lurasidone Side Effects
Also known as: Latuda
Analysis of 20,544 adverse event reports submitted to the FDA from 2009 to 2025.
Total Reports
20,544
Death-Related
564
2.7% of reports
Hospitalizations
2,956
14.4% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 564 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 225 |
| DEATH | 152 |
| DRUG INEFFECTIVE | 51 |
| BLOOD GLUCOSE INCREASED | 43 |
| CONDITION AGGRAVATED | 43 |
| DYSTONIA | 43 |
| PERSONALITY CHANGE | 43 |
| SUICIDE ATTEMPT | 43 |
| DYSKINESIA | 42 |
| METABOLIC DISORDER | 42 |
| SCHIZOPHRENIA | 42 |
| SEDATION | 42 |
| ANOSOGNOSIA | 41 |
| BLOOD PROLACTIN ABNORMAL | 41 |
| DISTURBANCE IN SOCIAL BEHAVIOUR | 41 |
| SEXUAL DYSFUNCTION | 41 |
| OFF LABEL USE | 40 |
| TOXICITY TO VARIOUS AGENTS | 27 |
| ADVERSE DRUG REACTION | 26 |
| MYOCARDIAL INFARCTION | 22 |
Reactions in Hospitalization Reports
Top reactions in 2,956 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 323 |
| SUICIDAL IDEATION | 322 |
| DRUG INEFFECTIVE | 259 |
| SUICIDE ATTEMPT | 221 |
| DEPRESSION | 217 |
| ANXIETY | 161 |
| CONDITION AGGRAVATED | 150 |
| INSOMNIA | 146 |
| NAUSEA | 139 |
| FALL | 138 |
| TREMOR | 134 |
| WEIGHT INCREASED | 132 |
| PSYCHOTIC DISORDER | 125 |
| MANIA | 123 |
| AGITATION | 119 |
| AGGRESSION | 114 |
| WEIGHT DECREASED | 110 |
| CONFUSIONAL STATE | 106 |
| MENTAL DISORDER | 106 |
| VOMITING | 105 |
Nearby — Related Medications
What the FAERS Data Reveals About lurasidone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 20,544 voluntary reports linked to lurasidone and its brand equivalents (Latuda), spanning 2009 through 2025. Of those, 564 (2.7%) listed death as an outcome and 2,956 (14.4%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 70% were female and 30% male; age distribution skews toward 18-44, with 4,006 reports in that bracket. The single most reported reaction is off label use with 2,055 submissions, followed by drug ineffective and anxiety.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.