Drugs › Atypical antipsychotic
Brand name · Lurasidone hydrochloride
Latuda: adverse event reports filed with FDA
16,085 reports list it as a suspect or interacting product, 2009–2026. Class: Atypical antipsychotic. Also reported as Latuda 80mg, Latuda 40mg.
- 16,085
- reports as suspect product
- 0.1% of all reports · about 928 a year
- 183
- reports, 12 months to June 2026
- 276 in the 12 months before
- 40.7%
- marked serious by the reporter
- 70.7% across the class
- 2.6%
- record death among outcomes, as reported
- 415 reports · not verified by FDA
16,085 adverse event reports received by FDA list the brand name Latuda (lurasidone hydrochloride) as a suspect or interacting product, from March 2009 to June 2026. A further 3,967 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 183 reports listed it, down 34% from 276 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 928 reports a year and 0.1% of the 20,646,523 reports in the database, and 2.4% of the reports for the atypical antipsychotic class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are off label use (10.8%), drug ineffective (8.5%) and feeling abnormal (6.5%). A report can list several reactions, so shares add to more than 100%; 1,090 different terms appear across these reports. Off label use is recorded in 10.8% of these reports, a larger share than in the median atypical antipsychotic drug (6.9%).
40.7% of the reports are marked serious by the reporter (70.7% across the class); 2.6% record death among the outcomes and 11.6% record hospitalisation, as reported. 77.5% of the reports came from consumers, and the largest patient age group is 18 to 44 (17.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Latuda reports recording the termmedian drug in atypical antipsychotic
- Off label useused for a purpose or in a way not on the label10.8%1,745
- Drug ineffectivethe medicine did not work as expected8.5%1,371
- Feeling abnormalfeeling odd or not right6.5%1,039
- Anxietyanxiety6.1%975
- Somnolencedrowsiness5.6%898
- Weight increasedweight gain5.5%890
- Depressionlow mood5.3%850
- Insomniadifficulty sleeping5.1%823
- Nauseafeeling sick4.9%784
- Dyskinesiainvoluntary movements4.7%754
- Fatiguetiredness4.3%693
- Suicidal ideationthoughts of suicide4.3%686
- Suicide attempta suicide attempt3.7%591
- Tremorshaking3.5%570
- Sedationdrowsiness from a medicine3.4%547
- Restlessnessrestlessness3.4%544
- Malaisegeneral feeling of being unwell3.4%541
- Blood glucose increasedraised blood sugar reading3.3%537
- Dystoniainvoluntary muscle contractions3.3%533
- Vomitingbeing sick3.2%510
- Tardive dyskinesiainvoluntary repetitive movements3.1%505
- Akathisiainner restlessness and an urge to move3.1%500
- Mania3.1%498
- Sexual dysfunctiona sexual problem2.8%449
- Therapy cessation2.6%425
- Metabolic disorder2.6%412
- Anosognosia2.5%405
- Blood prolactin abnormal2.5%403
- Condition aggravatedthe condition being treated got worse2.5%399
- Schizophreniaschizophrenia2.5%399
Top 30 of 1,090 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 37 drugs in the atypical antipsychotic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 683,680 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 86.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Bipolar disorder | 2,807 | 17.5% |
| Schizophrenia | 1,218 | 7.6% |
| Depression | 424 | 2.6% |
| Bipolar i disorder | 385 | 2.4% |
| Schizoaffective disorder | 212 | 1.3% |
| Bipolar ii disorder | 184 | 1.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 16,085 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Latuda reports |
|---|---|---|
| Abilify | 750 | 4.7% |
| Zyprexa | 619 | 3.8% |
| Lamictal | 578 | 3.6% |
| Seroquel | 569 | 3.5% |
| Risperdal | 568 | 3.5% |
| Olanzapine | 561 | 3.5% |
| Lithium | 541 | 3.4% |
| Risperidone | 499 | 3.1% |
| Saphris | 426 | 2.6% |
| Quetiapine fumarate | 421 | 2.6% |
Other products listed in reports where Latuda is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Latuda | Atypical antipsychotic | All reports |
|---|---|---|---|
| Reports as suspect product | 16,085 | 683,680 | 20,646,523 |
| Share of that pool | — | 2.4% | 0.1% |
| Reports, latest 12 months | 183 | — | 1,332,454 |
| Marked serious | 40.7% | 70.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 26 | 121 | 91 |
| Hospitalisation recorded, per 1,000 reports | 116 | 304 | 213 |
| Consumer-filed share | 77.5% | 34% | 45.8% |
| Top term, share of reports | Off label use 10.8% | median 6.9% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the atypical antipsychotic class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Clozapine | generic | 73,023 | 3,252 | 93.4% |
| Abilify | brand | 54,645 | 625 | 58% |
| Risperdal | generic | 54,454 | 882 | 48.4% |
| Nuplazid | brand | 53,753 | 9,602 | 50.6% |
| Quetiapine | generic | 52,388 | 4,190 | 97.6% |
| Seroquel | brand | 52,272 | 265 | 62.9% |
| Clozaril | brand | 47,914 | 3,088 | 98.4% |
| Olanzapine | generic | 46,837 | 4,087 | 95.3% |
| Risperidone | generic | 44,962 | 2,511 | 76.9% |
| Aripiprazole | generic | 30,145 | 3,102 | 87.8% |
| Zyprexa | brand | 26,469 | 121 | 78.4% |
| Invega Sustenna | brand | 23,648 | 1,513 | 35.8% |
| Quetiapine fumarate | generic | 19,568 | 1,697 | 90.7% |
| Invega | brand | 16,672 | 238 | 35.5% |
| Rexulti | brand | 12,683 | 630 | 32.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Latuda reports
How many adverse event reports has FDA received for Latuda?
16,085 reports list Latuda as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 183 of them arrived in the latest 12 months. Another 3,967 list it only as a concomitant medication.
What reactions are recorded in Latuda reports?
off label use (10.8%), drug ineffective (8.5%), feeling abnormal (6.5%), anxiety (6.1%) and somnolence (5.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Latuda was responsible.
How serious are the reports?
40.7% are marked serious by the reporter. Among the outcomes recorded, 2.6% of reports include death and 11.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (77.5%), other health professional (9.4%) and physician (9.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Latuda rising?
183 reports in the 12 months to June 2026, down 34% from 276 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Latuda was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Latuda?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Latuda as a suspect or interacting product; reports listing it only as a concomitant medication (3,967) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.