Lurasidone

Pronunciation: loo-RAS-i-done.

Generic name
lurasidone hydrochloride
Drug class
Atypical antipsychotic (benzisothiazol derivative; dopamine D2 and serotonin 5-HT2A receptor antagonist)
Form
Tablet (20 mg, 40 mg, 60 mg, 80 mg, 120 mg in the US/Canada; 18.5 mg, 37 mg, 74 mg in the UK/EU)
Route
Oral
Legal status
Prescription-only

Supply Rules Vary

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: LATUDA (5) · Full directory

What lurasidone hydrochloride is and how it works

Lurasidone is a prescription-only atypical antipsychotic medicine. In the United States and Canada it is approved to treat both schizophrenia and depressive episodes associated with bipolar I disorder (bipolar depression). In the United Kingdom, the European Union, and Australia, it is approved for schizophrenia only -- bipolar depression is not an approved use in those markets. (1)

Lurasidone carries two real parts to its US boxed warning -- the FDA's strongest safety warning. The first concerns an increased risk of death in elderly people with dementia-related psychosis; lurasidone is not approved for that use. The second concerns an increased risk of suicidal thoughts and behaviour in children, adolescents, and young adults, which is relevant because lurasidone itself is used to treat bipolar depression in the US. Your prescriber will discuss both risks with you and monitor you closely, especially early in treatment. Lurasidone must be taken with a substantial meal, as food significantly increases how much of the medicine your body absorbs.

Mechanism of action: how lurasidone hydrochloride works

Lurasidone's mechanism of action in schizophrenia and bipolar depression is not fully established, but is thought to be mediated through a combination of central dopamine D2 and serotonin 5-HT2A receptor antagonism, with additional binding at serotonin 5-HT7 (antagonist) and 5-HT1A (partial agonist) receptors, moderate alpha-2C adrenergic affinity, and little or no affinity for histamine H1 or muscarinic M1 receptors. (1) (4)

What lurasidone hydrochloride is used for

Schizophrenia

Approved for the treatment of schizophrenia in adults in all 6 markets reviewed, and in adolescents in most: 13-17 years (US), 15-17 years (Canada), 13-17 years (UK, EU, Australia). (1) (2) (3) (4) (5)

Bipolar depression (United States and Canada only)

Approved in the US and Canada for major depressive episodes associated with bipolar I disorder, as monotherapy (adults, and pediatric/adolescent patients in both countries with different age bands) or as adjunctive therapy with lithium or valproate (adults only in both countries). This is NOT an approved use in the UK, EU, or Australia, where lurasidone is approved for schizophrenia only. (1) (4) (2) (3)

Before taking lurasidone hydrochloride

Do not take / not appropriate for

  • Do not take lurasidone if you have had an allergic reaction to it or any of its ingredients (angioedema has been observed). (all confirmed markets) (1) (4)
  • Do not take lurasidone together with a strong CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, ritonavir, voriconazole) or a strong CYP3A4 inducer (e.g. rifampin, phenytoin, carbamazepine, St John's Wort) -- these combinations are contraindicated. (all confirmed markets) (1) (4)
  • Lurasidone is not approved for treating psychosis related to dementia, and is not indicated in elderly patients with dementia. (United States, Canada) (1) (4)

Tell your clinician about

  • If lurasidone is being used to treat bipolar depression, whether you (or the person being treated) are a child, adolescent, or young adult -- this use carries a real risk of increased suicidal thinking and behaviour that needs close monitoring.
  • Any personal or family history of an irregular heartbeat, or other heart or blood vessel disease, especially if lurasidone is being considered for an elderly person with dementia-related symptoms.
  • Any history of diabetes, high blood sugar, or high cholesterol.
  • Any personal or family history of movement disorders or seizures.
  • Any history of low white blood cell count or blood disorders.
  • Any history of falls, fainting, or low blood pressure on standing.
  • All other medicines you take, especially strong or moderate CYP3A4 inhibitors or inducers.
  • Kidney or liver problems.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1) (2) (4)

