What the label lists and what reports show
Lurasidone side effects
Lurasidone's FDA label: “The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with LATUDA were somnolence, akathisia, extrapyramidal symptoms, and nausea.” FAERS holds 20,803 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is anxiety (1,236 reports).
- Generic listed
- Boxed warning
Check it at the source: the lurasidone FDA label on DailyMed (effective January 31, 2025, Sumitomo Pharma America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LATUDA?LATUDA may cause serious side effects, including: See “ What is the most important information I should know about LATUDA? ” Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS: high fever confusion changes in your breathing, heart rate, and blood pressure stiff muscles increased sweating Uncontrolled body movements (tardive dyskinesia). LATUDA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking LATUDA. Tardive dyskinesia may also start after you stop taking LATUDA. […]
Source: FDA drug label, NDA200603 (Sunovion Pharms Inc), as published by Sumitomo Pharma America, Inc., effective January 31, 2025 (SPL set afad3051-9df2-4c54-9684-e8262a133af8), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with LATUDA were somnolence, akathisia, extrapyramidal symptoms, and nausea.
Table 23: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the 6-Week Bipolar Depression Study in Pediatric Patients (10 to 17…
| Reaction | Placebo (N=172) | LATUDA 20 to 80 mg/day (N=175) |
|---|---|---|
| Nausea | 6 | 16 |
| Vomiting | 4 | 6 |
| Abdominal Pain Upper | 2 | 3 |
| Diarrhea | 2 | 3 |
| Abdominal Pain | 1 | 3 |
| Fatigue | 2 | 3 |
| Weight Increased | 2 | 7 |
| Decreased Appetite | 2 | 4 |
| Somnolence | 6 | 11 |
| Extrapyramidal symptoms | 5 | 6 |
| Dizziness | 5 | 6 |
| Insomnia | 2 | 5 |
| Abnormal Dreams | 2 | 2 |
| Oropharyngeal Pain | 2 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] Suicidal Thoughts and Behaviors [see Boxed Warning and Warnings and Precautions ( 5.2 )] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.4 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] Metabolic Changes [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.8 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.9 )] Falls [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions ( 5.11 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12 )] Body Temperature Dysregulation [see Warnings and Precautions ( 5.13 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.14 )] Dysphagia [see Warnings and Precautions ( 5.15 )] Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies [see Warnings and Precautions ( 5.16 )] Commonly observed adverse …
Source: FDA drug label, NDA200603 (Sunovion Pharms Inc), as published by Sumitomo Pharma America, Inc., effective January 31, 2025 (SPL set afad3051-9df2-4c54-9684-e8262a133af8), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,803 reports list lurasidone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 576 are coded as a death and 3,029 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lurasidone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions