Can tremors be a side effect of Breztri (budesonide, glycopyrrolate, and formoterol) in Chronic Obstructive Pulmonary Disease (COPD) patients?

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Last updated: March 26, 2025View editorial policy

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From the Guidelines

Tremors can be a possible side effect of Breztri Aerosphere in COPD patients, primarily associated with the formoterol component, a long-acting beta-agonist (LABA) 1.

Mechanism and Side Effects

The formoterol component in Breztri Aerosphere is a beta-2 agonist that can stimulate receptors in skeletal muscle, leading to tremors, particularly in the hands 1. This side effect is more common at higher doses but can occur at standard therapeutic doses as well.

  • The inhaled corticosteroid component, budesonide, is less likely to cause tremors compared to the LABA component.
  • The anticholinergic component, glycopyrrolate, is not typically associated with tremors.

Management and Patient Education

Patients should be aware that tremors are usually mild and often diminish with continued use as tolerance develops 1. If tremors become bothersome or severe, patients should not discontinue the medication abruptly but should consult their healthcare provider, who might adjust the dosage or consider alternative treatments.

  • Proper inhaler technique can also help minimize systemic absorption and reduce the likelihood of side effects like tremors.
  • Healthcare providers should monitor patients for signs of tremors and other side effects, especially when initiating or adjusting Breztri Aerosphere therapy.

From the FDA Drug Label

Common side effects of Formoterol Fumarate Inhalation Solution include: • headache • muscle cramps • dizziness • tremor • nausea • tiredness • nervousness • vomiting • trouble sleeping • dry mouth • diarrhea

Tremors can be a side effect of Formoterol Fumarate Inhalation Solution, which is a component of Breztri, in COPD patients 2.

From the Research

Side Effects of Breztri in COPD Patients

  • The studies provided do not directly mention Breztri (budesonide, glycopyrrolate, and formoterol) as a cause of tremors in COPD patients 3, 4, 5, 6.
  • However, one of the components of Breztri, formoterol, is a long-acting beta2-agonist that has been associated with tremors as a potential side effect 7.
  • According to the study published in 2004, long-acting beta2-agonists, including formoterol, can cause predictable adverse effects such as headache, tremor, palpitations, muscle cramps, and a fall in serum potassium concentration 7.
  • It is essential to note that the studies provided do not specifically investigate the side effects of Breztri in COPD patients, but rather the efficacy and safety of its components or similar medications 3, 4, 5, 6.

Efficacy and Safety of Breztri Components

  • Budesonide, glycopyrronium, and formoterol have been shown to be effective in improving lung function and reducing COPD exacerbations when used separately or in combination 3, 4, 5, 6.
  • The safety profiles of these medications have been generally well-tolerated, with common adverse events including headache, cough, and diarrhea 3, 5.
  • Formoterol, in particular, has been associated with a rapid onset of effect and a favorable safety profile when used as a maintenance or as-needed treatment for COPD 4, 6.

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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