Drug · FAERS side-effect profile with label screen
Tolterodine side effects: what 6,467 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Tolterodine Tartrate
openFDA label
Who reports
6,467 reports · 70% serious · 452 with death outcome · 70% 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 adverse reaction 4Labeled (related wording) 1Likely indication confounding 5Reporting / 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. 476 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 |
|---|---|---|---|---|---|---|
| Bladder disorder | 37 | 12.1 8.8–16.7ROR 12.2 · χ² 364 / p 2e-81 | 11.7 EB05 8.6 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=28 | no trial data cached |
| Urinary incontinence | 87 | 9.5 7.7–11.8ROR 9.7 · χ² 656 / p 6e-145 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.7 · 72% consumer | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 45 | 8.4 6.3–11.2ROR 8.4 · χ² 284 / p 4e-64 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 93% clinician | no trial data cached |
| Oesophagitis | 26 | 7.7 5.3–11.3ROR 7.7 · χ² 145 / p 1e-33 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 92% (drug 70%) | no trial data cached |
| Urinary retention | 79 | 7.7 6.2–9.6ROR 7.8 · χ² 454 / p 5e-101 | 7.4 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · ♀ 45% (drug 70%) | no trial data cached |
| Incontinence | 21 | 6.4 4.2–9.9ROR 6.5 · χ² 91 / p 8e-22 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.5 | no trial data cached |
| Dry mouth | 149 | 6.0 5.1–7.0ROR 6.1 · χ² 613 / p 1e-135 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Dry throat | 18 | 5.8 3.6–9.1ROR 5.8 · χ² 66 / p 2e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Subarachnoid haemorrhage | 18 | 5.7 3.6–9.1ROR 5.7 · χ² 65 / p 3e-16 | 5.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Nocturia (night-time urination) | 21 | 5.6 3.7–8.6ROR 5.6 · χ² 75 / p 2e-18 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Coordination abnormal | 24 | 5.5 3.7–8.3ROR 5.6 · χ² 85 / p 2e-20 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 74% consumer | no trial data cached |
| Motor dysfunction | 17 | 5.5 3.4–8.8ROR 5.5 · χ² 57 / p 2e-14 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Cystitis | 53 | 5.4 4.1–7.0ROR 5.4 · χ² 185 / p 2e-42 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 92% (drug 70%) | no trial data cached |
| Pollakiuria (frequent urination) | 68 | 5.3 4.2–6.7ROR 5.3 · χ² 233 / p 7e-53 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 48% (drug 70%) | no trial data cached |
| Micturition urgency | 18 | 5.2 3.2–8.2ROR 5.2 · χ² 56 / p 3e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.7 | no trial data cached |
| Sinus tachycardia | 22 | 5.0 3.3–7.6ROR 5.0 · χ² 67 / p 1e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 90% clinician | no trial data cached |
| Dysarthria (slurred speech) | 58 | 5.0 3.9–6.5ROR 5.0 · χ² 182 / p 1e-41 | 4.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Vitamin d deficiency | 15 | 5.0 3.0–8.3ROR 5.0 · χ² 44 / p 2e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Urosepsis | 14 | 4.9 2.9–8.3ROR 4.9 · χ² 40 / p 1e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hypomagnesaemia | 21 | 4.9 3.2–7.5ROR 4.9 · χ² 61 / p 2e-15 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 33% (drug 70%) | no trial data cached |
| Drug interaction | 239 | 4.9 4.3–5.5ROR 5.0 · χ² 739 / p 4e-163 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Serotonin syndrome | 28 | 4.7 3.3–6.9ROR 4.8 · χ² 79 / p 3e-19 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 92% (drug 70%) · 92% clinician | no trial data cached |
| Pharyngeal swelling | 14 | 4.7 2.8–8.0ROR 4.8 · χ² 38 / p 4e-10 | 4.2 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Foot deformity | 16 | 4.7 2.9–7.6ROR 4.7 · χ² 43 / p 3e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Multiple sclerosis | 69 | 4.7 3.7–5.9ROR 4.7 · χ² 195 / p 2e-44 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Clostridium difficile colitis | 15 | 4.6 2.8–7.6ROR 4.6 · χ² 38 / p 3e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Dysuria (painful urination) | 52 | 4.6 3.5–6.0ROR 4.6 · χ² 142 / p 5e-33 | 4.4 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 73% consumer | no trial data cached |