How to take lurasidone hydrochloride

  • Take lurasidone once daily with food -- at least 350 calories -- as food substantially increases how much of the medicine is absorbed (roughly doubling peak levels and increasing overall exposure).
  • Take it at the same time each day.
  • Do not change your dose or stop taking lurasidone without talking to your prescriber first.
  • Avoid grapefruit and grapefruit juice, which can affect lurasidone levels.
  • If you also take a moderate CYP3A4 inhibitor or inducer medicine, your prescriber will adjust your dose accordingly.
  • Attend all follow-up appointments so your prescriber can monitor for movement changes, blood sugar/cholesterol changes, blood counts, and mood or behaviour changes.
(1) (4) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember with food, unless it is almost time for your next dose -- in that case, skip the missed dose and continue your regular schedule. Do not take a double dose. Contact your prescriber if you are unsure.

Overdose

Seek urgent medical attention or contact a poison control centre if too much lurasidone may have been taken, or if you develop an irregular heartbeat, severe drowsiness, seizures, or fainting. There is no specific antidote; management is supportive with cardiac monitoring. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Somnolence (sleepiness) -- common, more frequent at higher doses (up to 26% at 120 mg/day in schizophrenia trials vs 7% placebo).

What to notice: Somnolence (sleepiness) -- common, more frequent at higher doses (up to 26% at 120 mg/day in schizophrenia trials vs 7% placebo).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Akathisia (an inner restlessness or urge to move) -- common, dose-related.

What to notice: Akathisia (an inner restlessness or urge to move) -- common, dose-related.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Extrapyramidal symptoms (movement-related side effects such as tremor, muscle stiffness) -- common, dose-related.

What to notice: Extrapyramidal symptoms (movement-related side effects such as tremor, muscle stiffness) -- common, dose-related.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea -- common in both schizophrenia and bipolar depression trials.

What to notice: Nausea -- common in both schizophrenia and bipolar depression trials.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Insomnia, weight increase -- more common in pediatric bipolar depression patients.

What to notice: Insomnia, weight increase -- more common in pediatric bipolar depression patients.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Increased risk of death in elderly patients with dementia-related psychosis — boxed_warning

Symptoms: This is a population-level risk identified in clinical trials of antipsychotic medicines as a class, not a specific symptom to watch for.

Action: Lurasidone is not approved for treating dementia-related psychosis. In the US FDA analysis of 17 placebo-controlled trials (modal duration 10 weeks), the death rate was about 4.5% in drug-treated patients vs about 2.6% in placebo-treated patients (a 1.6-1.7-fold increase), mostly from cardiovascular or infectious causes. Health Canada cites an equivalent 1.6-fold figure across 13 trials. Discuss the risks and benefits carefully with the prescriber if this medicine is being considered for an older adult. (1) (4)

Increased risk of suicidal thoughts and behaviour in pediatric and young adult patients — boxed_warning

Symptoms: New or worsening depression, anxiety, agitation, irritability, hostility, aggressiveness, impulsivity, or thoughts of self-harm or suicide.

Action: This applies specifically when lurasidone is used to treat bipolar depression. Monitor closely for these signs, particularly early in treatment or after a dose change, and contact a prescriber or emergency services immediately if they occur. (1)

Signs of tardive dyskinesia — high caution

Symptoms: Uncontrollable, repetitive body movements (such as grimacing, tongue movements, or lip smacking).

Action: Tell your prescriber promptly -- this may be irreversible in some cases and its likelihood generally increases with treatment duration and cumulative dose. Your prescriber aims to use the lowest effective dose for the shortest duration. (1)

Signs of neuroleptic malignant syndrome — emergency

Symptoms: High fever, severe muscle stiffness, altered mental status, rapid or irregular heartbeat, sweating, elevated creatine phosphokinase.

Action: Seek emergency medical attention immediately. Lurasidone should be discontinued right away if this is suspected, with intensive symptomatic treatment and monitoring. (1)

Low white blood cell count (leukopenia, neutropenia) or agranulocytosis — high caution

Symptoms: Fever, sore throat, mouth sores, signs of infection, or unusual tiredness.

