At what age can ibuprofen (nonsteroidal anti-inflammatory drug (NSAID)) be used in infants?

Ibuprofen Use in Infants: Age Restrictions

Ibuprofen should not be used in infants younger than 6 months of age due to safety concerns and limited efficacy data in this population. 1

Safety Considerations for Ibuprofen in Infants

Age Restrictions

• Ibuprofen is only approved for use in children aged ≥3 months in some countries 2
• However, most clinical evidence supports safety only in infants older than 6 months of age 1
• When used in infants 3-6 months, special conditions must be met:
  • Body weight must be above 5-6 kg
  • Patient must be well-hydrated
  • Short-term use only 1

Risk Factors for Adverse Events

• Dehydration significantly increases risk of renal damage 2
• Ibuprofen should never be administered to infants with:
  • Diarrhea and vomiting (with or without fever)
  • Known sensitivity to NSAIDs
  • Wheezing or persistent asthma
  • During varicella (chickenpox) infection 2, 3

Adverse Effects in Young Infants

The safety profile of ibuprofen in very young infants raises several concerns:

1. Gastrointestinal effects:

   • Higher risk of GI adverse events in infants under 6 months compared to acetaminophen (adjusted RR 1.25,95% CI 1.13-1.38) 4
   • Rare but potentially serious events include both upper and lower digestive tract lesions 2

2. Renal effects:

   • Increased risk of acute renal failure when used in hypovolemic states 3
   • Dehydration is a major trigger for renal damage 2

3. Infectious complications:

   • Increased risk of invasive group A streptococcal infection after chickenpox 3

Alternative Options for Infants

For infants younger than 6 months, acetaminophen is generally the preferred antipyretic and analgesic option:

• Lower risk of GI and renal adverse events 4
• Better established safety profile in very young infants

Appropriate Use When Necessary

If ibuprofen must be used in infants older than 6 months:

• Dose based on body weight: 5-10 mg/kg
• Can be administered 3-4 times daily
• Maximum total daily dose: 30-40 mg/kg
• Oral route preferred over rectal (which has erratic absorption) 1
• Ensure proper hydration status before administration
• Use for shortest duration necessary

Key Takeaway

While ibuprofen is effective for inflammatory pain in older children, its use in infants requires caution. The risk-benefit profile strongly favors avoiding ibuprofen in infants younger than 6 months of age, with acetaminophen being the safer alternative for fever and pain management in this vulnerable population.