Drug · FAERS side-effect profile with label screen
Tiotropium and Olodaterol side effects: what 4,975 FDA adverse event reports show
Drug class
Combination of tiotropium bromide and olodaterol
FDA label, Indications wording of the closest related product
Label matched
Tiotropium Bromide And Olodaterol (Stiolto 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
4,975 reports · 38% serious · 356 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD.
FDA label, Indications and Usage
What it is
STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA). The drug substance tiotropium bromide monohydrate is chemi.
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 3Labeled (related wording) 8Likely indication confounding 3Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 21
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. 154 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 |
|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | 201 | 16.3 14.2–18.6ROR 16.9 · χ² 2,859 / p <1e-300 | 16.2 EB05 14.4 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 21.3 | no trial data cached |
| Emphysema | 26 | 10.8 7.4–15.9ROR 10.9 · χ² 221 / p 2e-50 | 10.1 EB05 6.9 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.1 · 77% consumer | no trial data cached |
| Productive cough (cough with phlegm) | 99 | 8.8 7.2–10.7ROR 9.0 · χ² 677 / p 1e-149 | 8.6 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 79% consumer | no trial data cached |
| Respiratory tract congestion | 32 | 8.5 6.0–12.0ROR 8.5 · χ² 203 / p 2e-46 | 7.8 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.9 · 78% consumer | no trial data cached |
| Acute respiratory failure | 37 | 8.1 5.9–11.2ROR 8.2 · χ² 224 / p 6e-51 | 7.6 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Dyspnoea exertional | 72 | 8.1 6.4–10.2ROR 8.2 · χ² 439 / p 8e-98 | 7.8 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 88% consumer | no trial data cached |
| Candida infection (yeast infection) | 30 | 7.6 5.3–10.8ROR 7.6 · χ² 164 / p 6e-38 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 87% consumer | no trial data cached |
| Dry throat | 18 | 7.5 4.7–11.8ROR 7.5 · χ² 94 / p 1e-22 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Choking | 34 | 7.4 5.3–10.3ROR 7.4 · χ² 181 / p 2e-41 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 · 100% consumer | no trial data cached |
| Oral discomfort | 23 | 7.0 4.6–10.5ROR 7.0 · χ² 111 / p 3e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=4 · 91% consumer | no trial data cached |
| Oxygen saturation decreased | 91 | 6.9 5.6–8.4ROR 7.0 · χ² 450 / p 3e-100 | 6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 · 77% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 910 | 6.8 6.4–7.2ROR 8.1 · χ² 4,586 / p <1e-300 | 6.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 82% consumer | no trial data cached |
| Pulmonary congestion | 21 | 6.7 4.4–10.2ROR 6.7 · χ² 96 / p 7e-23 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.9 · 71% consumer | no trial data cached |
| Seasonal allergy | 22 | 6.6 4.3–10.0ROR 6.6 · χ² 98 / p 2e-23 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=8 · 86% consumer | no trial data cached |
| Dysphonia | 88 | 6.3 5.2–7.8ROR 6.4 · χ² 391 / p 3e-87 | 6.1 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 86% consumer | no trial data cached |
| Aphonia | 21 | 6.3 4.1–9.7ROR 6.4 · χ² 89 / p 2e-21 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 95% consumer | no trial data cached |
| Throat irritation | 65 | 6.1 4.8–7.8ROR 6.2 · χ² 273 / p 1e-61 | 5.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 83% consumer | no trial data cached |
| Cough | 405 | 6.1 5.5–6.7ROR 6.5 · χ² 1,739 / p <1e-300 | 6.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 82% consumer | no trial data cached |
| Hospice care | 14 | 6.0 3.5–10.1ROR 6.0 · χ² 53 / p 2e-13 | 5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Laryngitis | 15 | 5.8 3.5–9.6ROR 5.8 · χ² 55 / p 6e-14 | 5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=4 | no trial data cached |
| Secretion discharge | 17 | 5.8 3.6–9.3ROR 5.8 · χ² 63 / p 1e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Pulmonary mass | 20 | 5.7 3.7–8.8ROR 5.7 · χ² 72 / p 1e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Device delivery system issue | 35 | 5.6 4.0–7.8ROR 5.7 · χ² 129 / p 4e-30 | 5.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=3 · 97% consumer | no trial data cached |
| Extra dose administered | 51 | 5.4 4.1–7.1ROR 5.4 · χ² 177 / p 9e-41 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious n=10 · 90% consumer | no trial data cached |
| Product quality issue | 170 | 5.3 4.6–6.1ROR 5.5 · χ² 593 / p 3e-131 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 88% consumer | no trial data cached |
| Lung neoplasm malignant | 50 | 5.1 3.9–6.7ROR 5.1 · χ² 160 / p 5e-37 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 84% consumer | no trial data cached |
| Retching | 25 | 4.9 3.3–7.3ROR 5.0 · χ² 75 / p 3e-18 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 · 100% consumer | no trial data cached |
| Macular degeneration | 14 | 4.9 2.9–8.3ROR 5.0 · χ² 40 / p 1e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Wheezing | 68 | 4.8 3.8–6.1ROR 4.9 · χ² 203 / p 2e-46 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 78% consumer | no trial data cached |
