From the Guidelines
Acetaminophen (Tylenol) can be safely used in infants for pain relief, but with caution and careful monitoring.
Risks and Considerations
- The use of acetaminophen in infants should be guided by country- or region-specific neonatal prescribing guidelines to ensure a safe and legal dosage, monitoring, and weaning 1.
- Medical monitoring and resuscitation equipment should be available when administering acetaminophen to infants, especially for complex and ongoing pain management 1.
- Acetaminophen is not effective in stopping a seizure or preventing a subsequent febrile seizure in children who have experienced a febrile seizure, and its use in this context is not recommended 1.
- It is crucial to follow the recommended dosage and administration guidelines to minimize the risks associated with acetaminophen use in infants.
Safe Administration
- Acetaminophen can be used as a first-line medication for pain relief in infants, especially for degloved wounds, in conjunction with other medications such as oral morphine or oxycodone 1.
- Non-medication-based pain relief strategies, such as swaddling, patting, rocking, calm music, and singing, can be used as standalone relief or in conjunction with medication to support infant pain management 1.
From the FDA Drug Label
WARNINGS Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take Allergy alert: acetaminophen may cause severe skin reactions Symptoms may include: Do not use • with any other drugs containing acetaminophen (prescription or nonprescription).
The FDA drug label does not answer the question.
From the Research
Risks of Acetaminophen in Infants
- The use of acetaminophen in infants has been widely believed to be safe, but increasing evidence suggests that early life exposure to acetaminophen may cause long-term neurodevelopmental problems 2.
- A systematic review of 3096 papers found that none of the 52 experimental studies that tested the safety of acetaminophen in infants monitored neurodevelopment, and the median follow-up time was only 48 hours 2.
- Acetaminophen toxicity in children can occur due to intentional overdoses, unintended inappropriate dosing, or failure to recognize children at increased risk 3.
- The symptoms of acetaminophen intoxication are nonspecific, making diagnosis and treatment more likely to be delayed in unintentional cases of toxicity 3.
- Paracetamol overdose in newborns and infants can be a life-threatening event, and treatment with N-acetylcysteine is recommended 4.
- Parents often misdose acetaminophen, which can lead to unintended toxicity or inadequate symptomatic improvement, particularly in infants under 1 year old 5.
- Caregivers who base medication dosage on weight are less likely to give an inaccurate dose of medication, highlighting the importance of patient education 5.
Neurodevelopmental Risks
- Increasing evidence from studies in humans and laboratory animals indicates that the target organ for acetaminophen toxicity during early development is the brain, not the liver 2.
- The use of acetaminophen in infants has been linked to long-term neurodevelopmental problems, although the exact mechanisms are not fully understood 2.
Hepatotoxicity Risks
- Acetaminophen has not been associated with liver injury in neonates when used at recommended doses, but hepatotoxicity may occur after intake of a single high dose or multiple excessive doses 4.
- The treatment of choice for paracetamol poisoning is N-acetylcysteine, which reduces paracetamol hepatotoxic effects 4.