Infantile colic

Episodes of prolonged inconsolable crying in an otherwise healthy infant without identified organic cause. Rome IV criteria: ≥ 3 hours per day, ≥ 3 days per week, infant under 5 months. The condition is self-limited.

ICD-10 R10.41 drug

Also known as: Baby colic

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

DSimeticoneNot recommended · Drugs for functional bowel disorders. Antifoaming agentsSimethicone is an antifoaming agent: it lowers the surface tension of gas bubbles in the gut, so it is offered to babies for colic to ease bloating and crying. For this use no convincing benefit has been shown, and in good-quality studies simethicone eased colic no better than placebo. Infant colic responds more to reassurance and parental support, soothing techniques, and, when cow's milk protein allergy is suspected, a feeding change guided by the pediatrician. Simethicone is harmless here, but do not rely on it instead of approaches with proven benefit, since that can delay care for a condition that needs treatment.

How to read tiers A–F

Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit