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.
How to Take It
Take 1 puff of Incruse Ellipta once a day using the inhaler. Use it at the same time every day. Do not use it more than once in 24 hours. Breathe in the medicine through your mouth.
This is a plain-language summary of umeclidinium's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Not enough information is available to know if Incruse Ellipta is safe to use during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant.
This is a plain-language summary of umeclidinium's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not take two doses at once.
This is a plain-language summary of umeclidinium's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Incruse Ellipta at room temperature, away from heat and sunlight.
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
- Difficulty breathing
Difficulty breathing
1,352 reports
- Cough
Cough
701 reports
- Asthma
Asthma
604 reports
- Using the inhaler incorrectly 520
Using the inhaler incorrectly
520 reports
- Pneumonia 509
Pneumonia
509 reports
- Chronic obstructive pulmonary disease 403
Chronic obstructive pulmonary disease
403 reports
- Tiredness 364
Tiredness
364 reports
- Wheezing 325
Wheezing
325 reports
- Death 321
Death
321 reports
- Feeling unwell 315
Feeling unwell
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) 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.
What to do: Use this combination with caution and talk to your doctor about any new symptoms.
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.
What to do: Avoid using these medications at the same time.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is umeclidinium safe during pregnancy?
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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
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: June 2, 2023
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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