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What are the side effects of Onbrez Breezhaler?

4 min read

In clinical trials, a post-inhalation cough was observed in 17-20% of patients using Onbrez Breezhaler, occurring within 15 seconds of inhalation [1.2.3, 1.2.5]. This article details what are the side effects of Onbrez Breezhaler, from common occurrences to serious adverse reactions.

Quick Summary

An overview of potential side effects associated with Onbrez Breezhaler (indacaterol) for COPD. Details common issues like cough and headache, and serious risks such as heart problems and paradoxical bronchospasm.

Key Points

  • Primary Use: Onbrez Breezhaler (indacaterol) is a once-daily maintenance bronchodilator for adults with COPD, not for asthma or acute attacks [1.4.1, 1.4.5].

  • Common Side Effects: The most frequent adverse reactions are nasopharyngitis (cold-like symptoms), post-inhalation cough, headache, and muscle spasms [1.4.1, 1.2.3].

  • Serious Cardiovascular Risks: The medication can cause significant heart-related side effects, including fast or irregular heartbeat, chest pain, and changes in blood pressure [1.2.1, 1.3.1].

  • Paradoxical Bronchospasm: A rare but life-threatening risk where the airways tighten immediately after inhalation, requiring immediate cessation of the drug [1.2.5, 1.4.1].

  • Metabolic Effects: Onbrez can lead to low potassium levels (hypokalemia) and high blood sugar levels (hyperglycemia), requiring monitoring in at-risk patients [1.2.2, 1.3.1].

  • Drug Interactions: Use with caution alongside beta-blockers, certain diuretics, and other long-acting beta2-agonists, as they can alter its effects or increase risks [1.5.1, 1.5.2].

  • Allergic Reactions: Immediate hypersensitivity reactions, with symptoms like rash, hives, and swelling of the face and tongue, are possible and require urgent medical care [1.4.1, 1.6.1].

In This Article

Understanding Onbrez Breezhaler and Its Purpose

Onbrez Breezhaler is a prescription medication for oral inhalation containing the active ingredient indacaterol maleate [1.2.1, 1.4.2]. It is classified as a long-acting beta2-adrenergic agonist (LABA) and functions as a bronchodilator [1.4.1, 1.4.7]. Its primary indication is for the long-term, once-daily maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD), which includes conditions like chronic bronchitis and emphysema [1.4.1, 1.7.7]. By relaxing the muscles around the small air passages in the lungs, Onbrez helps to keep these airways open for 24 hours, making it easier for patients to breathe [1.4.2, 1.4.7]. The medication is administered as a powder from a capsule using a specific inhalation device called the Breezhaler [1.4.6]. It is important to note that Onbrez Breezhaler is not intended for the treatment of asthma or for acute episodes of bronchospasm (i.e., as a rescue inhaler) [1.4.1, 1.4.5].

Common Side Effects of Onbrez Breezhaler

Many users of Onbrez Breezhaler may experience side effects, though they are often mild to moderate and may decrease as the body adjusts to the medication [1.4.1, 1.3.7]. The most frequently reported side effects in clinical studies include:

  • Respiratory Issues: The most common adverse reactions are related to the respiratory tract. These include nasopharyngitis (inflammation of the nose and throat, cold-like symptoms), upper respiratory tract infections, cough, runny nose (rhinorrhea), and sore throat [1.2.3, 1.3.4, 1.4.1]. A characteristic sporadic cough occurring within 15 seconds of inhalation is also commonly reported, affecting 17-20% of patients in trials, particularly females and current smokers [1.2.3, 1.2.5].
  • Headache: Headache is another common side effect noted by patients [1.2.1, 1.2.3, 1.3.5].
  • Musculoskeletal Effects: Patients may experience muscle spasms, muscle pain (myalgia), or general musculoskeletal pain [1.2.1, 1.2.3, 1.2.6].
  • General Discomfort: Other common issues include dizziness, chest pain (non-cardiac), and peripheral oedema (swelling of hands, ankles, or feet) [1.2.5, 1.2.6].

For many of these common side effects, management strategies are available. For instance, drinking plenty of water and using pharmacist-recommended painkillers can help with headaches, while other remedies may be suggested for cold-like symptoms [1.6.2].

Less Common and Serious Side Effects

While less frequent, some side effects of Onbrez Breezhaler warrant closer medical attention. It is crucial to contact a doctor if these occur. They are categorized as uncommon, meaning they affect between 1 in 1,000 and 1 in 100 patients [1.4.1].

Serious Side Effects Requiring Immediate Medical Attention:

  • Paradoxical Bronchospasm: This is a potentially life-threatening event where the airways suddenly tighten immediately after using the inhaler, leading to wheezing, coughing, and difficulty breathing [1.2.5, 1.6.3]. If this occurs, use of Onbrez Breezhaler should be stopped immediately, and alternative therapy must be instituted [1.4.1].
  • Hypersensitivity (Allergic) Reactions: Signs of a severe allergic reaction include difficulty breathing or swallowing, swelling of the tongue, lips, and face, hives, and skin rash [1.2.1, 1.4.1]. These reactions require immediate discontinuation of the medication and medical intervention [1.6.1].
  • Cardiovascular Effects: As a beta2-adrenergic agonist, indacaterol can have significant effects on the cardiovascular system. Patients should seek immediate medical help if they experience chest pain, a fast or irregular heartbeat (tachycardia, palpitations, atrial fibrillation), or signs of heart problems like extreme fatigue, swelling of the face or limbs, and trouble breathing [1.2.1, 1.2.2, 1.3.4]. The medication should be used with caution in patients with pre-existing cardiovascular disorders [1.4.1].
  • Hypokalemia (Low Potassium): Onbrez can cause a significant decrease in blood potassium levels, which can lead to adverse cardiovascular effects like an abnormal heart rhythm [1.2.2, 1.2.4]. Symptoms include muscle weakness or cramps, mood changes, increased thirst, or numbness and tingling [1.2.2, 1.6.3].
  • Hyperglycemia (High Blood Sugar): The medication may affect blood sugar levels, causing symptoms like increased thirst and hunger, frequent urination, and fruity breath odor [1.2.2, 1.3.1]. Diabetic patients should monitor their blood glucose closely when starting treatment [1.2.2].

Comparison with Other COPD Inhalers

Onbrez Breezhaler is one of several long-acting beta2-agonists (LABAs) available for COPD management. Other LABAs include salmeterol (Serevent), formoterol (Perforomist), and olodaterol (Striverdi) [1.7.2, 1.7.4]. The side effect profile of Onbrez is generally similar to that of other drugs in its class, with cardiovascular stimulation (increased heart rate, palpitations) and musculoskeletal effects (tremor, muscle cramps) being characteristic of beta2-agonists [1.3.8, 1.4.1]. Onbrez is a once-daily inhaler, which can be an advantage over twice-daily options like salmeterol and formoterol [1.7.2, 1.7.4].

Feature Onbrez Breezhaler (Indacaterol) Spiriva (Tiotropium) Other LABAs (e.g., Salmeterol)
Drug Class Long-Acting Beta2-Agonist (LABA) [1.7.7] Long-Acting Muscarinic Antagonist (LAMA) [1.7.5] Long-Acting Beta2-Agonist (LABA) [1.7.2]
Dosing Frequency Once-daily [1.4.1] Once-daily [1.7.3] Often twice-daily [1.7.2]
Common Side Effects Cough, nasopharyngitis, headache, muscle spasms [1.4.1] Dry mouth, sore throat, sinus issues Headache, throat irritation, tremor
Key Serious Risks Paradoxical bronchospasm, cardiovascular events, hypokalemia [1.4.1, 1.2.2] Acute narrow-angle glaucoma, urinary retention Cardiovascular events, paradoxical bronchospasm

Precautions and Drug Interactions

Before using Onbrez Breezhaler, patients should inform their doctor of any existing medical conditions, especially heart problems, diabetes, seizure disorders, thyroid issues, or hypertension [1.3.1, 1.4.2]. Certain medications can interact with Onbrez and potentiate its side effects. These include:

  • Other Sympathomimetic Agents: Using other LABAs concurrently is not recommended [1.5.1].
  • Beta-Blockers: These drugs (including some eye drops) can weaken or antagonize the effect of Onbrez and should generally be avoided unless there are compelling reasons for their use [1.5.1, 1.5.2].
  • Diuretics and Steroids: Concomitant use with non-potassium-sparing diuretics or steroids may worsen hypokalemia [1.5.1].
  • Certain Antidepressants: MAO inhibitors and tricyclic antidepressants can potentiate Onbrez's effect on the cardiovascular system [1.5.3].

Conclusion

Onbrez Breezhaler is an effective once-daily maintenance therapy for COPD, but it carries a risk of side effects. Common adverse events like post-inhalation cough and headache are typically manageable [1.6.2]. However, patients must be aware of serious potential risks, including paradoxical bronchospasm, cardiovascular complications, and severe allergic reactions [1.4.1, 1.6.3]. Understanding these risks, adhering to the prescribed dosage, and maintaining open communication with a healthcare provider are essential for the safe and effective use of this medication. Any worsening of breathing or the appearance of serious side effects should prompt immediate medical consultation [1.2.4].


For more details on prescribing information, you can visit the European Medicines Agency (EMA) product page for Onbrez Breezhaler. [1.4.1]

Frequently Asked Questions

The most common side effects are nasopharyngitis (cold-like symptoms), upper respiratory tract infection, cough, headache, and muscle spasms [1.4.1].

Yes, as a beta2-adrenergic agonist, Onbrez Breezhaler can cause cardiovascular effects like a fast or irregular heartbeat, palpitations, and chest pain. It should be used with caution in patients with heart conditions [1.2.1, 1.4.1].

It is a serious and potentially life-threatening side effect where, instead of opening the airways, the medication causes them to tighten suddenly after inhalation. This leads to wheezing and difficulty breathing and requires immediate medical attention [1.2.5, 1.4.1].

A sporadic cough shortly after inhalation is a common side effect and did not lead to study discontinuation in clinical trials [1.2.3]. However, if the cough is accompanied by wheezing or difficulty breathing, you should stop using the medicine and tell your doctor immediately [1.6.4].

No, Onbrez Breezhaler is a long-acting maintenance medication for COPD and is not indicated for the treatment of asthma or for acute episodes of breathing difficulty (rescue therapy) [1.4.1, 1.4.5].

Yes, certain drugs can interact with Onbrez. These include beta-blockers, non-potassium-sparing diuretics, steroids, MAO inhibitors, and tricyclic antidepressants. You should not use it with other long-acting beta2-agonists [1.5.1, 1.5.3, 1.5.5].

If you experience symptoms of a serious side effect, such as severe difficulty breathing, chest pain, swelling of the face or tongue, or a rapid heartbeat, you should stop taking the medication and seek immediate medical attention [1.6.3, 1.6.4].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.