Fluticasone and Vilanterol Oral Inhalation
Fluticasone and vilanterol oral inhalation is a combination inhaled corticosteroid and long-acting bronchodilator used for the maintenance treatment of COPD and asthma.
🧬 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 2 clinical label sets 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 and Vilanterol Oral Inhalation: Patient Information Guide
A plain-language walkthrough of Fluticasone 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 and vilanterol oral inhalation is a combination maintenance inhaler approved for two respiratory conditions.
- Chronic obstructive pulmonary disease (COPD): Approved for maintenance treatment in adults. Breo Ellipta and Fluticasone Furoate and Vilanterol inhalation powder are both indicated for this use.
- Asthma: Approved for maintenance treatment in patients aged 5 years and older. Breo Ellipta and Fluticasone Furoate and Vilanterol inhalation powder are indicated for this use, with age-appropriate dosing depending on the patient's age group.
- Not a rescue inhaler: This medicine is not approved for relief of sudden breathing attacks (acute bronchospasm) or for use during an acute COPD or asthma episode requiring emergency care.
⚙️How it works▾
This inhaler delivers two medicines that work together through different pathways. Fluticasone furoate is an inhaled corticosteroid (ICS) — it binds to receptors inside airway cells and reduces inflammation by suppressing the release of substances that cause swelling, irritation, and mucus. Vilanterol is a long-acting beta-2 agonist (LABA) — it binds to receptors on the muscle wrapped around the airways, causing that muscle to relax, which opens the airways and makes breathing easier. By tackling both the inflammation and the airway narrowing, the combination addresses two of the main drivers of COPD and asthma symptoms.
💊How it's taken▾
This medicine is taken by inhalation through the mouth once daily, using the dry-powder Ellipta inhaler device. It should be used at the same time every day and no more than once every 24 hours — taking it more often does not improve control and raises the risk of side effects. It can be taken with or without food. After each use, rinse your mouth with water and spit it out (without swallowing) to lower the risk of a mouth yeast infection. The exact strength prescribed will depend on your age, condition, and how well your symptoms are controlled — your prescriber will determine the right strength for you. If you miss a dose, take it as soon as you remember unless it is almost time for your next dose; never double up.
🤒Side effects — in detail▾
The most commonly reported side effects include:
- Nasopharyngitis (runny or stuffy nose, sore throat)
- Headache
- Oral candidiasis (yeast infection in the mouth or throat)
- Upper respiratory tract infection
- Bronchitis and sinusitis
- Cough
- Oropharyngeal pain (throat discomfort)
- Dysphonia (hoarse or changed voice)
- Back pain and joint pain (arthralgia)
- Pneumonia (notably in COPD patients)
More serious reactions — including paradoxical bronchospasm (sudden worsening of breathing right after a dose), severe allergic reactions, significant heart rhythm changes, signs of adrenal suppression, or worsening eye symptoms — require prompt medical attention.
⚠️Warnings & precautions▾
- LABA and asthma risk: Long-acting beta-2 agonists used alone for asthma are linked to a higher risk of serious asthma-related events, including death. This inhaler combines a LABA with an ICS, which is the appropriate use — but never add another LABA-containing product to this regimen.
- Not for acute symptoms: Do not use this inhaler to treat sudden breathing attacks. Always have a short-acting rescue inhaler (such as albuterol) available for emergencies.
- Pneumonia risk in COPD: An increased rate of pneumonia, including cases requiring hospitalization and some fatal cases, has been observed in COPD patients using this inhaler. Watch for new cough, fever, or increased mucus.
- Adrenal suppression: Long-term or high-dose use of inhaled corticosteroids can reduce the body's ability to produce its own cortisol. Patients switching from oral steroids to this inhaler need careful, slow tapering under medical supervision.
- Mouth yeast infection (oropharyngeal candidiasis): Always rinse your mouth with water after use and spit it out. Tell your doctor if you notice white patches or soreness in your mouth.
- Bone density, eye health, and growth: Long-term use of inhaled corticosteroids may reduce bone mineral density, contribute to cataracts or glaucoma, and slow growth in children. Regular monitoring is recommended.
- Cardiovascular caution: The vilanterol component can affect heart rate and rhythm. Use with caution in patients with existing heart conditions.
🔀What it interacts with▾
Several medicines and drug classes can interact meaningfully with fluticasone and vilanterol:
- Strong CYP3A4 inhibitors (e.g., ketoconazole): Increase blood levels of both fluticasone and vilanterol, raising the risk of corticosteroid and cardiovascular side effects — use with caution.
- MAO inhibitors and tricyclic antidepressants: Can intensify vilanterol's effects on the cardiovascular system — use with extreme caution and avoid within 2 weeks of stopping these medicines.
- QTc-prolonging drugs: Increase the risk of dangerous heart rhythm abnormalities (ventricular arrhythmias) when combined with vilanterol.
- Beta-blockers: Can block the airway-opening effect of vilanterol and may trigger severe bronchospasm in COPD or asthma patients.
- Non-potassium-sparing diuretics (loop and thiazide water pills): Can worsen low potassium levels and heart rhythm changes when used alongside beta-agonists like vilanterol.
- Other LABA-containing inhalers (e.g., salmeterol, formoterol, indacaterol): Do not use at the same time — overlapping LABA doses can cause serious cardiovascular harm.
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 if you have a severe allergy to milk proteins or to fluticasone furoate, vilanterol, or any ingredient in this inhaler.
- Do not use as primary treatment during a severe acute asthma attack or acute COPD episode requiring intensive emergency care.
- Tell your doctor if you have heart disease, irregular heartbeat, or high blood pressure — vilanterol can affect the cardiovascular system.
