What nonsteroidal anti-inflammatory drug (NSAID) is approved for use in pediatric patients over 6 months of age?

NSAIDs Approved for Pediatric Use Over 6 Months

Ibuprofen is the only NSAID approved by the FDA for use in children aged 3 months and older, making it the primary NSAID approved for pediatric patients over 6 months of age. 1

Primary Recommendation: Ibuprofen

• Ibuprofen is approved for children ≥3 months of age and is the only NSAID with this broad pediatric approval, making it the first-line choice for pain, fever, and inflammation in infants and children. 1, 2

• The drug should be dosed at 5-10 mg/kg per dose, administered 3-4 times daily, with a maximum total daily dose of 30-40 mg/kg. 2

• Ibuprofen has the lowest gastrointestinal toxicity among NSAIDs and demonstrates a favorable safety profile when used appropriately in the pediatric population. 3, 4

Alternative NSAIDs for Specific Pediatric Conditions

While ibuprofen is the primary FDA-approved option for infants over 6 months, other NSAIDs have FDA or EMA approval for specific pediatric age groups and conditions:

Naproxen (Preferred for Chronic Inflammatory Conditions)

• Naproxen is the preferred NSAID for chronic inflammatory conditions such as juvenile idiopathic arthritis in children, based on its established efficacy and safety profile. 5, 6

• The Pan-American League of Associations for Rheumatology specifically recommends naproxen over other selective COX-1 or COX-2 inhibitors for children with polyarticular JIA. 5

• Naproxen requires an adequate trial period of at least 8 weeks for inflammatory conditions, given the time course to response of approximately 1 month. 5

Other FDA/EMA-Approved Pediatric NSAIDs

If ibuprofen or naproxen are contraindicated or unavailable, the following NSAIDs have FDA or EMA approval for pediatric use and can be considered: 5

• Selective COX-1 inhibitors: indomethacin, meloxicam, tolmetin, etodolac, ketorolac, and oxaprozin
• Selective COX-2 inhibitors: celecoxib

Critical Safety Considerations

Absolute Contraindications

• Never use in neonates (ibuprofen is only approved for ≥3 months). 1
• Avoid in dehydrated patients or those with vomiting and diarrhea, as dehydration significantly increases the risk of renal damage. 1, 3
• Contraindicated in children with wheezing, persistent asthma, or during varicella infection. 1
• Do not use aspirin (acetylsalicylic acid) in children with JIA due to controversial efficacy, safety concerns, and toxicity risks, despite FDA approval. 5

Monitoring Requirements for Chronic Use

• CBC, liver function tests, and renal function tests every 6-12 months are conditionally recommended for children on long-term NSAID therapy. 5
• Ensure adequate hydration status before each dose, particularly in febrile or ill children. 1, 3

Clinical Algorithm for NSAID Selection in Pediatrics

For acute pain or fever in children ≥6 months:

• Start with ibuprofen 5-10 mg/kg per dose every 6-8 hours as needed. 2

For chronic inflammatory conditions (e.g., JIA):

• Use naproxen as first-line NSAID at age-appropriate dosing. 5, 6
• NSAIDs serve as adjunct therapy only—do not delay initiation of disease-modifying therapy (methotrexate) when treating JIA. 5

For postoperative pain:

• Ibuprofen or ketorolac can be used, though ketorolac use after tonsillectomy remains controversial due to bleeding risk concerns. 4

Common Pitfalls to Avoid

• Do not use ibuprofen as a routine antipyretic except in rare cases; it should be reserved for inflammatory pain conditions. 1
• Avoid combining NSAIDs with aspirin, anticoagulants, or corticosteroids, as this dramatically increases bleeding risk. 7
• Do not prescribe diclofenac routinely, as it lacks FDA or EMA approval for pediatric use, though it may be considered at physician discretion based on clinical experience. 5
• The rectal route for ibuprofen shows erratic absorption in young infants and should be avoided. 2