Mucolytic agent
ATC code: R05CB06 (Ambroxol)
An active metabolite of bromhexine. Reduces bronchial secretion viscosity, stimulates surfactant synthesis by type II alveolocytes, and has mild local anesthetic action in the mouth (used as lozenges for sore throat). Glucuronidation-metabolized. Half-life 7–12 hours. In Spain widely prescribed under Mucosan; evidence for efficacy in acute bronchitis is limited.
Adjunct
Used symptomatically for cough with hard-to-clear sputum. Adult dose 30 mg three times daily or extended-release 75 mg once daily. Cochrane 2019 showed modest effect on cough duration and intensity with low certainty. In chronic bronchitis and COPD, long-term ambroxol or N-acetylcysteine modestly reduces exacerbation frequency ( 2024).
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
Ambroxol is a mucolytic that thins sputum. It is prescribed for chronic respiratory diseases with thick sputum – COPD, cystic fibrosis. For acute viral upper respiratory infections in children and adults, ambroxol is widely used for cold prevention and at the first signs of a cold. The Cochrane review by Chalumeau 2013 in children under 4 found safety signals (risk of paradoxical bronchial obstruction worsening in small children). In 2015 the restricted ambroxol use in children under 2. The drug carries specific risks: allergic reactions (rare cases of DRESS syndrome and anaphylaxis have been described). If ambroxol was prescribed to a child for a cold without marked thick sputum, consider seeking a second opinion.
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Avoid in T1 where possible. T2 and T3 use is acceptable when indicated.
Milk concentrations are low. Compatible with breastfeeding in short courses.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Ambroxol 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 Ambroxol (≥ 1 in 100): Nausea, vomiting, Diarrhea, Dry mouth, Taste alteration (metallic), Skin rash. See the Safety section for uncommon and serious reactions.
FDA category B. Avoid in T1 where possible. T2 and T3 use is acceptable when indicated.
Milk concentrations are low. Compatible with breastfeeding in short courses.
Ambroxol is contraindicated in: Ambroxol hypersensitivity; Severe hepatic or renal impairment; Age under 2 (most formulations). Full list in the Safety section.