umeclidinium/vilanterol
Brand names: Anoro Ellipta
Anoro Ellipta is a combination medicine used long-term to help people with COPD breathe better. It contains two medicines that open airways.
Drug Pricing (NADAC)
Brand Price
$7.59/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Anoro Ellipta is used to treat chronic obstructive pulmonary disease (COPD).
Common side effects
Sore throat, Sinus infection, Lower respiratory infection
Key warnings
LABA medicines like vilanterol, when used alone for asthma, can increase the risk of serious asthma problems, including death.
How It Works
Anoro Ellipta contains two medicines, umeclidinium and vilanterol. Umeclidinium is an anticholinergic that relaxes the muscles around your airways. Vilanterol is a LABA that also relaxes airway muscles. Together, they help to keep your airways open.
How to Take It
Take 1 puff of Anoro Ellipta once a day using the inhaler. Use it at the same time every day. Do not use it more than once in 24 hours. It is for inhalation into your lungs only.
Pregnancy & Breastfeeding
There is not enough information about using Anoro Ellipta during pregnancy to know if it is safe. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Anoro Ellipta passes into breast milk.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not take two doses at once.
Storage
Store Anoro Ellipta at room temperature, away from heat, sunlight, and moisture, and out of the reach of children.
Side Effects (from patient reports)
Based on 5,851 FDA adverse event reports.
Serious Warnings
LABA medicines like vilanterol, when used alone for asthma, can increase the risk of serious asthma problems, including death. Anoro Ellipta is not for asthma. Do not use Anoro Ellipta if you are allergic to milk proteins or any of the ingredients in Anoro Ellipta.
Known Drug Interactions
7 DRUG INTERACTIONS • Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to vilanterol. Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.4 ), Clinical Pharmacology ( 12.3 )] .
Mechanism: Ketoconazole prevents the body from clearing the vilanterol part of this medicine, which increases the amount of drug in your body.
What to do: Use this combination with caution and monitor for increased side effects.
Avoid administration of ANORO ELLIPTA with other anticholinergic-containing drugs. Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.4 ), Clinical Pharmacology ( 12.3 )] . Therefore, avoid coadministration of ANORO ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5.9 , 5.10 )] .
Mechanism: Taking these two drugs together causes an additive effect because they both work the same way, which can lead to more side effects.
What to do: Avoid using these medications at the same time.
Common Questions
Can I use Anoro Ellipta for asthma?
How often should I use Anoro Ellipta?
What should I do if I don't feel better after using Anoro Ellipta?
Can I use a spacer with Anoro Ellipta?
What do I do if I use too much Anoro Ellipta?
Can I stop taking Anoro Ellipta if I feel better?
Does Anoro Ellipta have any side effects?
How long does Anoro Ellipta take to work?
Can I use Anoro Ellipta with other inhalers?
How long is Anoro Ellipta good for after I open the foil tray?
What are the common side effects of umeclidinium/vilanterol?
Does umeclidinium/vilanterol interact with other medications?
What drug class is umeclidinium/vilanterol?
Is umeclidinium/vilanterol safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
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Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for umeclidinium/vilanterol
The FDA label for umeclidinium/vilanterol (sold under brand names such as Anoro Ellipta) classifies it as a prescription-only medication in the LAMA / LABA Combination class. Anoro Ellipta is used to treat chronic obstructive pulmonary disease (COPD). Official labeling lists 9 commonly reported side effects, including Sore throat, Sinus infection, Lower respiratory infection.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 5,851 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: June 2, 2023
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages