Indacaterol

Pronunciation: in-da-KAT-er-ol.

Generic name
indacaterol (as indacaterol maleate)
Drug class
Long-acting beta-2 adrenergic agonist (LABA) bronchodilator
Form
Inhalation powder, hard capsule, used only with its matching inhaler device (Neohaler in the US, Breezhaler elsewhere) -- never swallowed
Route
Inhaled
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Onbrez Breezhaler (5) · Full directory

What indacaterol (as indacaterol maleate) is and how it works

Indacaterol is an inhaled, long-acting bronchodilator used for the ongoing (maintenance) treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It works by relaxing the muscles around the airways, making breathing easier over the course of the day, and is taken once daily. (1) (2)

Indacaterol is for COPD only -- it is not approved, and is specifically contraindicated, as the only treatment for asthma, because using this type of medicine (a long-acting beta agonist) alone without an inhaled corticosteroid has been linked to an increased risk of asthma-related death. It does not carry the FDA's strongest boxed-warning label, reflecting the FDA's current position for LABAs indicated specifically for COPD, but the asthma-related risk itself is real and must still be taken seriously if you also have asthma. It is not a rescue inhaler and will not relieve a sudden worsening of symptoms.

Mechanism of action: how indacaterol (as indacaterol maleate) works

Indacaterol is a long-acting beta-2 adrenergic receptor agonist. Stimulating beta-2 receptors in airway smooth muscle activates adenylate cyclase and increases intracellular cyclic AMP, producing sustained relaxation of bronchial smooth muscle and bronchodilation, providing 24-hour symptom control with once-daily dosing. (1)

What indacaterol (as indacaterol maleate) is used for

Long-term maintenance treatment of chronic obstructive pulmonary disease (COPD)

Used once daily as an ongoing bronchodilator to help relieve COPD symptoms (including chronic bronchitis and/or emphysema). Not for relieving a sudden worsening of COPD symptoms, and not approved for asthma. (1) (2)

Before taking indacaterol (as indacaterol maleate)

Do not take / not appropriate for

  • Do not use indacaterol (alone, without an inhaled corticosteroid) as a treatment for asthma -- this is specifically contraindicated because of an increased risk of asthma-related death associated with this class of medicine used this way. (United States, Canada) (1) (4)
  • Do not use indacaterol to treat a sudden worsening of breathing symptoms -- it is not a rescue/reliever inhaler and does not work quickly enough for an acute attack. (all countries) (1) (2)
  • Do not exceed the maximum recommended dose (300 micrograms once daily in markets using the 150/300 mcg capsules; the fixed 75 mcg dose in the US) under any circumstances. (all countries) (2) (1)

Tell your clinician about

  • Any history of heart problems, irregular heartbeat, high blood pressure, or coronary artery disease.
  • Any history of seizures, thyroid problems (thyrotoxicosis), or diabetes.
  • If you also have asthma, since this medicine is not an asthma treatment on its own.
  • Any known allergic reaction to indacaterol or other ingredients in your capsules or inhaler device.
  • All other medicines you take, especially other bronchodilators, beta-blockers, diuretics, or medicines affecting heart rhythm.
(1) (2)

How to take indacaterol (as indacaterol maleate)

  • Use exactly as prescribed: one capsule inhaled once daily, at the same time each day, using only the specific inhaler device (Neohaler or Breezhaler) provided with this medicine.
  • Capsules must never be swallowed -- they are for inhalation only, using the device provided.
  • Do not change your dose or stop taking this medicine without your prescriber's guidance -- COPD maintenance treatment is generally continued long-term under medical supervision.
  • If you have been prescribed a fast-acting reliever inhaler for sudden symptoms, keep using that as directed -- indacaterol is not a substitute for it.
  • If your COPD symptoms worsen while taking this medicine, contact your clinician for a re-evaluation of your treatment plan rather than increasing the dose yourself.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If a dose is missed, contact your prescriber or pharmacist for guidance rather than following a generic rule, and never take more than one dose in any 24-hour period.

Overdose

Seek urgent medical attention if too much has been inhaled, or if you notice a very fast or irregular heartbeat, chest pain, severe tremor, or severe dizziness. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Cough.

What to notice: Cough.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Sore throat (oropharyngeal pain) and nasopharyngitis (common cold-type symptoms).

What to notice: Sore throat (oropharyngeal pain) and nasopharyngitis (common cold-type symptoms).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache and nausea.

What to notice: Headache and nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Sudden worsening of breathing after a dose (paradoxical bronchospasm) — emergency

Symptoms: Sudden wheezing, tightness in the chest, or worsening breathing difficulty immediately after using the inhaler.

Action: Seek emergency medical help immediately and use a fast-acting reliever inhaler if one has been prescribed. This medicine must be stopped and an alternative treatment found if this occurs. (1)

Signs of a serious allergic reaction (hypersensitivity) — emergency

Symptoms: Swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, or widespread rash/hives.

Action: Seek emergency medical help immediately and stop the medicine. (1)

Use as the only asthma treatment (relevant if you also have asthma) — high caution

Symptoms: Not applicable -- this is a warning about how the medicine is used, not a symptom to watch for.

Action: This medicine (used alone, without an inhaled corticosteroid) must not be used as the sole treatment for asthma, because of an increased risk of asthma-related death associated with this type of medicine used this way. Discuss your full asthma treatment plan with your clinician. (1)

Heart-related symptoms (cardiovascular effects) — moderate caution

Symptoms: A noticeably fast or irregular heartbeat, palpitations, or chest pain.

Action: Contact your clinician promptly, or seek emergency help for severe or persistent symptoms -- this medicine can affect heart rate and rhythm, especially in people with existing heart conditions. (2) (1)

Signs of low blood potassium or raised blood sugar — moderate caution

Symptoms: Muscle weakness or cramps (low potassium); increased thirst or urination (raised blood sugar).

Action: Contact your clinician if these develop, particularly if you also take other medicines that lower potassium (such as certain water tablets/diuretics) or have diabetes. (1)

Worsening COPD symptoms during treatment — moderate caution

Symptoms: Increasing breathlessness, more frequent flare-ups, or needing your reliever inhaler more often.

Action: Contact your clinician for a re-evaluation of your COPD treatment plan -- do not simply increase your indacaterol dose yourself. (2)

Interactions

  • Other adrenergic (beta-agonist) medicines can add to indacaterol's effects and side effects. (1)
  • Xanthine derivatives, steroids, and non-potassium-sparing diuretics can add to the risk of low blood potassium. (1)
  • Beta-blockers can reduce how well this medicine works and, in people with COPD, may trigger severe bronchospasm. (1)
  • Medicines that prolong the QT interval or MAO inhibitors/tricyclic antidepressants may increase cardiovascular effects -- use with caution. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Limited human data. Discuss use during pregnancy with your clinician. (1) (2) (3) (4) (5) (6)

Breastfeeding

No adequate human data on whether indacaterol passes into breast milk. Discuss with your clinician. (1) (2) (3) (4) (5) (6)

Children

Not established for use in children in the sources reviewed for this dossier -- this is a COPD medicine, a condition that does not typically occur in children. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

No dose adjustment needed for mild-to-moderate liver impairment; limited data for severe liver impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

No dose adjustment needed based on kidney function in the sources reviewed. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Assessment of underlying heart condition, blood pressure, and heart rhythm
  • Confirmation that the diagnosis is COPD, not asthma monotherapy
  • Review of other medicines for interactions

During treatment

  • Ongoing assessment for cardiovascular symptoms (palpitations, chest pain) and for signs of paradoxical bronchospasm after dosing.
  • Periodic review of inhaler technique to ensure correct use of the Neohaler/Breezhaler device.
  • Re-evaluation of the treatment plan if COPD symptoms worsen during treatment.
(1) (2)

Storage

Store the capsules in their original blister packaging, away from moisture, and only remove a capsule from the blister immediately before use. Keep out of reach of children.

Study the drug class: Beta-2 agonist bronchodilators

Professional information

Clinician-facing context only, sourced from the current US FDA and UK SmPC labels reviewed for this dossier; verify against the current full label and local product/marketing status before prescribing.

United States

Indication: COPD maintenance bronchodilator treatment (Arcapta Neohaler)

Dose summary: 75 mcg once daily via the Neohaler device; no adjustment for geriatric patients, mild-to-moderate hepatic impairment, or renal impairment described in the sources reviewed.

Renal context: No dose adjustment required based on the sources reviewed. (1)

United Kingdom

Indication: COPD maintenance bronchodilator treatment (Onbrez Breezhaler)

Dose summary: 150 mcg once daily, increased to 300 mcg once daily for severe COPD at prescriber discretion; 300 mcg once daily is the maximum dose.

