Drug · FAERS side-effect profile with label screen
Tiotropium side effects: what 136,142 FDA adverse event reports show
Drug class
Anticholinergic
FDA label, Indications wording of the closest related product
Label matched
Tiotropium Bromide (Tiotropium Bromide)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
136,142 reports · 50% serious · 9,792 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Tiotropium bromide inhalation powder is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiotropium bromide inhalation powder is indicated to reduce exacerbations in COPD patients.
FDA label, Indications and Usage
What it is
Tiotropium is a quaternary ammonium ion obtained by methylation of the tertiary amino group of (1alpha,2beta,4beta,5alpha,7beta)-7-[(hydroxydi-2-thienylacetyl)oxy]-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane.
PubChem CID 5487427 (ChEBI)
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 7Reporting / coding artifact 3Lab value / disease marker 7Not in label — unassessed 22
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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,184 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 |
|---|---|---|---|---|---|---|
| Right atrial hypertrophy | 89 | 639.8 397.7–1,029.3ROR 640.2 · calibrated p 9e-14 ✓ | 119.8 EB05 100.4 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=89 · ♀ 0% (drug 61%) | no trial arm names this drug |
| Incorrect route of drug administration | 23,320 | 282.5 276.6–288.6ROR 340.7 · calibrated p 3e-12 ✓ | 99.0 EB05 98.0 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 249.5 · serious PRR 14.9 · 78% consumer | no trial arm names this drug |
| Total lung capacity increased | 152 | 194.5 152.9–247.3ROR 194.7 · calibrated p 8e-10 ✓ | 84.7 EB05 74.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=152 · ♀ 100% (drug 61%) | no trial arm names this drug |
| Spirometry abnormal | 323 | 189.7 161.1–223.5ROR 190.2 · calibrated p 8e-10 ✓ | 84.2 EB05 76.8 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=322 · ♀ 13% (drug 61%) | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 271 | 168.4 141.6–200.2ROR 168.7 · calibrated p 2e-9 ✓ | 79.7 EB05 72.0 · IC025 +5.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=270 | no trial arm names this drug |
| Congenital hiatus hernia | 115 | 166.9 128.0–217.6ROR 167.1 · calibrated p 3e-9 ✓ | 78.8 EB05 67.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=115 · ♀ 0% (drug 61%) · 100% clinician | no trial arm names this drug |
| Mite allergy | 299 | 136.4 116.6–159.4ROR 136.7 · calibrated p 1e-8 ✓ | 71.8 EB05 65.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=299 · ♀ 0% (drug 61%) | no trial arm names this drug |
| Total lung capacity abnormal | 152 | 102.4 83.4–125.9ROR 102.6 · calibrated p 1e-7 ✓ | 61.0 EB05 53.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=141 · ♀ 0% (drug 61%) | no trial arm names this drug |
| Dust allergy | 359 | 91.4 80.2–104.2ROR 91.6 · calibrated p 2e-7 ✓ | 57.1 EB05 52.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=357 · ♀ 17% (drug 61%) | no trial arm names this drug |
| Reversible airways obstruction | 184 | 85.7 71.5–102.7ROR 85.8 · calibrated p 4e-7 ✓ | 54.7 EB05 48.4 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=184 | no trial arm names this drug |
| Mycotic allergy | 295 | 82.9 72.0–95.6ROR 83.1 · calibrated p 5e-7 ✓ | 53.7 EB05 48.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=294 · ♀ 0% (drug 61%) | no trial arm names this drug |
| Prolonged expiration | 92 | 82.2 63.8–105.9ROR 82.2 · calibrated p 7e-7 ✓ | 53.0 EB05 44.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=92 | no trial arm names this drug |
| Bronchial wall thickening | 248 | 80.0 68.6–93.3ROR 80.1 · calibrated p 7e-7 ✓ | 52.4 EB05 47.2 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=248 · ♀ 38% (drug 61%) | no trial arm names this drug |
| Forced expiratory volume decreased | 904 | 72.0 66.5–77.9ROR 72.5 · calibrated p 1e-6 ✓ | 49.0 EB05 46.4 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=893 | no trial arm names this drug |
| Dyspnoea exacerbated | 149 | 61.5 50.8–74.3ROR 61.5 · calibrated p 4e-6 ✓ | 43.7 EB05 38.2 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | 100% clinician | no trial arm names this drug |
| Pulmonary vasculitis | 151 | 61.4 50.9–74.2ROR 61.5 · calibrated p 4e-6 ✓ | 43.7 EB05 38.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=151 · ♀ 0% (drug 61%) | no trial arm names this drug |
| Obstructive airways disorder | 2,820 | 51.9 49.8–54.2ROR 53.0 · calibrated p 9e-6 ✓ | 38.9 EB05 37.7 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | age-adj. PRR 55.5 · serious PRR 46.2 | no trial arm names this drug |
| Forced vital capacity decreased | 161 | 50.7 42.4–60.7ROR 50.8 · calibrated p 1e-5 ✓ | 38.1 EB05 33.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=160 | no trial arm names this drug |
| Vital capacity decreased | 107 | 47.8 38.5–59.4ROR 47.8 · calibrated p 2e-5 ✓ | 36.3 EB05 30.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 0% (drug 61%) | no trial arm names this drug |
