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Clozapine-Related Appendicitis: UK Pharmacovigilance Data, 1992-2022.
Robert James Flanagan1, Simon Alfred Handley2, Charlotte James3
1Precision Medicine, Networked Services, Third Floor, Bessemer Wing, King's College Hospital, Denmark Hill, London, UK.
Journal of Clinical Psychopharmacology
|September 17, 2025
Summary
Clozapine use is linked to appendicitis, often a sign of harmful gastrointestinal hypomotility (CIGH). Monitoring bowel function and ensuring laxative adherence are crucial for patients on clozapine.
Area of Science:
- Psychopharmacology
- Gastroenterology
- Drug Safety
Background:
- Appendicitis has been anecdotally linked to clozapine use.
- Previous associations lacked systematic investigation.
- Clozapine is an atypical antipsychotic with known gastrointestinal side effects.
Purpose of the Study:
- To systematically document and analyze cases of appendicitis/appendectomy associated with clozapine.
- To investigate the characteristics and potential mechanisms of clozapine-induced appendicitis.
Main Methods:
- Audit of UK MHRA Yellow Card reports from 1992-2022.
- Focused on reports classified as clozapine-related gastrointestinal disorders.
- Analysis of 65 unique cases of appendicitis/appendectomy in patients taking clozapine.
Main Results:
- 65 cases of clozapine-associated appendicitis/appendectomy were identified.
- Commonly reported symptoms included abdominal pain, constipation, ileus, and intestinal obstruction.
- Appendectomy was performed in 59 cases; peritonitis and death were noted in some instances.
Conclusions:
- Appendicitis in clozapine users often indicates harmful clozapine-induced gastrointestinal hypomotility (CIGH).
- This complication can occur at any point during clozapine treatment.
- Close monitoring of bowel function and consistent laxative use are essential for clozapine prescribers.
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