Mucolytic agent
ATC code: R05CB02 (Bromhexine)
A semisynthetic vasicine alkaloid derivative. Depolymerizes mucopolysaccharide fibres in bronchial secretions, activates serous bronchial gland cells, and raises pulmonary surfactant synthesis. In vivo metabolized to ambroxol – the main active metabolite. In Spain widely prescribed under Bisolvon, but international evidence for efficacy in acute bronchitis is limited.
Adjunct
Used symptomatically for cough with hard-to-clear sputum as part of combined therapy in acute bronchitis and chronic lung disease. Adult dose 8–16 mg three times daily. Cochrane 2019 meta-analysis of mucolytics in acute bronchitis showed modest effect on cough duration (mean 1–2 days shorter) with low certainty. ACCP 2018 does not recommend mucolytics in acute bronchitis in otherwise healthy adults.
Sources
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Bromhexine is a mucolytic. It is prescribed for chronic respiratory diseases with thick sputum. For acute viral infections, bromhexine is widely recommended for sputum thinning in colds and for immune support. The Cochrane review by Chalumeau 2013 does not recommend mucolytics in children under 4. The drug carries specific risks: allergic reactions, with cases of severe skin reactions described. For ordinary colds without marked thick sputum, mucolytics are not justified – treatment is based on rest, humidified air, plenty of fluids, and symptomatic agents (paracetamol for fever). If bromhexine was prescribed for an ordinary cold, consider seeking a second opinion.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Direct links to regulator labels. Open in a new tab.
Safety not established. Not recommended in pregnancy without clear indication.
Limited data. Use with caution during lactation.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Bromhexine is evaluated for the following indications with varying evidence strength: Productive cough (evidence tier C), Immune support and respiratory infection care (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Bromhexine (≥ 1 in 100): Nausea, vomiting, Abdominal pain, Diarrhea, Skin rash, Headache. See the Safety section for uncommon and serious reactions.
FDA category B. Safety not established. Not recommended in pregnancy without clear indication.
Limited data. Use with caution during lactation.
Bromhexine is contraindicated in: Bromhexine hypersensitivity; Severe hepatic or renal impairment; Age under 2 (most formulations). Full list in the Safety section.