From the FDA Drug Label
Carcinogenesis Carcinogenesis was evaluated in 2-year studies conducted in CD-1 mice and Wistar rats. Empagliflozin did not increase the incidence of tumors in female rats dosed at 100,300, or 700 mg/kg/day (up to 72 times the exposure from the maximum clinical dose of 25 mg) In male rats, hemangiomas of the mesenteric lymph node were increased significantly at 700 mg/kg/day or approximately 42 times the exposure from a 25 mg clinical dose. Empagliflozin did not increase the incidence of tumors in female mice dosed at 100,300, or 1,000 mg/kg/day (up to 62 times the exposure from a 25 mg clinical dose) Renal tubule adenomas and carcinomas were observed in male mice at 1,000 mg/kg/day, which is approximately 45 times the exposure of the maximum clinical dose of 25 mg.
Key Findings:
- Empagliflozin did not increase the incidence of tumors in female rats and female mice.
- Hemangiomas of the mesenteric lymph node were increased in male rats at high doses.
- Renal tubule adenomas and carcinomas were observed in male mice at high doses.
Clinical Decision: Based on the available data from animal studies, there is a potential relationship between empagliflozin and an increased risk of certain tumors in male rats and mice at high doses. However, the clinical significance of these findings is unclear, and no conclusion can be drawn regarding the risk of cancer in humans taking Jardiance (empagliflozin) at the maximum clinical dose of 25 mg. 1
From the Research
Relationship between Jardiance (Empagliflozin) and Cancer
- The relationship between Jardiance (Empagliflozin) and cancer is still being researched, with some studies suggesting a potential increased risk of certain types of cancer, particularly bladder cancer 2, 3.
- A 2016 study found that empagliflozin may have a diuretic effect, which could lead to a reduction in cardiovascular mortality, but also noted that a risk of cancer, especially bladder cancer, cannot be ruled out 4.
- A 2017 systematic review and meta-analysis found that SGLT2 inhibitors, including empagliflozin, were not significantly associated with an increased risk of overall cancer, but may be associated with an increased risk of bladder cancer 2.
- A 2020 overview of quantitative systematic reviews found that SGLT2 inhibitors, as a class, were not associated with an increased risk of any cancer event, but empagliflozin was associated with an increased risk of bladder cancer in two reviews 3.
- A 2024 study found that empagliflozin was associated with a lower risk of cardiovascular events, but also found no difference in the short-term risks of bladder cancer 5.
- An earlier review in 2014 noted that the relationship between SGLT2 inhibitors and cancer is still inconclusive, and that studies with larger sample sizes, longer exposure durations, and different ethnicities are warranted to fully understand the potential risks 6.
Specific Cancer Types
- Bladder cancer: Some studies suggest a potential increased risk of bladder cancer associated with empagliflozin 2, 3.
- Breast cancer: Some early studies suggested a potential increased risk of breast cancer, but more recent studies have found no significant association 6.
- Other cancer types: The current evidence does not suggest a significant association between empagliflozin and other types of cancer, such as gastrointestinal cancer, prostate cancer, or skin cancer 2, 3, 5.