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

From the Guidelines

You should not give ibuprofen to a 4-month-old baby due to safety concerns and potential risks to their developing kidneys and metabolism. The primary concern with administering ibuprofen to infants under 6 months of age is the potential for adverse effects, particularly on the kidneys, which are still developing at this age 1. Additionally, very young babies have different metabolism rates and may be more susceptible to side effects. For fever or pain in a 4-month-old, acetaminophen (Tylenol) is the only over-the-counter medication recommended, and should be given only at the appropriate weight-based dose using the infant formulation 1. Some key points to consider when deciding on a treatment for a 4-month-old include:

• The safety and efficacy of the medication
• The potential risks and side effects
• The age and weight of the child
• The guidance of a pediatrician Always consult your pediatrician before giving any medication to an infant this young, as they can provide personalized guidance on appropriate treatment options. It's also worth noting that while ibuprofen has been shown to be effective in reducing fever and pain in older children and adults, its use in infants under 6 months is not recommended due to the potential risks 1.

From the FDA Drug Label

Safety and effectiveness of ibuprofen tablets in pediatric patients have not been established

• Pediatric Use: The FDA drug label does not provide information on the safety and effectiveness of ibuprofen in pediatric patients, including 4-month-old infants.
• Key Consideration: The lack of established safety and effectiveness in pediatric patients means that ibuprofen should not be given to a 4-month-old without consulting a healthcare professional, as the potential risks and benefits are unknown 2.

From the Research

Ibuprofen Administration to Infants

• Ibuprofen can be administered to infants older than 3 months of age, with a body weight above 5-6 kg, when special attention is given to the hydration of the patient 3.
• The recommended dose of ibuprofen for infants is 5-10 mg/kg, which can be administered 3-4 times a day, resulting in a maximum total daily dose of 30-40 mg/kg 3.
• Ibuprofen should be prescribed based on body weight, and the rectal route is less reliable due to erratic absorption, especially in young infants 3.

Safety and Efficacy of Ibuprofen in Infants

• Short-term use of ibuprofen is considered safe in infants older than 3 months of age, with a low risk of adverse events 4, 5, 6.
• Ibuprofen has been shown to be effective in reducing fever and pain in infants, with a similar safety profile to acetaminophen 5, 6, 7.
• However, ibuprofen should not be given to patients with dehydration, diarrhea, and vomiting, or to those who are sensitive to it or other NSAIDs 4.

Comparison with Acetaminophen

• Ibuprofen and acetaminophen have similar efficacy and safety profiles for relieving moderate to severe pain and reducing fever in children, including infants 5, 6, 7.
• However, ibuprofen may be more effective than acetaminophen in reducing fever and pain in some cases, especially in children younger than 2 years 6.