VILAZODONE HYDROCHLORIDE

N/A

Manufactured by Allergan, Inc.

19,367 FDA adverse event reports analyzed

Last updated: 2026-04-14

About VILAZODONE HYDROCHLORIDE

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

Top Adverse Reactions

OFF LABEL USE1,111 reports
DIARRHOEA809 reports
NAUSEA808 reports
ANXIETY662 reports
INSOMNIA634 reports
DRUG INEFFECTIVE610 reports
HEADACHE565 reports
DEPRESSION522 reports
DIZZINESS508 reports
FATIGUE490 reports
SUICIDAL IDEATION436 reports
FEELING ABNORMAL421 reports
WEIGHT INCREASED307 reports
PARAESTHESIA303 reports
VOMITING287 reports
TREMOR281 reports
SOMNOLENCE277 reports
PAIN269 reports
PRURITUS238 reports
AGITATION215 reports
HALLUCINATION209 reports
MALAISE206 reports
RASH204 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS197 reports
FALL195 reports
ASTHENIA194 reports
CONDITION AGGRAVATED191 reports
ARTHRALGIA181 reports
CRYING177 reports
WEIGHT DECREASED177 reports
DYSPNOEA176 reports
COMPLETED SUICIDE174 reports
ABDOMINAL DISCOMFORT171 reports
PALPITATIONS166 reports
BLOOD PRESSURE INCREASED163 reports
ABDOMINAL PAIN UPPER162 reports
IRRITABILITY162 reports
NIGHTMARE162 reports
ABNORMAL DREAMS158 reports
CONFUSIONAL STATE156 reports
HYPERHIDROSIS156 reports
MUSCLE SPASMS156 reports
ANGER151 reports
MEMORY IMPAIRMENT148 reports
ALOPECIA146 reports
PANIC ATTACK146 reports
SEROTONIN SYNDROME145 reports
VISION BLURRED145 reports
MIGRAINE133 reports
BACK PAIN128 reports
PAIN IN EXTREMITY127 reports
PRODUCT DOSE OMISSION ISSUE125 reports
DECREASED APPETITE124 reports
PYREXIA119 reports
UNEVALUABLE EVENT117 reports
HYPERTENSION116 reports
DRUG DOSE OMISSION112 reports
DRUG HYPERSENSITIVITY107 reports
MYALGIA106 reports
ABDOMINAL PAIN105 reports
WITHDRAWAL SYNDROME104 reports
CONSTIPATION103 reports
GAIT DISTURBANCE99 reports
HYPOAESTHESIA99 reports
SUICIDE ATTEMPT98 reports
VISUAL IMPAIRMENT97 reports
LOSS OF CONSCIOUSNESS96 reports
MANIA96 reports
CHEST PAIN93 reports
COUGH93 reports
DRUG INTERACTION93 reports
MUSCLE TWITCHING91 reports
DRY MOUTH90 reports
HEART RATE INCREASED90 reports
AMNESIA89 reports
INTENTIONAL PRODUCT MISUSE89 reports
INCORRECT DOSE ADMINISTERED88 reports
INJECTION SITE PAIN86 reports
SEIZURE86 reports
ABDOMINAL DISTENSION84 reports
CONTUSION84 reports
NERVOUSNESS84 reports
AGGRESSION83 reports
HYPERSENSITIVITY83 reports
PRODUCT USE IN UNAPPROVED INDICATION83 reports
OVERDOSE82 reports
PRODUCT USE ISSUE80 reports
BALANCE DISORDER79 reports
DISTURBANCE IN ATTENTION78 reports
SINUSITIS78 reports
THERAPEUTIC RESPONSE UNEXPECTED78 reports
URINARY TRACT INFECTION78 reports
DEATH77 reports
PNEUMONIA77 reports
RESTLESSNESS74 reports
SLEEP DISORDER74 reports
NASOPHARYNGITIS73 reports
TOXICITY TO VARIOUS AGENTS73 reports
FEELING JITTERY70 reports
DEHYDRATION69 reports

Report Outcomes

Out of 9,760 classified reports for VILAZODONE HYDROCHLORIDE:

Serious 41.3%Non-Serious 58.7%

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

Female6,520 (71.5%)
Male2,551 (28.0%)
Unknown43 (0.5%)

Reports by Age

Age 59154 reports
Age 55152 reports
Age 54144 reports
Age 57137 reports
Age 56128 reports
Age 35125 reports
Age 48125 reports
Age 60125 reports
Age 50124 reports
Age 58124 reports
Age 51114 reports
Age 41113 reports
Age 49110 reports
Age 52110 reports
Age 40109 reports
Age 45108 reports
Age 65107 reports
Age 64106 reports
Age 42104 reports
Age 61104 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 VILAZODONE HYDROCHLORIDE?

This profile reflects 19,367 FDA FAERS reports that mention VILAZODONE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for VILAZODONE HYDROCHLORIDE?

Frequently reported terms in FAERS include OFF LABEL USE, DIARRHOEA, NAUSEA, ANXIETY, INSOMNIA, DRUG INEFFECTIVE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures VILAZODONE HYDROCHLORIDE?

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

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.