Vraylar

N/A

Manufactured by Allergan, Inc.

13,652 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Vraylar

Vraylar is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. The most commonly reported adverse reactions for Vraylar include OFF LABEL USE, DRUG INEFFECTIVE, WEIGHT INCREASED, AKATHISIA, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Vraylar.

Top Adverse Reactions

OFF LABEL USE1,037 reports
DRUG INEFFECTIVE515 reports
WEIGHT INCREASED453 reports
AKATHISIA406 reports
ANXIETY362 reports
TARDIVE DYSKINESIA360 reports
NAUSEA344 reports
TREMOR338 reports
FATIGUE334 reports
INSOMNIA333 reports
SUICIDAL IDEATION311 reports
DEPRESSION274 reports
DIZZINESS272 reports
SOMNOLENCE239 reports
FEELING ABNORMAL219 reports
HEADACHE203 reports
DRUG INTERACTION199 reports
VOMITING194 reports
RESTLESSNESS190 reports
EXTRAPYRAMIDAL DISORDER182 reports
MANIA165 reports
DYSKINESIA152 reports
DYSPNOEA146 reports
DIARRHOEA145 reports
PAIN142 reports
PRODUCT USE IN UNAPPROVED INDICATION142 reports
RASH136 reports
CONDITION AGGRAVATED132 reports
MALAISE132 reports
FALL131 reports
AGITATION128 reports
VISION BLURRED126 reports
PRODUCT DOSE OMISSION ISSUE121 reports
SEDATION119 reports
HALLUCINATION114 reports
SEIZURE114 reports
ASTHENIA111 reports
MUSCLE SPASMS111 reports
HALLUCINATION, AUDITORY106 reports
DEATH104 reports
SUICIDE ATTEMPT102 reports
PSYCHOTIC DISORDER101 reports
CONFUSIONAL STATE100 reports
HYPERHIDROSIS100 reports
CONSTIPATION99 reports
WEIGHT DECREASED95 reports
ARTHRALGIA91 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION90 reports
MEMORY IMPAIRMENT88 reports
MUSCULOSKELETAL STIFFNESS86 reports
PAIN IN EXTREMITY86 reports
PARKINSONISM86 reports
PRURITUS86 reports
IRRITABILITY82 reports
TREATMENT NONCOMPLIANCE82 reports
GAIT DISTURBANCE78 reports
MATERNAL EXPOSURE DURING PREGNANCY78 reports
HOSPITALISATION77 reports
AGGRESSION75 reports
MIGRAINE75 reports
ABDOMINAL PAIN UPPER74 reports
HYPOAESTHESIA73 reports
BLOOD PRESSURE INCREASED72 reports
COMPLETED SUICIDE72 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE71 reports
PANIC ATTACK70 reports
SLEEP DISORDER70 reports
BIPOLAR DISORDER69 reports
DYSPHAGIA69 reports
PALPITATIONS69 reports
LOSS OF CONSCIOUSNESS68 reports
PRODUCT USE ISSUE68 reports
TACHYCARDIA68 reports
ILLNESS66 reports
DYSTONIA65 reports
MUSCLE TWITCHING65 reports
DECREASED APPETITE64 reports
WITHDRAWAL SYNDROME64 reports
ADVERSE DRUG REACTION63 reports
DELUSION63 reports
DEPRESSED MOOD63 reports
OVERDOSE63 reports
PYREXIA63 reports
SPEECH DISORDER63 reports
BACK PAIN62 reports
INTENTIONAL OVERDOSE62 reports
MYALGIA61 reports
PARAESTHESIA61 reports
NEUROLEPTIC MALIGNANT SYNDROME60 reports
BLOOD GLUCOSE INCREASED59 reports
HYPERTENSION59 reports
MUSCULAR WEAKNESS59 reports
ANGER58 reports
PARANOIA58 reports
THERAPY INTERRUPTED58 reports
COVID 1957 reports
CHEST PAIN56 reports
DRUG HYPERSENSITIVITY56 reports
PNEUMONIA56 reports
PRODUCT ADMINISTRATION INTERRUPTED56 reports

Report Outcomes

Out of 8,899 classified reports for Vraylar:

  • Serious: 3,144 reports (35.3%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 5,755 reports (64.7%)
Serious 35.3%Non-Serious 64.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,754 (67.3%)
Male2,305 (32.6%)
Unknown7 (0.1%)

Reports by Age

Age 50102 reports
Age 3097 reports
Age 1791 reports
Age 4088 reports
Age 2185 reports
Age 6083 reports
Age 3882 reports
Age 2680 reports
Age 3577 reports
Age 4577 reports
Age 4876 reports
Age 3175 reports
Age 5175 reports
Age 5473 reports
Age 1671 reports
Age 2971 reports
Age 4771 reports
Age 4971 reports
Age 5868 reports
Age 2567 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Vraylar?

This profile reflects 13,652 FDA FAERS reports that mention Vraylar. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Vraylar?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, WEIGHT INCREASED, AKATHISIA, ANXIETY, TARDIVE DYSKINESIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Vraylar?

Labeling and FAERS entries often list Allergan, Inc. in connection with Vraylar. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Allergan, Inc.

Explore other medications manufactured by Allergan, Inc. and compare their safety profiles:

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View all Allergan, Inc. drugs →

Drugs Also Linked to OFF LABEL USE

The following drugs share commonly reported adverse reactions with Vraylar:

0XYGEN (75/100)ABACAVIR SULFATE (85/100)ABATACEPT (78/100)Abilify MaintenaABIRATERONE ACETATE (72/100)ACALABRUTINIB (78/100)ACETAMINOPHEN (35/100)ACETAMINOPHEN 500MG (85/100)ACETAMINOPHEN AND CODEINE (85/100)ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (72/100)ACETAMINOPHEN AND IBUPROFEN (45/100)ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE (65/100)

View all drugs reporting OFF LABEL USE →

Explore More

Safety RankingsSearch All DrugsCompare DrugsAllergan, Inc. PortfolioOFF LABEL USE in Other DrugsDRUG INEFFECTIVE in Other DrugsWEIGHT INCREASED in Other Drugs
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.