Drug · FAERS side-effect profile with label screen
Tiotropium Inhalation Spray side effects: what 11,124 FDA adverse event reports show
Drug class
Anticholinergic
FDA label, Indications wording of the closest related product
Label matched
Tiotropium Bromide Inhalation Spray (Spiriva Respimat)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
11,124 reports · 60% serious · 764 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SPIRIVA RESPIMAT is an anticholinergic indicated for: The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations ( 1.1 ) The long-term, once-daily, .
FDA label, Indications and Usage
What it is
The active component of SPIRIVA RESPIMAT is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically de.
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 8Reporting / coding artifact 2Lab value / disease marker 6Not in label — unassessed 23
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 985 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 |
|---|---|---|---|---|---|---|
| Amniotic fluid index increased | 15 | 9,280.9 2,687.2–32,054.3ROR 9,293.4 · χ² 21,676 / p <1e-300 | 518.6 EB05 333.6 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Genital infection viral | 11 | 1,701.5 750.9–3,855.3ROR 1,703.2 · χ² 8,886 / p <1e-300 | 348.7 EB05 207.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Heart sounds | 20 | 488.5 298.6–799.1ROR 489.3 · χ² 7,321 / p <1e-300 | 282.5 EB05 193.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Total lung capacity increased | 24 | 181.1 119.1–275.3ROR 181.5 · χ² 3,754 / p <1e-300 | 146.1 EB05 103.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Prolonged expiration | 21 | 162.4 104.0–253.6ROR 162.7 · χ² 2,951 / p <1e-300 | 131.8 EB05 90.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 63%) | no trial data cached |
| Congenital megaureter | 12 | 123.7 69.0–221.9ROR 123.9 · χ² 1,257 / p 1e-275 | 98.4 EB05 60.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 31 | 119.1 82.9–171.2ROR 119.5 · χ² 3,302 / p <1e-300 | 104.9 EB05 77.4 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=30 | no trial data cached |
| Foetal macrosomia | 15 | 109.2 64.9–183.7ROR 109.3 · χ² 1,418 / p <1e-300 | 91.5 EB05 58.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Kidney duplex | 12 | 100.3 56.1–179.3ROR 100.4 · χ² 1,027 / p 1e-225 | 83.1 EB05 50.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Left-to-right cardiac shunt | 15 | 100.2 59.6–168.3ROR 100.3 · χ² 1,305 / p 6e-286 | 85.1 EB05 54.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Respiratory gas exchange disorder | 18 | 96.0 59.8–154.1ROR 96.2 · χ² 1,520 / p <1e-300 | 83.5 EB05 55.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Dose calculation error | 25 | 83.6 56.0–124.8ROR 83.8 · χ² 1,874 / p <1e-300 | 75.6 EB05 53.8 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | 84% consumer | no trial data cached |
| Reversible airways obstruction | 15 | 56.5 33.8–94.4ROR 56.6 · χ² 740 / p 3e-163 | 51.5 EB05 33.1 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Sleep disorder due to a general medical condition | 438 | 52.4 47.7–57.5ROR 54.5 · χ² 21,435 / p <1e-300 | 50.9 EB05 47.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 93.5 | no trial data cached |
| Vital capacity decreased | 11 | 47.0 25.9–85.6ROR 47.1 · χ² 440 / p 7e-98 | 42.8 EB05 25.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Bronchial obstruction | 34 | 46.6 33.2–65.4ROR 46.7 · χ² 1,435 / p <1e-300 | 44.4 EB05 33.2 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=34 · ♀ 36% (drug 63%) | no trial data cached |
