lurasidone

Score breakdown (78/100)

Safety: 65

• Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
• 2,783 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site
• Death share in reports is near or below the FAERS average (0.4x)
• Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)

Evidence: 64

• 77 randomized trials and 24 systematic reviews/meta-analyses indexed in PubMed
• 1 independent Cochrane review(s) exist

Regulatory history: 92

• Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 19 generic makers (-3)
• Label lists recent major changes to warnings or indications (-5)

Money & lawsuits: 100

• Pharma paid doctors $18,129 tied to this drug last year: negligible
• Not named in any pending federal MDL

Options: 100

• Generic versions approved (19 applications)
• 4 same-class alternatives exist

What the FDA label says

Approved uses

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 )] . LATUDA is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) 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 adjunctive therapy with lithium or valproate ( 1 , 14.2 )

Contraindications

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 ).

Source: FDA SPL label for Latuda (Sumitomo Pharma America, Inc.), effective 20250131. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

Problems reported most often

Reports per year

2,783 reports blaming this drug for every million Medicare prescriptions filled, which is 1.0× the typical drug on this site. (2,376 reports in 2024–2026, against 853,871 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

Independent Cochrane reviews

• Lurasidone versus typical antipsychotics for schizophrenia (2025)

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $18,129 in payments to US physicians and hospitals tied to this drug across 22 transactions (Latuda $18,129).

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

Same-class alternatives

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

1. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
2. The most-reported problems in FDA's adverse event data are anxiety, depression. How would we recognize and handle those?
3. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
4. Why this one over molindone, oxypertine, sertindole? What would make you pick one of those instead?
5. What result are we expecting, by when, and what is the plan if it does not happen?
6. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)