Drug · FAERS side-effect profile with label screen
Fesoterodine side effects: what 10,773 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Fesoterodine Fumarate (Fesoterodine Fumarate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
10,773 reports · 56% serious · 439 with death outcome · 69% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Fesoterodine fumarate extended-release tablets are indicated for the treatment of: • Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg.
FDA label, Indications and Usage
What it is
Fesoterodine fumarate tablet contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist.
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 3Labeled (related wording) 2Likely indication confounding 8Lab value / disease marker 4Not in label — unassessed 23
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. 983 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 |
|---|---|---|---|---|---|---|
| Steroid dependence | 135 | 368.1 306.5–442.2ROR 372.8 · χ² 41,170 / p <1e-300 | 296.1 EB05 256.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=135 · ♀ 16% (drug 69%) · 95% clinician | no trial data cached |
| Catarrh | 138 | 358.0 298.8–428.9ROR 362.6 · χ² 41,110 / p <1e-300 | 289.8 EB05 251.4 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=138 · ♀ 17% (drug 69%) · 95% clinician | no trial data cached |
| Carbuncle | 34 | 266.4 186.2–381.2ROR 267.3 · χ² 7,663 / p <1e-300 | 207.0 EB05 154.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 69%) | no trial data cached |
| Burns second degree | 139 | 168.0 141.4–199.6ROR 170.2 · χ² 21,071 / p <1e-300 | 151.4 EB05 131.4 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=139 · ♀ 17% (drug 69%) · 94% clinician | no trial data cached |
| Monoclonal immunoglobulin present | 34 | 90.5 64.2–127.6ROR 90.8 · χ² 2,790 / p <1e-300 | 82.6 EB05 61.8 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=34 · ♀ 100% (drug 69%) | no trial data cached |
| Hypopnoea | 139 | 81.5 68.8–96.4ROR 82.5 · χ² 10,521 / p <1e-300 | 77.4 EB05 67.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=139 · ♀ 17% (drug 69%) · 94% clinician | no trial data cached |
| Alcohol poisoning | 94 | 71.5 58.2–87.7ROR 72.1 · χ² 6,230 / p <1e-300 | 68.0 EB05 57.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=94 · ♀ 0% (drug 69%) · 97% clinician | no trial data cached |
| Wrist deformity | 21 | 68.2 44.2–105.4ROR 68.3 · χ² 1,279 / p 2e-280 | 62.4 EB05 43.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 69%) · 100% clinician | no trial data cached |
| Hypothalamo-pituitary disorder | 34 | 46.9 33.4–65.9ROR 47.1 · χ² 1,447 / p <1e-300 | 44.8 EB05 33.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 69%) | no trial data cached |
| Hypertonic bladder | 65 | 45.0 35.2–57.4ROR 45.2 · χ² 2,687 / p <1e-300 | 43.4 EB05 35.3 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=44 | no trial data cached |
| Bronchiectasis | 141 | 42.1 35.6–49.7ROR 42.6 · χ² 5,495 / p <1e-300 | 41.0 EB05 35.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=140 · ♀ 16% (drug 69%) · 94% clinician | no trial data cached |
| Bladder spasm | 37 | 39.5 28.5–54.6ROR 39.6 · χ² 1,323 / p 7e-290 | 38.0 EB05 28.8 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=25 · 76% consumer | no trial data cached |
| Gingival pain | 144 | 35.8 30.4–42.2ROR 36.3 · χ² 4,754 / p <1e-300 | 35.0 EB05 30.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=143 · ♀ 19% (drug 69%) · 94% clinician | no trial data cached |
| Parosmia | 136 | 35.8 30.2–42.3ROR 36.2 · χ² 4,479 / p <1e-300 | 35.0 EB05 30.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=136 · ♀ 15% (drug 69%) · 94% clinician | no trial data cached |
| Rhinitis | 137 | 33.6 28.4–39.8ROR 34.1 · χ² 4,233 / p <1e-300 | 32.9 EB05 28.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=137 · ♀ 17% (drug 69%) · 94% clinician | no trial data cached |