- Tell your doctor if you have diabetes, seizure disorders, or thyroid problems — these conditions may be affected by LABA or corticosteroid use.
- Tell your doctor if you have any active or past infections, including tuberculosis, fungal infections, or eye herpes — inhaled corticosteroids can reduce the body's ability to fight infection.
- If you have liver impairment (moderate or severe), tell your doctor — fluticasone furoate may build up to higher-than-normal levels in the body.
- Pregnancy: Poorly controlled asthma in pregnancy carries real risks to mother and baby. Discuss the benefits and risks carefully with your doctor.
- Breastfeeding: It is not known whether these medicines pass into breast milk. Discuss with your doctor before breastfeeding.
- Children under 5: Safety and effectiveness have not been established in this age group.
- Children and adolescents: Inhaled corticosteroids can slow growth; doctors should monitor height routinely in pediatric patients using this inhaler.
🚑If you take too much▾
Taking too much of this medicine can cause signs of excessive stimulation from the vilanterol component — such as rapid heart rate, tremor, headache, nervousness, chest pain, low potassium, high blood sugar, or in severe cases, serious heart rhythm problems or cardiac arrest. Overdose of the fluticasone component is less likely to cause acute harm due to its low absorption, but prolonged excessive use can lead to cortisol suppression. If you suspect an overdose, stop using the inhaler and seek medical attention right away — heart monitoring is recommended.
📡Pharmacodynamics — effects in the body▾
At therapeutic doses, fluticasone furoate does not significantly suppress the body's own cortisol production. Studies in people with COPD and asthma — including children aged 5 to 11 years — showed no meaningful effect on cortisol levels with standard dosing. Vilanterol can cause a small, dose-related increase in heart rate and a slight prolongation of the heart's electrical cycle (QTc interval); these effects are more pronounced at doses higher than those prescribed for routine use.
🔬Pharmacokinetics — how your body processes it▾
After inhalation, both medicines reach peak blood levels quickly — fluticasone furoate within 30 to 60 minutes and vilanterol within about 10 minutes. Steady blood levels are reached after about 6 days of once-daily use. Both medicines are broken down primarily in the liver via the CYP3A4 enzyme pathway, and their breakdown products have little to no activity. Fluticasone furoate is eliminated mainly through the stool; vilanterol's metabolites are cleared through both urine and stool. Fluticasone furoate has a half-life (the time for half the drug to leave the body) of about 24 hours, and vilanterol's half-life ranges from roughly 16 to 21 hours depending on the condition being treated.
📦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 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 and Vilanterol Oral Inhalation
172 supplements and herbal products have documented interactions with Fluticasone 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 · 9
- Moderate · 126
- Minor · 37
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 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 and Vilanterol Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
Can I use this inhaler when I'm having an asthma attack or sudden shortness of breath? ▾
Why do I have to rinse my mouth after using this inhaler? ▾
Is it safe for my child to use this inhaler long-term? ▾
Are there any medicines I definitely should not take with this inhaler? ▾
I've been on oral steroids (prednisone) for a while. Can I just switch straight to this inhaler? ▾
How will I know if this inhaler is actually working? ▾
Is Fluticasone and Vilanterol Oral Inhalation available over the counter? ▾
When was Fluticasone and Vilanterol Oral Inhalation first available? ▾
Who makes Fluticasone and Vilanterol Oral Inhalation? ▾
💬 Answers drafted from Fluticasone 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 and Vilanterol Oral Inhalation comes
Fluticasone 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
- Breo Ellipta is used for the maintenance treatment of COPD in adults
- Breo Ellipta is used for the maintenance treatment of asthma in patients aged 5 years and older
- Fluticasone Furoate and Vilanterol inhalation powder is used for maintenance treatment of COPD
- Fluticasone Furoate and Vilanterol inhalation powder is not indicated for relief of sudden breathing attacks (acute bronchospasm)
- Breo Ellipta is inhaled once daily by mouth — do not use more than once every 24 hours
- After each inhalation, rinse your mouth with water and spit — do not swallow — to reduce the risk of mouth yeast infection
- Use Breo Ellipta at the same time every day for best effect
- If shortness of breath occurs between doses, use your prescribed short-acting rescue inhaler, not an extra dose of Breo Ellipta
📊 Fluticasone and Vilanterol Oral Inhalation across the U.S. market
How Fluticasone 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Fluticasone and Vilanterol Oral Inhalation is used
A general measure of how commonly Fluticasone 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 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 and Vilanterol Oral Inhalation prescribed? Of the 1,594 medications we measure, Fluticasone and Vilanterol Oral Inhalation ranks #412 by Medicaid prescriptions — more than 74% of them.
Utilization by Fluticasone 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 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 7 of 9 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 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 7 of 9 listed Fluticasone and Vilanterol Oral Inhalation NDCs with Medicaid activity.
🔍 Compare Fluticasone and Vilanterol Oral Inhalation products
A representative set of FDA-listed product records for Fluticasone 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 50 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| FLUTICASONE FUROATE 100 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| FLUTICASONE FUROATE 200 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| 50; 25 mcg/1; mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| 100; 25 mcg/1; mcg | Respiratory (inhalation) | GlaxoSmithKline LLC × 2 listings | NDA | View NDC → |
| 200; 25 mcg/1; mcg | Respiratory (inhalation) | GlaxoSmithKline LLC × 2 listings | NDA | View NDC → |
| FLUTICASONE FUROATE 100 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| FLUTICASONE FUROATE 200 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
| 100; 25 mcg/1; mcg | Respiratory (inhalation) | Prasco Laboratories × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 200; 25 mcg/1; mcg | Respiratory (inhalation) | Prasco Laboratories × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Fluticasone 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 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 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 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 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 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 2 FDA-filed SPL label sets 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. Prasco Laboratories 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.