Solifenacin side effects: what 1,844 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Solifenacin Succinate (Solifenacin Succinate)
Who reports
1,844 reports · 75% serious · 133 with death outcome · 61% female
Used for
Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin Succinate Tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )
What it is
Solifenacin Succinate Tablets are a muscarinic receptor antagonist.
Boxed warning
None in the current label
Causality screen of the 28 strongest signals
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- 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. 29 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Micturition urgency | 31 | 31.1 22.0–44.2ROR 31.7 · χ² 872 / p 5e-192 | 30.5 EB05 22.5 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 38.1 · ♀ 3% (drug 61%) | no trial data cached |
| Nocturia (night-time urination) | 29 | 27.3 19.0–39.1ROR 27.7 · χ² 706 / p 6e-156 | 26.8 EB05 19.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 33.4 · ♀ 4% (drug 61%) | no trial data cached |
| Feeling cold | 50 | 20.4 15.5–26.8ROR 20.9 · χ² 902 / p 1e-198 | 20.2 EB05 15.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 25.7 · ♀ 4% (drug 61%) | no trial data cached |
| Urinary incontinence | 39 | 15.0 11.0–20.4ROR 15.3 · χ² 495 / p 6e-110 | 14.7 EB05 11.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 13.8 | no trial data cached |
| Diplopia (double vision) | 34 | 14.9 10.7–20.8ROR 15.1 · χ² 427 / p 5e-95 | 14.6 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · ♀ 25% (drug 61%) | no trial data cached |
| Presyncope (near-fainting) | 28 | 13.2 9.1–19.0ROR 13.3 · χ² 302 / p 5e-68 | 12.7 EB05 8.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 11% (drug 61%) | no trial data cached |
| Dizziness postural | 11 | 13.0 7.2–23.5ROR 13.1 · χ² 110 / p 4e-26 | 11.3 EB05 5.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Neuralgia | 27 | 12.7 8.7–18.4ROR 12.8 · χ² 278 / p 9e-63 | 12.1 EB05 8.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 4% (drug 61%) | no trial data cached |
| Speech disorder | 58 | 12.6 9.8–16.2ROR 13.0 · χ² 608 / p 2e-134 | 12.4 EB05 9.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · ♀ 11% (drug 61%) | no trial data cached |
| Ataxia | 12 | 11.4 6.5–20.1ROR 11.5 · χ² 104 / p 9e-25 | 9.7 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Urinary retention | 33 | 11.3 8.0–15.8ROR 11.5 · χ² 299 / p 3e-67 | 10.7 EB05 7.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · ♀ 29% (drug 61%) | no trial data cached |
| Dysarthria (slurred speech) | 30 | 9.1 6.4–12.9ROR 9.2 · χ² 207 / p 2e-47 | 8.4 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 17% (drug 61%) | no trial data cached |
| Thirst | 14 | 8.9 5.3–15.0ROR 9.0 · χ² 91 / p 8e-22 | 7.5 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Dry mouth | 61 | 8.6 6.7–11.0ROR 8.8 · χ² 401 / p 2e-89 | 8.2 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 73% consumer | no trial data cached |
| Dysuria (painful urination) | 27 | 8.3 5.7–12.1ROR 8.4 · χ² 167 / p 2e-38 | 7.6 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Seasonal allergy | 10 | 8.1 4.3–14.9ROR 8.1 · χ² 55 / p 6e-14 | 6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Pollakiuria (frequent urination) | 29 | 7.9 5.5–11.4ROR 8.0 · χ² 169 / p 8e-39 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Blood sodium decreased | 13 | 7.9 4.6–13.5ROR 7.9 · χ² 71 / p 2e-17 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.8 | no trial data cached |
| Blood pressure systolic increased | 13 | 7.5 4.4–13.0ROR 7.6 · χ² 67 / p 1e-16 | 6.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.3 | no trial data cached |
| Balance disorder | 56 | 7.4 5.7–9.5ROR 7.5 · χ² 302 / p 6e-68 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Oral pain | 14 | 7.1 4.2–11.9ROR 7.1 · χ² 67 / p 1e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Dementia | 17 | 6.9 4.3–11.1ROR 7.0 · χ² 81 / p 1e-19 | 6.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Dysphonia | 32 | 6.2 4.4–8.8ROR 6.3 · χ² 135 / p 1e-31 | 5.8 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · ♀ 23% (drug 61%) | no trial data cached |
