Lurasidone hydrochloride: adverse event reports filed with FDA

860

reports as suspect product

0% of all reports · about 57 a year

83

reports, 12 months to June 2026

141 in the 12 months before

82.6%

marked serious by the reporter

70.7% across the class

6.9%

record death among outcomes, as reported

59 reports · not verified by FDA

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 Lurasidone hydrochloride reports recording the termmedian drug in atypical antipsychotic

1. Drug ineffectivethe medicine did not work as expected37.4%322
2. Suicide attempta suicide attempt26.7%230
3. Condition aggravatedthe condition being treated got worse18%155
4. Sedationdrowsiness from a medicine17.7%152
5. Dyskinesiainvoluntary movements17.2%148
6. Dystoniainvoluntary muscle contractions16.4%141
7. Anosognosia16.2%139
8. Blood prolactin abnormal16.2%139
9. Sexual dysfunctiona sexual problem16.2%139
10. Metabolic disorder15.9%137
11. Blood glucose increasedraised blood sugar reading15.8%136
12. Disturbance in social behaviour15.8%136
13. Schizophreniaschizophrenia14.9%128
14. Personality change14.5%125
15. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine13%112
16. Suicidal ideationthoughts of suicide12.7%109
17. Off label useused for a purpose or in a way not on the label11%95
18. Weight increasedweight gain5.7%49
19. Completed suicidedeath by suicide5.2%45
20. Akathisiainner restlessness and an urge to move5%43
21. Myocarditisinflammation of the heart muscle4.4%38
22. Underdoseless than the intended dose4.2%36
23. Product use in unapproved indicationused for a purpose not on the label4%34
24. Agitationrestlessness3.8%33
25. Drug interactionan interaction between medicines3.8%33
26. Insomniadifficulty sleeping3.8%33
27. Therapy non-responderthe treatment did not work3.8%33
28. Depressionlow mood3.7%32
29. Insurance issue3.3%28
30. Intentional product misusedeliberate use not as intended3%26

Top 30 of 250 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 35.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 860 reports.

In context

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

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.

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 Lurasidone hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (160) 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.