LOW-VOLUME · SEX-BALANCED
vibegron Side Effects
vibegron (also sold as Gems) is a LOW-VOLUME FAERS extract #369 of 524 by FAERS report count. Still opens on SEX-BALANCED: 67% of sex-coded reports are female (3,210 F / 1,605 M).
Data updated 2026-05-15
- 6,501
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
vibegron reporting skew - 67% of sex-coded reports are female (3,210 F / 1,605 M). Volume band LOW-VOLUME #369 of 524 by FAERS report count; caseload WATCHLIST.
Thinner FAERS extract for vibegron (Gems) (6,501 reports #369 of 524 by FAERS report count). 67% of sex-coded reports are female (3,210 F / 1,605 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2016–2025). Stamps WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
DIARRHOEA leads 328 of 6,501 reports
Who reports · age peak 75+ (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 75+ (1,179 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 296 reports (4.6% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 200 |
| NEOPLASM MALIGNANT | 15 |
| FALL | 11 |
| PNEUMONIA | 8 |
| MYOCARDIAL INFARCTION | 7 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 6 |
| PARKINSON^S DISEASE | 6 |
| PNEUMONIA ASPIRATION | 6 |
| URINARY TRACT INFECTION | 6 |
| DECREASED APPETITE | 5 |
| INTERSTITIAL LUNG DISEASE | 5 |
| MALAISE | 5 |
| PYREXIA | 5 |
| SEPSIS | 5 |
| ACUTE KIDNEY INJURY | 4 |
| ASTHENIA | 4 |
| CONDITION AGGRAVATED | 4 |
| CYTOKINE RELEASE SYNDROME | 4 |
Reactions in Hospitalization Reports
Hospitalization mid-share (687, 10.6%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| FALL | 89 |
| URINARY TRACT INFECTION | 71 |
| COVID-19 | 39 |
| PNEUMONIA | 38 |
| FATIGUE | 35 |
| HOSPITALISATION | 33 |
| URINARY RETENTION | 33 |
| ASTHENIA | 32 |
| DIARRHOEA | 31 |
| NAUSEA | 29 |
| MALAISE | 28 |
| DECREASED APPETITE | 26 |
| DIZZINESS | 25 |
| HEADACHE | 25 |
| SEIZURE | 25 |
| DYSPNOEA | 24 |
| CONSTIPATION | 23 |
| GAIT DISTURBANCE | 22 |
How to read vibegron FAERS figures (WATCHLIST · DEATH-MARKED · HOSP-MID)
FAERS holds 6,501 voluntary reports linked to vibegron (Gems), 2016-2025. Death is listed on 296 (4.6%). Hospitalization appears on 687 (10.6%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with vibegron
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.
ABS(total_reports) peer at 6,539 FAERS cases (Δ 38 heavier vs vibegron); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 6,460 FAERS cases (Δ 41 lighter vs vibegron); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 6,450 FAERS cases (Δ 51 lighter vs vibegron); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 6,445 FAERS cases (Δ 56 lighter vs vibegron); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 57.6 pp vs vibegron's DEATH-MARKED): CASELOAD · HOSP-MID.
vibegron stamps WATCHLIST · SEX-BALANCED; class peers and methodology beat restating the same FAERS caveats on every effects URL.