Is ibuprofen (nonsteroidal anti-inflammatory drug (NSAID)) safe for infants under 12 months?

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Last updated: June 8, 2025 • View editorial policy

From the Research

Ibuprofen is not recommended for infants under 6 months of age, but can be used safely in infants 6-12 months old under medical supervision, with a typical dosage of 5-10 mg per kilogram of body weight every 6-8 hours, not exceeding 40 mg/kg per day, as supported by the most recent study 1.

Key Considerations

  • The safety and efficacy of ibuprofen in infants have been evaluated in several studies, with the most recent and highest quality study published in 2022 1 providing comprehensive guidance on the use of NSAIDs, including ibuprofen, in infants.
  • According to this study, ibuprofen can be used safely in infants older than 3 months with a body weight above 5-6 kg, with special attention to hydration, and a dose of 5-10 mg/kg administered 3-4 times a day, resulting in a maximum total daily dose of 30-40 mg/kg.
  • Another study published in 2017 2 also supports the safe use of ibuprofen in infants older than 3 months, with a dose of 5-10 mg/kg administered 3-4 times a day.
  • However, a study published in 2018 3 found that gastrointestinal and renal adverse events were more common in infants younger than six months who were prescribed ibuprofen compared to those prescribed acetaminophen alone.

Dosage and Administration

  • The typical dosage of ibuprofen for infants 6-12 months is 5-10 mg per kilogram of body weight every 6-8 hours, not exceeding 40 mg/kg per day.
  • Parents should always use infant-specific formulations and follow the dosing instructions carefully using the provided measuring device.
  • It's essential to consult a healthcare provider before giving ibuprofen to any infant, as they can recommend the appropriate dosage based on the child's exact weight and condition.

Important Precautions

  • Ibuprofen can mask fever, which is an important diagnostic sign in very young infants.
  • Always use ibuprofen only when necessary for fever over 102°F or significant discomfort, and never for more than 3 days without medical consultation.
  • Ibuprofen works by blocking enzymes that produce prostaglandins, which cause inflammation and pain, but its use in infants under 6 months is not recommended due to the potential risk of adverse effects on the developing kidneys and liver.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.