Renal context: No dose adjustment required based on the sources reviewed. (2)

Mechanism of action

Hepatic guidance

No dose adjustment needed for mild-to-moderate hepatic impairment; limited data for severe hepatic impairment.

Overdose note

No specific antidote; manage with supportive care and monitoring of cardiovascular status, potassium, and glucose. Cardioselective beta-blockade may be considered under specialist guidance but with caution given bronchospasm risk. (1)

Frequently asked questions

Does indacaterol have a boxed warning?

No, indacaterol does not carry an FDA boxed warning. This reflects the FDA's current position for long-acting beta agonists (LABAs) indicated specifically for COPD, based on large safety trials. Its main safety warning -- that this class of medicine used alone for asthma is linked to an increased risk of asthma-related death -- is presented in the standard Warnings and Precautions section of the label rather than as a boxed warning. (1)

Can indacaterol be used to treat asthma?

No -- indacaterol (used alone, without an inhaled corticosteroid) is specifically not approved and is contraindicated for asthma, because this class of medicine (long-acting beta agonists) used this way has been linked to an increased risk of asthma-related death. It is approved only for COPD maintenance treatment. (1) (4)

Is indacaterol the same as Ultibro Breezhaler?

No -- indacaterol on its own (Arcapta Neohaler in the US, Onbrez Breezhaler elsewhere) is a single-ingredient bronchodilator. Ultibro Breezhaler is a separate, distinct combination product that combines indacaterol with a second medicine, glycopyrronium, in one inhaler, and is covered separately. (4) (5)

What is the mechanism of action of indacaterol (as indacaterol maleate)?

Indacaterol is a long-acting beta-2 adrenergic receptor agonist. Stimulating beta-2 receptors in airway smooth muscle activates adenylate cyclase and increases intracellular cyclic AMP, producing sustained relaxation of bronchial smooth muscle and bronchodilation, providing 24-hour symptom control with once-daily dosing. (1)

What is the generic name of Indacaterol?

The generic name is indacaterol (as indacaterol maleate). (1) (2)

What class of drug is indacaterol (as indacaterol maleate)?

Indacaterol is classed as: Long-acting beta-2 adrenergic agonist (LABA) bronchodilator. (1) (2)

References

  1. ARCAPTA NEOHALER (indacaterol inhalation powder) -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Sunovion Pharmaceuticals Inc. (Novartis Pharmaceuticals Corporation) · United States · accessed 2026-07-30 · source 1
  2. Onbrez Breezhaler 150 microgram / 300 microgram inhalation powder, hard capsules -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Novartis Pharmaceuticals UK Limited · United Kingdom · accessed 2026-07-30 · source 2
  3. Onbrez Breezhaler, INN-indacaterol -- EPAREuropean Medicines Agency (EMA) -- centralised EU marketing authorisation, EPAR · European Union · accessed 2026-07-30 · source 3
  4. Onbrez Breezhaler (indacaterol maleate) -- Health Canada Summary Basis of Decision and Product MonographHealth Canada, Notice of Compliance and product monograph, Novartis Pharmaceuticals Canada Inc. · Canada · accessed 2026-07-30 · source 4
  5. ONBREZ BREEZHALER indacaterol maleate 150/300 microgram hard capsules -- ARTG entries 160172 (150 mcg), 160177 (300 mcg)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 5
  6. Onbrez Breezhaler (indacaterol) -- Medsafe Consumer Medicine Information and data sheetMedsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient indacaterol (as indacaterol maleate) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Arcapta Neohaler (1)FDA approved currently labeled · 75 mcg · Sunovion Pharmaceuticals Inc. (Novartis Pharmaceuticals Corporation)

United Kingdom

  • Onbrez Breezhaler (2)MHRA licensed emc smpc confirmed · 150 mcg, 300 mcg · Novartis Pharmaceuticals UK Limited

Canada

  • ONBREZ BREEZHALER

Australia

  • Onbrez Breezhaler (5)TGA ARTG registered 2010-08-03 PBS listed confirmed · 150 mcg, 300 mcg · Novartis Pharmaceuticals Australia Pty Ltd

New Zealand

  • Onbrez Breezhaler (6)Medsafe confirmed consumer medicine information · 150 mcg, 300 mcg · Novartis New Zealand Limited
View brands in additional countries.

European Union

Onbrez Breezhaler (3)

This page provides general reference information about indacaterol and is not a substitute for advice from the prescriber managing your treatment. Do not change your dose, stop this medicine, or manage a worsening of your COPD symptoms without your prescriber's specific guidance.

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