Drug · FAERS side-effect profile with label screen
Vibegron side effects: what 7,872 FDA adverse event reports show
Drug class
beta3-Adrenergic Agonist
FDA label (Established Pharmacologic Class)
Brand names
Gemtesa
openFDA label
Who reports
7,872 reports · 30% serious · 402 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).
FDA label, Indications and Usage
What it is
Vibegron is a selective beta-3 adrenergic agonist.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 4Likely indication confounding 9Reporting / coding artifact 12Lab value / disease marker 2Not in label — unassessed 13
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 855 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Inability to afford medication | 266 | 73.1 64.9–82.5ROR 75.6 · χ² 18,346 / p <1e-300 | 70.8 EB05 64.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=6 · 98% consumer | no trial data cached |
| Drug effect less than expected | 233 | 44.2 38.9–50.2ROR 45.5 · χ² 9,636 / p <1e-300 | 43.3 EB05 38.9 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=17 · 97% consumer | no trial data cached |
| Nocturia (night-time urination) | 192 | 42.4 36.8–48.8ROR 43.4 · χ² 7,594 / p <1e-300 | 41.5 EB05 36.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 · 96% consumer | no trial data cached |
| Bladder spasm | 26 | 37.3 25.3–54.9ROR 37.4 · χ² 870 / p 2e-191 | 35.9 EB05 25.7 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=8 · 73% consumer | no trial data cached |
| Therapeutic product effect variable | 49 | 34.2 25.8–45.3ROR 34.4 · χ² 1,526 / p <1e-300 | 33.4 EB05 26.2 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=4 · 100% consumer | no trial data cached |
| Hypertonic bladder | 36 | 33.3 24.0–46.2ROR 33.5 · χ² 1,082 / p 1e-237 | 32.4 EB05 24.4 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial data cached |
| Pleurothotonus | 10 | 29.2 15.6–54.4ROR 29.2 · χ² 242 / p 8e-55 | 27.4 EB05 15.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Urine flow decreased | 25 | 27.9 18.8–41.4ROR 28.0 · χ² 616 / p 3e-136 | 27.1 EB05 19.3 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=5 · ♀ 25% (drug 68%) · 100% consumer | no trial data cached |
| Urinary hesitation | 25 | 27.7 18.7–41.0ROR 27.8 · χ² 610 / p 5e-135 | 26.9 EB05 19.2 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=7 · 92% consumer | no trial data cached |
| Urinary retention | 310 | 24.7 22.2–27.6ROR 25.7 · χ² 6,978 / p <1e-300 | 24.5 EB05 22.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.2 | no trial data cached |
| Micturition urgency | 103 | 24.1 19.9–29.2ROR 24.4 · χ² 2,239 / p <1e-300 | 23.8 EB05 20.2 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.7 · 93% consumer | no trial data cached |
| Bladder pain | 27 | 22.7 15.5–33.1ROR 22.8 · χ² 534 / p 2e-118 | 22.2 EB05 16.0 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=5 · 96% consumer | no trial data cached |
| Product availability issue | 164 | 19.4 16.6–22.6ROR 19.8 · χ² 2,822 / p <1e-300 | 19.2 EB05 16.9 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 98% consumer | no trial data cached |
| Urinary incontinence | 215 | 19.2 16.8–22.0ROR 19.7 · χ² 3,676 / p <1e-300 | 19.1 EB05 17.0 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.2 · 95% consumer | no trial data cached |
| Therapeutic product effect delayed | 30 | 17.6 12.3–25.2ROR 17.7 · χ² 451 / p 3e-100 | 17.3 EB05 12.6 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Pollakiuria (frequent urination) | 210 | 13.3 11.7–15.2ROR 13.7 · χ² 2,375 / p <1e-300 | 13.2 EB05 11.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 96% consumer | no trial data cached |
| Enuresis | 20 | 13.1 8.4–20.3ROR 13.1 · χ² 210 / p 6e-48 | 12.3 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=3 · 95% consumer | no trial data cached |
| Incontinence | 51 | 12.7 9.7–16.7ROR 12.8 · χ² 537 / p 5e-119 | 12.4 EB05 9.7 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.0 · 88% consumer | no trial data cached |
| Bladder disorder | 40 | 10.6 7.8–14.5ROR 10.7 · χ² 338 / p 1e-75 | 10.1 EB05 7.6 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=15 · 98% consumer | no trial data cached |
| Dysuria (painful urination) | 127 | 9.1 7.7–10.8ROR 9.2 · χ² 905 / p 4e-199 | 8.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 86% consumer | no trial data cached |
| Thoracic vertebral fracture | 10 | 9.0 4.8–16.7ROR 9.0 · χ² 63 / p 1e-15 | 7.0 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Therapeutic product effect decreased | 150 | 8.9 7.6–10.5ROR 9.1 · χ² 1,045 / p 1e-229 | 8.8 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 93% consumer | no trial data cached |
| Product colour issue | 16 | 8.3 5.1–13.6ROR 8.3 · χ² 96 / p 7e-23 | 7.1 EB05 4.5 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Therapeutic product effect incomplete | 205 | 7.6 6.7–8.8ROR 7.8 · χ² 1,178 / p 2e-258 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 95% consumer | no trial data cached |
| Therapy interrupted | 200 | 7.6 6.7–8.8ROR 7.8 · χ² 1,149 / p 4e-252 | 7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · 94% consumer | no trial data cached |
| Anal incontinence | 23 | 6.8 4.5–10.3ROR 6.8 · χ² 108 / p 1e-25 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 · 96% consumer | no trial data cached |
| Product dispensing error | 52 | 6.3 4.8–8.3ROR 6.3 · χ² 226 / p 2e-51 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=5 · 100% consumer | no trial data cached |
