Drug · FAERS side-effect profile with label screen
Tolterodine Tartrate side effects: what 8,919 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Tolterodine Tartrate
openFDA label
Who reports
8,919 reports · 64% serious · 548 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 ) Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [ see CLINICAL STUDIES ( 14 ) ].
FDA label, Indications and Usage
What it is
Tolterodine tartrate extended-release capsules, USP contain tolterodine tartrate, USP. The active moiety, tolterodine, 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 (related wording) 1Likely indication confounding 11Lab value / disease marker 7Not in label — unassessed 21
What the badges mean
- 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. 1,037 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 |
|---|---|---|---|---|---|---|
| Anticholinergic syndrome | 55 | 84.0 64.2–109.8ROR 84.5 · χ² 4,273 / p <1e-300 | 78.9 EB05 62.9 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=55 · 91% clinician | no trial data cached |
| Seronegative arthritis | 31 | 66.7 46.7–95.3ROR 67.0 · χ² 1,888 / p <1e-300 | 62.5 EB05 46.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 0% (drug 77%) · 100% clinician | no trial data cached |
| Urge incontinence | 17 | 47.4 29.3–76.5ROR 47.5 · χ² 711 / p 5e-157 | 44.3 EB05 29.3 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious n=14 | no trial data cached |
| Hypertonic bladder | 47 | 39.0 29.3–52.0ROR 39.2 · χ² 1,674 / p <1e-300 | 37.8 EB05 29.6 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=37 | no trial data cached |
| Cystocele | 13 | 35.9 20.8–62.0ROR 35.9 · χ² 400 / p 2e-89 | 33.8 EB05 21.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Stress urinary incontinence | 15 | 32.9 19.8–54.7ROR 33.0 · χ² 427 / p 5e-95 | 31.3 EB05 20.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Lipoma | 35 | 32.2 23.1–44.9ROR 32.3 · χ² 1,014 / p 1e-222 | 31.3 EB05 23.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 0% (drug 77%) · 91% clinician | no trial data cached |
| Intervertebral disc space narrowing | 10 | 29.6 15.9–55.2ROR 29.6 · χ² 245 / p 2e-55 | 27.7 EB05 15.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Bladder spasm | 20 | 25.5 16.4–39.7ROR 25.6 · χ² 442 / p 2e-98 | 24.7 EB05 16.9 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Bladder dysfunction | 10 | 23.1 12.4–43.0ROR 23.1 · χ² 188 / p 5e-43 | 21.7 EB05 12.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=9 | no trial data cached |
| Body temperature fluctuation | 20 | 22.8 14.7–35.4ROR 22.8 · χ² 391 / p 2e-87 | 22.1 EB05 15.0 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=20 | no trial data cached |
| Pulmonary granuloma | 11 | 22.6 12.5–41.0ROR 22.7 · χ² 204 / p 1e-46 | 21.4 EB05 12.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Excoriation | 23 | 21.2 14.1–31.9ROR 21.2 · χ² 418 / p 3e-93 | 20.6 EB05 14.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Hyperparathyroidism secondary | 21 | 19.6 12.8–30.2ROR 19.7 · χ² 350 / p 2e-78 | 19.1 EB05 13.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Neurogenic bladder | 16 | 17.9 10.9–29.2ROR 17.9 · χ² 237 / p 1e-53 | 17.1 EB05 10.8 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Blood iron increased | 14 | 17.6 10.4–29.8ROR 17.6 · χ² 202 / p 5e-46 | 16.7 EB05 10.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Polyp | 48 | 17.3 13.1–23.0ROR 17.4 · χ² 718 / p 2e-158 | 17.1 EB05 13.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 100% (drug 77%) | no trial data cached |
| Therapeutic agent toxicity | 23 | 16.1 10.7–24.2ROR 16.1 · χ² 308 / p 2e-69 | 15.6 EB05 10.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Micturition urgency | 74 | 15.4 12.3–19.4ROR 15.6 · χ² 979 / p 4e-215 | 15.2 EB05 12.5 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 18.3 | no trial data cached |
| Blood pressure systolic abnormal | 16 | 15.2 9.3–24.8ROR 15.2 · χ² 197 / p 5e-45 | 14.3 EB05 8.7 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=16 | no trial data cached |
| Secondary progressive multiple sclerosis | 12 | 15.0 8.5–26.4ROR 15.0 · χ² 142 / p 5e-33 | 13.6 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Inflammatory marker increased | 31 | 14.9 10.5–21.3ROR 15.0 · χ² 387 / p 2e-86 | 14.6 EB05 10.5 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=31 · ♀ 0% (drug 77%) · 100% clinician | no trial data cached |
| Intermittent claudication | 10 | 14.8 8.0–27.6ROR 14.8 · χ² 115 / p 5e-27 | 13.0 EB05 6.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Nephrogenic anaemia | 29 | 14.7 10.2–21.1ROR 14.7 · χ² 354 / p 4e-79 | 14.2 EB05 10.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Urinary incontinence | 177 | 14.1 12.2–16.4ROR 14.4 · χ² 2,136 / p <1e-300 | 14.0 EB05 12.3 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 13.5 | no trial data cached |
| Bladder disorder | 59 | 14.0 10.9–18.1ROR 14.1 · χ² 696 / p 1e-153 | 13.8 EB05 11.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=47 | no trial data cached |
