Umeclidinium: uses, dosing, side effects & brands
Umeclidinium is a medicine sold in the U.S. under one brand, for pulmonary emphysema and chronic bronchitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Pulmonary Emphysema and Chronic Bronchitis
- Available as
- Spray/Inhaler
- Sold as
- Incruse Ellipta
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How umeclidinium is dosed
From the FDA label for Incruse Ellipta (application NDA205382). Other umeclidinium products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dosage of Umeclidinium ELLIPTA for maintenance treatment of COPD is 1 actuation (umeclidinium 62.5 mcg) once daily by oral inhalation. • Umeclidinium ELLIPTA should be used at the same time every day. Do not use Umeclidinium ELLIPTA more than 1 time every 24 hours. • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see Clinical Pharmacology ( 12.3 )] . • For oral inhalation only. ( 2 ) • Maintenance treatment of COPD: 1 actuation of Umeclidinium ELLIPTA once daily administered by oral inhalation. ( 2 )
Umeclidinium side effects
The following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm [see Warnings and Precautions ( 5.2 )] • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.4 )] • Worsening of urinary retention [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 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, 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. In the 8 clinical trials conducted to support initial approval of Umeclidinium ELLIPTA, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg. In the 4 randomized, double-blind, placebo- or active-controlled, efficacy clinical trials, 1,185 subjects received umeclidinium for up to 24 weeks, of which 487 subjects received the recommended dose of umeclidinium…
Who shouldn’t take umeclidinium
Umeclidinium ELLIPTA is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions ( 5.3 )] • Hypersensitivity to umeclidinium or any of the excipients [see Warnings and Precautions ( 5.3 ), Description ( 11 )] • Severe hypersensitivity to milk proteins. ( 4 ) • Hypersensitivity to any ingredient. ( 4 )
Umeclidinium drug interactions
Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of Umeclidinium ELLIPTA with other anticholinergic-containing drugs. ( 7.1 ) 7.1 Anticholinergics There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of Umeclidinium ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5.4 , 5.5 )] .
Every umeclidinium product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Incruse Ellipta.
Combination products containing umeclidinium
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
How long umeclidinium keeps
No umeclidinium label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does umeclidinium expire? The in-use limits and storage rules from its labelsUmeclidinium and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for umeclidinium: levels in milk, effects in breastfed infants, and the drugs it would consider insteadAlthough no published data exist on the use of umeclidinium during breastfeeding, it produces low systemic maternal serum levels and any drug in breastmilk would not be absorbed by the infant. The risk to the breastfed infant of maternal umeclidinium inhalation is small. Breastfeeding can be continued during umeclidinium therapy. Combination products such as Anoro Ellipta are acceptable for similar reasons.
National Institute of Child Health and Human Development, record revised January 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about umeclidinium
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4,815 reports naming umeclidinium, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- asthma1,878 reports
- dyspnoea1,567 reports
- wheezing1,233 reports
- therapeutic product effect incomplete1,079 reports
- obstructive airways disorder799 reports
- loss of personal independence in daily activities792 reports
- cough780 reports
- chronic obstructive pulmonary disease625 reports
Read these as a signal, not a rate. A report does not mean umeclidinium caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
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Frequently asked questions
What is umeclidinium?
Umeclidinium ELLIPTA is an inhalation powder drug product for delivery of umeclidinium (an anticholinergic) to patients by oral inhalation.
Can you take umeclidinium with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run umeclidinium against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does umeclidinium come in?
Across the brands we track, umeclidinium is currently marketed as spray/inhaler, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic umeclidinium?
We do not currently list a generic-labelled umeclidinium product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Umeclidinium: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/umeclidinium
- MLA
- “Umeclidinium: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/umeclidinium.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for umeclidinium on DailyMed (NIH) ↗.