    • Take with food (at least 350 calories)
  • Schizophrenia – adolescents (13 to 17 years)
    • Starting dose 40 mg once daily
    • Initial dose titration is not required
    • Effective in a dose range of 40 mg per day to 80 mg per day
    • Maximum: 80 mg per day
    • Take with food (at least 350 calories)
  • Bipolar Depression – adults
    • Starting dose 20 mg once daily as monotherapy or as adjunctive therapy with lithium or valproate
    • Initial dose titration is not required
    • Effective in a dose range of 20 mg per day to 120 mg per day
    • Maximum: 120 mg per day
    • In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day)
  • Bipolar Depression – pediatric patients (10 to 17 years)
    • Starting dose 20 mg once daily as monotherapy
    • Initial dose titration is not required
    • The dose may be increased after one week based on clinical response
    • Effective in a dose range of 20 mg per day to 80 mg per day
    • Maximum: 80 mg per day
    • Most of the patients (67%) received 20 mg or 40 mg once daily at the end of the clinical study
  • Moderate and Severe Renal Impairment
    • Recommended starting dose is 20 mg per day
    • Maximum: 80 mg per day
    • Renal impairment adjustment
  • Moderate and Severe Hepatic Impairment
    • Recommended starting dose is 20 mg per day
    • Maximum: 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment
    • Hepatic impairment adjustment
  • Concomitant use of a moderate CYP3A4 inhibitor (e.g., diltiazem)
    • Dose should be reduced to half of the original dose level
    • Recommended starting dose is 20 mg per day
    • Maximum: 80 mg per day
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Lurasidone hydrochloride tablets should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of lurasidone hydrochloride tablets (2.3, 12.3). Indication Starting Dose Recommended Dose Schizophrenia – adults ( 2.1 ) 40 mg per day 40 mg to 160 mg per day Schizophrenia – adolescents (13 to 17 years) ( 2.1 ) 40 mg per day 40 mg to 80 mg per day Bipolar Depression – adults ( 2.2 ) 20 mg per day 20 mg to 120 mg per day Bipolar Depression – pediatric patients (10 to 17 years) ( 2.2 ) 20 mg per day 20 mg to 80 mg per day • Moderate and Severe Renal Impairment: Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day ( 2.4 , 8.6 ). • Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day. The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment ( 2.5 , 8.7 ). • Concomitant Use of a Moderate CYP3A4 inhibitor (e.g., diltiazem): Lurasidone hydrochloride tablets dose should be reduced to half of the original dose level. Recommended starting dose is 20 mg per day. Maximum recommended dose is 80 mg per day ( 2.6 , 7.1 ). • Concomitant Use of a Moderate CYP3A4 Inducer: It may be necessary to increase the dose of lurasidone hydrochloride tablets ( 2.6 , 7.1 ). 2.1 Schizophrenia Adults The recommended starting dose of lurasidone hydrochloride tablets is 40 mg once daily. Initial dose titration is not required. Lurasidone hydrochloride tablets have been shown to be effective in a dose range of 40 mg per day to 160 mg per day [see Clinical Studies (14.1) ] . The maximum recommended dose is 160 mg per day. Adolescents (13 to 17 years) The recommended starting dose of lurasidone hydrochloride tablets is 40 mg once daily. Initial dose titration is not required. Lurasidone hydrochloride tablets have been shown to be effective in a dose range of 40 mg per day to 80 mg per day [see Clinical Studies (14.1) ] . The maximum recommended dose is 80 mg per day. 2.2 Depressive Episodes Associated with Bipolar I Disorder Adults The recommended starting dose of lurasidone hydrochloride tablets is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Lurasidone side effects

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The most commonly reported side effects of lurasidone include:

Common side effects

  • Sleepiness or sedation
  • Nausea
  • Akathisia (a restless, urgent need to move)
  • Extrapyramidal symptoms (movement-related side effects such as stiffness or tremor)
  • Vomiting
  • Dizziness
  • Insomnia
  • Weight gain (particularly in pediatric patients with bipolar depression)
  • Akathisia — an uncomfortable inner restlessness or urge to keep moving
  • Extrapyramidal symptoms — movement-related effects like muscle stiffness, tremor, or slow movement
  • Anxiety

