Drug · FAERS side-effect profile with label screen
Trospium side effects: what 2,272 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Trospium Chloride (Trospium Chloride Er)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,272 reports · 70% serious · 177 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
FDA label, Indications and Usage
What it is
Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α).
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 4Labeled (related wording) 2Likely indication confounding 4Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 27
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.
- 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. 73 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 |
|---|---|---|---|---|---|---|
| Mitral valve incompetence | 34 | 27.8 19.9–38.8ROR 28.2 · χ² 849 / p 5e-187 | 27.3 EB05 20.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.9 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Joint dislocation | 30 | 26.4 18.5–37.6ROR 26.7 · χ² 705 / p 1e-155 | 25.9 EB05 19.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 · ♀ 96% (drug 65%) · 93% clinician | no trial data cached |
| Hiatus hernia | 31 | 22.1 15.6–31.4ROR 22.4 · χ² 602 / p 3e-133 | 21.8 EB05 16.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 · ♀ 100% (drug 65%) | no trial data cached |
| Cardiogenic shock | 31 | 20.1 14.2–28.5ROR 20.3 · χ² 542 / p 3e-120 | 19.8 EB05 14.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · 97% clinician | no trial data cached |
| Muscle spasticity | 22 | 16.4 10.8–24.9ROR 16.5 · χ² 302 / p 5e-68 | 16.0 EB05 10.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · 90% consumer | no trial data cached |
| Urinary retention | 57 | 15.8 12.2–20.5ROR 16.2 · χ² 777 / p 3e-171 | 15.7 EB05 12.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.1 | no trial data cached |
| Osteopenia | 26 | 15.7 10.7–23.1ROR 15.9 · χ² 344 / p 4e-77 | 15.4 EB05 10.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 · ♀ 96% (drug 65%) · 92% clinician | no trial data cached |
| Myelodysplastic syndrome | 24 | 15.3 10.3–22.8ROR 15.5 · χ² 307 / p 5e-69 | 14.9 EB05 10.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · ♀ 100% (drug 65%) · 100% clinician | no trial data cached |
| Eructation (belching) | 29 | 14.1 9.8–20.2ROR 14.3 · χ² 339 / p 4e-76 | 13.7 EB05 9.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 96% (drug 65%) · 96% clinician | no trial data cached |
| Incontinence | 16 | 14.0 8.6–22.7ROR 14.0 · χ² 179 / p 3e-41 | 13.0 EB05 7.9 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 11.6 | no trial data cached |
| Coronary artery disease | 46 | 13.9 10.5–18.5ROR 14.2 · χ² 539 / p 2e-119 | 13.7 EB05 10.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 93% (drug 65%) · 91% clinician | no trial data cached |
| Pulmonary hypertension | 31 | 13.7 9.7–19.4ROR 13.9 · χ² 352 / p 8e-79 | 13.3 EB05 9.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 93% (drug 65%) · 94% clinician | no trial data cached |
| Urinary incontinence | 38 | 11.9 8.6–16.2ROR 12.0 · χ² 367 / p 5e-82 | 11.4 EB05 8.5 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.6 · 75% consumer | no trial data cached |
| Cardiovascular disorder | 29 | 10.5 7.3–15.0ROR 10.6 · χ² 239 / p 3e-54 | 9.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.9 · ♀ 93% (drug 65%) | no trial data cached |
| Oral herpes | 22 | 10.4 6.9–15.8ROR 10.5 · χ² 179 / p 5e-41 | 9.5 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · 82% consumer | no trial data cached |
| Ejection fraction decreased | 17 | 10.1 6.3–16.2ROR 10.2 · χ² 130 / p 2e-30 | 8.8 EB05 5.5 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 9.1 | no trial data cached |
| Nocturia (night-time urination) | 12 | 9.1 5.2–16.1ROR 9.2 · χ² 79 / p 3e-19 | 7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Micturition urgency | 11 | 9.0 5.0–16.2ROR 9.0 · χ² 70 / p 3e-17 | 7.2 EB05 4.1 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.7 | no trial data cached |
| Impaired healing | 30 | 8.4 5.9–12.0ROR 8.5 · χ² 189 / p 2e-43 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · ♀ 96% (drug 65%) · 90% clinician | no trial data cached |
| Haematuria (blood in urine) | 31 | 8.3 5.9–11.8ROR 8.4 · χ² 193 / p 3e-44 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 86% (drug 65%) · 94% clinician | no trial data cached |
| Hepatic cytolysis | 11 | 8.3 4.6–15.0ROR 8.3 · χ² 64 / p 8e-16 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Muscle tightness | 14 | 8.0 4.7–13.5ROR 8.0 · χ² 79 / p 4e-19 | 6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Hyponatraemia (low sodium) | 47 | 7.7 5.8–10.2ROR 7.9 · χ² 269 / p 1e-60 | 7.3 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 29 | 7.7 5.3–11.0ROR 7.8 · χ² 162 / p 2e-37 | 7.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 93% (drug 65%) | no trial data cached |
| Urinary tract infection (bladder infection) | 137 | 7.4 6.3–8.7ROR 7.8 · χ² 762 / p 4e-168 | 7.3 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · ♀ 86% (drug 65%) | no trial data cached |
| Mental impairment | 19 | 7.2 4.6–11.3ROR 7.3 · χ² 96 / p 6e-23 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Mydriasis | 10 | 7.2 3.9–13.4ROR 7.2 · χ² 47 / p 3e-12 | 5.7 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Sciatica | 12 | 7.0 4.0–12.3ROR 7.0 · χ² 56 / p 4e-14 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Dementia | 21 | 7.0 4.5–10.7ROR 7.0 · χ² 101 / p 4e-24 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 40% (drug 65%) | no trial data cached |
| Sensory disturbance | 12 | 6.9 3.9–12.1ROR 6.9 · χ² 54 / p 8e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Lymphocyte count decreased | 13 | 6.8 3.9–11.7ROR 6.8 · χ² 58 / p 1e-14 | 5.6 EB05 3.5 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 | no trial data cached |
| Peripheral coldness | 10 | 6.7 3.6–12.4ROR 6.7 · χ² 43 / p 3e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Dry mouth | 54 | 6.2 4.7–8.0ROR 6.3 · χ² 229 / p 6e-52 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Erectile dysfunction | 17 | 6.1 3.8–9.8ROR 6.1 · χ² 67 / p 1e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Pollakiuria (frequent urination) | 27 | 6.0 4.1–8.7ROR 6.0 · χ² 107 / p 2e-25 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · ♀ 42% (drug 65%) | no trial data cached |
| Neuralgia | 15 | 5.7 3.4–9.5ROR 5.7 · χ² 54 / p 1e-13 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Muscle twitching | 14 | 5.6 3.3–9.4ROR 5.6 · χ² 48 / p 2e-12 | 4.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Hallucination (hallucinations) | 45 | 5.5 4.1–7.4ROR 5.6 · χ² 163 / p 1e-37 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · ♀ 32% (drug 65%) | no trial data cached |
| Face oedema | 10 | 5.4 2.9–10.1ROR 5.5 · χ² 32 / p 8e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Scar | 10 | 5.4 2.9–10.0ROR 5.4 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.8 | 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 |
|---|---|---|---|---|---|---|
| Fall | 178 | 4.9 4.3–5.7ROR 5.3 · χ² 564 / p 5e-125 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Urinary tract infection (bladder infection) | 137 | 7.4 6.3–8.7ROR 7.8 · χ² 762 / p 4e-168 | 7.3 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · ♀ 86% (drug 65%) | no trial data cached |
| Gait disturbance | 97 | 4.7 3.8–5.7ROR 4.8 · χ² 278 / p 1e-62 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Urinary retention | 57 | 15.8 12.2–20.5ROR 16.2 · χ² 777 / p 3e-171 | 15.7 EB05 12.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.1 | no trial data cached |
| Dry mouth | 54 | 6.2 4.7–8.0ROR 6.3 · χ² 229 / p 6e-52 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Myocardial infarction (heart attack) | 50 | 2.6 2.0–3.5ROR 2.7 · χ² 49 / p 1e-12 | 2.6 EB05 2.0 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 · 94% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 47 | 7.7 5.8–10.2ROR 7.9 · χ² 269 / p 1e-60 | 7.3 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Coronary artery disease | 46 | 13.9 10.5–18.5ROR 14.2 · χ² 539 / p 2e-119 | 13.7 EB05 10.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 93% (drug 65%) · 91% clinician | no trial data cached |
| Hallucination (hallucinations) | 45 | 5.5 4.1–7.4ROR 5.6 · χ² 163 / p 1e-37 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · ♀ 32% (drug 65%) | no trial data cached |
| Multiple sclerosis relapse | 38 | 5.1 3.7–7.0ROR 5.1 · χ² 121 / p 2e-28 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 92% (drug 65%) | no trial data cached |
| Urinary incontinence | 38 | 11.9 8.6–16.2ROR 12.0 · χ² 367 / p 5e-82 | 11.4 EB05 8.5 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.6 · 75% consumer | no trial data cached |
| Gastrointestinal haemorrhage | 36 | 4.0 2.9–5.5ROR 4.0 · χ² 77 / p 1e-18 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · ♀ 91% (drug 65%) · 97% clinician | no trial data cached |
| Mitral valve incompetence | 34 | 27.8 19.9–38.8ROR 28.2 · χ² 849 / p 5e-187 | 27.3 EB05 20.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.9 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Haematuria (blood in urine) | 31 | 8.3 5.9–11.8ROR 8.4 · χ² 193 / p 3e-44 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 86% (drug 65%) · 94% clinician | no trial data cached |
| Pulmonary hypertension | 31 | 13.7 9.7–19.4ROR 13.9 · χ² 352 / p 8e-79 | 13.3 EB05 9.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 93% (drug 65%) · 94% clinician | 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.
- Mitral valve incompetence — n=34, PRR 27.8
- Joint dislocation — n=30, PRR 26.4
- Hiatus hernia — n=31, PRR 22.1
- Cardiogenic shock — n=31, PRR 20.1
- Muscle spasticity — n=22, PRR 16.4
- Osteopenia — n=26, PRR 15.7
- Myelodysplastic syndrome — n=24, PRR 15.3
- Eructation — n=29, PRR 14.1
- Coronary artery disease — n=46, PRR 13.9
- Pulmonary hypertension — n=31, PRR 13.7
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 Trospium?
In FDA FAERS, the most frequently co-reported reaction terms for Trospium are fall, urinary tract infection, gait disturbance, urinary retention, dry mouth, myocardial infarction. 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 Trospium have an FDA boxed warning?
No. The FDA label retrieved for Trospium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Trospium 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 2f431dd1-e130-45e5-a796-1662f498585e, effective 20231106; matched on
openfda.generic_name.exact:"TROSPIUM CHLORIDE") - 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, 113 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.