Action: Tell your prescriber immediately. Patients with a pre-existing low white blood cell count or history of drug-induced leukopenia/neutropenia should have blood counts monitored frequently during the first months of therapy; lurasidone should be discontinued at the first sign of a clinically significant decline in white blood cells. (1)

Orthostatic hypotension and syncope — moderate caution

Symptoms: Dizziness, lightheadedness, or fainting on standing up, especially at the start of treatment or after a dose increase.

Action: Tell your prescriber, particularly if you have heart or blood vessel disease, are dehydrated, or take blood pressure medicines. Rise slowly from sitting or lying positions. (1)

New or worsening high blood sugar or metabolic changes — moderate caution

Symptoms: Increased thirst, frequent urination, unexplained weight gain, fatigue.

Action: Your prescriber will monitor blood sugar, cholesterol, and weight during treatment, especially if you have risk factors for diabetes. Rare cases of severe hyperglycemia with ketoacidosis or hyperosmolar coma have been reported. (1)

Falls — moderate caution

Symptoms: Dizziness, unsteadiness, or a fall, related to somnolence, postural hypotension, or motor/sensory instability.

Action: Your prescriber should assess fall risk before starting and periodically during long-term treatment, especially in patients with conditions or other medicines that increase this risk. (1)

Seizures — moderate caution

Symptoms: Convulsions or loss of consciousness.

Action: Tell your prescriber about any seizure history or conditions that lower seizure threshold (such as Alzheimer's dementia) -- lurasidone should be used cautiously in these patients. (1)

Difficulty swallowing (dysphagia) or aspiration — moderate caution

Symptoms: Coughing or choking while eating or drinking, chest discomfort after swallowing.

Action: Tell your prescriber, particularly if you are elderly or have advanced dementia -- antipsychotic medicines including lurasidone have been associated with oesophageal dysmotility and aspiration, and should be used cautiously in patients at risk of aspiration pneumonia. (1)

New or worsening manic or hypomanic symptoms (when used for bipolar depression) — moderate caution

Symptoms: Unusually elevated mood, increased energy, decreased need for sleep, racing thoughts, or impulsive behaviour.

Action: Tell your prescriber -- treatment for a manic or hypomanic episode itself can increase the risk of these symptoms emerging, particularly in patients with bipolar disorder. (1)

Interactions

  • Strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil): contraindicated -- significantly increase lurasidone exposure. (1) (2)
  • Moderate CYP3A4 inhibitors (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil): reduce lurasidone dose to about half. (1)
  • Strong CYP3A4 inducers (e.g. rifampin, avasimibe, St John's Wort, phenytoin, carbamazepine): contraindicated -- significantly decrease lurasidone exposure and effectiveness. (1) (2)
  • Moderate CYP3A4 inducers (e.g. bosentan, efavirenz, etravirine, modafinil, nafcillin): may need to increase lurasidone dose after 7 or more days of concomitant use. (1)
  • Grapefruit and grapefruit juice: avoid -- can inhibit CYP3A4 and alter lurasidone concentrations. (1) (2)
  • Lithium or valproate (used as adjunctive bipolar-depression therapy): population pharmacokinetic analyses found minimal effect on lurasidone, lithium, or valproate exposure at studied doses; no dose adjustment required for this combination alone. (1)
  • Other serotonergic medicines (e.g. SSRIs, SNRIs, MAOIs): increased risk of serotonin syndrome noted in the UK/EU product information. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Third-trimester exposure to antipsychotics including lurasidone may cause extrapyramidal and/or withdrawal symptoms in newborns (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder). No adequate human studies exist; animal studies did not show teratogenic effects at the doses tested. Should be used in pregnancy only if clearly necessary, weighing benefits against risks. (1) (2) (3) (4) (5) (6)

Breastfeeding

Lurasidone is present in animal milk; no human lactation studies have been conducted. The benefits of breastfeeding should be weighed against the mother's clinical need for lurasidone and any potential effects on the breastfed infant. (1) (2) (3) (4) (5) (6)

Children

Approved uses in children/adolescents vary by market: schizophrenia from age 13 (US, UK, EU, Australia) or 15 (Canada); bipolar depression monotherapy from age 10 (US) or 13 (Canada) -- not an approved indication at all in the UK, EU, or Australia. Not established for irritability associated with autistic disorder (a study did not demonstrate effectiveness for this use). (1) (2) (3) (4) (5) (6)

