Is ibuprofen (nonsteroidal anti-inflammatory drug, NSAID) safe for a 4-month-old infant?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: April 3, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

From the Guidelines

No, you should not give ibuprofen to a 4-month-old baby. According to the American Family Physician journal, the main risk to children taking NSAIDs, such as ibuprofen, is dosage errors resulting in overdose, which can cause significant morbidity and death 1. For fever or pain relief in a 4-month-old, acetaminophen (Tylenol) is the appropriate medication option. The typical infant acetaminophen dosage is based on weight, usually 10-15 mg per kg of body weight every 4-6 hours as needed, not exceeding 5 doses in 24 hours.

  • Key considerations for medication administration in infants include:
    • Using the measuring device provided with the medication for accurate dosing
    • Avoiding combination cold medications that may contain NSAIDs
    • Storing medications in childproof containers
    • Parental education on correct dosing and dosing intervals Ibuprofen is not recommended for young infants because their kidneys are still developing, and the medication could potentially cause kidney damage. Additionally, very young infants metabolize medications differently than older children and adults. If your 4-month-old is experiencing discomfort or fever, consult with your pediatrician before administering any medication to ensure proper treatment and dosing for your baby's specific situation.

From the Research

Ibuprofen Administration to 4-Month-Old Infants

  • The safety and efficacy of ibuprofen in infants aged between 3 and 6 months have been assessed in a study published in 2017 2.
  • According to this study, short-term use of ibuprofen is considered safe in infants older than 3 months of age with a body weight above 5-6 kg, with special attention given to patient hydration.
  • The recommended dose is 5-10 mg/kg, administered 3-4 times a day, resulting in a maximum total daily dose of 30-40 mg/kg 2.
  • Another study published in 1999 compared the incidence of serious adverse clinical events among children under 2 years old given ibuprofen and acetaminophen to control fever, and found that the risk of hospitalization with any diagnosis did not vary by antipyretic assignment 3.
  • A retrospective cohort study published in 2018 found that gastrointestinal and renal adverse events were not higher in infants younger than six months who were prescribed ibuprofen compared with those aged six to 12 months 4.
  • However, the same study found that any gastrointestinal and moderate or severe gastrointestinal adverse events were more common in infants younger than six months who were prescribed ibuprofen versus acetaminophen alone 4.
  • A systematic review published in 2024 found that the efficacy of acetaminophen for ductus arteriosus closure is comparable to ibuprofen, with no statistically significant difference in the incidence of related adverse effects between the two drugs in most studies 5.
  • It is also important to consider the potential effects of repeated exposure to ibuprofen and acetaminophen on the intestinal immune response in young infants, as suggested by a study published in 2016 6.

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.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.