Umeclidinium and Vilanterol Oral Inhalation
Umeclidinium and vilanterol is a combination inhaled medicine used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD).
🧬 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 →
📖 Umeclidinium and Vilanterol Oral Inhalation: Patient Information Guide
A plain-language walkthrough of 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▾
Umeclidinium and vilanterol inhalation powder is used for long-term maintenance treatment of COPD. Here is what the supported products are approved for:
- Anoro Ellipta — maintenance treatment of adults with chronic obstructive pulmonary disease (COPD)
- Umeclidinium and Vilanterol Ellipta — maintenance treatment of adults with COPD
- Neither product is approved for the relief of sudden breathing attacks (acute bronchospasm)
- Neither product is approved or safe for use in treating asthma — effectiveness has not been established, and there are serious safety concerns with LABA use in asthma without an inhaled corticosteroid
⚙️How it works▾
This inhaler brings together two different bronchodilators (medicines that open the airways) that work through separate pathways. Umeclidinium is an anticholinergic — it blocks muscarinic receptors on the smooth muscle lining the airways. Blocking these receptors prevents nerve signals that would normally tighten the airways, so the muscles stay relaxed and the passages stay open. Vilanterol is a long-acting beta-2 agonist (LABA) — it activates beta-2 receptors on airway smooth muscle cells, boosting a molecule called cyclic AMP inside the cells. This causes the muscle to relax and the airway to widen, making it easier to breathe. Because they work in different ways, the two medicines complement each other.
💊How it's taken▾
Both Anoro Ellipta and Umeclidinium and Vilanterol Ellipta are inhaled once daily through the mouth. Use one inhalation at the same time each day — do not exceed one dose in any 24-hour period. No dosage adjustment is needed for older adults or people with mild-to-moderate kidney or hepatic (liver) impairment, though people with severe liver impairment have not been well studied.
- Use at the same time every day to keep medication levels steady
- Do not use extra doses if symptoms flare — use a short-acting rescue inhaler instead and contact your doctor
- Can be taken with or without food
🤒Side effects — in detail▾
The most commonly reported side effects with this inhaler include:
- Pharyngitis (sore or scratchy throat)
- Sinusitis (sinus congestion or infection)
- Lower respiratory tract infection
- Constipation
- Diarrhea
- Pain in the arms or legs
- Muscle spasms
- Neck pain
- Chest pain
Serious reactions that need prompt medical attention include sudden worsening of breathing (including paradoxical bronchospasm), fast or irregular heartbeat, signs of a severe allergic reaction (throat swelling, hives, difficulty breathing), eye pain or vision changes suggesting glaucoma, and difficulty urinating.
⚠️Warnings & precautions▾
- LABA in asthma without an inhaled corticosteroid increases the risk of asthma-related death — this medicine is not approved for asthma and must not be used that way
- Not for acute symptoms — do not use this inhaler to treat sudden breathing attacks; use a short-acting rescue inhaler instead
- Do not use alongside other LABA-containing inhalers — doubling up on LABAs can cause serious, even fatal, heart effects
- Paradoxical bronchospasm (sudden airway tightening after using the inhaler) can occur — stop the inhaler immediately and seek care
- Can raise heart rate and blood pressure; use with caution in people with heart disease, coronary artery disease, or heart rhythm problems
- Can worsen narrow-angle glaucoma — watch for eye pain, blurred vision, or halos and contact your doctor immediately
- Can worsen urinary retention — especially in men with an enlarged prostate; contact your doctor if you have trouble urinating
- May lower potassium levels (hypokalemia) or raise blood sugar (hyperglycemia) in some people
- Severe allergy to milk proteins: do not use — the inhaler contains lactose
🔀What it interacts with▾
Several medicines can interact with this inhaler and increase the risk of side effects, particularly heart-related ones:
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, itraconazole, clarithromycin) — raise vilanterol blood levels and may increase cardiovascular side effects
- MAO inhibitors (MAOIs) and tricyclic antidepressants — amplify vilanterol's cardiovascular effects; use with extreme caution and avoid within 2 weeks of stopping these drugs
- QTc-prolonging medicines — combined use raises the risk of dangerous heart rhythm problems (ventricular arrhythmias)
- Beta-blockers — can block the bronchodilating effect of vilanterol and may provoke severe bronchospasm in COPD patients
- Non-potassium-sparing diuretics (loop or thiazide diuretics) — may worsen low potassium levels and abnormal heart rhythm changes
- Other anticholinergic medicines — additive effects increase the risk of urinary retention and glaucoma worsening
- Other LABA inhalers (salmeterol, formoterol, arformoterol, indacaterol) — do not use with this inhaler; excess LABA can cause serious heart complications or death
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 umeclidinium or vilanterol
- Do not use for asthma — using a LABA without an inhaled corticosteroid in asthma is dangerous
- Tell your doctor about any heart conditions — coronary artery disease, arrhythmias, or high blood pressure all require caution
- Tell your doctor if you have narrow-angle glaucoma or are at risk — this medicine can make it worse
- Tell your doctor about prostate enlargement or any urinary problems
- Tell your doctor about seizure disorders or thyroid problems (thyrotoxicosis)
- Tell your doctor if you have diabetes — beta-agonists can raise blood sugar
- Pregnancy: use near labor only if the benefit outweighs the risk; there is limited safety data in humans
- Breastfeeding: it is not known whether this medicine passes into human breast milk; discuss with your doctor
- Children: safety and effectiveness have not been established — not approved for pediatric patients
- Older adults: no dose change is needed, but some older individuals may be more sensitive to effects
- Moderate liver impairment: no dose change needed; severe liver impairment has not been well studied
🚑If you take too much▾
Taking too much of this inhaler can cause signs of too much anticholinergic effect (from umeclidinium) or too much beta-agonist stimulation (from vilanterol), such as seizures, fast heartbeat (up to 200 beats per minute), irregular heartbeat, chest pain, tremor, headache, nervousness, nausea, dizziness, low potassium, or high blood sugar. In severe cases, cardiac arrest can occur. If overdose is suspected, stop the inhaler, seek medical care immediately, and heart monitoring is recommended.
