Lurasidone: uses, dosing, side effects & brands

Lurasidone is an atypical antipsychotic sold in the U.S. under 2 brand and generic names, for bipolar disorder, major depressive disorder and schizophrenia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Atypical Antipsychotic
Treats: Bipolar Disorder, Major Depressive Disorder and Schizophrenia
Available as: Tablet
Sold as: 2 products — Latuda and Lurasidone Hydrochloride
Prescription?: Prescription only
Generic available?: Yes
Half-life: about 18 hours (mean, %CV 7), measured after a 40 mg oral dose in adults
What the pharmacy pays: about $9 for a 30-count supply — not your price
Boxed warning: Boxed warning

How lurasidone is dosed

From the FDA label for Latuda (application NDA200603). Other lurasidone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA ( 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): LATUDA 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 LATUDA ( 2.6 , 7.1 ). 2.1 Schizophrenia Adults The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective…

Lurasidone side effects

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] Suicidal Thoughts and Behaviors [see Boxed Warning and Warnings and Precautions ( 5.2 )] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.8 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.9 )] Falls [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12 )] Body Temperature Dysregulation [see Warnings and Precautions ( 5.13 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.14 )] Dysphagia [see Warnings and Precautions ( 5.15 )] Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies [see Warnings and Precautions ( 5.16 )] Commonly observed adverse…

Who shouldn’t take lurasidone

Known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone [see Adverse Reactions ( 6.1 )] . Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ( 7.1 )]. Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) [see Drug Interactions ( 7.1 )]. Known hypersensitivity to LATUDA or any components in the formulation ( 4 ). Concomitant use with a strong CYP3A4 inhibitor (e.g., ketoconazole) ( 2.6 , 4 , 7.1 ). Concomitant use with a strong CYP3A4 inducer (e.g., rifampin) ( 2.6 , 4 , 7.1 ).

Lurasidone drug interactions

7.1 Drugs Having Clinically Important Interactions with LATUDA Table 34: Clinically Important Drug Interactions with LATUDA Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA 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 LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA 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 LATUDA with strong CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA 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 LATUDA with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA dose should be increased when used concomitantly with moderate inducers of CYP3A4 [see Dosage and Administration ( 2.6 )] . Examples: Bosentan, efavirenz, etravirine, modafinil, nafcillin 7.2 Drugs Having No Clinically Important 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 )] .

Lurasidone and food

Grapefruit & grapefruit juice
Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA ↗

Every lurasidone product we track (2)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Lurasidone products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Latuda Boxed warning	Not yet rated	Prescription	Tablet	Generic	$9	View →
2	Lurasidone Hydrochloride Boxed warning	Not yet rated	Prescription	Tablet	Generic	$9	View →

What lurasidone pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Lurasidone pill imprints
Imprint	Strength	Colour	Shape	Maker
578	20 mg	white	round	—
684	40 mg	white	round	—
639	60 mg	white	capsule	—
685	80 mg	green	oval	—
579	120 mg	white	oval	—
F3	20 mg	white	round	—
F5	60 mg	white	capsule	—
F6	80 mg	yellow	oval	—
F7	120 mg	white	oval	—
64	20 mg	white	round	—
65	40 mg	white	round	—
509	60 mg	white	capsule	—

Lurasidone recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long lurasidone keeps

No lurasidone label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does lurasidone expire? The in-use limits and storage rules from its labels

Lurasidone and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Lurasidone is more than 99% bound to plasma proteins, so it is unlikely that the drug would be excreted into milk in sufficient amounts to affect a breastfed infant. Data from one mother-infant pair appears to support the poor excretion into milk and lack of effect on the breastfed infant. Until more data are available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Full LactMed record for lurasidone: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised November 15, 2025. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about lurasidone

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,045 reports naming lurasidone, and the FDA flagged 83% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

sedation152 reports
dyskinesia151 reports
dystonia142 reports
anosognosia139 reports
blood prolactin abnormal139 reports
sexual dysfunction139 reports
blood glucose increased138 reports
metabolic disorder137 reports

Read these as a signal, not a rate. A report does not mean lurasidone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved August 25, 2026.

How long lurasidone stays in your system

The elimination half-life of lurasidone is about 18 hours (mean, %CV 7), measured after a 40 mg oral dose in adults. This is the terminal elimination half-life explicitly labeled as such in §12.3, not a distribution-phase value. The label states activity is primarily due to the parent drug; it names two active metabolites (ID-14283 and ID-14326) but gives no half-life for them and does not indicate any active metabolite outlasts the parent, so there is no longer-lasting active moiety to report. Lurasidone is not a prodrug. The label does not state a specific half-life for older adults, or for kidney or liver impairment (its intrinsic-factor PK appears only in an image, Figure 3); it instead caps dosing in these groups because exposure rises — moderate/severe renal impairment and moderate hepatic impairment max 80 mg/day, severe hepatic impairment max 40 mg/day. Not a drug-test detection window and not dosing guidance.

Lurasidone Hydrochloride Tablets — FDA Prescribing Information (DailyMed, §12.3 Pharmacokinetics) ↗

Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.

Related calculators

How long it stays in your system →

Frequently asked questions

What is lurasidone?

LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives.

What kind of drug is lurasidone?

The FDA classifies lurasidone as an atypical antipsychotic. Atypical antipsychotics block dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, rebalancing these signaling chemicals to reduce hallucinations, delusions, and mood symptoms in conditions like schizophrenia and bipolar disorder. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

How long does lurasidone stay in your system?

The elimination half-life of lurasidone is about 18 hours (mean, %CV 7), measured after a 40 mg oral dose in adults — that is how long the body takes to clear half of a dose. This is the terminal elimination half-life explicitly labeled as such in §12.3, not a distribution-phase value. The label states activity is primarily due to the parent drug; it names two active metabolites (ID-14283 and ID-14326) but gives no half-life for them and does not indicate any active metabolite outlasts the parent, so there is no longer-lasting active moiety to report. Lurasidone is not a prodrug. The label does not state a specific half-life for older adults, or for kidney or liver impairment (its intrinsic-factor PK appears only in an image, Figure 3); it instead caps dosing in these groups because exposure rises — moderate/severe renal impairment and moderate hepatic impairment max 80 mg/day, severe hepatic impairment max 40 mg/day. Not a drug-test detection window and not dosing guidance. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take lurasidone with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run lurasidone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is lurasidone sold under?

We track 2 lurasidone-containing products in the U.S.: Latuda and Lurasidone Hydrochloride. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does lurasidone come in?

Across the brands we track, lurasidone is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic lurasidone?

Yes. Our catalog lists 1 generic lurasidone product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has lurasidone been recalled?

The FDA's Enforcement database lists 2 recall records whose product description mentions lurasidone. The most recent: Lurasidone Hydrochloride Tablets 60mg (Jan 18, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

What should I avoid while taking lurasidone?

Food: grapefruit and grapefruit juice (and, for some drugs, seville oranges) — see the food section above for what each one does and whether it means avoiding it or just being consistent. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.

Cite this page

APA: pharmaranks. (2026, July 24). Lurasidone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/lurasidone
MLA: “Lurasidone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/lurasidone.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for lurasidone on DailyMed (NIH) ↗ — including its boxed warning in full.