Dapagliflozin: Side Effects, Uses & Monitoring
Dapagliflozin and metformin hydrochloride extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic c
- Data source
- FDA labeling via NIH DailyMed (label 7d575ca8…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
Dapagliflozin and metformin hydrochloride extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin hydrochloride extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. • Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. • Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use • Dapagliflozin and metformin hydrochloride extended-release tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2 )]. • Because of the metformin HCl component, th…
Tests providers may use to monitor Dapagliflozin therapy
Conditions associated with Dapagliflozin in labeling
Chronic Kidney Disease
Progressive loss of kidney function over time, often caused by diabetes and hypertension, leading to buildup o...
Heart Failure
A condition in which the heart cannot pump blood effectively, leading to fluid buildup in the lungs and body a...
Type 1 Diabetes
An autoimmune condition in which the pancreas stops producing insulin, usually beginning in childhood or young...
Type 2 Diabetes
A chronic condition in which the body becomes resistant to insulin or does not produce enough insulin to maint...
Frequently Asked Questions
What is Dapagliflozin used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Dapagliflozin?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Dapagliflozin require lab monitoring?
Labeling and standard practice associate Dapagliflozin with periodic laboratory monitoring; the tests above are commonly ordered by clinicians to monitor patients on therapy. Your provider decides what is appropriate.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.