📡Pharmacodynamics — effects in the body▾
At doses much higher than recommended, this medicine caused small increases in the QTc interval (a measure of heart electrical activity) and a dose-dependent rise in heart rate in healthy volunteers. In COPD patients monitored over 6 to 12 months, no clinically meaningful effects on heart rhythm were observed at the approved dose. Beta-agonist medicines like vilanterol may also cause transient drops in blood potassium and rises in blood sugar in some people, though clinical trials in COPD patients did not show a meaningful effect on these levels at the approved dose.
🔬Pharmacokinetics — how your body processes it▾
Both umeclidinium and vilanterol are absorbed primarily through the lungs after inhalation, with peak blood levels reached within 5 to 15 minutes. Most of the therapeutic effect is local — in the airways — so blood levels do not reliably predict how well the medicine is working. Steady-state levels are reached within about 14 days of once-daily use. Umeclidinium is broken down mainly by the CYP2D6 enzyme in the liver, while vilanterol is metabolized mainly by CYP3A4; both are also transported by P-glycoprotein. Umeclidinium is cleared primarily through the bile and feces, with some in the urine; vilanterol is also cleared through metabolism to inactive compounds. The effective half-life of umeclidinium after once-daily dosing is about 11 hours.
📦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 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 →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Umeclidinium and Vilanterol Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this inhaler for — and can I use it if I also have asthma? ▾
Can I use this inhaler when I'm having a breathing attack? ▾
What side effects should I expect, and which ones are serious enough to call my doctor about? ▾
Are there medicines I should avoid while using this inhaler? ▾
Is it safe to use during pregnancy or while breastfeeding? ▾
I have an enlarged prostate — is this inhaler safe for me? ▾
Is Umeclidinium and Vilanterol Oral Inhalation available over the counter? ▾
When was Umeclidinium and Vilanterol Oral Inhalation first available? ▾
Who makes Umeclidinium and Vilanterol Oral Inhalation? ▾
💬 Answers drafted from 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 Umeclidinium and Vilanterol Oral Inhalation comes
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
- Anoro Ellipta is used for the maintenance treatment of COPD in adults
- Umeclidinium and Vilanterol Ellipta is used for the maintenance treatment of COPD in adults
- Not indicated for relieving acute bronchospasm or for treating asthma
- Anoro Ellipta and Umeclidinium and Vilanterol Ellipta are each inhaled once daily through the mouth using the Ellipta inhaler device
- Use at the same time every day — do not use more than once every 24 hours
- For inhalation use only — do not swallow
- Always follow the step-by-step instructions provided with your specific inhaler device
📊 Umeclidinium and Vilanterol Oral Inhalation across the U.S. market
How 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Umeclidinium and Vilanterol Oral Inhalation is used
A general measure of how commonly 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 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 Umeclidinium and Vilanterol Oral Inhalation prescribed? Of the 1,596 medications we measure, Umeclidinium and Vilanterol Oral Inhalation ranks #340 by Medicaid prescriptions — more than 79% of them.
Utilization by 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 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 3 of 4 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 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 3 of 4 listed Umeclidinium and Vilanterol Oral Inhalation NDCs with Medicaid activity.
🔍 Compare Umeclidinium and Vilanterol Oral Inhalation products
A representative set of FDA-listed product records for 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 | ||||
| UMECLIDINIUM BROMIDE 62.5 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | GlaxoSmithKline LLC | NDA | View NDC → |
| 62.5; 25 mcg/1; mcg | Respiratory (inhalation) | GlaxoSmithKline LLC × 2 listings | NDA | View NDC → |
| UMECLIDINIUM BROMIDE 62.5 mcg/1; VILANTEROL TRIFENATATE 25 mcg | Respiratory (inhalation) | Prasco Laboratories | NDA AUTHORIZED GENERIC | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 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 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 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 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 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
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 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. 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.