What the label lists and what reports show
Cariprazine side effects
Cariprazine's FDA label: “Most common adverse reactions in adults (incidence ≥ 5% and at least twice the rate of placebo) were ( 6.1 ): Schizophrenia: extrapyramidal symptoms and akathisia Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and …” FAERS holds 9,254 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 weight increased (477 reports).
- No generic listed
- Boxed warning
Check it at the source: the cariprazine FDA label on DailyMed (effective December 18, 2025, Allergan, 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 VRAYLAR?VRAYLAR may cause serious side effects, including: See “What is the most important information I should know about VRAYLAR?” Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS) is 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 ○ stiff muscles ○ confusion ○ increased sweating ○ changes in your breathing, heart rate, and blood pressure Uncontrolled body movements (tardive dyskinesia). VRAYLAR 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 VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR. Late occurring side effects. […]
Source: FDA drug label, NDA204370 (Abbvie), as published by Allergan, Inc., effective December 18, 2025 (SPL set 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in adults (incidence ≥ 5% and at least twice the rate of placebo) were ( 6.1 ): Schizophrenia: extrapyramidal symptoms and akathisia Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness Bipolar depression: nausea, akathisia, restlessness, and extrapyramidal symptoms Adjunctive treatment of MDD: akathisia, restlessness, fatigue, constipation, nausea, insomnia, increased appetite, dizziness, and extrapyramidal symptoms
Table 8. Adverse Reactions Occurring in ≥ 2% of VRAYLAR-treated Patients and > Placebo-treated Adult Patients in 6-Week Schizophrenia Trials
| System Organ Class / Preferred Term | Placebo (N= 584) (%) | 1.5 to 3 mg/day (N=539) (%) | 4.5 to 6 mg/day (N=575) (%) | 9 to 12 mg/day ⸰ (N=203) (%) |
|---|---|---|---|---|
| Tachycardia a | 1 | 2 | 2 | 3 |
| Abdominal pain b | 5 | 3 | 4 | 7 |
| Constipation | 5 | 6 | 7 | 10 |
| Diarrhea c | 3 | 1 | 4 | 5 |
| Dry Mouth | 2 | 1 | 2 | 3 |
| Dyspepsia | 4 | 4 | 5 | 5 |
| Nausea | 5 | 5 | 7 | 8 |
| Toothache | 4 | 3 | 3 | 6 |
| Vomiting | 3 | 4 | 5 | 5 |
| Fatigue d | 1 | 1 | 3 | 2 |
| Nasopharyngitis | 1 | 1 | 1 | 2 |
| Urinary tract infection | 1 | 1 | <1 | 2 |
| Blood creatine phosphokinase increased | 1 | 1 | 2 | 3 |
| Hepatic enzyme increased e | <1 | 1 | 1 | 2 |
| Weight increased | 1 | 3 | 2 | 3 |
| Decreased appetite | 2 | 1 | 3 | 2 |
| Arthralgia | 1 | 2 | 1 | 2 |
| Back pain | 2 | 3 | 3 | 1 |
| Pain in extremity | 3 | 2 | 2 | 4 |
| Akathisia | 4 | 9 | 13 | 14 |
| Extrapyramidal symptoms f | 8 | 15 | 19 | 20 |
| Headache g | 13 | 9 | 11 | 18 |
| Somnolence h | 5 | 5 | 8 | 10 |
| Dizziness | 2 | 3 | 5 | 5 |
| Agitation | 4 | 3 | 5 | 3 |
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 )] Late Occurring Adverse Reactions [see Warnings and Precautions ( 5.6 )] Metabolic Changes [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 )] Dysphagia [see Warnings and Precautions ( 5.14 )] Most common adverse reactions in adults (incidence ≥ 5% and at least twice the rate of placebo) were ( 6.1 ): Schizophrenia: extrapyramidal symptoms and akathisia Bipolar mania: extrapyramidal symptoms, akathisia …
Source: FDA drug label, NDA204370 (Abbvie), as published by Allergan, Inc., effective December 18, 2025 (SPL set 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,254 reports list cariprazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 244 are coded as a death and 1,289 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, 17 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?
- Cariprazine: 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