Colicaid EZ (Simethicone) for Infantile Colic
Simethicone is not recommended for the treatment of infantile colic, as high-quality evidence demonstrates it is no more effective than placebo in reducing crying duration or severity of symptoms. 1, 2
Evidence Against Simethicone Use
The evidence consistently shows simethicone lacks efficacy for infantile colic:
A Cochrane systematic review found no difference in daily crying hours or response rates between simethicone and placebo (RR 0.95% CI 0.73 to 1.23), with low-quality evidence from multiple studies involving 110 infants 1
A large randomized, double-blind, placebo-controlled multicenter trial of 83 infants showed simethicone performed identically to placebo, with 28% responding only to simethicone, 37% only to placebo, and 20% to both—no statistically significant differences 2
Even when infants with "gas-related symptoms" were analyzed separately, simethicone showed no benefit over placebo 2
Multiple systematic reviews from 2012-2018 conclude there is little to no scientific evidence supporting simethicone use for infantile colic 3, 4
Recommended First-Line Management Instead
The American Academy of Pediatrics recommends behavioral and dietary interventions as first-line management, not medications 5, 6:
For Breastfed Infants:
- Maternal elimination diet restricting at least milk and eggs for 2-4 weeks may help alleviate symptoms 5, 6
For Formula-Fed Infants:
- Switch to extensively hydrolyzed protein or amino acid-based formula if cow's milk protein intolerance is suspected 5, 6
Behavioral Interventions:
- Gentle motion, rhythmic movement, and white noise can calm overstimulated infants 6
- Avoid overstimulation from excessive tactile, visual, auditory, and kinesthetic stimuli 6
- Reduce feeding volume while increasing frequency to minimize gastric distension 5
- Keep infant completely upright when awake and avoid seated positions after feeding 5
Critical Safety Considerations
This is the peak age (2-4 months) for abusive head trauma risk, with crying being the most common trigger 6:
- Nearly 6% of parents admit to smothering, slapping, or shaking their infant at least once because of crying 6
- Explicitly counsel parents that it is safe to put the baby down in a safe place and take a break if overwhelmed 6
When to Reassess
If crying persists beyond 4 months of age, reconsider the diagnosis and evaluate for other conditions such as gastroesophageal reflux disease or cow's milk protein allergy 7
Warning signs requiring immediate evaluation include 5, 6, 7:
- Bilious vomiting
- Gastrointestinal bleeding
- Consistently forceful vomiting
- Fever or lethargy
- Abdominal tenderness or distension
Close monitoring of weight gain is critical to ensure the infant continues to thrive despite excessive crying 5, 7
Common Pitfall to Avoid
Avoid overdiagnosis and overtreatment with medications like simethicone before trying conservative behavioral and dietary measures 5. The evidence clearly shows simethicone provides no benefit beyond placebo, and parents should be counseled about the benign, self-limiting nature of colic while implementing evidence-based behavioral interventions 4.