indacaterol
Brand names: Arcapta Neohaler
UTIBRON NEOHALER is a medicine that helps people with COPD breathe easier. It contains two medicines that work together to open up your airways.
What it does
UTIBRON NEOHALER is used long-term to treat airflow blockage caused by COPD.
Common side effects
Common cold symptoms (nasopharyngitis), High blood pressure (hypertension)
Key warnings
LABA medicines like UTIBRON NEOHALER can raise the risk of asthma-related death.
How It Works
UTIBRON NEOHALER has two medicines. Indacaterol opens airways by relaxing airway muscles. Glycopyrrolate reduces airway tightening. Together, they help you breathe easier.
How to Take It
Use UTIBRON NEOHALER exactly as your doctor tells you. Inhale one capsule twice a day using the NEOHALER device. Take one capsule in the morning and one in the evening, at the same times each day. Do not swallow the capsule; it must be inhaled.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if UTIBRON NEOHALER will harm your unborn baby. Talk to your doctor about the risks and benefits of using this medicine while pregnant.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store UTIBRON NEOHALER capsules in a dry place at room temperature (between 59°F and 86°F).
Serious Warnings
LABA medicines like UTIBRON NEOHALER can raise the risk of asthma-related death. Because of this risk, you should not take this medication if you have asthma. Do not use UTIBRON NEOHALER to treat sudden COPD symptoms. Do not use with other LABA medicines.
Known Drug Interactions
7.7 Inhibitors of Cytochrome P450 3A4 and P-gp Efflux Transporter Drug interaction studies with indacaterol, a component of UTIBRON NEOHALER, were carried out using potent and specific inhibitors of CYP3A4 and P-gp (i.e., ketoconazole, erythromycin, verapamil, and ritonavir). The data suggest that systemic clearance of indacaterol is influenced by modulation of both P-gp and CYP3A4 activities and that the 2-fold area under the curve (AUC) increase caused by the strong dual inhibitor ketoconazole reflects the impact of maximal combined inhibition.
Mechanism: Ketoconazole stops the body from breaking down indacaterol. This leads to higher levels of the drug in your blood.
What to do: Your doctor may need to watch you more closely for side effects while you take both medications.
7.7 Inhibitors of Cytochrome P450 3A4 and P-gp Efflux Transporter Drug interaction studies with indacaterol, a component of UTIBRON NEOHALER, were carried out using potent and specific inhibitors of CYP3A4 and P-gp (i.e., ketoconazole, erythromycin, verapamil, and ritonavir).
Mechanism: Verapamil blocks the enzymes that clear indacaterol from your system. This can cause the drug to build up in your body.
What to do: Tell your doctor if you notice any new side effects, as they may need to monitor your treatment.
7.7 Inhibitors of Cytochrome P450 3A4 and P-gp Efflux Transporter Drug interaction studies with indacaterol, a component of UTIBRON NEOHALER, were carried out using potent and specific inhibitors of CYP3A4 and P-gp (i.e., ketoconazole, erythromycin, verapamil, and ritonavir).
Mechanism: Erythromycin slows down how fast your body removes indacaterol. This can result in more of the drug staying in your bloodstream.
What to do: Your healthcare provider should monitor you to make sure you do not experience too many side effects.
Common Questions
Can I use UTIBRON NEOHALER for asthma?
What should I do if my breathing gets worse suddenly?
Can I take UTIBRON NEOHALER with other inhalers?
How often should I clean my NEOHALER device?
What if I accidentally swallow a UTIBRON capsule?
Can I use a different inhaler device with UTIBRON capsules?
What are the ingredients in UTIBRON NEOHALER?
Can UTIBRON NEOHALER cause heart problems?
Does UTIBRON NEOHALER have steroids?
How long does UTIBRON NEOHALER take to start working?
What are the common side effects of indacaterol?
Does indacaterol interact with other medications?
What drug class is indacaterol?
Is indacaterol 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
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Common Drug Interactions
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What the FDA Data Shows for indacaterol
The FDA label for indacaterol (sold under brand names such as Arcapta Neohaler) classifies it as a prescription-only medication in the Long-Acting Beta-2 Agonist (LABA) class. UTIBRON NEOHALER is used long-term to treat airflow blockage caused by COPD. Official labeling lists 2 commonly reported side effects, including Common cold symptoms (nasopharyngitis), High blood pressure (hypertension).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
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).
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: July 30, 2021
Read our methodology — how this data is sourced, computed, and verified.
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