Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation
A three-ingredient inhaled combination (fluticasone, umeclidinium, and vilanterol) 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 three-in-one combination used for long-term maintenance of chronic lung disease in adults. It is available as Trelegy Ellipta.
- COPD (chronic obstructive pulmonary disease): Trelegy Ellipta is approved for maintenance treatment in adults with COPD.
- Asthma: Trelegy Ellipta is approved for maintenance treatment of asthma in adults aged 18 and older.
- Not for acute symptoms: Trelegy Ellipta is not approved for relieving sudden bronchospasm or for use as a rescue inhaler in either COPD or asthma.
⚙️How it works▾
Trelegy Ellipta works through three separate mechanisms at once. Fluticasone is an inhaled corticosteroid that damps down the inflammation in the airways that drives both COPD and asthma. Umeclidinium is a long-acting anticholinergic — it blocks the muscarinic M3 receptor on airway smooth muscle, which prevents the muscle from tightening and keeps the airways open. Vilanterol is a long-acting beta-2 agonist (LABA) that relaxes airway smooth muscle by stimulating receptors that cause the muscle to stay relaxed, making breathing easier.
Because each ingredient targets a different part of the problem, the three together provide broader control of symptoms than any one ingredient could on its own.
💊How it's taken▾
Trelegy Ellipta is inhaled through the mouth once daily, at the same time every day. It can be taken with or without food. After each inhalation, rinse your mouth with water and spit — do not swallow — to lower the risk of a mouth yeast infection.
- Never use Trelegy Ellipta more than once every 24 hours.
- If you miss a dose, take it as soon as you remember — unless it is almost time for your next scheduled dose. Never double up.
- Always keep a short-acting rescue inhaler (e.g., albuterol) available for sudden symptoms — Trelegy Ellipta will not work fast enough in an emergency.
🤒Side effects — in detail▾
Like any inhaled combination medicine, Trelegy Ellipta can cause side effects. The most commonly reported ones include:
- Upper respiratory tract infections (colds, sinusitis, pharyngitis)
- Oral thrush — a yeast infection in the mouth or throat (rinsing your mouth after each dose helps prevent this)
- Headache
- Bronchitis
- Back pain or joint pain
- Cough or hoarseness (dysphonia)
- Urinary tract infection
- Altered taste (dysgeusia) and constipation
More serious reactions — including pneumonia, paradoxical bronchospasm (sudden worsening of wheezing), vision changes, urinary retention, and signs of low potassium — require prompt medical attention. Contact your doctor right away if any of these occur.
⚠️Warnings & precautions▾
- Not a rescue inhaler: Trelegy Ellipta must never be used to treat a sudden asthma or COPD attack. Using it for acute symptoms delays proper emergency treatment.
- LABA risk in asthma: LABAs used alone (without an inhaled corticosteroid) have been linked to serious asthma-related events including death. In Trelegy Ellipta, vilanterol is always paired with fluticasone, and large trials have not shown a significant added risk — but do not use any other LABA-containing product at the same time.
- Pneumonia: People with COPD have a higher risk of pneumonia while using inhaled corticosteroids. Tell your doctor about any fever, increased mucus, or worsening breathlessness.
- Oral thrush: The steroid component can cause a fungal infection in the mouth. Always rinse and spit after each dose.
- Bone density and eye effects: Long-term use of inhaled corticosteroids may gradually reduce bone density and increase the risk of glaucoma and cataracts. Your doctor may monitor these periodically.
- Adrenal suppression: If you're switching from long-term oral steroids, your body may need time to adjust. Do not stop oral steroids abruptly without guidance from your doctor.
- Cardiovascular effects: The LABA and anticholinergic components can affect heart rate. Use with caution if you have heart disease.
- Urinary retention: The anticholinergic component can worsen difficulty urinating, especially in men with an enlarged prostate.
🔀What it interacts with▾
Several types of medicines can interact with the ingredients in Trelegy Ellipta:
- Strong CYP3A4 inhibitors (e.g., ketoconazole, certain HIV medicines): Can increase blood levels of fluticasone and vilanterol, raising the risk of corticosteroid and cardiovascular side effects.
- MAO inhibitors and tricyclic antidepressants (e.g., phenelzine, amitriptyline): Can powerfully amplify vilanterol's effects on the heart — avoid use within 2 weeks of stopping these medicines.
- QTc-prolonging drugs: Medicines that affect heart electrical rhythm may have additive effects with vilanterol and increase arrhythmia risk.
- Beta-blockers (e.g., atenolol, propranolol): Can block vilanterol's bronchodilating effect and provoke severe bronchospasm in people with COPD or asthma.