When to get medical help

  • Signs of neuroleptic malignant syndrome (NMS): high fever, severe muscle stiffness, confusion, or irregular heartbeat — seek emergency care immediately
  • Signs of tardive dyskinesia: uncontrolled, repetitive movements of the face, tongue, or limbs — contact your doctor
  • Signs of high blood sugar: increased thirst, frequent urination, increased appetite, or weakness
  • Fainting or significant drop in blood pressure when standing (orthostatic hypotension)
  • New or worsening suicidal thoughts or behaviors — especially in children, teens, and young adults — call your doctor or 911 right away
  • Significant drop in white blood cell count: fever, chills, or signs of infection — contact your doctor
  • Seizures
  • Swelling of the face, lips, or throat (angioedema) — seek emergency help

Akathisia and extrapyramidal symptoms tend to increase with higher doses. Serious reactions — including signs of NMS (high fever, severe rigidity, confusion), uncontrolled movements (tardive dyskinesia), significant blood sugar changes, or suicidal thoughts — require immediate medical attention.

Lurasidone warnings and precautions

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  • Elderly patients with dementia-related psychosis: Lurasidone is not approved for this group. Antipsychotics increase the risk of death in these patients — do not use lurasidone for dementia-related psychosis.
  • Suicidal thoughts in young people: Children, teens, and young adults may experience increased suicidal thoughts when taking lurasidone for bipolar depression. Monitor closely, especially at the start of treatment or after dose changes.
  • Neuroleptic malignant syndrome (NMS): A rare but potentially fatal reaction causing high fever, severe muscle stiffness, confusion, and unstable blood pressure. Stop the medication and seek emergency care immediately if this occurs.
  • Tardive dyskinesia: Long-term use can cause potentially irreversible uncontrolled muscle movements, especially in older women. Risk increases with longer use and higher doses.
  • Metabolic changes: Lurasidone can raise blood sugar and affect cholesterol levels. Patients with or at risk for diabetes should be monitored regularly.
  • Low blood pressure when standing (orthostatic hypotension): Can cause dizziness or fainting — take care when getting up quickly, especially if you have heart or blood vessel disease.
  • Low white blood cell count: Patients with a history of low white blood cells need monitoring; a significant drop may require stopping the medication.

Lurasidone interactions

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Lurasidone is broken down by a liver enzyme called CYP3A4, so drugs that affect this enzyme can significantly change how much lurasidone is in your system:

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole) — must not be taken with lurasidone; they raise lurasidone levels to potentially dangerous amounts
  • Strong CYP3A4 inducers (e.g., rifampin, St. John's wort, phenytoin, carbamazepine) — must not be taken with lurasidone; they reduce lurasidone levels so much the medication may not work
  • Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, fluconazole, verapamil, atazanavir) — can be used together, but lurasidone dose must be reduced; inform your doctor
  • Moderate CYP3A4 inducers (e.g., efavirenz, modafinil, bosentan) — may require a lurasidone dose increase; discuss with your prescriber
  • Lithium and valproate — no significant interaction with lurasidone; no dose adjustment needed for any of these drugs when used together

Interactions listed in the FDA-approved label

From the Lurasidone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil): Concomitant use increased the exposure of lurasidone compared to lurasidone alone. Should not be used concomitantly with strong CYP3A4 inhibitors.
  • Moderate CYP3A4 inhibitors (diltiazem, atazanavir, erythromycin, fluconazole, verapamil): Concomitant use increased the exposure of lurasidone compared to lurasidone alone. Lurasidone dose should be reduced to half of the original level when used concomitantly.
  • Strong CYP3A4 inducers (rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine): Concomitant use decreased the exposure of lurasidone compared to lurasidone alone. Should not be used concomitantly with strong CYP3A4 inducers.
  • Moderate CYP3A4 inducers (bosentan, efavirenz, etravirine, modafinil, nafcillin): Concomitant use decreased the exposure of lurasidone compared to lurasidone alone. Lurasidone dose should be increased when used concomitantly.
  • Lithium: No clinically important interaction; no dosage adjustment of lurasidone is required.
  • Valproate: No clinically important interaction; no dosage adjustment of lurasidone is required.
  • Substrates of P-gp or CYP3A4: No clinically important interaction; no dosage adjustment of lurasidone is required.
Read the label’s full interactions text