| Cardiac murmur | 144 | 32.7 27.8–38.6ROR 33.2 · χ² 4,328 / p <1e-300 | 32.1 EB05 27.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 35.8 · ♀ 18% (drug 69%) · 94% clinician | no trial data cached |
| Urinary retention | 502 | 29.8 27.3–32.5ROR 31.2 · χ² 13,751 / p <1e-300 | 29.3 EB05 27.2 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 31.7 · ♀ 40% (drug 69%) | no trial data cached |
| Urine flow decreased | 33 | 27.4 19.4–38.6ROR 27.4 · χ² 800 / p 2e-176 | 26.6 EB05 19.8 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=17 · ♀ 31% (drug 69%) | no trial data cached |
| Pulseless electrical activity | 47 | 22.2 16.6–29.5ROR 22.3 · χ² 918 / p 6e-202 | 21.7 EB05 17.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 48% (drug 69%) | no trial data cached |
| Fibrosis | 34 | 21.7 15.5–30.5ROR 21.8 · χ² 645 / p 1e-142 | 21.3 EB05 15.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 69%) | no trial data cached |
| Bladder pain | 33 | 20.6 14.6–29.0ROR 20.6 · χ² 588 / p 3e-130 | 20.1 EB05 15.0 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | no trial data cached |
| Dry mouth | 823 | 20.0 18.7–21.3ROR 21.5 · χ² 14,720 / p <1e-300 | 19.8 EB05 18.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · 71% consumer | no trial data cached |
| Bladder dilatation | 11 | 19.8 11.0–35.9ROR 19.9 · χ² 177 / p 1e-40 | 18.6 EB05 10.3 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Bladder disorder | 88 | 17.4 14.1–21.4ROR 17.5 · χ² 1,329 / p 3e-291 | 17.1 EB05 14.3 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=58 · 78% consumer | no trial data cached |
| Anticholinergic syndrome | 14 | 17.2 10.2–29.2ROR 17.3 · χ² 196 / p 6e-45 | 16.3 EB05 9.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Impaired quality of life | 123 | 16.8 14.1–20.0ROR 17.0 · χ² 1,794 / p <1e-300 | 16.6 EB05 14.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 18% (drug 69%) · 94% clinician | no trial data cached |
| Monocyte count decreased | 10 | 16.2 8.7–30.2ROR 16.2 · χ² 127 / p 1e-29 | 14.5 EB05 7.3 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Nocturia (night-time urination) | 99 | 16.0 13.2–19.5ROR 16.2 · χ² 1,370 / p 4e-300 | 15.8 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · 70% consumer | no trial data cached |
| Body height decreased | 88 | 16.0 13.0–19.7ROR 16.1 · χ² 1,210 / p 2e-265 | 15.8 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=56 | no trial data cached |
| Bladder discomfort | 10 | 16.0 8.6–29.7ROR 16.0 · χ² 125 / p 3e-29 | 14.3 EB05 7.1 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=8 | no trial data cached |
| Tubulointerstitial nephritis | 149 | 15.6 13.3–18.3ROR 15.8 · χ² 2,007 / p <1e-300 | 15.4 EB05 13.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · ♀ 25% (drug 69%) · 94% clinician | no trial data cached |
| Micturition urgency | 88 | 15.2 12.3–18.8ROR 15.3 · χ² 1,146 / p 1e-251 | 15.0 EB05 12.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 15.1 | no trial data cached |
| Forced expiratory volume decreased | 22 | 15.2 10.0–23.1ROR 15.2 · χ² 276 / p 3e-62 | 14.6 EB05 9.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=22 | no trial data cached |
| Overweight | 41 | 15.0 11.0–20.4ROR 15.0 · χ² 518 / p 7e-115 | 14.7 EB05 11.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 95% (drug 69%) | no trial data cached |
| Cystitis interstitial | 12 | 14.6 8.3–25.8ROR 14.7 · χ² 138 / p 3e-32 | 13.2 EB05 7.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Finger deformity | 36 | 14.6 10.5–20.2ROR 14.6 · χ² 438 / p 2e-97 | 14.2 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 69%) | no trial data cached |
| Dry throat | 73 | 14.1 11.2–17.7ROR 14.2 · χ² 869 / p 3e-191 | 13.9 EB05 11.4 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=36 · 77% consumer | no trial data cached |
