What the label lists and what reports show
Olodaterol side effects
Olodaterol's FDA label: “Most common adverse reactions (incidence ≥2% and more than placebo) are nasopharyngitis, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain and arthralgia.” FAERS holds 370 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 (54 reports).
- No generic listed
Check it at the source: the olodaterol FDA label on DailyMed (effective January 3, 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 STRIVERDI RESPIMAT?STRIVERDI 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 STRIVERDI 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 STRIVERDI RESPIMAT. You may need a different treatment. Get emergency medical care if: your breathing problems worsen quickly you use your rescue inhaler medicine, but it does not relieve your breathing problems. using too much of a LABA medicine may cause: chest pain fast and irregular heartbeat tremor increased blood pressure headache nervousness COPD symptoms can get worse over time. […]
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 3, 2025 (SPL set 5d9a5433-857e-44ea-b3d6-2a400ca0cef5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥2% and more than placebo) are nasopharyngitis, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain and arthralgia.
Table 1 Number and frequency of adverse drug reactions greater than 2% (and higher than placebo) in COPD patients exposed to STRIVERDI RESPIMAT 5 mcg: Pooled data from the four 48-week, double-blind, active- and…
| Reaction | STRIVERDI 5 mcg once-daily n=876 n (%) | Placebo n=885 n (%) |
|---|---|---|
| Nasopharyngitis | 99 (11.3) | 68 (7.7) |
| Upper Respiratory Tract Infection | 72 (8.2) | 66 (7.5) |
| Bronchitis | 41 (4.7) | 32 (3.6) |
| Urinary Tract Infection | 22 (2.5) | 9 (1.0) |
| Cough | 37 (4.2) | 35 (4.0) |
| Dizziness | 20 (2.3) | 19 (2.1) |
| Rash | 19 (2.2) | 10 (1.1) |
| Diarrhea | 25 (2.9) | 22 (2.5) |
| Back Pain | 31 (3.5) | 24 (2.7) |
| Arthralgia | 18 (2.1) | 7 (0.8) |
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, continuedLong-acting beta 2 -adrenergic agonists, such as STRIVERDI RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma-related events. STRIVERDI RESPIMAT is not indicated for the treatment of asthma [see Warnings and Precautions (5.1) ]. Most common adverse reactions (incidence ≥2% and more than placebo) are nasopharyngitis, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain and arthralgia. ( 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 in Chronic Obstructive Pulmonary Disease Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The STRIVERDI RESPIMAT clinical development program included seven dose-ranging trials and eight confirmatory trials. Four of the confirmatory trials were 6-week cross-over trials and four were 48-week parallel group trials. …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 3, 2025 (SPL set 5d9a5433-857e-44ea-b3d6-2a400ca0cef5), via openFDA; the full label on DailyMed
What do FAERS reports show?
370 reports list olodaterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 95 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, 8 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.
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: 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