| Heart rate irregular | 26 | 4.8 3.3–7.1ROR 4.8 · χ² 75 / p 3e-18 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 81% consumer | no trial data cached |
| Pneumothorax | 17 | 4.5 2.8–7.3ROR 4.5 · χ² 43 / p 3e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Infusion site pain | 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 | Labeled (related wording) related wording | serious n=6 | no trial data cached |
| Product packaging quantity issue | 11 | 4.2 2.3–7.6ROR 4.2 · χ² 24 / p 5e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Respiratory tract infection | 26 | 4.2 2.9–6.2ROR 4.2 · χ² 60 / p 4e-15 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.2 | no trial data cached |
| Device malfunction | 66 | 4.1 3.2–5.2ROR 4.2 · χ² 154 / p 1e-35 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 92% consumer | no trial data cached |
| Oropharyngeal pain (sore throat) | 90 | 4.1 3.3–5.0ROR 4.1 · χ² 208 / p 2e-47 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · 81% consumer | no trial data cached |
| Bronchitis | 70 | 4.0 3.1–5.0ROR 4.0 · χ² 152 / p 3e-35 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.5 | no trial data cached |
| Rhinorrhoea (runny nose) | 60 | 3.9 3.0–5.0ROR 4.0 · χ² 128 / p 7e-30 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 83% consumer | no trial data cached |
| Sinus disorder | 18 | 3.8 2.4–6.1ROR 3.8 · χ² 35 / p 2e-9 | 3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Musculoskeletal chest pain | 14 | 3.8 2.3–6.4ROR 3.8 · χ² 26 / p 2e-7 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | 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) | 910 | 6.8 6.4–7.2ROR 8.1 · χ² 4,586 / p <1e-300 | 6.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 82% consumer | no trial data cached |
| Cough | 405 | 6.1 5.5–6.7ROR 6.5 · χ² 1,739 / p <1e-300 | 6.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 82% consumer | no trial data cached |
| Pneumonia (lung infection) | 208 | 2.7 2.4–3.1ROR 2.8 · χ² 225 / p 3e-51 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Chronic obstructive pulmonary disease | 201 | 16.3 14.2–18.6ROR 16.9 · χ² 2,859 / p <1e-300 | 16.2 EB05 14.4 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 21.3 | no trial data cached |
| Product quality issue | 170 | 5.3 4.6–6.1ROR 5.5 · χ² 593 / p 3e-131 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 88% consumer | no trial data cached |
| Product dose omission issue | 123 | 1.8 1.5–2.2ROR 1.8 · χ² 45 / p 1e-11 | 1.8 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 5.5 · 80% consumer | no trial data cached |
| Back pain | 118 | 2.1 1.8–2.6ROR 2.2 · χ² 71 / p 2e-17 | 2.1 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 · 79% consumer | no trial data cached |
| Productive cough (cough with phlegm) | 99 | 8.8 7.2–10.7ROR 9.0 · χ² 677 / p 1e-149 | 8.6 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 79% consumer | no trial data cached |
| Oxygen saturation decreased | 91 | 6.9 5.6–8.4ROR 7.0 · χ² 450 / p 3e-100 | 6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 · 77% consumer | no trial data cached |
| Oropharyngeal pain (sore throat) | 90 | 4.1 3.3–5.0ROR 4.1 · χ² 208 / p 2e-47 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · 81% consumer | no trial data cached |
| Covid-19 | 88 | 2.1 1.7–2.6ROR 2.1 · χ² 49 / p 1e-12 | 2.1 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 3.6 · 80% consumer | no trial data cached |
| Dysphonia | 88 | 6.3 5.2–7.8ROR 6.4 · χ² 391 / p 3e-87 | 6.1 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 86% consumer | no trial data cached |
| Chest discomfort | 86 | 3.5 2.9–4.4ROR 3.6 · χ² 155 / p 6e-36 | 3.5 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 79% consumer | no trial data cached |
| Peripheral swelling | 79 | 2.2 1.7–2.7ROR 2.2 · χ² 49 / p 2e-12 | 2.1 EB05 1.8 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.9 · 72% consumer | no trial data cached |
| Muscle spasms | 77 | 1.8 1.4–2.2ROR 1.8 · χ² 25 / p 3e-7 | 1.8 EB05 1.5 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.6 | 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.
- Productive cough — n=99, PRR 8.8
- Acute respiratory failure — n=37, PRR 8.1
- Dyspnoea exertional — n=72, PRR 8.1
- Candida infection — n=30, PRR 7.6
- Choking — n=34, PRR 7.4
- Oral discomfort — n=23, PRR 7.0
- Dyspnoea — n=910, PRR 6.8
- Seasonal allergy — n=22, PRR 6.6
- Aphonia — n=21, PRR 6.3
- Throat irritation — n=65, PRR 6.1
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 and Olodaterol?
In FDA FAERS, the most frequently co-reported reaction terms for Tiotropium and Olodaterol are dyspnoea, cough, pneumonia, chronic obstructive pulmonary disease, back pain, productive cough. 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 and Olodaterol have an FDA boxed warning?
No. The FDA label retrieved for Tiotropium and Olodaterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tiotropium and Olodaterol 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 01e15aee-40e0-23f3-537f-c96dd63e2cb1, effective 20250630; matched on
openfda.generic_name.exact:"TIOTROPIUM BROMIDE AND OLODATEROL") - 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, 194 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.