Is it safe to give ibuprofen (Nonsteroidal Anti-Inflammatory Drug (NSAID)) to infants less than 6 months old?

Ibuprofen Safety in Infants Under 6 Months

Ibuprofen should not be given to infants under 6 months of age as it is not FDA-approved for this age group and safety data is limited. 1

Safety Concerns for Infants Under 6 Months

• The FDA drug label for ibuprofen clearly states that "Safety and effectiveness of ibuprofen tablets in pediatric patients have not been established" 1
• Ibuprofen poses several specific risks in very young infants:
  • Immature renal function in young infants increases risk of kidney impairment 2
  • Dehydration, which is common in febrile infants, significantly increases the risk of renal damage when combined with ibuprofen 2
  • Gastrointestinal adverse events, though rare, can affect both upper and lower digestive tract 2

Evidence from Research Studies

• A 2018 retrospective cohort study found that infants under 6 months who received ibuprofen had higher rates of gastrointestinal adverse events compared to those who received acetaminophen alone (adjusted RR 1.25,95% CI 1.13-1.38) 3
• While a 2017 review suggested that short-term use of ibuprofen might be considered in infants older than 3 months weighing above 5-6 kg, this was only with special attention to hydration status and is not aligned with FDA approval 4
• The 2020 meta-analysis comparing acetaminophen and ibuprofen in children under 2 years found similar serious adverse event profiles, but this study did not specifically analyze safety in the under 6-month population 5

Specific Contraindications

• Ibuprofen should never be administered to infants who:
  • Are dehydrated or experiencing diarrhea/vomiting 2
  • Have sensitivity to NSAIDs 2
  • Have wheezing or persistent asthma 2
  • Have varicella (chickenpox) 2

Alternative Approaches

• For fever management in infants under 6 months:
  • Acetaminophen is the preferred antipyretic medication 3, 5
  • Proper dosing of acetaminophen should be based on weight rather than age 6
  • Non-pharmacological measures such as appropriate clothing and environmental temperature control should be considered 2

Important Clinical Considerations

• If treatment for pain or fever is necessary in infants under 6 months, acetaminophen is the safer alternative with established dosing guidelines 3, 5
• The use of ibuprofen as an antipyretic should be avoided in infants under 6 months except in rare cases where specifically indicated and after careful consideration of risks 2
• When evaluating medication options for infants, mortality and morbidity risks should always be prioritized over convenience factors such as dosing frequency 2, 3

Remember that while some research suggests ibuprofen might be used in infants as young as 3 months with careful monitoring, this contradicts the FDA labeling and should not be standard practice given the availability of safer alternatives.