From the Guidelines
Bromhexine is not approved for use in the United States, and therefore, it is not recommended for use in the US due to the lack of FDA approval. Despite being available as a mucolytic medication in many countries worldwide, bromhexine has never received FDA approval for marketing in the US 1. American healthcare providers instead typically prescribe alternative mucolytics such as guaifenesin (available over-the-counter as Mucinex and other brands) for similar indications. Bromhexine works by breaking down mucus glycoproteins, making thick secretions thinner and easier to clear from the respiratory tract. In countries where it is available, it's commonly used for conditions with excessive or thick mucus production like bronchitis, COPD, and other respiratory conditions. The typical adult dosage in countries where it's approved is 8-16 mg three times daily. If you're seeking a mucolytic treatment in the US, consult with your healthcare provider about FDA-approved alternatives like guaifenesin or other appropriate treatments for your specific respiratory condition.
Some key points to consider:
- Bromhexine has been tested in patients with chronic bronchitis or bronchiectasis in several studies employing both subjective and objective indexes of cough, but the results are inconsistent 1.
- A study published in 2019 found that bromhexine was effective in reducing sputum production and improving ease of expectoration in patients with bronchiectasis, but it had no impact on FEV1 1.
- The European Respiratory Society and American Thoracic Society guideline on prevention of COPD exacerbations recommends the use of mucolytic agents such as N-acetylcysteine, ambroxol, or carbocisteine to reduce the likelihood of hospitalization and COPD exacerbations 1.
- The American College of Chest Physicians and Canadian Thoracic Society guideline on prevention of acute exacerbations of COPD suggests the use of macrolides, such as azithromycin, to prevent acute exacerbations of COPD in patients with a history of exacerbations 1.
It's essential to prioritize FDA-approved treatments and consult with a healthcare provider to determine the best course of treatment for your specific respiratory condition.
From the Research
Bromhexine Use in the US
- Bromhexine is a mucoactive agent that has been used in the treatment of various respiratory diseases, including chronic bronchitis and acute bronchitis 2, 3.
- The evidence for the use of bromhexine in the US is limited, and most studies were conducted outside of the US 2, 4, 3.
- A study published in 2019 found that bromhexine, along with other mucoactive agents, has a good safety profile and is effective in the symptomatic treatment of productive cough 2.
- Another study published in 2002 found that mucolytics, including bromhexine, are useful in the adjunctive therapy of respiratory tract disorders and produce a modest improvement in symptom control and lung function 4.
- However, a 2025 review of acute bronchitis found that evidence does not support the use of mucolytics, including bromhexine, in the treatment of acute bronchitis 5.
- A 2017 reappraisal of bromhexine's mucoactive activity and clinical efficacy found that bromhexine has been found to enhance the secretion of various mucus components and increase mucociliary clearance, but larger trials with adequate methodology are required to identify when treatment with bromhexine can improve clinical outcomes 3.
- A 2020 protocol for a systematic review and meta-analysis aimed to evaluate the efficacy and safety of bromhexine hydrochloride tablets in treating pediatric COVID-19, but the results of this study are not available 6.