Benylan (Dextromethorphan) Safety and Efficacy
Benylan containing dextromethorphan is generally safe for adults but should NOT be used in children, particularly those under 6 years of age, due to lack of proven efficacy and potential for serious adverse events including death. 1, 2
For Children: Strong Recommendation AGAINST Use
The American Academy of Pediatrics specifically advises against using dextromethorphan for any type of cough in children. 1
Age-Specific Restrictions
- Under 4 years: Absolutely contraindicated - OTC cold medications should not be used due to potential toxicity and lack of proven efficacy 2
- Ages 4-6 years: Should generally be avoided, as FDA advisory committees recommended against use in children under 6 years 2
- 6 years and older: May use according to package directions, though benefits remain limited 2
Evidence Against Pediatric Use
- Systematic reviews demonstrate that dextromethorphan is no different than placebo in reducing nocturnal cough or sleep disturbance in children 1
- Between 1969-2006, there were 54 deaths associated with decongestants and 69 deaths associated with antihistamines in children under 6 years 2
- OTC cough medications have been associated with significant morbidity and even mortality in young children 1
- Controlled trials show OTC cough medicines have little to no benefit in symptomatic control of acute cough in children 3
Recommended Alternative for Children
Honey is the first-line treatment for cough in children over 1 year old, providing more relief than dextromethorphan, diphenhydramine, or placebo. 1 Never give honey to infants under 12 months due to botulism risk 1
For Adults: Conditional Use with Caveats
When It May Be Used
- FDA-approved indication: Temporarily relieves cough due to minor throat and bronchial irritation from common cold or inhaled irritants 4
- Thorax guidelines note that "cough remedies containing dextromethorphan may be the most effective" among OTC options for viral upper respiratory infections 5
Critical Limitations
However, there are no effective treatments controlling the cough response per se with an acceptable therapeutic ratio. 5 The evidence base is weak:
- Cochrane reviews found variable results for antitussives in adults, with some studies showing benefit for dextromethorphan while others did not 3, 6
- Most studies were poorly reported, making assessment of true efficacy difficult 3
- Home remedies like honey and lemon are recommended as first-line options even in adults 5
Safety Profile in Adults
- Adverse drug reactions are infrequent and usually not severe when used appropriately 7
- Predominant symptoms are dose-related: neurological, cardiovascular, and gastrointestinal disturbances 7
- Critical drug interaction: Dangerous when combined with monoamine oxidase inhibitors (MAOIs) 7
- Abuse potential is the most significant hazard identified in safety monitoring 7
When to Seek Medical Evaluation Instead
Do not rely on Benylan if any of the following are present: 5
- Coughing up blood
- Breathlessness
- Prolonged fever and feeling unwell
- Pre-existing medical conditions (COPD, heart disease, diabetes, asthma)
- Recent hospitalization
- Symptoms persisting beyond 3 weeks
Common Pitfalls to Avoid
- Using multiple OTC products simultaneously - common cause of adverse events due to overlapping ingredients 2
- Giving to young children due to parental pressure - despite lack of efficacy and potential for harm 1
- Assuming all coughs need suppression - cough is a protective reflex that enhances clearance of secretions 8
- Delaying evaluation of underlying causes - treating symptomatically without addressing the root cause 9