JARDIANCE®
Side effects and safety
JARDIANCE® has a consistent and well-established safety profile across multiple trials in monotherapy or in combination therapy. Common adverse effects (AE) include:1
| Common AEs in monotherapy and combination therapy trials | |||
|---|---|---|---|
| Placebo (n=995) | JARDIANCE® 10 mg (n=999) | JARDIANCE® 25 mg (n=977) | |
| Urinary tract infection | 7.6% | 9.3% | 7.6% |
| UTIs*: Males | 3.2% | 3.6% | 4.1% |
| UTIs*: Females | 3.2% | 3.6% | 4.1% |
| Female genital mycotic infections | 1.5% | 5.4% | 6.4% |
| Upper respiratory tract infection | 3.8% | 3.1% | 4.0% |
| Increased urination | 1.0% | 3.4% | 3.2% |
| Dyslipidemia | 3.4% | 3.9% | 2.9% |
| Arthralgia | 2.2% | 2.4% | 2.3% |
| Male genital mycotic infections | 0.4% | 3.1% | 1.6% |
| Nausea | 1.4% | 2.3% | 1.1% |
JARDIANCE® demonstrated similar hypoglycemia rates compared with placebo. When used in combination with sulfonylurea or insulin, hypoglycemia rates were higher. Therefore, a lower dose of insulin or insulin secretagogues (eg, sulfonylureas) may be required to reduce the risk of hypoglycemia when JARDIANCE® is used in combination with these agents.1
| Hypoglycemia rates in trials up to 24 weeks | |||
|---|---|---|---|
| Placebo (n=229) | JARDIANCE® 10 mg (n=224) | JARDIANCE® 25 mg (n=223) | |
| Overall (plasma glucose ≤70 mg/dL) | 0.4% | 0.4% | 0.4% |
| Severe (requiring assistance regardless of blood glucose) | 0% | 0% | 0% |
| Add-on to metformin (24 weeks) | |||
| Placebo (n=206) | JARDIANCE® 10 mg (n=217) | JARDIANCE® 25 mg (n=214) | |
| Overall (plasma glucose ≤70 mg/dL) | 0.5% | 1.8% | 1.4% |
| Severe (requiring assistance regardless of blood glucose) | 0% | 0% | 0% |
| Add-on metformin + sulfonylurea (24 weeks) | |||
| Placebo (n=225) | JARDIANCE® 10 mg (n=224) | JARDIANCE® 25 mg (n=217) | |
| Overall (plasma glucose ≤70 mg/dL) | 8.4% | 16.1% | 11.5% |
| Severe (requiring assistance regardless of blood glucose) | 0% | 0% | 0% |
| Add-on basal insulin ± orals (18 weeks)*† | |||
| Placebo (n=170) | JARDIANCE® 10 mg (n=169) | JARDIANCE® 25 mg (n=155) | |
| Overall (plasma glucose ≤70 mg/dL) | 20.6% | 19.5% | 28.4% |
| Severe (requiring assistance regardless of blood glucose) | 0% | 0% | 1.3% |
Adverse events (AE) reported in the EMPEROR-Reduced trial was similar to those trials in patients with type 2 diabetes mellitus.2
Incidence of hypoglycemia was similar in JARDIANCE® group and in placebo group, and did not increase in patients without type 2 diabetes.
JARDIANCE® should not be used in patients with type 1 diabetes or who have or may have ketoacidosis. For full safety information, please refer to the JARDIANCE® approved package insert.1
Footnotes:
-
* Basal insulin study: No insulin adjustment during the first 18 weeks.
-
† Orals included metformin and/or sulfonylurea.
-
§ Safety analyses included all the patients who had received at least one dose of empagliflozin or placebo. The 4 patients in the placebo group who did not receive placebo were
excluded from the safety analyses. -
‡ Hypoglycemic was defined as a plasma glucose value of ≤ 70 mg/dL or that required assistance.
-
AE, adverse event.
References:
-
JARDIANCE® approved package insert. Updated in October 2020 and approved in August 2021.
-
Packer M et al. N Engl J Med. 2020;383(15):1413-1424.
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