What the label lists and what reports show
Olodaterol and tiotropium side effects
Olodaterol and tiotropium's FDA label: “The most common adverse reactions (>3% incidence and more than an active control) were nasopharyngitis, cough, and back pain.” FAERS holds 4,990 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 (910 reports).
- No generic listed
Check it at the source: the olodaterol and tiotropium FDA label on DailyMed (effective June 30, 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 with STIOLTO RESPIMAT?STIOLTO RESPIMAT can cause serious side effects, including: serious problems from asthma. People with asthma who take long-acting beta 2 -adrenergic agonist (LABA) medicines, such as olodaterol (one of the medicines in STIOLTO RESPIMAT), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. call your healthcare provider if breathing problems worsen over time while using STIOLTO RESPIMAT. You may need a different treatment. […]
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective June 30, 2025 (SPL set 01e15aee-40e0-23f3-537f-c96dd63e2cb1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>3% incidence and more than an active control) were nasopharyngitis, cough, and back pain.
From the label: adverse reactions, continuedLABA, such as olodaterol, one of the active components in STIOLTO RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma-related events. STIOLTO RESPIMAT is not indicated for the treatment of asthma [see Warning and Precautions (5.1) ]. The following adverse reactions are described, or described in greater detail, in other sections: Immediate hypersensitivity reactions [see Warnings and Precautions (5.4) ] Paradoxical bronchospasm [see Warnings and Precautions (5.5) ] Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.8) ] Worsening of urinary retention [see Warnings and Precautions (5.9) ] The most common adverse reactions (>3% incidence and more than an active control) were nasopharyngitis, cough, and back pain. ( 6 ) 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 in Chronic Obstructive Pulmonary Disease 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. …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective June 30, 2025 (SPL set 01e15aee-40e0-23f3-537f-c96dd63e2cb1), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,990 reports list olodaterol and tiotropium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 356 are coded as a death and 1,032 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 19 reactions below, 6 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?
- Olodaterol and 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