7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with Lurasidone Hydrochloride Table 34: Clinically Important Drug Interactions with Lurasidone Hydrochloride Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of lurasidone hydrochloride with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Lurasidone hydrochloride should not be used concomitantly with strong CYP3A4 inhibitors [ see Contraindications ( 4 ) ]. Examples: Ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of lurasidone hydrochloride with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Lurasidone hydrochloride dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 [ see Dosage and Administration ( 2.6 ) ]. Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil Strong CYP3A4 Inducers Clinical Impact: Concomitant use of lurasidone hydrochloride with strong CYP3A4 inducers decreased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Lurasidone hydrochloride should not be used concomitantly with strong CYP3A4 inducers [ see Contraindications ( 4 ) ]. Examples: Rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of lurasidone hydrochloride with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [ see Clinical Pharmacology ( 12.3 ) ].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿149 supplements and herbs with documented Lurasidone interactions, ranked by severity Check Lurasidone against a supplement or herb →

Before taking Lurasidone

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  • Do not take lurasidone if you are allergic to lurasidone hydrochloride or any ingredient in the tablet
  • Do not take lurasidone with strong CYP3A4 inhibitors or inducers (see interactions above)
  • Pregnant? Babies exposed to antipsychotics in the third trimester may have movement difficulties or withdrawal symptoms after birth. A pregnancy registry is available at 1-866-961-2388 for tracking outcomes.
  • Breastfeeding? It is not known if lurasidone passes into human breast milk. Discuss the risks and benefits with your doctor.
  • Older adults with dementia: Lurasidone is not approved for dementia-related psychosis and carries increased mortality risk in this group.
  • Kidney or liver impairment: Moderate or severe kidney or liver problems require a lower starting dose and a lower maximum dose — tell your doctor about any kidney or liver conditions.
  • Children: Not established for schizophrenia under age 13 or for bipolar depression under age 10.
  • Tell your doctor if you have a history of diabetes, high cholesterol, seizures, low white blood cell counts, heart or blood vessel disease, or Parkinson's disease.

Lurasidone overdose

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In clinical studies, one person was known to have taken a large overdose of lurasidone and recovered fully without lasting effects. There is no specific antidote for lurasidone overdose. If an overdose is suspected, call Poison Control immediately at 1-800-222-1222 or go to the nearest emergency room.

Medical management focuses on supportive care, heart monitoring, and watching for serious symptoms such as low blood pressure, seizures, severe muscle spasms, or loss of consciousness. Certain heart and blood pressure medications may interact dangerously in an overdose situation, so emergency providers should be told exactly what was taken.

What Lurasidone does in the body

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Lurasidone blocks dopamine D2 receptors and serotonin 5-HT2A and 5-HT7 receptors with high affinity, and partially activates serotonin 5-HT1A receptors. It also has moderate blocking activity at alpha-2C and alpha-2A adrenergic receptors. Importantly, lurasidone has very little activity at histamine H1 and muscarinic M1 receptors, which are often associated with sedation and weight gain seen with other antipsychotics. In dedicated studies, lurasidone produced only small, clinically unremarkable changes in the heart's QT interval (a measure of electrical activity), and no dangerous QT prolongations were seen in controlled studies.

How your body processes Lurasidone

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After taking lurasidone by mouth with food, peak blood levels are reached in about 1 to 3 hours. Food substantially increases absorption — roughly doubling the overall exposure and tripling peak levels compared to taking it on an empty stomach. Lurasidone is almost entirely bound to proteins in the blood (about 99%) and has a half-life of approximately 18 hours, meaning it takes about that long for blood levels to drop by half. It is broken down primarily by the liver enzyme CYP3A4 into active and inactive byproducts, with about 80% eliminated in stool and 9% in urine. Steady-state levels in the blood are generally reached within 7 days of consistent daily dosing.