| Lung hyperinflation | 195 | 44.7 38.1–52.5ROR 44.8 · calibrated p 3e-5 ✓ | 34.6 EB05 30.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=190 | no trial arm names this drug |
| Bronchopulmonary aspergillosis allergic | 205 | 44.2 37.8–51.7ROR 44.3 · calibrated p 3e-5 ✓ | 34.3 EB05 30.6 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=204 | no trial arm names this drug |
| Vocal cord dysfunction | 111 | 43.9 35.5–54.2ROR 43.9 · calibrated p 4e-5 ✓ | 34.0 EB05 29.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=107 · ♀ 100% (drug 61%) | no trial arm names this drug |
| Eosinophil count abnormal | 164 | 43.3 36.4–51.5ROR 43.3 · calibrated p 4e-5 ✓ | 33.7 EB05 29.6 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=162 | no trial arm names this drug |
| Respiratory gas exchange disorder | 80 | 42.2 33.0–54.1ROR 42.3 · calibrated p 5e-5 ✓ | 33.0 EB05 27.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=80 | no trial arm names this drug |
| Lung diffusion test decreased | 79 | 38.2 29.9–48.9ROR 38.2 · calibrated p 9e-5 ✓ | 30.5 EB05 25.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=79 | no trial arm names this drug |
| Blood immunoglobulin e increased | 480 | 37.6 34.1–41.6ROR 37.8 · calibrated p 8e-5 ✓ | 30.3 EB05 28.1 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=472 | no trial arm names this drug |
| Conjunctivitis allergic | 288 | 37.6 33.1–42.8ROR 37.7 · calibrated p 8e-5 ✓ | 30.3 EB05 27.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=285 · ♀ 0% (drug 61%) | no trial arm names this drug |
| Bronchial secretion retention | 245 | 36.9 32.1–42.4ROR 36.9 · calibrated p 9e-5 ✓ | 29.8 EB05 26.8 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=230 | no trial arm names this drug |
| Sedation complication | 473 | 35.8 32.4–39.6ROR 35.9 · calibrated p 1e-4 ✓ | 29.1 EB05 27.0 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=473 · ♀ 100% (drug 61%) | no trial arm names this drug |
| Pulmonary function test abnormal | 295 | 35.7 31.5–40.5ROR 35.8 · calibrated p 1e-4 ✓ | 29.0 EB05 26.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=271 · ♀ 39% (drug 61%) | no trial arm names this drug |
| Peak expiratory flow rate decreased | 82 | 35.0 27.5–44.5ROR 35.0 · calibrated p 1e-4 ✓ | 28.4 EB05 23.6 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=75 · ♀ 100% (drug 61%) · 100% clinician | no trial arm names this drug |
| Laryngeal stenosis | 103 | 33.3 26.9–41.2ROR 33.3 · calibrated p 2e-4 ✓ | 27.3 EB05 23.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=103 · ♀ 100% (drug 61%) · 100% consumer | no trial arm names this drug |
| Sleep disorder due to a general medical condition | 2,521 | 28.3 27.1–29.5ROR 28.8 · calibrated p 3e-4 ✓ | 24.0 EB05 23.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 29.1 · serious PRR 53.9 | no trial arm names this drug |
| Full blood count abnormal | 1,623 | 27.9 26.5–29.4ROR 28.2 · calibrated p 4e-4 ✓ | 23.7 EB05 22.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 36.2 · ♀ 38% (drug 61%) | no trial arm names this drug |
| Allergy to animal | 161 | 27.8 23.5–32.9ROR 27.8 · calibrated p 4e-4 ✓ | 23.6 EB05 20.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=158 | no trial arm names this drug |
| Restrictive pulmonary disease | 173 | 26.6 22.7–31.3ROR 26.7 · calibrated p 5e-4 ✓ | 22.8 EB05 20.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=173 | no trial arm names this drug |
| Sputum discoloured | 1,395 | 26.5 25.1–28.1ROR 26.8 · calibrated p 5e-4 ✓ | 22.7 EB05 21.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 32.4 | no trial arm names this drug |
| Eosinophilic granulomatosis with polyangiitis | 294 | 26.1 23.1–29.6ROR 26.2 · calibrated p 6e-4 ✓ | 22.4 EB05 20.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=294 · ♀ 18% (drug 61%) | no trial arm names this drug |
| Sputum purulent | 95 | 25.7 20.6–31.9ROR 25.7 · calibrated p 7e-4 ✓ | 22.0 EB05 18.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=92 | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 102 | 25.0 20.2–30.8ROR 25.0 · calibrated p 8e-4 ✓ | 21.5 EB05 18.2 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=102 · ♀ 0% (drug 61%) · 100% clinician | no trial arm names this drug |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Serious infection | 11,391 | 2.32.3–2.3 | signal |
| Heart failure | 2,240 | 1.91.9–2.0 | raised |
| Interstitial lung disease | 1,112 | 1.81.7–1.9 | raised |
| Fall / fracture | 4,228 | 1.71.7–1.8 | raised |
| Arrhythmia / qt | 2,046 | 1.61.6–1.7 | raised |
| Hyponatraemia | 813 | 1.61.5–1.7 | raised |
| Gi bleeding | 1,703 | 1.41.4–1.5 | raised |
| Myocardial infarction | 1,757 | 1.31.3–1.4 | raised |
| Kidney injury | 3,358 | 1.11.1–1.2 | raised |
| Venous thromboembolism | 1,579 | 1.11.1–1.2 | raised |
| Tendon disorder | 272 | 1.11.0–1.2 | no difference |
| Anaemia | 2,073 | 1.11.0–1.1 | raised |
| Depression | 1,900 | 1.01.0–1.1 | no difference |
| Malignancy | 2,458 | 1.01.0–1.0 | no difference |
| Opportunistic infection | 867 | 1.00.9–1.0 | no difference |
| Hyperglycaemia / diabetes | 2,199 | 1.00.9–1.0 | no difference |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Tiotropium (searched TIOTROPIUM).
