VIBEGRON

N/A

Manufactured by Sumitomo Pharma America, Inc.

10,281 FDA adverse event reports analyzed

Last updated: 2026-04-15

About VIBEGRON

VIBEGRON is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sumitomo Pharma America, Inc.. The most commonly reported adverse reactions for VIBEGRON include DRUG INEFFECTIVE, DIARRHOEA, HEADACHE, URINARY TRACT INFECTION, INABILITY TO AFFORD MEDICATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VIBEGRON.

Top Adverse Reactions

DRUG INEFFECTIVE886 reports
DIARRHOEA328 reports
HEADACHE328 reports
URINARY TRACT INFECTION280 reports
INABILITY TO AFFORD MEDICATION265 reports
URINARY RETENTION258 reports
FATIGUE248 reports
NAUSEA219 reports
DEATH205 reports
CONSTIPATION202 reports
POLLAKIURIA196 reports
URINARY INCONTINENCE193 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE183 reports
DIZZINESS181 reports
NOCTURIA174 reports
FALL172 reports
PRODUCT AVAILABILITY ISSUE163 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION154 reports
DRUG EFFECT LESS THAN EXPECTED153 reports
OFF LABEL USE145 reports
THERAPY INTERRUPTED145 reports
PAIN144 reports
PRODUCT DOSE OMISSION ISSUE135 reports
RASH133 reports
THERAPEUTIC PRODUCT EFFECT DECREASED122 reports
PRURITUS121 reports
COUGH117 reports
DRY MOUTH115 reports
HOT FLUSH112 reports
DYSURIA109 reports
DYSPNOEA107 reports
RHINORRHOEA107 reports
ASTHENIA105 reports
INSOMNIA104 reports
CONDITION AGGRAVATED99 reports
MICTURITION URGENCY94 reports
PRODUCT USE ISSUE92 reports
ARTHRALGIA87 reports
ILLNESS87 reports
COVID 1986 reports
BLOOD PRESSURE INCREASED83 reports
PERIPHERAL SWELLING83 reports
FEELING ABNORMAL81 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS81 reports
BACK PAIN79 reports
MALAISE78 reports
GAIT DISTURBANCE76 reports
ABDOMINAL PAIN UPPER75 reports
ABDOMINAL DISCOMFORT72 reports
NASOPHARYNGITIS71 reports
PAIN IN EXTREMITY65 reports
VOMITING65 reports
ERYTHEMA64 reports
FLUSHING62 reports
HYPERSENSITIVITY62 reports
SOMNOLENCE62 reports
ADVERSE EVENT60 reports
CONFUSIONAL STATE60 reports
PNEUMONIA60 reports
ANXIETY58 reports
WEIGHT DECREASED56 reports
HYPERTENSION54 reports
DECREASED APPETITE53 reports
HALLUCINATION53 reports
PRODUCT DISPENSING ERROR52 reports
MEMORY IMPAIRMENT51 reports
NASAL CONGESTION51 reports
WEIGHT INCREASED51 reports
DEPRESSION50 reports
VISION BLURRED49 reports
INCONTINENCE48 reports
MUSCULAR WEAKNESS48 reports
PRODUCT USE IN UNAPPROVED INDICATION48 reports
THERAPEUTIC PRODUCT EFFECT VARIABLE47 reports
URTICARIA47 reports
BALANCE DISORDER46 reports
MUSCLE SPASMS46 reports
JOINT SWELLING45 reports
OROPHARYNGEAL PAIN44 reports
INCORRECT DOSE ADMINISTERED43 reports
TREMOR42 reports
NO ADVERSE EVENT41 reports
ATRIAL FIBRILLATION40 reports
EYE PAIN39 reports
SURGERY39 reports
ABDOMINAL DISTENSION38 reports
DRUG INTERACTION38 reports
FEELING HOT38 reports
PYREXIA38 reports
SEIZURE38 reports
ALOPECIA37 reports
BLADDER DISORDER37 reports
DRUG HYPERSENSITIVITY37 reports
MYALGIA36 reports
NEOPLASM MALIGNANT36 reports
OEDEMA PERIPHERAL36 reports
CEREBROVASCULAR ACCIDENT35 reports
DEHYDRATION35 reports
HOSPITALISATION34 reports
INFECTION34 reports

Demographics Breakdown

Reports by Sex

Female3,210 (66.6%)
Male1,605 (33.3%)
Unknown2 (0.0%)

Reports by Age

Age 79104 reports
Age 7698 reports
Age 8396 reports
Age 7894 reports
Age 7589 reports
Age 8085 reports
Age 7480 reports
Age 7078 reports
Age 7372 reports
Age 7771 reports
Age 8270 reports
Age 7269 reports
Age 8165 reports
Age 6961 reports
Age 8560 reports
Age 7159 reports
Age 8655 reports
Age 8454 reports
Age 6846 reports
Age 8738 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 VIBEGRON?

This profile reflects 10,281 FDA FAERS reports that mention VIBEGRON. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for VIBEGRON?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DIARRHOEA, HEADACHE, URINARY TRACT INFECTION, INABILITY TO AFFORD MEDICATION, URINARY RETENTION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures VIBEGRON?

Labeling and FAERS entries often list Sumitomo Pharma America, Inc. in connection with VIBEGRON. 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.