From the Guidelines
No antihistamines are generally recommended for infants under 6 months of age without specific medical supervision. The provided evidence 1 discusses the use of decongestants and antihistamines in various populations, but it does not specifically address the safety of antihistamines in infants under 6 months. However, it highlights the importance of cautious use of oral decongestants in young children due to potential side effects such as agitated psychosis, ataxia, hallucinations, and even death.
Given the lack of specific information on antihistamine use in infants under 6 months in the provided evidence, it is crucial to prioritize caution. Most over-the-counter antihistamines are not approved for use in babies younger than 6 months due to safety concerns and lack of dosing guidelines for this age group. The immature organ systems of young infants, particularly their liver and kidneys which metabolize and eliminate medications, make them more vulnerable to potential side effects.
If an infant is experiencing symptoms that might typically be treated with antihistamines, such as allergic reactions or congestion, it's essential to consult with a pediatrician first. They may recommend alternative approaches like:
- Saline drops for nasal congestion
- Gentle suctioning
- Humidifiers
- In some cases, might prescribe a specific medication with appropriate dosing for the baby's particular condition under careful monitoring.
The key consideration is the potential for significant side effects and the lack of established safety profiles for antihistamines in this very young age group, as indirectly suggested by the cautious approach to decongestant use in young children discussed in the evidence 1.
From the FDA Drug Label
Directions • take every 4 to 6 hours, or as directed by a physician• do not take more than 6 doses in 24 hours age/dose Adults and children over 12 years of age10 mL (25 mg) to 20 mL (50 mg) Children 6 to under 12 years of age10 mL (25 mg) Children under 6 years of ageDo not use
The FDA drug label does not answer the question.
From the Research
Antihistamine Safety for Infants Under 6 Months
- There is no clear evidence to support the use of any antihistamine as safe for infants under 6 months 2, 3, 4, 5, 6.
- Diphenhydramine, a first-generation antihistamine, has been associated with cardiac arrest and fatal intoxication in infants 2, 3.
- The use of antihistamines in children, especially those under 2 years of age, is often off-label due to a lack of data on drug safety 4.
- Adverse events associated with diphenhydramine in children, including those under 6 months, have been reported, with symptoms ranging from mild to severe, including seizures and death 5.
- A randomized, controlled trial found that diphenhydramine was no more effective than placebo in reducing nighttime awakenings or improving overall parental happiness with sleep for infants aged 6 to 15 months 6.
Considerations for Antihistamine Use in Infants
- The potential risks and benefits of antihistamine use in infants under 6 months should be carefully considered, and alternative treatments should be explored 2, 3, 4, 5, 6.
- Parents and caregivers should be aware of the potential dangers of administering antihistamines to infants, including the risk of overdose and adverse reactions 3, 5.