- Non-potassium-sparing diuretics (loop or thiazide water pills): Combined with vilanterol, these can worsen low potassium levels and heart rhythm changes.
- Other anticholinergic medicines: Adding more anticholinergics can increase side effects such as dry mouth, constipation, blurred vision, urinary retention, and worsened glaucoma.
- Other LABA-containing inhalers (e.g., salmeterol, formoterol, indacaterol): Do not use alongside Trelegy Ellipta — overdose of the LABA component is a real risk.
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▾
- Allergy: Do not use Trelegy Ellipta if you have a severe allergy to milk proteins or to fluticasone furoate, umeclidinium, vilanterol, or any other ingredient.
- Acute illness: Do not start Trelegy Ellipta during a severe asthma attack or acute COPD episode requiring emergency care.
- Heart disease: Tell your doctor if you have any heart rhythm problems, high blood pressure, or other cardiovascular conditions.
- Eye problems: Tell your doctor if you have glaucoma or cataracts — long-term inhaled corticosteroid use can worsen these.
- Enlarged prostate or bladder problems: The anticholinergic component can worsen urinary retention.
- Diabetes, seizures, or thyroid disease: Use with caution; tell your prescriber about these conditions.
- Liver impairment: Moderate or severe liver disease can increase fluticasone exposure — your doctor should monitor for steroid-related side effects.
- Pregnancy: There are no well-controlled human studies. Poorly controlled asthma during pregnancy carries serious risks to mother and baby; discuss the balance of risks with your doctor.
- Breastfeeding: It is unknown whether the ingredients pass into human breast milk. Discuss the risks and benefits with your doctor.
- Children and teenagers: Trelegy Ellipta is not approved for anyone aged 17 or younger.
- Older adults: No dose adjustment is generally needed, but older individuals may be more sensitive to side effects.
🚑If you take too much▾
Taking too much Trelegy Ellipta can cause signs of excessive stimulation from the LABA component — such as fast heart rate, shakiness, chest pain, low potassium, high blood sugar, or in severe cases, seizures or dangerous heart rhythms. Too much of the anticholinergic (umeclidinium) can cause anticholinergic effects like dry mouth, blurred vision, and difficulty urinating. If you think you or someone else has used too much, seek medical attention right away and bring the inhaler with you. Cardiac monitoring is recommended in overdose situations.
📡Pharmacodynamics — effects in the body▾
Trelegy Ellipta's three ingredients work at different points in the airway. Fluticasone reduces airway inflammation — at therapeutic doses it does not meaningfully suppress the body's normal cortisol production. Umeclidinium relaxes airway muscle by blocking muscarinic receptors, with effects lasting more than 24 hours. Vilanterol further relaxes airway muscle and, like other medicines in its class, can modestly increase heart rate at higher-than-recommended doses — though no clinically meaningful heart rhythm changes were seen in COPD studies at recommended doses.
🔬Pharmacokinetics — how your body processes it▾
All three ingredients are absorbed mainly through the lungs after inhalation, with very little absorbed through the gut. Fluticasone reaches peak blood levels within 30–60 minutes and is broken down primarily by the liver enzyme CYP3A4. Umeclidinium and vilanterol both peak in blood within 5–15 minutes and are also processed by liver enzymes (CYP2D6 for umeclidinium and CYP3A4 for vilanterol). Steady, stable blood levels are reached within about 6 days for fluticasone and within about 14 days for umeclidinium and vilanterol. People with moderate to severe liver disease may have significantly higher fluticasone exposure, which is why extra monitoring is recommended in those patients.
📦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 if I'm having trouble breathing right now? ▾
Why do I need to rinse my mouth after every dose? ▾
I take Trelegy Ellipta for asthma — are there any special concerns I should know about? ▾
What medicines should I tell my doctor about before using this inhaler? ▾
I have an enlarged prostate — is this inhaler safe for me? ▾
I'm pregnant — can I keep using Trelegy Ellipta? ▾
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 for relief of sudden breathing episodes (acute bronchospasm)
- Trelegy Ellipta is inhaled through the mouth once daily at the same time each day — do not use more than once every 24 hours
- After inhaling Trelegy Ellipta, rinse your mouth with water and spit it out (do not swallow) to reduce the risk of oral yeast infection
- If shortness of breath occurs between doses, use a short-acting rescue inhaler (e.g., albuterol) — do not take an extra dose of Trelegy Ellipta
- Keep Trelegy Ellipta dry and store it in its tray until ready to use
📊 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 1,594 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.