| Bronchial wall thickening | 16 | 42.4 25.9–69.6ROR 42.5 · χ² 593 / p 3e-131 | 39.7 EB05 25.9 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Motor developmental delay | 12 | 40.0 22.6–70.8ROR 40.0 · χ² 409 / p 3e-91 | 37.1 EB05 22.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Obstructive airways disorder | 226 | 38.9 34.1–44.3ROR 39.7 · χ² 8,136 / p <1e-300 | 38.0 EB05 34.0 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 37.0 | no trial data cached |
| Lung hyperinflation | 17 | 37.7 23.4–61.0ROR 37.8 · χ² 561 / p 3e-124 | 35.7 EB05 23.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Spirometry abnormal | 11 | 35.9 19.8–65.1ROR 35.9 · χ² 333 / p 1e-74 | 33.4 EB05 19.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Sputum purulent | 12 | 34.7 19.6–61.4ROR 34.7 · χ² 353 / p 4e-79 | 32.5 EB05 19.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Congenital hydronephrosis | 12 | 32.0 18.1–56.5ROR 32.0 · χ² 324 / p 1e-72 | 30.1 EB05 18.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Asthmatic crisis | 60 | 31.4 24.3–40.5ROR 31.5 · χ² 1,706 / p <1e-300 | 30.6 EB05 24.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=60 | no trial data cached |
| Blood immunoglobulin e increased | 39 | 30.6 22.3–42.0ROR 30.7 · χ² 1,070 / p 7e-235 | 29.7 EB05 22.7 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=36 · ♀ 25% (drug 63%) | no trial data cached |
| Product delivery mechanism issue | 74 | 29.1 23.1–36.5ROR 29.3 · χ² 1,947 / p <1e-300 | 28.4 EB05 23.4 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=12 · 100% consumer | no trial data cached |
| Wheezing | 840 | 27.1 25.4–28.9ROR 29.2 · χ² 20,841 / p <1e-300 | 26.7 EB05 25.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.8 | no trial data cached |
| Full blood count abnormal | 145 | 26.2 22.3–30.9ROR 26.6 · χ² 3,447 / p <1e-300 | 25.8 EB05 22.5 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 32.7 · ♀ 36% (drug 63%) | no trial data cached |
| Asthma | 1,473 | 25.0 23.9–26.3ROR 28.7 · χ² 33,715 / p <1e-300 | 24.7 EB05 23.7 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 29.3 | no trial data cached |
| Total lung capacity decreased | 21 | 25.0 16.3–38.4ROR 25.0 · χ² 454 / p 5e-101 | 24.2 EB05 16.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Infusion site discharge | 22 | 24.5 16.1–37.3ROR 24.6 · χ² 467 / p 8e-104 | 23.8 EB05 16.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 63%) · 86% consumer | no trial data cached |
| Blood count abnormal | 195 | 24.2 21.0–27.8ROR 24.6 · χ² 4,254 / p <1e-300 | 23.8 EB05 21.1 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 32.2 | no trial data cached |
| Eosinophil count increased | 102 | 23.4 19.3–28.4ROR 23.6 · χ² 2,137 / p <1e-300 | 23.0 EB05 19.5 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 25.6 · ♀ 22% (drug 63%) | no trial data cached |
| Bronchial secretion retention | 15 | 22.6 13.6–37.6ROR 22.6 · χ² 285 / p 4e-64 | 21.7 EB05 13.8 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Pneumonia streptococcal | 13 | 22.5 13.0–38.9ROR 22.6 · χ² 243 / p 4e-55 | 21.5 EB05 13.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Sputum discoloured | 110 | 22.1 18.4–26.7ROR 22.4 · χ² 2,175 / p <1e-300 | 21.8 EB05 18.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.9 | no trial data cached |
| Bronchial hyperreactivity | 14 | 22.1 13.1–37.5ROR 22.2 · χ² 259 / p 2e-58 | 21.2 EB05 13.2 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | no trial data cached |
| Bronchiectasis | 75 | 21.4 17.1–26.9ROR 21.6 · χ² 1,424 / p <1e-300 | 21.1 EB05 17.4 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=70 | no trial data cached |
| Stress urinary incontinence | 12 | 21.0 11.9–37.1ROR 21.0 · χ² 207 / p 3e-47 | 19.9 EB05 11.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Loss of personal independence in daily activities | 520 | 20.8 19.1–22.6ROR 21.8 · χ² 9,694 / p <1e-300 | 20.6 EB05 19.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 2,291 | 7.7 7.4–7.9ROR 9.4 · χ² 13,550 / p <1e-300 | 7.6 EB05 7.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Asthma | 1,473 | 25.0 23.9–26.3ROR 28.7 · χ² 33,715 / p <1e-300 | 24.7 EB05 23.7 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 29.3 | no trial data cached |
| Cough | 1,068 | 7.2 6.8–7.6ROR 7.9 · χ² 5,759 / p <1e-300 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Pneumonia (lung infection) | 883 | 5.2 4.8–5.5ROR 5.5 · χ² 2,989 / p <1e-300 | 5.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Wheezing | 840 | 27.1 25.4–28.9ROR 29.2 · χ² 20,841 / p <1e-300 | 26.7 EB05 25.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.8 | no trial data cached |
| Drug ineffective (drug did not work) | 757 | 1.1 1.0–1.2ROR 1.1 · χ² 5 / p 0.013 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Off label use (used outside approved label) | 696 | 1.5 1.4–1.6ROR 1.5 · χ² 124 / p 4e-29 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 0.9 · 84% consumer | no trial data cached |
| Therapeutic product effect incomplete | 580 | 15.6 14.4–16.8ROR 16.4 · χ² 7,847 / p <1e-300 | 15.4 EB05 14.4 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 27.5 | no trial data cached |
| Chronic obstructive pulmonary disease | 561 | 20.5 18.9–22.2ROR 21.5 · χ² 10,278 / p <1e-300 | 20.2 EB05 18.9 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 19.4 | no trial data cached |
| Loss of personal independence in daily activities | 520 | 20.8 19.1–22.6ROR 21.8 · χ² 9,694 / p <1e-300 | 20.6 EB05 19.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 | no trial data cached |
| Fatigue (tiredness) | 496 | 1.2 1.1–1.3ROR 1.2 · χ² 17 / p 2e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Headache | 450 | 1.4 1.2–1.5ROR 1.4 · χ² 42 / p 4e-11 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Sleep disorder due to a general medical condition | 438 | 52.4 47.7–57.5ROR 54.5 · χ² 21,435 / p <1e-300 | 50.9 EB05 47.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 93.5 | no trial data cached |
| Death | 413 | 0.9 0.8–1.0ROR 0.9 · χ² 4 / p 0.018 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.9 | no trial data cached |
| Malaise (feeling unwell) | 398 | 1.7 1.5–1.9ROR 1.7 · χ² 118 / p 1e-27 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.1 | 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.
- Heart sounds — n=20, PRR 488.5
- Total lung capacity increased — n=24, PRR 181.1
- Prolonged expiration — n=21, PRR 162.4
- Sleep disorder due to a general medical condition — n=438, PRR 52.4
- Asthmatic crisis — n=60, PRR 31.4
- Wheezing — n=840, PRR 27.1
- Total lung capacity decreased — n=21, PRR 25.0
- Infusion site discharge — n=22, PRR 24.5
- Sputum discoloured — n=110, PRR 22.1
- Loss of personal independence in daily activities — n=520, PRR 20.8
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 Inhalation Spray?
In FDA FAERS, the most frequently co-reported reaction terms for Tiotropium Inhalation Spray 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 Inhalation Spray have an FDA boxed warning?
No. The FDA label retrieved for Tiotropium Inhalation Spray has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tiotropium Inhalation Spray 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 7b656b14-fcaa-2741-f6f0-e0be48971c02, effective 20260817; matched on
openfda.generic_name.exact:"TIOTROPIUM BROMIDE INHALATION SPRAY") - 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, 1,025 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.