How to store Lurasidone

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Store LATUDA tablets at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

149

Supplements & herbs that interact with Lurasidone

149 supplements and herbal products have documented interactions with Lurasidone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 104
  • Minor · 40
ACTIVATED CHARCOAL Major GRAPEFRUIT Major INDIAN SNAKEROOT Major RAUVOLFIA VOMITORIA Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate +141 more
Every supplement checked against Lurasidone — ranked by severity The full interaction hub: 5 major · 104 moderate · 40 minor · every one linked to its full report. Check Lurasidone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Lurasidone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Lurasidone — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to take lurasidone with food? Does it matter what I eat?

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Yes, food really does matter here. Taking lurasidone with a meal of at least 350 calories more than doubles the amount of medication your body actually absorbs — so if you take it on an empty stomach, you may not be getting the full effect. The good news is it doesn't matter what kind of food you eat or how big the meal is, as long as it hits that 350-calorie mark. A regular-sized lunch or dinner works perfectly. Try to take it at the same meal every day to keep things consistent.

What side effects should I actually expect, and which ones do I need to call my doctor about?

▾
The most common things people notice are sleepiness, nausea, and a restless feeling called akathisia — where you feel like you need to keep moving or can't sit still. These are usually manageable and often improve with time. What you should call your doctor about right away: a high fever with severe muscle stiffness and confusion (which could signal a rare but serious reaction called neuroleptic malignant syndrome), any uncontrolled twitching or jerky movements, fainting, or if you notice you're extremely thirsty and urinating much more than usual. And if you ever have thoughts of harming yourself, contact your doctor or go to the emergency room immediately.

I take other medications. Are there any I should be worried about combining with lurasidone?

▾
Absolutely bring up everything you're taking — including supplements and herbal products — because some combinations are a serious problem. Lurasidone cannot be taken with certain strong antifungals, antibiotics, or HIV medications (like ketoconazole, clarithromycin, or ritonavir), or with drugs like rifampin, phenytoin, carbamazepine, or St. John's wort. These can either push lurasidone levels dangerously high or drop them so low the medication won't work. Other medications in the middle — like the heart drug diltiazem or the antifungal fluconazole — may just require a dose adjustment. Your pharmacist or doctor can check all your medications for you.

Is lurasidone safe if I'm pregnant or thinking about becoming pregnant?

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This is an important conversation to have with your doctor before making any changes. Babies born to people who took antipsychotic medications in the last trimester of pregnancy sometimes have temporary movement problems or withdrawal-like symptoms after birth, though these often resolve on their own. There isn't enough human data yet to say definitively whether lurasidone causes birth defects. If you're pregnant or planning to become pregnant, don't stop taking it suddenly — talk to your prescriber first so you can weigh the risks of the medication against the risks of untreated illness. You can also enroll in a pregnancy registry at 1-866-961-2388 to help researchers learn more.

My doctor mentioned monitoring my blood sugar and cholesterol. Why is that necessary?

▾
Lurasidone belongs to a class of medications called atypical antipsychotics, and this whole group can sometimes affect blood sugar and fat levels in the blood. This doesn't mean it will definitely happen to you, but it's worth keeping an eye on — especially if you already have diabetes or a family history of it. Your doctor will likely check a fasting blood sugar and lipid panel at the start of treatment and periodically after that. If you notice symptoms like unusual thirst, frequent urination, or feeling weak, let your doctor know right away.

Is lurasidone approved for my child or teenager?

▾
It depends on your child's age and diagnosis. For schizophrenia, lurasidone is approved for adolescents aged 13 to 17. For bipolar depression, it's approved for children and teens aged 10 to 17. It has not been established as safe or effective in younger children for these conditions. One important note: children and young adults taking lurasidone for bipolar depression should be watched carefully for any changes in mood or new thoughts of self-harm — this is a real risk with this medication class in younger patients, and your prescriber will want to monitor closely, especially at the start of treatment.

Is Lurasidone available over the counter?

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No. Lurasidone is a prescription medicine: every Lurasidone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Lurasidone first available?

▾
The earliest FDA record we hold for Lurasidone is from 2010: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Lurasidone was first used.

Who makes Lurasidone?

