What the label lists and what reports show
Tiotropium side effects
Tiotropium's FDA label: “The most common adverse reactions (>5% incidence in the 1-year placebo-controlled trials) were upper respiratory tract infection, dry mouth, sinusitis, pharyngitis, non-specific chest pain, urinary tract infection, dyspepsia, and rhinitis ( 6.1 ) To report …” FAERS holds 146,625 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (24,617 reports).
- Generic listed
Check it at the source: the tiotropium FDA label on DailyMed (effective November 10, 2025, Boehringer Ingelheim Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SPIRIVA HANDIHALER?SPIRIVA HANDIHALER can cause serious side effects, including: Allergic reaction. Symptoms may include: raised red patches on your skin (hives) itching rash swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing If you have these symptoms of an allergic reaction, stop taking SPIRIVA HANDIHALER and call your doctor right away or go to the nearest hospital emergency room. Sudden narrowing and blockage of the airways into the lungs (bronchospasm). Your breathing suddenly gets worse. If you have these symptoms of bronchospasm, stop taking SPIRIVA HANDIHALER and call your doctor right away or go to the nearest hospital emergency room. New or worsened increased pressure in the eyes (acute narrow-angle glaucoma). […]
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective November 10, 2025 (SPL set 820839ef-e53d-47e8-a3b9-d911ff92e6a9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>5% incidence in the 1-year placebo-controlled trials) were upper respiratory tract infection, dry mouth, sinusitis, pharyngitis, non-specific chest pain, urinary tract infection, dyspepsia, and rhinitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.
Table 1 Adverse Reactions (% Patients) in One-Year COPD Clinical Trials
| Reaction | SPIRIVA (n = 550) | Placebo (n = 371) | SPIRIVA (n = 356) | Ipratropium (n = 179) |
|---|---|---|---|---|
| Chest Pain (non-specific) | 7 | 5 | 5 | 2 |
| Edema, Dependent | 5 | 4 | 3 | 5 |
| Dry Mouth | 16 | 3 | 12 | 6 |
| Dyspepsia | 6 | 5 | 1 | 1 |
| Abdominal Pain | 5 | 3 | 6 | 6 |
| Constipation | 4 | 2 | 1 | 1 |
| Vomiting | 4 | 2 | 1 | 2 |
| Myalgia | 4 | 3 | 4 | 3 |
| Infection | 4 | 3 | 1 | 3 |
| Moniliasis | 4 | 2 | 3 | 2 |
| Upper Respiratory Tract Infection | 41 | 37 | 43 | 35 |
| Sinusitis | 11 | 9 | 3 | 2 |
| Pharyngitis | 9 | 7 | 7 | 3 |
| Rhinitis | 6 | 5 | 3 | 2 |
| Epistaxis | 4 | 2 | 1 | 1 |
| Rash | 4 | 2 | 2 | 2 |
| Urinary Tract Infection | 7 | 5 | 4 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described, or described in greater detail, in other sections: Immediate hypersensitivity reactions [see Warnings and Precautions (5.2) ] Paradoxical bronchospasm [see Warnings and Precautions (5.3) ] Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.4) ] Worsening of urinary retention [see Warnings and Precautions (5.5) ] The most common adverse reactions (>5% incidence in the 1-year placebo-controlled trials) were upper respiratory tract infection, dry mouth, sinusitis, pharyngitis, non-specific chest pain, urinary tract infection, dyspepsia, and rhinitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidences in the clinical trials of another drug and may not reflect the incidences observed in practice. 6-Month to 1-Year Trials The data described below reflect exposure to SPIRIVA HANDIHALER in 2,663 patients. SPIRIVA HANDIHALER was studied in two 1-year placebo-controlled trials, two 1-year active-controlled trials, and two 6-month placebo-controlled trials in patients with COPD. …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective November 10, 2025 (SPL set 820839ef-e53d-47e8-a3b9-d911ff92e6a9), via openFDA; the full label on DailyMed
What do FAERS reports show?
146,625 reports list tiotropium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10,513 are coded as a death and 42,641 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tiotropium: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions