Prescription medication · Corticosteroid / Long-Acting Beta-2 Agonist Combination
fluticasone/vilanterol
Also sold as Breo Ellipta. Breo Ellipta is used to treat COPD in adults.
Data updated 2026-05-15
- 2
- InteractionsFew interactions
- $5.36
- Brand price (NADAC)
fluticasone/vilanterol (Breo Ellipta) is a prescription Corticosteroid / Long-Acting Beta-2 Agonist Combination. Breo Ellipta is used to treat COPD in adults.
Breo Ellipta is a medicine that contains a corticosteroid and a long-acting beta-agonist. It is used to help control symptoms of COPD and asthma.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$5.36/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Breo Ellipta is used to treat COPD in adults.
Common side effects
Sore throat, Upper respiratory infection, Headache
Key warnings
LABA medicines such as vilanterol, when used alone, increase the risk of asthma-related death.
The sections below are summarized in plain English from fluticasone/vilanterol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Breo Ellipta contains two medicines. Fluticasone furoate reduces inflammation in the lungs. Vilanterol helps to relax the muscles around your airways, making it easier to breathe.
Serious Warnings
LABA medicines such as vilanterol, when used alone, increase the risk of asthma-related death. Breo Ellipta should not be used to treat sudden breathing problems. Do not use Breo Ellipta with other medicines that contain a LABA.
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 fluticasone furoate and vilanterol. Caution should be exercised when considering the coadministration of BREO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.9 ), Clinical Pharmacology ( 12.3 )] .
Mechanism: Ketoconazole interferes with how your body processes the inhaler, which can result in higher-than-normal levels of the medicine in your body.
( 7.4 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate and vilanterol are both substrates of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol.
Mechanism: These two medications contain the same active steroid. Using them at the same time can cause the drug levels to build up too high in your system.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What should I do if Breo Ellipta doesn't seem to be working?
Can I use Breo Ellipta as a rescue inhaler?
How long does it take for Breo Ellipta to start working?
Can Breo Ellipta cause thrush?
Does Breo Ellipta contain steroids?
Can I stop taking Breo Ellipta if I feel better?
Can Breo Ellipta affect my heart?
Can children use Breo Ellipta?
How often should I clean my Breo Ellipta inhaler?
What are the common side effects of fluticasone/vilanterol?
Does fluticasone/vilanterol interact with other medications?
What drug class is fluticasone/vilanterol?
What pregnancy or breastfeeding source fields are listed for fluticasone/vilanterol?
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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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for fluticasone/vilanterol
The FDA label for fluticasone/vilanterol (sold under brand names such as Breo Ellipta) classifies it as a prescription-only medication in the Corticosteroid / Long-Acting Beta-2 Agonist Combination class. Breo Ellipta is used to treat COPD in adults. Official labeling lists 15 commonly reported side effects, including Sore throat, Upper respiratory infection, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: November 7, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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