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Paracetamol orodispersible tablets: a risk for severe poisoning in children?
Alessandro Ceschi1, Katharina E Hofer, Christine Rauber-Lüthy
1Division of Science, Swiss Toxicological Information Centre, Freiestrasse 16, CH-8032, Zurich, Switzerland. Alessandro.Ceschi@usz.ch
Insights
Orodispersible paracetamol tablets pose a higher risk for severe poisoning in children compared to standard tablets. Increased accidental ingestion of these fast-dissolving formulations may lead to more childhood paracetamol poisoning cases.
Area of Science:
- Toxicology
- Pediatrics
- Pharmacology
Background:
- Childhood paracetamol (acetaminophen) overdose is a significant health concern.
- Investigating the specific risks associated with fast-disintegrating orodispersible paracetamol tablets in young children is crucial.
Observation:
- A retrospective study analyzed accidental ingestions of 500-mg paracetamol tablets in children under 6 years old.
- 187 cases involved standard tablets, while 16 involved orodispersible formulations.
- The mean ingested dose was 59% higher in the orodispersible group.
Findings:
- Children ingesting orodispersible paracetamol were more likely to receive recommendations for activated charcoal or N-acetylcysteine treatment.
- The orodispersible formulation group showed a higher incidence of potentially hepatotoxic doses (≥ 150 mg/kg).
Implications:
- Orodispersible paracetamol formulations may increase the risk of severe paracetamol poisoning in pediatric populations.
- The over-the-counter accessibility of these formulations could contribute to a rise in childhood poisoning incidents.
Purpose:
Childhood paracetamol (acetaminophen) ingestion with subsequent risk of hepatotoxicity is a major medical problem. The aim of this study was to investigate the risk of high-dose ingestion of orodispersible, fast-disintegrating paracetamol tablets in children.
Methods:
A retrospective single-center case study of all accidental selfadministrations of solid or orodispersible 500-mg paracetamol tablets occurring in children ≤ 6 years, reported to the Swiss Toxicological Information Centre between June 2003 and August 2009.
Results:
We found 187 cases with ingestion of solid 500-mg paracetamol tablets and 16 cases with ingestion of orodispersible 500-mg tablets. The mean ingested dose in the orodispersible-tablet group was 59% higher than in the solid-tablet group (p = 0.085). Administration of activated charcoal and/or N-acetylcysteine because of ingestion of a potentially hepatotoxic paracetamol dose ( ≥ 150 mg/kg body weight) was recommended in 32 patients (17.1%) in the solid-tablet group and in five (31%) in the orodispersible-tablet group.
Conclusions:
Orodispersible paracetamol formulations may represent an important risk factor for severe paracetamol poisoning in children. Over-the-counter availability may contribute to increasing the use of this galenic formulation and eventually the number of poisonings in children.
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