Elderly

Lurasidone is not indicated in elderly patients with dementia because of the boxed-warning mortality risk. Clinical studies did not include sufficient numbers of patients 65 and older to determine if they respond differently; it is unknown whether dose adjustment is needed on the basis of age alone. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Reduce the maximum recommended dose in moderate to severe hepatic impairment (higher lurasidone exposure observed); starting dose typically reduced. (1) (2) (3) (4) (5) (6)

Renal_impairment

Reduce the maximum recommended dose in moderate to severe renal impairment (creatinine clearance below 50 mL/min); higher lurasidone exposure and increased risk of adverse reactions observed. (1) (2) (3) (4) (5) (6)

Source_ids

US-FDA-LATUDA-2025,UK-EMC-LATUDA-74MG-2026,CA-HEALTHCANADA-LATUDA-2018 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline weight, blood sugar, and cholesterol
  • Complete blood count if pre-existing low white blood cell count or history of leukopenia/neutropenia
  • Review of personal/family history of movement disorders, seizures, or cardiovascular disease
  • Fall-risk assessment
  • For bipolar depression use in children/adolescents/young adults: assessment of suicide risk

During treatment

  • Monitoring for movement changes (possible tardive dyskinesia).
  • Monitoring blood sugar, cholesterol, and weight.
  • Monitoring for new or worsening depression or suicidal thoughts, especially in children, adolescents, and young adults being treated for bipolar depression.
  • Monitoring for orthostatic hypotension, falls, and signs of neuroleptic malignant syndrome.
  • Periodic complete blood counts in at-risk patients.
(1)

Storage

Store at room temperature, away from moisture and light, out of reach of children.

Study the drug class: Atypical antipsychotics

Professional information

Clinician-facing context only, sourced from the current US, UK, EU, and Canadian labels reviewed; verify against the current full label before prescribing, and note the market-specific indication differences described above.

United States

Indication: Schizophrenia (adults, adolescents 13-17); bipolar depression monotherapy (adults, pediatric 10-17) or adjunctive with lithium/valproate (adults)

Dose summary: Schizophrenia: 40 mg/day starting, up to 160 mg/day (adults) or 80 mg/day (adolescents). Bipolar depression: 20 mg/day starting, up to 120 mg/day (adults) or 80 mg/day (pediatric). Must be taken with food (>=350 calories). CYP3A4-based dose adjustments apply.

Renal context: Reduce max dose to 80 mg/day in moderate/severe impairment (CrCl <50 mL/min), starting dose 20 mg/day. (1)

Canada

Indication: Schizophrenia (adults, adolescents 15-17); bipolar depression monotherapy or adjunctive with lithium/valproate (adults), monotherapy only (adolescents 13-17)

Dose summary: Similar dose ranges to the US for approved indications; same food and CYP3A4 requirements.

Renal context: Same renal dose-reduction approach as the US label. (4)

United Kingdom / European Union

Indication: Schizophrenia only (adults 18+, adolescents 13-17) -- no bipolar depression indication

Dose summary: Starting dose 37 mg once daily, range 37-148 mg/day (adults); with food. CYP3A4 contraindications/adjustments apply. Different mg strengths (18.5/37/74 mg) from the US/Canada (20/40/60/80/120 mg).

Renal context: Starting dose 18.5 mg/day in moderate/severe/ESRD impairment; maximum 74 mg/day. (2) (3)

Mechanism of action

Hepatic guidance

Reduce maximum dose in moderate to severe hepatic impairment; higher exposure observed with worsening Child-Pugh score.

Overdose note

No specific antidote. Manage supportively with continuous cardiac monitoring for arrhythmias; consider gastric lavage and activated charcoal; avoid epinephrine/dopamine or other beta-agonist sympathomimetics due to risk of worsening alpha-blockade-related hypotension. (1) (4)

Frequently asked questions

Does lurasidone carry a boxed warning?

