The most commonly reported side effects of lurasidone include off label use, anxiety, and depression, based on 22,843 FDA adverse event reports from 2010 to 2025. 9.3% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for lurasidone.
1
Off Label Use9.6%2,198
2
Drug Ineffective9.3%2,127
3
Anxiety5.7%1,296
4
Depression5.3%1,209
5
Weight Increased5.3%1,205
6
Feeling Abnormal5.2%1,177
7
Somnolence4.9%1,130
8
Nausea4.9%1,110
9
Insomnia4.5%1,039
10
Suicidal Ideation4.5%1,017
11
Fatigue4.4%997
12
Dyskinesia3.7%849
13
Suicide Attempt3.4%786
14
Tremor3.3%759
15
Vomiting3.1%716
These are voluntary reports and do not establish that lurasidone caused these reactions.
Report severity
48.3%Serious11,036 reports
16.9%Hospitalizations3,868 reports
4.1%Fatal931 reports
Seriousness is determined by the reporter, not by OpenClaim.
Lurasidone drug interactions
Other drugs that appear in adverse event reports alongside lurasidone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
1
Aripiprazole6.4%1,454
2
Olanzapine5.6%1,288
3
Quetiapine-fumarate5.3%1,207
4
Risperidone4.6%1,046
5
Clozapine4.1%937
6
Paliperidone3.1%718
7
Lamotrigine2.9%670
8
Sodium-oxybate2.8%650
9
Ziprasidone2.6%583
10
Asenapine2.4%541
11
Lithium2.2%493
12
Bupropion2.1%474
13
Venlafaxine1.6%356
14
Valbenazine1.6%355
15
Sertraline-hydrochloride1.5%349
Taken alongside
1
Lamotrigine6.6%1,510
2
Clonazepam5.4%1,228
3
Gabapentin4.6%1,051
4
Lithium4.4%1,005
5
Trazodone-hydrochloride4.4%1,002
6
Quetiapine-fumarate4.3%981
7
Bupropion4.2%966
8
Lorazepam3.8%875
9
Levothyroxine-sodium3.8%872
10
Acetaminophen3.8%858
11
Ergocalciferol3.8%857
12
Omeprazole3.2%727
13
Aripiprazole3.1%707
14
Duloxetine-hydrochloride3.0%684
15
Sertraline-hydrochloride3.0%675
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
Who reports lurasidone side effects
55.0% of lurasidone adverse event reports involve female patients and 24.7% involve male patients. The largest age group is adult at 83%. These figures reflect who reports side effects, not underlying risk.
Sex
Female55.0%
Male24.7%
Unknown20.3%
Age group
< 20.9%
2–111.0%
12–175.5%
18–6482.8%
65+9.9%
What is lurasidone used for
Conditions and purposes for which patients were taking lurasidone when the adverse event was reported.