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29 companies currently list Lurasidone products in the FDA's NDC Directory, including Major Pharmaceuticals, Remedyrepack Inc., Torrent Pharmaceuticals Limited. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Lurasidone on HelloPharmacist

📊Lurasidone supplement interactions149 checked — ranked by severity 🌿Drug & Supplement CheckerLurasidone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Lurasidone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Lurasidone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Lurasidone forms and strengths (how it comes)

Lurasidone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Latuda
How this form is used
What it may be used for
  • Lurasidone Hydrochloride tablets are used to treat schizophrenia in adults and adolescents aged 13 to 17
  • Lurasidone Hydrochloride tablets are used to treat bipolar depression in adults and pediatric patients aged 10 to 17 as monotherapy
  • Lurasidone Hydrochloride tablets are used to treat bipolar depression in adults as adjunctive therapy with lithium or valproate
  • Latuda tablets are approved for the same indications: schizophrenia in adults and adolescents (13–17), and bipolar depression in adults and pediatric patients (10–17) as monotherapy or with lithium or valproate in adults
Important instructions
  • Latuda and lurasidone hydrochloride tablets should be taken once daily by mouth with food providing at least 350 calories
  • Lurasidone Hydrochloride tablets do not require initial dose titration — your prescriber will set your starting dose
  • Lurasidone HCL tablets: if you also take a moderate CYP3A4 inhibitor (such as diltiazem), your doctor will likely reduce your lurasidone dose
  • Lurasidone Hydrochloride tablets: patients with moderate or severe kidney or liver impairment may need a lower dose — follow your prescriber's guidance
Available strengths 5 strengths
20 mg 40 mg 60 mg 80 mg 120 mg
274 FDA-listed product records ⓘ

Lurasidone on the U.S. market: products, makers and brands

How Lurasidone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

29 companies list 138 Lurasidone product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2010. Brand names on the directory include Latuda; the rest are generics.

1
Dose forms ⓘ
29
Labelers (makers, repackagers, distributors)
3
Brand names
138
FDA-listed product records ⓘ
2010
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (25) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Major Pharmaceuticals7%
Remedyrepack Inc.4%
Torrent Pharmaceuticals Limited4%
Accord Healthcare, Inc.4%
Alembic Pharmaceuticals Inc.4%
Alembic Pharmaceuticals Limited4%
Other makers73%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Lurasidone is used (Medicaid data)

A general measure of how commonly Lurasidone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Lurasidone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,049,340
Medicaid prescriptions filled (Q1–Q4 2025)
$42.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Lurasidone prescribed? Of the 1,601 medications we measure, Lurasidone ranks #172 by Medicaid prescriptions — more than 89% of them.

Where Lurasidone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #172 of 1,601
#167 Clobetasol Topical 1,093,267 Rx #168 Cyanocobalamin Injecti... 1,087,734 Rx #169 Nifedipine 1,079,242 Rx #170 Cariprazine 1,076,596 Rx #171 Naltrexone 1,052,053 Rx #172 Lurasidone 1,049,340 Rx #173 Paliperidone 1,015,111 Rx #174 Levocetirizine 1,014,061 Rx #175 Ethinyl Estradiol / Fe... 1,010,948 Rx #176 Clotrimazole Topical 1,007,055 Rx #177 Insulin Aspart (rDNA O... 1,003,363 Rx

Utilization by Lurasidone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 40 mg oral tablet is the most-dispensed Lurasidone product — about 30% of these Medicaid prescriptions.

lurasidone hydrochloride 40 MG Oral Tablet Most dispensed

310,586 Medicaid prescriptions (Q1–Q4 2025) 30% of Lurasidone prescriptions shown $11.3M gross reimbursement (before rebates) ≈ $36 per prescription (gross)

Summed across the 18 of 93 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1040031

lurasidone hydrochloride 20 MG Oral Tablet

278,750 Medicaid prescriptions (Q1–Q4 2025) 27% of Lurasidone prescriptions shown $8.8M gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 17 of 98 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1235247

lurasidone hydrochloride 60 MG Oral Tablet

192,406 Medicaid prescriptions (Q1–Q4 2025) 18% of Lurasidone prescriptions shown $8.2M gross reimbursement (before rebates) ≈ $42 per prescription (gross)

