What are the risks and recommended alternatives for over-the-counter (OTC) cough medicine side effects in children under 6 years old?

Side Effects of Cough Medicine in Children Under 6 Years Old

Over-the-counter cough and cold medications should not be used in children under 6 years of age due to documented fatalities, lack of proven efficacy, and significant risk of toxicity. 1

Documented Mortality and Serious Adverse Events

The evidence reveals alarming safety data that should guide all clinical decisions:

• Between 1969 and 2006, there were 123 deaths in children under 6 years: 54 deaths associated with decongestants and 69 deaths associated with antihistamines 1
• Infants are at highest risk: 43 decongestant deaths occurred in infants under 1 year, and 41 antihistamine deaths occurred in children under 2 years 1, 2
• Three infant deaths under 6 months occurred in 2005 alone where cough and cold medications were determined by medical examiners to be the underlying cause 3
• During 2004-2005, an estimated 1,519 children under 2 years were treated in U.S. emergency departments for adverse events including overdoses associated with these medications 3

Specific Side Effects by Drug Class

Antihistamines

• Minimal to no efficacy for cough relief in children, in contrast to adults 4
• Preparations containing antihistamines are associated with adverse events including death from toxicity 4
• First-generation antihistamines cause cognitive impairment and antimuscarinic effects (dry mouth, urinary retention, constipation) 1

Dextromethorphan

• Associated with adverse events when used in young children 4
• FDA labeling explicitly states "do not use" in children under 4 years 5
• No proven superiority over honey for cough relief 4

Decongestants

• Extremely narrow therapeutic window in infants under 1 year 1
• Risk of cardiovascular and central nervous system toxicity 1, 2
• Can cause rhinitis medicamentosa (rebound congestion) as early as 3-4 days of use 2

Codeine and Opioid-Containing Products

• Potential for serious side effects including respiratory distress 4
• In 2018, FDA altered labeling to limit prescription opioid cough medicines to adults ≥18 years only 4, 1

Common Causes of Adverse Events

The mechanisms of harm are well-documented:

• Unintentional overdose from incorrect dosing, particularly common in young children 1
• Use of multiple products containing the same ingredients leading to cumulative toxicity 1, 3
• Intentional overdose (though less common in this age group) 1
• Unknown toxic dosage thresholds: The dosages at which these medications cause illness or death in children under 2 years are not established 3

Regulatory Response and Current Recommendations

The severity of this issue prompted coordinated action:

• 2007: FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended against use in children under 6 years 1
• 2007: Major manufacturers voluntarily removed products for children under 2 years from the market 1, 2
• 2008: Consumer Healthcare Products Association stated OTC cough and cold medications should not be used in children under 4 years 6
• Current FDA/AAP position: Do not use in children under 4 years; avoid in children 4-6 years 1

Evidence on Lack of Efficacy

Beyond safety concerns, these medications simply don't work:

• Controlled trials show antihistamine-decongestant combinations are not effective for upper respiratory tract infection symptoms in young children 1, 2
• OTC cough medications have little, if any, benefit in symptomatic control of acute cough in children 4, 1
• No FDA-approved dosing recommendations exist for children under 2 years because efficacy has not been established 3

Safe and Effective Alternatives

For Children Over 1 Year

• Honey provides more relief than no treatment, diphenhydramine, or placebo (though not superior to dextromethorphan) 4, 1, 2
• Honey should not be used in infants under 1 year due to botulism risk 1

For All Ages Under 6 Years

• Adequate hydration through continued breastfeeding or formula feeding helps thin secretions 2
• Gentle nasal suctioning clears secretions and improves breathing 2
• Supported sitting position during feeding and rest helps expand lungs 2
• Weight-based acetaminophen for fever and discomfort can help reduce coughing episodes 2
• Isotonic or hypertonic saline solutions provide modest benefit with minimal side effects 7

For Suspected Asthma (Chronic Cough with Wheeze)

• Trial of inhaled corticosteroids (400 mcg/day equivalent of budesonide or beclomethasone) with reassessment in 2-4 weeks 4
• Do not use increased doses if unresponsive 4
• Beta-2 agonists have no evidence of benefit for acute cough without airflow obstruction 1

Critical Clinical Pitfalls to Avoid

• Never prescribe topical decongestants in infants under 1 year due to cardiovascular and CNS toxicity risk 2
• Do not assume cough equals asthma and treat with bronchodilators without evidence of airflow obstruction 1
• Always ask caregivers about all medications being used to prevent overdose from multiple products containing the same ingredients 3
• Clinicians should use extreme caution when prescribing any cough/cold medication to children under 2 years, and only after careful consideration of risks versus unproven benefits 3
• Parents should not administer these medications without first consulting a healthcare provider and following instructions precisely 3

When to Escalate Care

Red flag symptoms requiring immediate medical attention include 2:

• Respiratory rate >70 breaths/minute
• Difficulty breathing, grunting, or cyanosis
• Oxygen saturation <92%
• Poor feeding or dehydration signs
• Persistent high fever (rectal temperature ≥100.4°F/38°C)