What are the contraindications for Bromhexine (mucolytic agent) in patients with various medical conditions, including hypersensitivity, respiratory impairment, peptic ulcer disease, and impaired renal (kidney) or hepatic (liver) function?

Bromhexine Contraindications

Bromhexine has a known hypersensitivity reaction as its primary absolute contraindication, with documented cases of urticaria, angioedema, and anaphylaxis, while use in children under 18 years should be avoided due to lack of proven efficacy and concerns about adverse effects. 1, 2

Absolute Contraindications

• Known hypersensitivity to bromhexine is the primary absolute contraindication, with documented skin reactions including generalized urticaria (most common), angioedema, and anaphylactic reactions occurring within 1-30 days of initiation 2

Pediatric Population (Strong Recommendation Against Use)

• The European Respiratory Society conditionally recommends against routine use in children and adolescents (ages 0-18 years) with bronchiectasis due to potential adverse effects and lack of proven efficacy in this population 1
• Studies demonstrate increased adverse events compared to placebo (OR 2.93,95% CI 0.12-73.97), though confidence intervals are wide 1, 3
• All available evidence derives from adult-based trials with no pediatric-specific studies, creating substantial uncertainty about safety and efficacy in children 1
• Young children (particularly infants) have limited ability to cooperate with expectoration, making the theoretical mucolytic benefit questionable from a practical standpoint 1

Relative Contraindications and Precautions

Hepatic Impairment

• Use with caution in patients with liver disease as limited safety data exists for this population, though no specific dose adjustments are established 4
• Close monitoring for adverse effects is prudent when bromhexine must be used in hepatic dysfunction 4

Renal Impairment

• Impaired renal function warrants careful monitoring due to potential metabolite accumulation 4
• No established dose adjustments exist, but heightened surveillance for adverse effects is recommended 4

Peptic Ulcer Disease

• While not explicitly contraindicated in available guidelines, gastrointestinal adverse effects have been documented with bromhexine use 5
• Clinical judgment should guide use in patients with active peptic ulcer disease given the potential for mucosal irritation

Common Pitfalls to Avoid

• Do not assume bromhexine is benign simply because it is available over-the-counter—documented hypersensitivity reactions including anaphylaxis have occurred 2
• Avoid routine use in pediatric populations despite historical prescribing patterns, as current European Respiratory Society guidelines recommend against this practice 1
• Do not use bromhexine as a substitute for proven airway clearance techniques in bronchiectasis, particularly in children where physiotherapy-based approaches are strongly recommended 1
• Monitor patients carefully during the first 30 days of therapy when hypersensitivity reactions are most likely to manifest 2

Clinical Context

The evidence base for bromhexine demonstrates modest positive results in improving respiratory symptoms and sputum characteristics (decreased volume and viscosity) in chronic bronchitis, but these studies were conducted before modern methodological standards were established 5, 6. The balance of evidence, particularly in vulnerable populations like children, favors alternative approaches such as airway clearance techniques over routine bromhexine use 1.