| Urinary incontinence | 208 | 13.8 12.0–15.8ROR 14.0 · χ² 2,435 / p <1e-300 | 13.6 EB05 12.1 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 11.4 | no trial data cached |
| Frequent bowel movements | 188 | 13.7 11.9–15.8ROR 13.9 · χ² 2,186 / p <1e-300 | 13.6 EB05 12.0 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 21.2 · ♀ 39% (drug 69%) | no trial data cached |
| Dyslipidaemia | 35 | 13.5 9.7–18.8ROR 13.5 · χ² 390 / p 5e-87 | 13.1 EB05 9.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 69%) | 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) | 1,679 | 2.5 2.4–2.6ROR 2.8 · χ² 1,585 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · 74% consumer | no trial data cached |
| Dry mouth | 823 | 20.0 18.7–21.3ROR 21.5 · χ² 14,720 / p <1e-300 | 19.8 EB05 18.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · 71% consumer | no trial data cached |
| Fall | 534 | 3.1 2.9–3.4ROR 3.2 · χ² 783 / p 1e-172 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Off label use (used outside approved label) | 523 | 1.2 1.1–1.3ROR 1.2 · χ² 14 / p 1e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Fatigue (tiredness) | 519 | 1.3 1.2–1.4ROR 1.3 · χ² 37 / p 6e-10 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Constipation | 505 | 4.6 4.2–5.0ROR 4.7 · χ² 1,407 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 70% consumer | no trial data cached |
| Urinary retention | 502 | 29.8 27.3–32.5ROR 31.2 · χ² 13,751 / p <1e-300 | 29.3 EB05 27.2 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 31.7 · ♀ 40% (drug 69%) | no trial data cached |
| Pain | 456 | 1.4 1.3–1.6ROR 1.5 · χ² 63 / p 9e-16 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Headache | 431 | 1.3 1.2–1.5ROR 1.4 · χ² 38 / p 4e-10 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Dizziness | 394 | 1.5 1.4–1.7ROR 1.6 · χ² 76 / p 1e-18 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Condition aggravated | 341 | 2.2 2.0–2.4ROR 2.2 · χ² 225 / p 4e-51 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Confusional state (confusion) | 340 | 4.1 3.7–4.5ROR 4.2 · χ² 796 / p 2e-175 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · ♀ 43% (drug 69%) | no trial data cached |
| Malaise (feeling unwell) | 334 | 1.5 1.3–1.6ROR 1.5 · χ² 52 / p 2e-13 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Rash | 333 | 1.5 1.3–1.7ROR 1.5 · χ² 55 / p 5e-14 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Diarrhoea (diarrhea) | 325 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.391 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | 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.
- Steroid dependence — n=135, PRR 368.1
- Catarrh — n=138, PRR 358.0
- Carbuncle — n=34, PRR 266.4
- Burns second degree — n=139, PRR 168.0
- Hypopnoea — n=139, PRR 81.5
- Alcohol poisoning — n=94, PRR 71.5
- Wrist deformity — n=21, PRR 68.2
- Hypothalamo-pituitary disorder — n=34, PRR 46.9
- Bronchiectasis — n=141, PRR 42.1
- Gingival pain — n=144, PRR 35.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
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 Fesoterodine?
In FDA FAERS, the most frequently co-reported reaction terms for Fesoterodine are dry mouth, fall, fatigue, constipation, urinary retention, pain. 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 Fesoterodine have an FDA boxed warning?
No. The FDA label retrieved for Fesoterodine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fesoterodine 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 299db62d-9658-4796-b449-657fa859c5cd, effective 20250617; matched on
openfda.generic_name.exact:"FESOTERODINE FUMARATE") - 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, 1,023 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.