Can Simethicone Be Given to Newborns?
Yes, simethicone can be administered to term newborns for gas symptoms, though the evidence shows it is no more effective than placebo for treating infantile colic.
Safety Profile
Simethicone is generally considered safe for use in newborns and infants. The FDA-approved drug label 1 indicates it is used for relief of pressure and bloating commonly referred to as gas, with no specific age restrictions listed. The medication has been studied in infants as young as 2 weeks of age 2.
Efficacy Considerations
The evidence regarding simethicone's effectiveness in newborns is disappointing:
A high-quality randomized, double-blind, placebo-controlled multicenter trial found simethicone was no more effective than placebo for infantile colic 2. In this study of 83 infants aged 2-8 weeks, 28% responded only to simethicone, 37% only to placebo, and 20% to both—with no statistically significant differences between groups.
A second double-blind crossover study confirmed these findings, showing no effect of simethicone on colic symptoms, though 67% of infants improved during treatment due to a high placebo effect 3.
A 2020 systematic review of reviews and guidelines concluded that simethicone had moderate to low evidence showing no benefit or negative effect for reducing crying time in colicky infants 4.
Important Caveats and Warnings
Potential Drug Interactions
Avoid concurrent use of simethicone with oral lactase treatment. A 2024 retrospective study found that simethicone reduced the efficacy of lactase treatment in infants with lactose intolerance 5. This is a critical consideration when evaluating gas symptoms that may be lactose-related.
Rare Adverse Event
One case report documented simethicone retinopathy in an immature infant, with retinal findings consistent with an embolic phenomenon possibly from systemic absorption 6. While extremely rare, this highlights that simethicone is not entirely without risk in vulnerable populations.
Clinical Algorithm
When a newborn presents with gas symptoms:
- Provide parental education and reassurance as first-line management (supported by national guidelines 4)
- Evaluate feeding technique and maternal diet if breastfeeding
- Consider probiotics if breastfed—strongest evidence for reducing crying time (25-65 minutes per 24 hours) 4
- Simethicone may be offered but counsel parents that it works no better than placebo
- Do NOT combine simethicone with lactase if lactose intolerance is suspected 5
Bottom Line
While simethicone can be safely administered to term newborns, its use should be considered primarily for parental reassurance rather than expected therapeutic benefit, given the robust evidence showing equivalence to placebo 2, 3, 4. Probiotics for breastfed infants have stronger evidence for symptom reduction 4.