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: • skin reddening • blisters • rash Do not use • with any other drugs containing acetaminophen (prescription or nonprescription).
The risks associated with acetaminophen use in infants are not directly stated in the provided drug labels.
- Liver damage and severe skin reactions are potential risks associated with acetaminophen use, but it is not specified if these risks apply to infants. The FDA drug label does not answer the question.
From the Research
Risks Associated with Acetaminophen Use in Infants
- The use of acetaminophen in infants has been linked to potential long-term neurodevelopmental problems, as evidenced by studies in animal models and increasing evidence in humans 1.
- Despite its widespread use and perceived safety, acetaminophen has not been proven to be safe for neurodevelopment in infants, with most studies only assessing its safety for the pediatric liver 1.
- Acetaminophen toxicity can occur in infants due to intentional overdoses, unintentional inappropriate dosing, or failure to recognize children at increased risk 2.
- Newborns and infants who receive a single overdose of paracetamol are at low risk of serious hepatic damage if paracetamol concentrations are below the Rumack-Matthew nomogram limits, but those who have ingested multiple supratherapeutic doses should be managed with caution 3.
- The treatment of choice for paracetamol poisoning is N-acetylcysteine, which reduces paracetamol hepatotoxic effects, and should be given according to specific regimens through weight-based dosing tables 3.
Specific Risks and Considerations
- Elevated liver enzymes and acute liver injury can occur in infants and children due to acetaminophen ingestion, particularly in cases of intentional overdose 4.
- A positive history of acetaminophen ingestion is associated with a 28-fold higher risk for detectable acetaminophen blood level in children 4.
- The risk of hepatotoxicity is relatively low in young children with accidental intoxication and no positive history of acetaminophen ingestion 4.
- Acetaminophen use has also been linked to an increased risk of asthma in children and adults, with a pooled odds ratio of 1.63 (95% CI, 1.46 to 1.77) in a systematic review and meta-analysis 5.