Drug‐Associated Ketoacidosis: A Comprehensive Disproportionality Analysis Based on the FAERS Database
Authors' conclusion
The high-risk drugs for inducing ketoacidosis are mainly sodium-glucose cotransporter 2 (SGLT2) inhibitors (e.g., dapagliflozin and empagliflozin), followed by psychotropic drugs (e.g., quetiapine). Attention should also be paid to the potential risk of ketoacidosis induced by some drugs that do not mention this adverse reaction in their package inserts.
Study context
- Population
- Adverse event reports in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), Q1 2004 to Q2 2025; ketoacidosis-related Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms as outcomeadverse event reports
- Participants
- 22,375,298 reports
- Outcome
- Drugs with the closest association and highest signal strength for drug-induced ketoacidosis
Methodological detailsFAERS database, Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and Information Component (IC) (Bayesian Confidence Propagation Neural Network), time-to-onset analysis
- FAERS database
- ROR, PRR and IC (Bayesian Confidence Propagation Neural Network)
- Time-to-onset analysis
Main finding
As reported in the abstract
Drug-induced ketoacidosis signals
Ketoacidosis-related reports
6977
Top 50 drugs by ROR without ketoacidosis risk in package inserts
36
72%
Observational data: associations, not effects.
Further findings
Time to onset
- Incidence frequency stable with duration of medication: quetiapine, olanzapine, aripiprazole, pembrolizumab, empagliflozin/linagliptin, nivolumab
- Increased gradually over time: tirzepatide, alpelisib
- Decreased gradually with time: empagliflozin, canagliflozin and other drugs
Original publication
Drug‐Associated Ketoacidosis: A Comprehensive Disproportionality Analysis Based on the FAERS Database. Diabetes Obes Metab. Published 20 April 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →