Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation
Fluticasone, umeclidinium, and vilanterol is a three-medicine inhaled combination used for the long-term maintenance treatment of COPD and asthma in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation: Patient Information Guide
A plain-language walkthrough of Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Fluticasone, umeclidinium, and vilanterol oral inhalation is a combination of three different medicines used together to manage chronic respiratory conditions on a long-term basis.
- Trelegy Ellipta is approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.
- Trelegy Ellipta is approved for the maintenance treatment of asthma in adults aged 18 years and older.
- Trelegy Ellipta is not approved for use in patients aged 17 years and younger.
- Trelegy Ellipta is not indicated for the relief of sudden bronchospasm (acute airway tightening) — it does not replace a rescue inhaler.
⚙️How it works▾
Trelegy Ellipta works through three complementary mechanisms. Fluticasone furoate is an inhaled corticosteroid that damps down airway inflammation — a key driver of both COPD and asthma. Umeclidinium is an anticholinergic (it blocks muscarinic receptors in the airway muscles), which causes the smooth muscle around the airways to relax and the airways to open up. Vilanterol is a long-acting beta-agonist (LABA) that stimulates beta-2 receptors in airway smooth muscle, causing further relaxation and airway widening; it also helps prevent the release of substances that cause allergic airway reactions.
Because the three medicines target different pathways, using them together provides broader and more sustained airway control than any single medicine alone.
💊How it's taken▾
Trelegy Ellipta is taken by oral inhalation once daily, at the same time every day. It should not be used more than once in any 24-hour period.
- After each inhalation, rinse your mouth with water and spit — do not swallow — to lower the risk of a mouth or throat yeast infection.
- It can be taken with or without food.
- If you miss a dose, take it as soon as you remember — but if it's almost time for your next dose, skip the missed one and resume your regular schedule. Do not double up.
- Your prescriber will choose the right strength based on your condition and previous treatment; always follow their specific guidance.
🤒Side effects — in detail▾
The most commonly reported side effects vary slightly between COPD and asthma use, but overall include:
- Upper respiratory tract infections (colds, sinusitis, pharyngitis)
- Oral thrush — a yeast infection in the mouth or throat (candidiasis)
- Pneumonia (especially in COPD patients)
- Headache
- Back pain and joint pain (arthralgia)
- Cough or hoarse voice (dysphonia)
- Urinary tract infection
- Altered sense of taste (dysgeusia)
- Constipation and diarrhea
Serious reactions to watch for and act on include sudden worsening of breathing (paradoxical bronchospasm), signs of pneumonia (fever, increased or colored sputum), eye pain or vision changes suggesting worsening glaucoma, fast or irregular heartbeat, or difficulty urinating. Contact your doctor or seek care right away if any of these occur.
⚠️Warnings & precautions▾
- LABA in asthma: Using a long-acting beta-agonist (LABA) alone in asthma raises the risk of serious asthma-related events, including death. In Trelegy Ellipta, vilanterol is always paired with an inhaled steroid; clinical trial data do not show a significant increase in serious asthma events with this fixed combination.
- Not for acute symptoms: Trelegy Ellipta must not be used to treat a sudden asthma or COPD attack. Always use a short-acting rescue inhaler for acute symptoms.
- Increased pneumonia risk: People with COPD using inhaled corticosteroids have a higher chance of developing pneumonia. Watch for fever, increased cough, or changes in sputum.
- Oral thrush: The inhaled steroid can cause a yeast infection in the mouth. Rinsing after every dose significantly reduces this risk.
- Adrenal suppression: Switching from oral steroids to Trelegy Ellipta requires a careful, gradual taper — stopping oral steroids too quickly can cause the body's stress-response system to fail.
- Bone density: Long-term use of inhaled steroids may reduce bone mineral density. Your doctor may monitor this over time.
- Eye effects: Long-term use may worsen glaucoma or cataracts. Tell your doctor about any eye symptoms.
- Urinary retention: The anticholinergic component can worsen difficulty urinating, particularly in men with prostate problems.
- Cardiovascular effects: Use with caution if you have heart disease — the LABA component can affect heart rate and rhythm.
🔀What it interacts with▾
Several medicines can interact meaningfully with Trelegy Ellipta's three components:
- Strong CYP3A4 inhibitors (e.g., ketoconazole, some HIV medicines): increase blood levels of fluticasone furoate and vilanterol, raising the risk of corticosteroid and cardiovascular side effects — use with caution.
- MAO inhibitors and tricyclic antidepressants (e.g., phenelzine, amitriptyline): amplify vilanterol's effect on the heart and blood vessels — use with extreme caution, including for 2 weeks after stopping these medicines.
- Beta-blockers (e.g., propranolol, metoprolol): can counteract vilanterol's airway-opening effect and may trigger severe bronchospasm — avoid if possible.
- Non-potassium-sparing diuretics (loop or thiazide water pills): can worsen low blood potassium or abnormal heart rhythm changes when combined with vilanterol.
- Other anticholinergic medicines: combining with Trelegy Ellipta can increase anticholinergic side effects such as urinary retention and worsening glaucoma — avoid.
- Other LABA-containing inhalers (e.g., salmeterol, formoterol, indacaterol): do not use with Trelegy Ellipta — this risks LABA overdose and serious cardiovascular effects.
- QTc-prolonging drugs: medicines that lengthen the heart's electrical cycle should be used carefully alongside vilanterol due to increased risk of dangerous heart rhythms.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use Trelegy Ellipta if you have a severe allergy to milk proteins or to any of the active ingredients (fluticasone furoate, umeclidinium, or vilanterol).
- Do not use Trelegy Ellipta as the primary treatment for a severe, life-threatening asthma or COPD episode requiring intensive care.
- Tell your doctor if you have glaucoma (especially narrow-angle glaucoma) or cataracts.
- Tell your doctor if you have an enlarged prostate or bladder problems — the anticholinergic component can make urination harder.
- Tell your doctor if you have heart disease, arrhythmia, or high blood pressure — the LABA component can affect heart rate.
- Tell your doctor if you have diabetes, seizures, or a thyroid disorder — Trelegy Ellipta should be used with caution in these conditions.
- Tell your doctor about any current infections, including tuberculosis or eye herpes — inhaled steroids can impair immune responses and make some infections worse.
- Pregnancy: There are no well-controlled studies in pregnant women. Uncontrolled asthma in pregnancy carries its own risks. Discuss the benefits and risks with your doctor.
- Breastfeeding: It is unknown whether fluticasone furoate or vilanterol pass into human breast milk; animal data suggest umeclidinium may. Weigh benefits against potential risks with your doctor.
- Children and adolescents: Trelegy Ellipta is not approved for anyone aged 17 or younger.
- Liver problems: Fluticasone furoate exposure can increase significantly in people with moderate or severe liver impairment. Your doctor should monitor you more closely in this case.
- Older adults: No dose adjustment is generally needed, but older patients may be more sensitive to side effects.
🚑If you take too much▾
Taking too much Trelegy Ellipta can cause symptoms from each of its three components: the steroid component may cause hormonal (adrenal) effects with prolonged excess use; the anticholinergic component may cause anticholinergic effects such as dry mouth, blurred vision, rapid heart rate, and urinary difficulty; and too much of the LABA vilanterol can cause fast or irregular heartbeat, shakiness, low potassium, high blood sugar, chest pain, seizures, or in severe cases, cardiac arrest. If overdose is suspected, seek medical attention immediately. The label recommends stopping the inhaler, providing supportive treatment, and cardiac monitoring — a beta-blocker may sometimes be used with caution by medical staff.
