fluticasone/umeclidinium/vilanterol
Brand names: Trelegy Ellipta
Trelegy Ellipta is a medicine that contains three drugs in one inhaler. It helps people with COPD and asthma breathe easier.
Drug Pricing (NADAC)
Brand Price
$10.50/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Trelegy Ellipta is used to help people with chronic obstructive pulmonary disease (COPD) breathe better.
Common side effects
Upper respiratory infection, Pneumonia, Bronchitis
Key warnings
LABA medicines like vilanterol can raise the risk of asthma-related problems.
How It Works
Trelegy Ellipta contains three medicines that work in different ways. Fluticasone reduces swelling in the lungs. Umeclidinium and vilanterol relax the muscles around your airways, making it easier to breathe.
How to Take It
Use one puff of Trelegy Ellipta every day, using the inhaler. Use it at the same time each day. After you inhale, rinse your mouth with water and spit it out. Do not use Trelegy Ellipta more than once in 24 hours.
Pregnancy & Breastfeeding
Not enough information exists to determine if Trelegy Ellipta is safe during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine 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 Trelegy Ellipta at room temperature, away from heat, sunlight, and moisture.
Serious Warnings
LABA medicines like vilanterol can raise the risk of asthma-related problems. Do not use Trelegy Ellipta for sudden, severe COPD or asthma symptoms. Rinse your mouth after use to prevent thrush. Trelegy Ellipta may increase your risk of pneumonia. It can also weaken your immune system and raise your risk of infections. It may cause problems with your heart, blood pressure, blood sugar, or bones. Long-term use may lead to glaucoma or cataracts. Tell your doctor if your glaucoma or urinary retention gets worse.
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 TRELEGY ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.9 ), Clinical Pharmacology ( 12.3 )] .
Mechanism: Ketoconazole blocks the enzyme that clears the inhaler's ingredients from your system, causing the drug levels to rise.
What to do: Use this combination with caution. Your doctor should monitor you for increased side effects while taking both medications.
( 7.5 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate and vilanterol are substrates of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol.
Mechanism: Both of these medications contain the same steroid ingredient. Taking them together increases the total amount of medicine in your body, which can lead to more side effects.
What to do: Your doctor should review your medications to ensure you are not taking duplicate ingredients. Monitor for signs of excessive steroid exposure.
Common Questions
What should I do if I have trouble breathing between doses?
Can I use Trelegy Ellipta for a sudden asthma attack?
Will Trelegy Ellipta cure my COPD or asthma?
Can I stop taking my other asthma medicines when I start Trelegy Ellipta?
Does Trelegy Ellipta contain steroids?
Can I use a spacer with Trelegy Ellipta?
What if I get a white coating in my mouth?
Can I use Trelegy Ellipta if I am allergic to milk?
How long after opening the foil tray is Trelegy Ellipta good for?
What should I do if I accidentally take two doses in one day?
What are the common side effects of fluticasone/umeclidinium/vilanterol?
Does fluticasone/umeclidinium/vilanterol interact with other medications?
What drug class is fluticasone/umeclidinium/vilanterol?
Is fluticasone/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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for fluticasone/umeclidinium/vilanterol
The FDA label for fluticasone/umeclidinium/vilanterol (sold under brand names such as Trelegy Ellipta) classifies it as a prescription-only medication in the Triple Therapy (ICS/LAMA/LABA) class. Trelegy Ellipta is used to help people with chronic obstructive pulmonary disease (COPD) breathe better. Official labeling lists 19 commonly reported side effects, including Upper respiratory infection, Pneumonia, Bronchitis.
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: 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