Summed across the 18 of 87 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1431235

lurasidone hydrochloride 80 MG Oral Tablet

191,545 Medicaid prescriptions (Q1–Q4 2025) 18% of Lurasidone prescriptions shown $9.2M gross reimbursement (before rebates) ≈ $48 per prescription (gross)

Summed across the 18 of 81 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1040041

lurasidone hydrochloride 120 MG Oral Tablet

76,053 Medicaid prescriptions (Q1–Q4 2025) 7% of Lurasidone prescriptions shown $5M gross reimbursement (before rebates) ≈ $66 per prescription (gross)

Summed across the 17 of 80 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1297278

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lurasidone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 88 of 439 listed Lurasidone NDCs with Medicaid activity.

Compare Lurasidone products

A representative set of FDA-listed product records for Lurasidone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 111 of 138 products — FDA National Drug Code Directory. See every product, package size and price: browse all 138 Lurasidone NDCs →

Lurasidone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Lurasidone recall since July 2021, covering 2 product listings. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Jan 18, 2024 · Completed · SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
  • Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., S… Lots: Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024 FDA record D-0267-2024 →
  • Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Su… Lots: Lot #: DNE0620A Exp. 05/31/2025 FDA record D-0266-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Lurasidone RxCUI 1040028 1 dose form · 5 strengths

Look up RxCUI 1040028 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Lurasidone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 20 mg $0.142 per tablet NDC details & price history
Tablet, Film Coated · Oral 40 mg $0.210 per tablet NDC details & price history
Tablet, Film Coated · Oral 60 mg $0.291 per tablet NDC details & price history
Tablet, Film Coated · Oral 80 mg $0.328 per tablet NDC details & price history
Tablet, Film Coated · Oral 120 mg $0.487 per tablet NDC details & price history
Tablet · Oral 40 mg $0.210 per tablet NDC details & price history
Tablet · Oral 60 mg $0.291 per tablet NDC details & price history
Tablet · Oral 20 mg $0.142 per tablet NDC details & price history
Tablet · Oral 80 mg $0.328 per tablet NDC details & price history
Tablet · Oral 120 mg $0.482 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Lurasidone brand names

Lurasidone is sold under one brand name in the FDA directory — Latuda. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Latuda

Who makes Lurasidone: manufacturers and labelers

29 companies list Lurasidone products with the FDA. By number of product records, the largest are Major Pharmaceuticals, Remedyrepack Inc., Torrent Pharmaceuticals Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Major Pharmaceuticals 10 Remedyrepack Inc. 6 Torrent Pharmaceuticals Limited 6 Accord Healthcare, Inc. 5 Alembic Pharmaceuticals Inc. 5 Alembic Pharmaceuticals Limited 5 Amneal Pharmaceuticals LLC 5 Amneal Pharmaceuticals of New York LLC 5 Ascend Laboratories, LLC 5 Aurobindo Pharma Limited 5 Camber Pharmaceuticals, Inc. 5 Cipla USA, Inc. 5 Dr. Reddys Laboratories Inc 5 Exelan Pharmaceuticals Inc. 5 Golden State Medical Supply, Inc. 5 Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc. 5 Lupin Pharmaceuticals, Inc. 5 Macleods Pharmaceuticals Limited 5 Novadoz Pharmaceuticals LLC 5 Sumitomo Pharma America, Inc. 5 Sun Pharmaceutical Industries, Inc. 5 Zydus Lifesciences Limited 5 Zydus Pharmaceuticals USA Inc. 5 American Health Packaging 4

…and 5 more on the FDA NDC directory.

Lurasidone drug class (RxNorm)

Lurasidone belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Indole derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Lurasidone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 31, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lurasidone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lurasidone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
42
Finished products in the current FDA directory
138
Companies listing them (makers, repackagers, distributors)
29
FDA labeler codes behind them ⓘ
29
Linked representative label ⓘ
Sunovion Pharmaceuticals Inc.
Linked label effective
Jan 31, 2025
Composite sections available
27
Linked SPL Set ID
afad3051-9df2-4c54-9684-e8262a133af8
Linked SPL Document ID
7383b0e0-01e8-4778-96f0-6f2e0c9586ae
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sunovion Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →