fluticasone/vilanterol
Brand names: Breo Ellipta
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.
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.
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.
How to Take It
Use Breo Ellipta exactly as your doctor tells you. For COPD, you will usually inhale 1 puff of the 100/25 mcg strength once a day. For asthma, the dose depends on your age and condition. Inhale the medicine through your mouth using the Ellipta inhaler. If you have shortness of breath between doses, use a rescue inhaler like albuterol.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Breo Ellipta will harm your unborn baby. Breo Ellipta should be used during late pregnancy only if the potential benefit justifies the potential risk.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store Breo Ellipta at room temperature, away from heat and sunlight, in a dry place and out of the reach of children.
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.
What to do: Use this combination with caution. Your healthcare provider should watch for signs of too much steroid or heart-related side effects.
( 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.
What to do: Avoid using these together unless specifically directed by your healthcare provider. Your doctor may need to adjust your treatment plan to prevent duplication.
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?
Are there any foods I should avoid while taking Breo Ellipta?
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?
Is fluticasone/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 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 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: November 7, 2024
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