What the label lists and what reports show
Revefenacin side effects
Revefenacin's FDA label: “Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.” FAERS holds 812 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 (208 reports).
- No generic listed
Check it at the source: the revefenacin FDA label on DailyMed (effective May 3, 2022, Viatris Specialty LLC); 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 YUPELRI?YUPELRI can cause serious side effects, including: • Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using YUPELRI and call your healthcare provider right away. • New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include: • red eyes • blurred vision • seeing halos or bright colors around lights • eye pain or discomfort • nausea or vomiting If you have any of these symptoms, call your healthcare provider right away before using another dose of YUPELRI. 1. Urinary retention. People who use YUPELRI may develop new or worse urinary retention. […]
Source: FDA drug label, NDA210598 (Mylan Ireland Ltd), as published by Viatris Specialty LLC, effective May 3, 2022 (SPL set 6dfebf04-7c90-436a-9b16-750d3c1ee0a6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.
Table 1: Adverse Reactions with YUPELRI ≥2% Incidence and Higher than Placebo
| Adverse Reaction | Placebo (N = 418) | YUPELRI 175 mcg (N = 395) |
|---|---|---|
| Cough | 17 (4%) | 17 (4%) |
| Nasopharyngitis | 9 (2%) | 15 (4%) |
| Upper respiratory tract infection | 9 (2%) | 11 (3%) |
| Headache | 11 (3%) | 16 (4%) |
| Back pain | 3 (1%) | 9 (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 clinically significant adverse reactions are described elsewhere in labeling: • Paradoxical bronchospasm [see Warnings and Precautions (5.2) ] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.3) ] • Worsening of urinary retention [see Warnings and Precautions (5.4) ] • Immediate hypersensitivity reactions [ see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The YUPELRI safety database included 2,285 subjects with COPD in two 12-week efficacy studies and one 52-week long-term safety study. A total of 730 subjects received treatment with YUPELRI 175 mcg once daily. The safety data described below are based on the two 12-week trials and the one 52-week trial. …
Source: FDA drug label, NDA210598 (Mylan Ireland Ltd), as published by Viatris Specialty LLC, effective May 3, 2022 (SPL set 6dfebf04-7c90-436a-9b16-750d3c1ee0a6), via openFDA; the full label on DailyMed
What do FAERS reports show?
812 reports list revefenacin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 72 are coded as a death and 175 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 20 reactions below, 5 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?
- Revefenacin: 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