| Eye pain | 28 | 5.8 4.0–8.3ROR 5.8 · χ² 106 / p 4e-25 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 · 89% consumer | no trial data cached |
| Nightmare | 14 | 4.6 2.7–7.7ROR 4.6 · χ² 36 / p 1e-9 | 4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Mucosal inflammation | 10 | 4.4 2.3–8.1ROR 4.4 · χ² 23 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Hot flush (hot flashes) | 27 | 4.1 2.8–5.9ROR 4.1 · χ² 60 / p 6e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.2 · 93% consumer | no trial data cached |
| Multiple sclerosis | 11 | 2.6 1.4–4.7ROR 2.6 · χ² 9 / p 0.001 | 2.4 EB05 1.5 · IC025 +0.3 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Dry mouth | 61 | 8.6 6.7–11.0ROR 8.8 · χ² 401 / p 2e-89 | 8.2 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 73% consumer | no trial data cached |
| Speech disorder | 58 | 12.6 9.8–16.2ROR 13.0 · χ² 608 / p 2e-134 | 12.4 EB05 9.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · ♀ 11% (drug 61%) | no trial data cached |
| Balance disorder | 56 | 7.4 5.7–9.5ROR 7.5 · χ² 302 / p 6e-68 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Feeling cold | 50 | 20.4 15.5–26.8ROR 20.9 · χ² 902 / p 1e-198 | 20.2 EB05 15.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 25.7 · ♀ 4% (drug 61%) | no trial data cached |
| Urinary incontinence | 39 | 15.0 11.0–20.4ROR 15.3 · χ² 495 / p 6e-110 | 14.7 EB05 11.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 13.8 | no trial data cached |
| Diplopia (double vision) | 34 | 14.9 10.7–20.8ROR 15.1 · χ² 427 / p 5e-95 | 14.6 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · ♀ 25% (drug 61%) | no trial data cached |
| Urinary retention | 33 | 11.3 8.0–15.8ROR 11.5 · χ² 299 / p 3e-67 | 10.7 EB05 7.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · ♀ 29% (drug 61%) | no trial data cached |
| Dysphonia | 32 | 6.2 4.4–8.8ROR 6.3 · χ² 135 / p 1e-31 | 5.8 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 · ♀ 23% (drug 61%) | no trial data cached |
| Micturition urgency | 31 | 31.1 22.0–44.2ROR 31.7 · χ² 872 / p 5e-192 | 30.5 EB05 22.5 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 38.1 · ♀ 3% (drug 61%) | no trial data cached |
| Dysarthria (slurred speech) | 30 | 9.1 6.4–12.9ROR 9.2 · χ² 207 / p 2e-47 | 8.4 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 17% (drug 61%) | no trial data cached |
| Pollakiuria (frequent urination) | 29 | 7.9 5.5–11.4ROR 8.0 · χ² 169 / p 8e-39 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Nocturia (night-time urination) | 29 | 27.3 19.0–39.1ROR 27.7 · χ² 706 / p 6e-156 | 26.8 EB05 19.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 33.4 · ♀ 4% (drug 61%) | no trial data cached |
| Eye pain | 28 | 5.8 4.0–8.3ROR 5.8 · χ² 106 / p 4e-25 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 · 89% consumer | no trial data cached |
| Presyncope (near-fainting) | 28 | 13.2 9.1–19.0ROR 13.3 · χ² 302 / p 5e-68 | 12.7 EB05 8.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 11% (drug 61%) | no trial data cached |
| Hot flush (hot flashes) | 27 | 4.1 2.8–5.9ROR 4.1 · χ² 60 / p 6e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.2 · 93% 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.
- Nocturia — n=29, PRR 27.3
- Feeling cold — n=50, PRR 20.4
- Diplopia — n=34, PRR 14.9
- Presyncope — n=28, PRR 13.2
- Neuralgia — n=27, PRR 12.7
- Speech disorder — n=58, PRR 12.6
- Dysarthria — n=30, PRR 9.1
- Dysuria — n=27, PRR 8.3
- Pollakiuria — n=29, PRR 7.9
- Balance disorder — n=56, PRR 7.4
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 Solifenacin?
In FDA FAERS, the most frequently co-reported reaction terms for Solifenacin are dry mouth, speech disorder, balance disorder, feeling cold, urinary incontinence, diplopia. 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 Solifenacin have an FDA boxed warning?
No. The FDA label retrieved for Solifenacin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Solifenacin 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 1d96b386-febf-a510-a896-033e832c8f30, effective 20251011; matched on
openfda.generic_name.exact:"SOLIFENACIN SUCCINATE") - 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, 57 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.