Drug-associated acute pancreatitis in paediatric versus adult reports: a disproportionality analysis using FAERS

While drug-associated acute pancreatitis is proportionally more prevalent in children than adults, age-stratified pharmacovigilance data remain limited. This study analysed paediatric-specific signals to improve recognition and safety. This study aimed to identify drugs associated with acute pancreatitis in children compared with adults and explored age-related differences in patterns using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). A retrospective disproportionality analysis was conducted on 29,349 reports (November 1970-February 2026) from the FAERS. The dataset included 2138 (7.3%) paediatric cases (0-17 years). Suspected active pharmaceutical ingredients (APIs) were identified, and reporting patterns were compared between age groups (chi-squared, reporting odds ratio (ROR), proportional reporting ratio (PRR), multivariate regression analysis). The top ten suspected drugs in children were as follows: methotrexate, pegaspargase, asparaginase, dexamethasone, acetaminophen, prednisone, vincristine sulphate, cytarabine, valproic acid, and mercaptopurine. Paediatric cases were primarily linked to oncologic and immunomodulatory treatments, whereas adult reports were mainly linked to antidiabetic and cardiovascular agents. Seven APIs present in the top 25 list of children and adults (dexamethasone, acetaminophen, prednisone, tacrolimus, lamivudine, didanosine, furosemide) showed significantly higher reporting proportions in children (p < 0.01). Dexamethasone, tacrolimus, and didanosine showed positive interaction terms with serious outcomes in adjusted models. Serious outcome and consumer-reporting were more common in neonates and infants.

Distinct age-dependent patterns were identified. These findings support paediatric-specific pharmacovigilance assessment and caution against direct extrapolation of adult spontaneous-reporting patterns to children. A clinically useful list of drugs with the highest reporting frequencies in children has been generated.

• Drug-associated acute pancreatitis is proportionally more prevalent in children. • The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) can be used to analyse and explore age-dependent patterns.

• The top ten suspected drugs in children were as follows: methotrexate, pegaspargase, asparaginase, dexamethasone, acetaminophen, prednisone, vincristine sulphate, cytarabine, valproic acid, and mercaptopurine, linked to oncology and immunomodulation. • Compared to adults, seven drugs (dexamethasone, acetaminophen, prednisone, tacrolimus, lamivudine, didanosine, furosemide) showed significantly higher reporting proportions in children. Dexamethasone, tacrolimus, and didanosine were associated with serious events.