Vraylarcariprazine
According to the FDA label: 1 . INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )] • Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies ( 14.3 )] • Adjunctive…
8,903 adverse event reports submitted to the FDA (2011–2026)
Top Reported Adverse Events
The most frequently reported events in association with Vraylar in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Off Label Use 1,037 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 515 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Weight Increased 453 reports
Akathisia 406 reports
A feeling of inner restlessness and an inability to stay still, sometimes associated with certain medications.
Full definition in the glossary →Anxiety 362 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →- Tardive Dyskinesia 360 reports
Nausea 344 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Tremor 338 reports
Involuntary shaking or trembling, often in the hands.
Full definition in the glossary → See all drugs reporting this event →Fatigue 334 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Insomnia 333 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Suicidal Ideation 311 reports
Thoughts of suicide. This term records that such thoughts were reported, and its presence does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Depression 274 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Dizziness 272 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Somnolence 239 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Feeling Abnormal 219 reports
A general report that the person did not feel like themselves, without a more specific description.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 4,754 |
| Male | 2,305 |
| Unknown | 7 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 468 |
| 18-34 | 1,106 |
| 35-49 | 968 |
| 50-64 | 912 |
| 65-74 | 291 |
| 75+ | 103 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Vraylar. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 5,755 |
| Other Serious | 2,255 |
| Hospitalization | 1,221 |
| Death | 237 |
| Disability | 150 |
| Life-Threatening | 142 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Vraylar. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2011 | 2 |
| 2015 | 1 |
| 2016 | 156 |
| 2017 | 337 |
| 2018 | 415 |
| 2019 | 890 |
| 2020 | 1,029 |
| 2021 | 853 |
| 2022 | 850 |
| 2023 | 1,259 |
| 2024 | 1,291 |
| 2025 | 1,509 |
| 2026 (partial) | 311 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Vraylar
In FDA adverse event reports that mention Vraylar, these medications appeared most often in the same report.
- Lamotrigine (692 reports)
- Quetiapine (626 reports)
- Aripiprazole (549 reports)
- Clonazepam (479 reports)
- Gabapentin (475 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026