PHARMACOLOGIC SURVEILLANCE STUDY OF FDA ADVERSE EVENT REPORTING SYSTEM (FAERS) EVENTS OF EMPAGOFLOZIN AND CANAGLIFLOZIN

Abstract

Therapeutic Area

Pharmacologic Therapy

Background

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are widely used to manage type 2 diabetes, heart failure, and chronic kidney disease by preventing glucose reabsorption in the renal tubules. These medications effectively reduce the risk of major adverse cardiovascular events. However, SGLT2 inhibitors have been associated with specific adverse events, necessitating a careful evaluation of their safety profiles.

Methods

Adverse event data for empagliflozin and canagliflozin from January 2016 to September 2024 were extracted from the FAERS database. Reported side effects analyzed included DKA, euDKA, bacterial UTIs, fungal urogenital infections, and Fournier's gangrene. RORs and 95% confidence intervals (CIs) were calculated to compare the relative risk of these adverse events for the two medications.

Results

The total reported adverse events for empagliflozin and canagliflozin were 32,471 and 16,322, respectively. Empagliflozin was associated with a significantly higher risk of euDKA (ROR 2.88, CI 2.47–3.35), bacterial UTIs (ROR 1.29, CI 1.15– 1.46), fungal urogenital infections (ROR 1.66, C 1.50–1.84), and Fournier's gangrene (ROR 1.91, CI 1.65–2.23) compared to canagliflozin. In contrast, empagliflozin demonstrated a lower risk of developing DKA compared to canagliflozin (ROR 0.81, CI 0.76–0.86). All findings were statistically significant.

Conclusions

Empagliflozin and canagliflozin are SGLT2 inhibitors with distinct safety profiles commonly used. Empagliflozin is associated with a higher risk of euDKA, bacterial UTIs, fungal urogenital infections, and Fournier's gangrene but a lower risk of DKA compared to canagliflozin. For patients with a predisposition to urinary tract infections (bacterial or fungal), canagliflozin may be preferred. Similarly, canagliflozin may be a better option for patients with uncontrolled diabetes due to its lower risk of euDKA. Individualized therapy based on patient- specific risk factors is recommended.