| Cervical spinal stenosis | 10 | 13.7 7.3–25.4ROR 13.7 · χ² 104 / p 8e-25 | 11.7 EB05 5.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Spondylolisthesis | 10 | 13.6 7.3–25.2ROR 13.6 · χ² 103 / p 1e-24 | 11.6 EB05 5.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Escherichia urinary tract infection | 24 | 13.3 8.9–19.9ROR 13.4 · χ² 260 / p 7e-59 | 12.7 EB05 8.6 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · 100% clinician | no trial data cached |
| Blood pressure diastolic abnormal | 14 | 12.9 7.6–21.7ROR 12.9 · χ² 141 / p 9e-33 | 11.5 EB05 6.6 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Hypertensive heart disease | 10 | 12.5 6.7–23.3ROR 12.6 · χ² 95 / p 1e-22 | 10.5 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mastication disorder | 15 | 11.6 7.0–19.3ROR 11.6 · χ² 134 / p 2e-31 | 10.3 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Diverticulum | 35 | 11.5 8.2–16.0ROR 11.5 · χ² 323 / p 2e-72 | 10.9 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=33 | no trial data cached |
| Ventricular hypertrophy | 12 | 11.2 6.3–19.7ROR 11.2 · χ² 101 / p 5e-24 | 9.4 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Incontinence | 50 | 11.1 8.4–14.7ROR 11.2 · χ² 450 / p 4e-100 | 10.8 EB05 8.3 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 11.1 | no trial data cached |
| Aortic arteriosclerosis | 12 | 11.0 6.2–19.3ROR 11.0 · χ² 99 / p 2e-23 | 9.2 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Spinal osteoarthritis | 41 | 11.0 8.1–14.9ROR 11.0 · χ² 360 / p 2e-80 | 10.5 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Blood chloride decreased | 12 | 10.9 6.2–19.2ROR 10.9 · χ² 98 / p 2e-23 | 9.1 EB05 5.1 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Spinal column stenosis | 22 | 10.8 7.1–16.5ROR 10.9 · χ² 186 / p 1e-42 | 9.9 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Blood pressure diastolic decreased | 32 | 10.2 7.2–14.4ROR 10.2 · χ² 255 / p 1e-57 | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 9.7 | 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) | 876 | 1.6 1.5–1.7ROR 1.6 · χ² 189 / p 2e-43 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.4 · 71% consumer | no trial data cached |
| Fatigue (tiredness) | 582 | 1.8 1.6–1.9ROR 1.8 · χ² 198 / p 3e-45 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Fall | 578 | 4.1 3.8–4.4ROR 4.3 · χ² 1,366 / p 2e-299 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Nausea | 531 | 1.6 1.5–1.7ROR 1.6 · χ² 118 / p 1e-27 | 1.6 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Dizziness | 466 | 2.2 2.0–2.4ROR 2.3 · χ² 311 / p 6e-70 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Headache | 445 | 1.7 1.5–1.8ROR 1.7 · χ² 123 / p 8e-29 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Asthenia (weakness) | 436 | 2.7 2.5–3.0ROR 2.8 · χ² 483 / p 2e-107 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Diarrhoea (diarrhea) | 414 | 1.5 1.4–1.7ROR 1.5 · χ² 74 / p 4e-18 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Pain | 399 | 1.5 1.4–1.7ROR 1.5 · χ² 74 / p 5e-18 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Urinary tract infection (bladder infection) | 375 | 5.2 4.7–5.7ROR 5.4 · χ² 1,272 / p 6e-279 | 5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 373 | 1.6 1.4–1.7ROR 1.6 · χ² 74 / p 3e-18 | 1.5 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Constipation | 321 | 3.5 3.1–3.9ROR 3.6 · χ² 573 / p 7e-127 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Vomiting | 309 | 1.5 1.4–1.7ROR 1.6 · χ² 61 / p 3e-15 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Weight decreased (weight loss) | 306 | 2.6 2.3–2.9ROR 2.6 · χ² 298 / p 5e-67 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Gait disturbance | 303 | 3.7 3.3–4.1ROR 3.8 · χ² 603 / p 2e-133 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | 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.
- Seronegative arthritis — n=31, PRR 66.7
- Lipoma — n=35, PRR 32.2
- Excoriation — n=23, PRR 21.2
- Hyperparathyroidism secondary — n=21, PRR 19.6
- Polyp — n=48, PRR 17.3
- Therapeutic agent toxicity — n=23, PRR 16.1
- Nephrogenic anaemia — n=29, PRR 14.7
- Diverticulum — n=35, PRR 11.5
- Spinal osteoarthritis — n=41, PRR 11.0
- Spinal column stenosis — n=22, PRR 10.8
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 Tolterodine?
In FDA FAERS, the most frequently co-reported reaction terms for Tolterodine are fatigue, fall, nausea, dizziness, headache, asthenia. 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 Tolterodine have an FDA boxed warning?
No. The FDA label retrieved for Tolterodine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tolterodine 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 db6e0b6d-0ce5-41d7-881f-881c11f530a4, effective 20260209; matched on
openfda.generic_name.exact:"TOLTERODINE") - 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, 1,077 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.