📡Pharmacodynamics — effects in the body▾
Trelegy Ellipta's three components produce complementary measurable effects on the body. The inhaled steroid (fluticasone furoate) reduces airway inflammation without significantly suppressing the body's cortisol system at recommended doses, as shown in clinical studies. The LABA (vilanterol) causes airway muscles to relax and stay open; because there are also beta-2 receptors in heart tissue, there is some potential for heart rate and rhythm effects, particularly at higher-than-recommended doses. Studies of the component combinations at recommended doses showed no clinically meaningful effects on heart rhythm in people with COPD, though dose-dependent increases in heart rate were observed in healthy subjects at supratherapeutic doses.
🔬Pharmacokinetics — how your body processes it▾
All three medicines are absorbed primarily through the lungs after inhalation, with very little absorbed from the stomach. Fluticasone furoate reaches peak blood levels within about 30–60 minutes; umeclidinium and vilanterol reach peak levels within 5–15 minutes. Fluticasone furoate and vilanterol are broken down mainly by liver enzymes (CYP3A4), while umeclidinium is metabolized mainly by a different enzyme (CYP2D6). Steady, stable blood levels are reached within about 6 days for fluticasone furoate and within about 14 days for both umeclidinium and vilanterol. All three components are highly bound to proteins in the blood and are cleared primarily through the feces.
📦How to store it▾
Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) . Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
📄 Written from Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation
195 supplements and herbal products have documented interactions with Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 11
- Moderate · 145
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation has been associated with lower levels of 8 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 1
- Moderate · 5
- Unrated · 2
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
Can I use Trelegy Ellipta when I'm having a sudden asthma attack or COPD flare? ▾
Why do I need to rinse my mouth after using this inhaler? ▾
Can I take Trelegy Ellipta with my other inhalers or medicines? ▾
I was just diagnosed with COPD. Will this inhaler cure it? ▾
I'm pregnant — is it safe for me to keep using this inhaler? ▾
What side effects are most common, and which ones should make me call my doctor? ▾
Is Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation available over the counter? ▾
When was Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation first available? ▾
💬 Answers drafted from Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation comes
Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Inhalation powder
How this form is used
- Trelegy Ellipta is used for the maintenance treatment of COPD in adults
- Trelegy Ellipta is used for the maintenance treatment of asthma in adults aged 18 and older
- Trelegy Ellipta is not intended to relieve sudden or acute breathing symptoms
- Trelegy Ellipta is inhaled through the mouth once daily at the same time each day — do not use more than once every 24 hours
- Trelegy Ellipta should be used by oral inhalation only, following the instructions provided with the Ellipta device
- After inhaling Trelegy Ellipta, rinse your mouth with water and spit it out — do not swallow — to reduce the risk of mouth yeast infection
- For sudden breathing symptoms between doses, use a short-acting rescue inhaler (such as albuterol), not an extra dose of Trelegy Ellipta
📊 Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation across the U.S. market
How Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation is used
A general measure of how commonly Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation prescribed? Of the 1,596 medications we measure, Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation ranks #204 by Medicaid prescriptions — more than 87% of them.
Utilization by Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 4 of 6 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 6 listed Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation NDCs with Medicaid activity.
🔍 Compare Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation products
A representative set of FDA-listed product records for Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Inhalation powder | ||||
| FLUTICASONE FUROATE 100 mcg/1; UMECLIDINIUM BROMIDE 62.5 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC × 2 listings | NDA | View NDC → |
| FLUTICASONE FUROATE 200 mcg/1; UMECLIDINIUM BROMIDE 62.5 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC × 2 listings | NDA | View NDC → |
| 100; 62.5; 25 mcg/1; mcg/1; mcg | Respiratory (inhalation) | GlaxoSmithKline LLC × 2 listings | NDA | View NDC → |
| 200; 62.5; 25 mcg/1; mcg/1; mcg | Respiratory (inhalation) | GlaxoSmithKline LLC × 2 listings | NDA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation belongs to the beta2-Adrenergic Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. GlaxoSmithKline LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.