Prescription medication · Long-Acting Muscarinic Antagonist (LAMA)
umeclidinium
Also sold as Incruse Ellipta. Incruse Ellipta is used to help people with chronic obstructive pulmonary disease (COPD) breathe better.
Data updated 2026-05-15
- 8,530
- FDA reportsLightly reported
- 2
- InteractionsFew interactions
- $10.29
- Brand price (NADAC)
What the data shows
umeclidinium (Incruse Ellipta) is a prescription Long-Acting Muscarinic Antagonist (LAMA), reported less often than most tracked drugs (8,530 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
umeclidinium (Incruse Ellipta) is a prescription Long-Acting Muscarinic Antagonist (LAMA). Incruse Ellipta is used to help people with chronic obstructive pulmonary disease (COPD) breathe better.
Incruse Ellipta is a medicine that helps people with COPD breathe easier. It contains umeclidinium, which is a long-acting muscarinic antagonist (LAMA).
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$10.29/unit
Generic Available
No
GLAXO GRP ENGLAND
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Incruse Ellipta is used to help people with chronic obstructive pulmonary disease (COPD) breathe better.
Common side effects
Sore throat, Sinus infection, Lower respiratory tract infection
Key warnings
Incruse Ellipta is not for treating asthma.
The sections below are summarized in plain English from umeclidinium's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Incruse Ellipta works by relaxing the muscles around your airways. This helps to open up your airways so that air can flow into your lungs more easily. It makes it easier to breathe.
Side Effects (from patient reports)
Based on 8,530 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for umeclidinium, by number of reports
- Dyspnoea
Dyspnoea
1,352 reports
- Cough
Cough
701 reports
- Asthma
Asthma
604 reports
- Wrong Technique In Device Usage Process 520
Wrong Technique In Device Usage Process
520 reports
- Pneumonia 509
Pneumonia
509 reports
- Chronic Obstructive Pulmonary Disease 403
Chronic Obstructive Pulmonary Disease
403 reports
- Fatigue 364
Fatigue
364 reports
- Wheezing 325
Wheezing
325 reports
- Death 321
Death
321 reports
- Malaise 315
Malaise
315 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for umeclidinium each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where umeclidinium sits
umeclidinium has more FDA adverse-event reports than 36% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is umeclidinium; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 8,530 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2010–2025.
Total Reports
8,530
Reports Mentioning Death
605
7.1% of reports — not proof of cause
Hospitalization Reports
2,270
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DYSPNOEA | 1,352 |
| 3 | COUGH | 701 |
| 4 | ASTHMA | 604 |
| 5 | WRONG TECHNIQUE IN DEVICE USAGE PROCESS | 520 |
| 6 | PNEUMONIA | 509 |
| 7 | CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 403 |
| 8 | FATIGUE | 364 |
| 9 | WHEEZING | 325 |
| 10 | DEATH | 321 |
| 12 | MALAISE | 315 |
| 13 | HEADACHE | 311 |
| 15 | NAUSEA | 284 |
| 16 | PRODUCT COMPLAINT | 265 |
| 17 | PAIN | 260 |
| 18 | DIARRHOEA | 259 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Incruse Ellipta is not for treating asthma. Do not use Incruse Ellipta if you are allergic to milk proteins or any of the ingredients in the inhaler. Talk to your doctor right away if you have new or worsening eye problems or problems passing urine.
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 vilanterol. Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.4 ), Clinical Pharmacology ( 12.3 )] .
Mechanism: Ketoconazole blocks the body's ability to break down this medication, which can lead to higher levels of the drug in your system.
Avoid administration of ANORO ELLIPTA with other anticholinergic-containing drugs. Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.4 ), Clinical Pharmacology ( 12.3 )] . Therefore, avoid coadministration of ANORO ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5.9 , 5.10 )] .
Mechanism: Taking these two drugs together causes an additive effect because they both work the same way, which can lead to more side effects.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What should I do if I feel worse after taking Incruse Ellipta?
Can I use Incruse Ellipta for a sudden asthma attack?
How long should I use Incruse Ellipta?
Can I stop taking Incruse Ellipta if I feel better?
Does Incruse Ellipta have any effect on my heart?
Can I use a nebulizer with Incruse Ellipta?
How will I know when the inhaler is empty?
Can I use Incruse Ellipta with other inhalers?
What if the medicine gets in my eyes?
Can I wash the inhaler?
What are the common side effects of umeclidinium?
Does umeclidinium interact with other medications?
What drug class is umeclidinium?
What pregnancy or breastfeeding source fields are listed for umeclidinium?
Related Medications in Long-Acting Muscarinic Antagonist (LAMA)
Other drugs grouped near umeclidinium - same-class peers and common alternatives.
aclidinium
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albuterol
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Albuterol is a drug that helps you breathe easier.
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albuterol/ipratropium
Combivent Respimat, DuoNeb
Combivent Respimat is a combination medicine that helps open your airways.
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beclomethasone
Qvar
Qvar Redihaler is an inhaled medicine that helps control asthma symptoms.
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benralizumab
Fasenra
Fasenra is a medicine that can help treat severe asthma and EGPA.
Compare with umeclidinium →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for umeclidinium: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 8,530.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.09%.
- tolterodine Δ 0.01 pts · 6,323 reports · Anticholinergic (Overactive Bladder) 7.10%death share
- penicillin V Δ 0.04 pts · 2,398 reports · Natural Penicillin 7.13%death share
- brodalumab Δ 0.06 pts · 1,890 reports · Anti-IL-17 Receptor Monoclonal Antibody 7.04%death share
- cholestyramine Δ 0.06 pts · 11,539 reports · Bile Acid Sequestrant 7.03%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for umeclidinium
The FDA label for umeclidinium (sold under brand names such as Incruse Ellipta) classifies it as a prescription-only medication in the Long-Acting Muscarinic Antagonist (LAMA) class. Incruse Ellipta is used to help people with chronic obstructive pulmonary disease (COPD) breathe better. Official labeling lists 9 commonly reported side effects, including Sore throat, Sinus infection, Lower respiratory tract infection.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 8,530 voluntary reports. 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: June 2, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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