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Characterizing pharmacobezoar formation: a descriptive analysis from VigiBase.

Massimo Carollo1, Nicoletta Luxi2, Salvatore Crisafulli1

  • 1Department of Diagnostics and Public Health, Clinical Pharmacology Unit, University of Verona, Verona, Italy.

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Pharmacobezoars, drug concretions in the GI tract, can cause serious adverse events. This analysis of 632 cases highlights their clinical severity and the frequent involvement of carbidopa/levodopa and psychotropic medications.

Keywords:
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Area of Science:

  • Pharmacology
  • Gastroenterology
  • Drug Safety

Background:

  • Pharmacobezoars are drug concretions in the GI tract, potentially causing obstruction and toxicity.
  • Understanding their occurrence and associated factors is crucial for patient safety.

Purpose of the Study:

  • To analyze reported cases of pharmacobezoars in the World Health Organization's VigiBase database.
  • To describe the characteristics and associated drugs in pharmacobezoar cases, including acute intoxications.

Main Methods:

  • Descriptive analysis of de-duplicated individual case safety reports of pharmacobezoars in VigiBase (1968-2025).
  • Subgroup analysis of cases involving drug overdose, misuse, or suicidal behavior.

Main Results:

  • 632 pharmacobezoar cases were analyzed, primarily in males (50.3%), median age 60.
  • Serious adverse drug reactions were reported in 68.4% of cases. Most frequent drugs: carbidopa/levodopa (23.4%), quetiapine (10.0%).
  • 158 acute intoxication cases involved females (65.2%), median age 43. Quetiapine, venlafaxine, and NSAIDs were common.

Conclusions:

  • Pharmacobezoars present with significant clinical severity and varied drug associations.
  • High prevalence of psychotropics necessitates targeted prevention in at-risk populations.
  • Increased clinical awareness for early recognition and management of pharmacobezoars is warranted.