| Nerve compression | 13 | 4.6 2.7–7.9ROR 4.6 · χ² 33 / p 5e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Body temperature decreased | 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 | Lab value / disease marker | serious PRR 4.2 | no trial data cached |
| Salivary hypersecretion | 14 | 4.5 2.7–7.7ROR 4.6 · χ² 35 / p 1e-9 | 4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Hiatus hernia | 18 | 4.5 2.8–7.1ROR 4.5 · χ² 46 / p 8e-12 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Hyponatraemia (low sodium) | 77 | 4.4 3.6–5.5ROR 4.5 · χ² 202 / p 3e-46 | 4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 90% clinician | no trial data cached |
| Mental impairment | 33 | 4.4 3.1–6.2ROR 4.4 · χ² 84 / p 3e-20 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 72% consumer | no trial data cached |
| Hospice care | 13 | 4.3 2.5–7.4ROR 4.3 · χ² 29 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Balance disorder | 114 | 4.3 3.6–5.1ROR 4.3 · χ² 283 / p 8e-64 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Upper gastrointestinal haemorrhage | 22 | 4.2 2.8–6.4ROR 4.2 · χ² 51 / p 5e-13 | 3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Head injury | 41 | 4.2 3.1–5.7ROR 4.2 · χ² 97 / p 3e-23 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 41% (drug 70%) | no trial data cached |
| Blood pressure systolic increased | 25 | 4.1 2.8–6.1ROR 4.2 · χ² 56 / p 3e-14 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 · 92% clinician | no trial data cached |
| Urinary tract infection (bladder infection) | 215 | 4.1 3.6–4.7ROR 4.2 · χ² 504 / p 5e-112 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.8 | no trial data cached |
| Fall | 419 | 4.1 3.7–4.5ROR 4.3 · χ² 989 / p 3e-217 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | 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 | 419 | 4.1 3.7–4.5ROR 4.3 · χ² 989 / p 3e-217 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Fatigue (tiredness) | 417 | 1.7 1.6–1.9ROR 1.8 · χ² 135 / p 1e-31 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Dizziness | 317 | 2.1 1.9–2.3ROR 2.1 · χ² 177 / p 1e-40 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Headache | 283 | 1.5 1.3–1.6ROR 1.5 · χ² 43 / p 3e-11 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Drug interaction | 239 | 4.9 4.3–5.5ROR 5.0 · χ² 739 / p 4e-163 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Asthenia (weakness) | 218 | 1.9 1.6–2.1ROR 1.9 · χ² 90 / p 1e-21 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Urinary tract infection (bladder infection) | 215 | 4.1 3.6–4.7ROR 4.2 · χ² 504 / p 5e-112 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.8 | no trial data cached |
| Constipation | 196 | 2.9 2.6–3.4ROR 3.0 · χ² 251 / p 9e-57 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Confusional state (confusion) | 174 | 3.5 3.0–4.0ROR 3.6 · χ² 308 / p 3e-69 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Gait disturbance | 167 | 2.8 2.4–3.3ROR 2.9 · χ² 196 / p 7e-45 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 · 72% consumer | no trial data cached |
| Pain in extremity | 154 | 1.7 1.4–2.0ROR 1.7 · χ² 43 / p 2e-11 | 1.7 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Back pain | 151 | 2.1 1.8–2.5ROR 2.1 · χ² 87 / p 4e-21 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Cough | 150 | 1.7 1.5–2.0ROR 1.8 · χ² 47 / p 4e-12 | 1.7 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Dry mouth | 149 | 6.0 5.1–7.0ROR 6.1 · χ² 613 / p 1e-135 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Balance disorder | 114 | 4.3 3.6–5.1ROR 4.3 · χ² 283 / p 8e-64 | 4.2 EB05 3.6 · IC025 +1.8 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.
- Orthostatic hypotension — n=45, PRR 8.4
- Oesophagitis — n=26, PRR 7.7
- Nocturia — n=21, PRR 5.6
- Coordination abnormal — n=24, PRR 5.5
- Cystitis — n=53, PRR 5.4
- Pollakiuria — n=68, PRR 5.3
- Dysarthria — n=58, PRR 5.0
- Hypomagnesaemia — n=21, PRR 4.9
- Serotonin syndrome — n=28, PRR 4.7
- Multiple sclerosis — n=69, PRR 4.7
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 Tolterodine?
In FDA FAERS, the most frequently co-reported reaction terms for Tolterodine are fall, fatigue, dizziness, headache, asthenia, urinary tract infection. 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, 516 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.