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 |
|---|---|---|---|---|---|---|
| Incorrect route of drug administration | 23,320 | 282.5 276.6–288.6ROR 340.7 · calibrated p 3e-12 ✓ | 99.0 EB05 98.0 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 249.5 · serious PRR 14.9 · 78% consumer | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 22,578 | 6.4 6.3–6.4ROR 7.4 · calibrated p 0.083 | 6.1 EB05 6.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.6 · serious PRR 6.3 | no trial arm names this drug |
| Asthma | 11,021 | 16.7 16.4–17.0ROR 18.1 · calibrated p 0.003 ✓ | 15.1 EB05 14.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | age-adj. PRR 22.1 · serious PRR 22.7 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 9,475 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.384 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | age-adj. PRR 1.4 · serious PRR 1.5 | no trial arm names this drug |
| Cough | 8,744 | 4.9 4.8–5.0ROR 5.2 · calibrated p 0.213 | 4.8 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.2 · serious PRR 6.8 | no trial arm names this drug |
| Pneumonia (lung infection) | 8,508 | 4.1 4.1–4.2ROR 4.3 · calibrated p 0.319 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 3.6 · serious PRR 4.6 | no trial arm names this drug |
| Wheezing | 6,890 | 20.2 19.7–20.7ROR 21.2 · calibrated p 0.001 ✓ | 17.9 EB05 17.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | age-adj. PRR 22.0 · serious PRR 25.4 | no trial arm names this drug |
| Chronic obstructive pulmonary disease | 6,301 | 21.1 20.5–21.6ROR 22.0 · calibrated p 0.001 ✓ | 18.6 EB05 18.2 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 21.9 | no trial arm names this drug |
| Product quality issue | 5,975 | 7.1 6.9–7.3ROR 7.4 · calibrated p 0.085 | 6.8 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 11.2 · serious PRR 5.5 · 86% consumer | no trial arm names this drug |
| Fatigue (tiredness) | 5,436 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.360 | 1.1 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 1.7 | no trial arm names this drug |
| Off label use (used outside approved label) | 4,758 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.205 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 0.8 | no trial arm names this drug |
| Malaise (feeling unwell) | 4,599 | 1.6 1.6–1.7ROR 1.6 · calibrated p 0.731 | 1.6 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | age-adj. PRR 1.7 · serious PRR 2.4 | no trial arm names this drug |
| Nausea | 4,084 | 0.8 0.8–0.8ROR 0.8 · calibrated p 0.178 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Not in label — unassessed | age-adj. PRR 0.9 · serious PRR 1.2 | no trial arm names this drug |
| Fall | 3,965 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.872 | 1.8 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | age-adj. PRR 1.5 · serious PRR 2.2 | no trial arm names this drug |
| Headache | 3,923 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.283 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.5 | no trial arm names this drug |
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.
- Total lung capacity increased — n=152, PRR 194.5
- Congenital hiatus hernia — n=115, PRR 166.9
- Mite allergy — n=299, PRR 136.4
- Total lung capacity abnormal — n=152, PRR 102.4
- Dust allergy — n=359, PRR 91.4
- Mycotic allergy — n=295, PRR 82.9
- Prolonged expiration — n=92, PRR 82.2
- Pulmonary vasculitis — n=151, PRR 61.4
- Forced vital capacity decreased — n=161, PRR 50.7
- Vital capacity decreased — n=107, PRR 47.8
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 Tiotropium?
In FDA FAERS, the most frequently co-reported reaction terms for Tiotropium are dyspnoea, asthma, cough, pneumonia, wheezing, chronic obstructive pulmonary disease. 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 Tiotropium have an FDA boxed warning?
No. The FDA label retrieved for Tiotropium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tiotropium 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 496b38ee-45b6-4bb2-a35e-9023c3b73719, effective 20251111; matched on
openfda.generic_name.exact:"TIOTROPIUM BROMIDE") - PubChem CID 5487427 description (ChEBI)
- 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, 1,224 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 - ClinicalTrials.gov API v2 (query
TIOTROPIUM, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.