| Product administration interrupted | 16 | 5.5 3.4–9.0ROR 5.5 · χ² 54 / p 8e-14 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Intentional underdose | 15 | 5.4 3.3–9.0ROR 5.4 · χ² 50 / p 9e-13 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Urinary tract infection (bladder infection) | 349 | 5.4 4.9–6.0ROR 5.6 · χ² 1,257 / p 1e-275 | 5.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 82% consumer | no trial data cached |
| Bowel movement irregularity | 15 | 5.2 3.1–8.6ROR 5.2 · χ² 46 / p 5e-12 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Rhinorrhoea (runny nose) | 123 | 5.0 4.2–6.0ROR 5.1 · χ² 393 / p 8e-88 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · 88% consumer | no trial data cached |
| Product packaging quantity issue | 20 | 4.8 3.1–7.5ROR 4.8 · χ² 57 / p 2e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=3 · 85% consumer | no trial data cached |
| Dry mouth | 140 | 4.6 3.9–5.4ROR 4.6 · χ² 386 / p 4e-86 | 4.5 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 91% consumer | no trial data cached |
| Hot flush (hot flashes) | 122 | 4.3 3.6–5.1ROR 4.3 · χ² 302 / p 6e-68 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 88% consumer | no trial data cached |
| Spinal operation | 19 | 4.1 2.6–6.5ROR 4.1 · χ² 42 / p 5e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 | no trial data cached |
| Urine output decreased | 13 | 3.9 2.3–6.7ROR 3.9 · χ² 25 / p 3e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 2.1 | no trial data cached |
| Faeces soft | 10 | 3.6 2.0–6.8ROR 3.6 · χ² 17 / p 2e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious n=4 | no trial data cached |
| Brain fog | 20 | 3.6 2.3–5.6ROR 3.6 · χ² 35 / p 2e-9 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 85% consumer | no trial data cached |
| Myasthenia gravis | 10 | 3.3 1.8–6.2ROR 3.3 · χ² 14 / p 8e-5 | 3.0 EB05 1.8 · IC025 +0.5 | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,083 | 2.2 2.0–2.3ROR 2.3 · χ² 722 / p 2e-159 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 · 91% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 399 | 1.6 1.5–1.8ROR 1.7 · χ² 100 / p 7e-24 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.2 · 84% consumer | no trial data cached |
| Headache | 376 | 1.6 1.4–1.7ROR 1.6 · χ² 82 / p 7e-20 | 1.6 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.3 · 83% consumer | no trial data cached |
| Urinary tract infection (bladder infection) | 349 | 5.4 4.9–6.0ROR 5.6 · χ² 1,257 / p 1e-275 | 5.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 82% consumer | no trial data cached |
| Urinary retention | 310 | 24.7 22.2–27.6ROR 25.7 · χ² 6,978 / p <1e-300 | 24.5 EB05 22.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.2 | no trial data cached |
| Death | 287 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.012 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 1.6 · 80% consumer | no trial data cached |
| Fatigue (tiredness) | 287 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.322 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.4 · 82% consumer | no trial data cached |
| Inability to afford medication | 266 | 73.1 64.9–82.5ROR 75.6 · χ² 18,346 / p <1e-300 | 70.8 EB05 64.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=6 · 98% consumer | no trial data cached |
| Nausea | 259 | 0.9 0.8–1.0ROR 0.9 · χ² 6 / p 0.009 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 · 80% consumer | no trial data cached |
| Constipation | 246 | 3.0 2.6–3.4ROR 3.1 · χ² 327 / p 2e-73 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 85% consumer | no trial data cached |
| Drug effect less than expected | 233 | 44.2 38.9–50.2ROR 45.5 · χ² 9,636 / p <1e-300 | 43.3 EB05 38.9 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=17 · 97% consumer | no trial data cached |
| Fall | 220 | 1.7 1.5–2.0ROR 1.8 · χ² 70 / p 3e-17 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 3.0 · 79% consumer | no trial data cached |
| Dizziness | 216 | 1.1 1.0–1.3ROR 1.1 · χ² 4 / p 0.027 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.3 · 81% consumer | no trial data cached |
| Urinary incontinence | 215 | 19.2 16.8–22.0ROR 19.7 · χ² 3,676 / p <1e-300 | 19.1 EB05 17.0 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.2 · 95% consumer | no trial data cached |
| Pollakiuria (frequent urination) | 210 | 13.3 11.7–15.2ROR 13.7 · χ² 2,375 / p <1e-300 | 13.2 EB05 11.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 96% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Inability to afford medication — n=266, PRR 73.1
- Nocturia — n=192, PRR 42.4
- Pollakiuria — n=210, PRR 13.3
- Enuresis — n=20, PRR 13.1
- Dysuria — n=127, PRR 9.1
- Rhinorrhoea — n=123, PRR 5.0
- Brain fog — n=20, PRR 3.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Vibegron?
In FDA FAERS, the most frequently co-reported reaction terms for Vibegron are diarrhoea, headache, urinary tract infection, urinary retention, fatigue, inability to afford medication. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Vibegron have an FDA boxed warning?
No. The FDA label retrieved for Vibegron has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Vibegron causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8, effective 20250401; matched on
openfda.generic_name.exact:"VIBEGRON") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 895 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.