Yes -- two parts, in fact, on the current US label. The first covers increased mortality in elderly patients with dementia-related psychosis (lurasidone is not approved for this use). The second covers increased risk of suicidal thoughts and behaviour in pediatric and young adult patients -- this is present because lurasidone itself is used to treat bipolar depression in the US, not because lurasidone is an antidepressant. Health Canada's monograph carries an equivalent dementia-mortality warning (1.6-fold increase in death rate across 13 trials) but does not include a separate suicidality box. (1) (4)

Is lurasidone approved for bipolar depression everywhere?

No. Lurasidone is approved to treat bipolar depression in the United States and Canada, either as monotherapy or (adults only) as an add-on to lithium or valproate. It is NOT an approved use in the United Kingdom, the European Union, or Australia, where lurasidone is approved for schizophrenia only. (1) (4) (2) (3) (5)

Why do I need to take lurasidone with food?

Taking lurasidone with a substantial meal (at least 350 calories) significantly increases how much of the medicine your body absorbs -- roughly doubling peak blood levels compared with taking it on an empty stomach. Clinical studies establishing its safety and effectiveness were all conducted with food, so taking it without food may make it less effective. (1)

Is lurasidone available in New Zealand?

Lurasidone is officially classified as a prescription medicine in New Zealand and is commercially available there (without government subsidy), but a specific Medsafe product data sheet confirming its exact approved indication in New Zealand could not be located during this research -- check directly with a New Zealand pharmacist or prescriber for current details. (6)

What is the mechanism of action of lurasidone hydrochloride?

Lurasidone's mechanism of action in schizophrenia and bipolar depression is not fully established, but is thought to be mediated through a combination of central dopamine D2 and serotonin 5-HT2A receptor antagonism, with additional binding at serotonin 5-HT7 (antagonist) and 5-HT1A (partial agonist) receptors, moderate alpha-2C adrenergic affinity, and little or no affinity for histamine H1 or muscarinic M1 receptors. (1) (4)

What is the generic name of Lurasidone?

The generic name is lurasidone hydrochloride. (1) (2)

What class of drug is lurasidone hydrochloride?

Lurasidone is classed as: Atypical antipsychotic (benzisothiazol derivative; dopamine D2 and serotonin 5-HT2A receptor antagonist). (1) (2)

References

  1. LATUDA (lurasidone hydrochloride) tablets -- full prescribing informationU.S. Food and Drug Administration · United States · dated 2025-01 · accessed 2026-07-31 · source 1
  2. Latuda 74mg film-coated tablets -- Summary of Product Characteristicselectronic Medicines Compendium (UK) · United Kingdom · accessed 2026-07-31 · source 2
  3. Latuda -- European Public Assessment Report (EPAR)European Medicines Agency · European Union · dated 2014-03-21 · accessed 2026-07-31 · source 3
  4. LATUDA (lurasidone hydrochloride) -- Product Monograph (Sunovion Pharmaceuticals Canada Inc.)Health Canada · Canada · dated 2018-04-19 · accessed 2026-07-31 · source 4
  5. LATUDA lurasidone hydrochloride 80 mg film-coated tablet blister pack -- ARTG 206651 (and 40 mg, ARTG 206650)Therapeutic Goods Administration · Australia · dated 2014-04-16 · accessed 2026-07-31 · source 5
  6. Classification of Medicines notice 2015-go3438 -- lurasidone listed under Prescription MedicinesNew Zealand Gazette (Medicines Classification Committee notice) · New Zealand · dated 2015 · accessed 2026-07-31 · source 6

Brand names by country

Single-ingredient lurasidone hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Latuda120 mg, 40 mg, 80 mg, 20 mg, 60 mg · sumitomo pharma america, inc.

United Kingdom

  • Latuda (2)current licensed product · 18.5 mg, 37 mg, 74 mg · See current emc SmPC listing

Canada

  • LATUDA

Australia

  • LATUDA (5)current register product example · 40 mg, 80 mg · Servier Laboratories (Aust) Pty Ltd
View brands in additional countries.

European Union

Latuda (3)

This page provides general reference information about lurasidone and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber, especially given the real market-specific differences in approved uses described above.

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