Skip to content
ppharmaranks
Menu

Empagliflozin: uses, dosing, side effects & brands

Empagliflozin is a medicine sold in the U.S. under one brand, for type 2 diabetes mellitus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats
Type 2 Diabetes Mellitus
Available as
Tablet
Sold as
Jardiance
Prescription?
Prescription only
Generic available?
Not in our catalog
Half-life
about 12 hours (apparent terminal elimination half-life ~12.4 h)

Get treated for Empagliflozin conditions online

Licensed online providers — consult & get prescribed if eligible.

Advertising disclosure: We may earn a commission, at no extra cost to you. This never affects our ratings. Details

How empagliflozin is dosed

From the FDA label for Jardiance (application NDA204629). Other empagliflozin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Assess volume status and correct volume depletion before initiating ( 2.1 ) Recommended dose is 10 mg once daily in the morning, taken with or without food ( 2.2 ) For additional glycemic control, dose may be increased to 25 mg in patients tolerating JARDIANCE ( 2.2 ) 2.1 Prior to Initiation of JARDIANCE Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions (5.2) ] . In patients with volume depletion, correct this condition before initiating JARDIANCE [see Warnings and Precautions (5.2) , Use in Specific Populations (8.5 , 8.6) ]. 2.2 Recommended Dosage The recommended dose of JARDIANCE is 10 mg once daily in the morning, taken with or without food. For additional glycemic control, the dose may be increased to 25 mg in patients tolerating JARDIANCE. Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m 2 . Data are insufficient to provide a dosing recommendation in patients; who have type 2 diabetes and established cardiovascular disease with an eGFR less than 30 mL/min/1.73 m 2 , or who have heart failure with an eGFR less than 20 mL/min/1.73 m 2 [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6) ] . JARDIANCE is contraindicated in patients on dialysis [see Contraindications (4) ] .

Empagliflozin side effects

The following important adverse reactions are described below and elsewhere in the labeling: Ketoacidosis [see Warnings and Precautions (5.1) ] Volume Depletion [see Warnings and Precautions (5.2) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see Warnings and Precautions (5.5) ] Genital Mycotic Infections [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. JARDIANCE has been evaluated in clinical trials in patients with type 2 diabetes mellitus and in patients with heart failure. The overall safety profile of JARDIANCE was generally consistent across the…

Who shouldn’t take empagliflozin

Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.7) ] . Patients on dialysis [see Use in Specific Populations (8.6) ] . Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE ( 4 ) Patients on dialysis ( 4 )

Empagliflozin drug interactions

Table 3 Clinically Relevant Interactions with JARDIANCE Diuretics Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Intervention Before initiating JARDIANCE, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating JARDIANCE. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy. Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Intervention Coadministration of JARDIANCE with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during JARDIANCE initiation and dosage changes. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Intervention Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control. See full prescribing information for information on drug interactions and interference of JARDIANCE with laboratory tests. ( 7 )

Every empagliflozin product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Jardiance.

What empagliflozin pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Empagliflozin pill imprints
ImprintStrengthColourShape
S;1010 mgyellowround
S;1010 mgyellowround
S;2525 mgyellowoval

Combination products containing empagliflozin

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

Empagliflozin recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long empagliflozin keeps

No empagliflozin label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does empagliflozin expire? The in-use limits and storage rules from its labels

Empagliflozin and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Little information is available on the clinical use of empagliflozin during breastfeeding. Empagliflozin is an uncharged molecule that is 86% protein bound in plasma, so it is unlikely to pass into breastmilk in clinically important amounts. The manufacturer does not recommend empagliflozin during breastfeeding because of a theoretical risk to the infant's developing kidney. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Full LactMed record for empagliflozin: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised May 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about empagliflozin

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 10,473 reports naming empagliflozin, and the FDA flagged 90% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • euglycaemic diabetic ketoacidosis814 reports
  • acute kidney injury790 reports
  • diabetic ketoacidosis550 reports
  • nausea475 reports
  • vomiting469 reports
  • dyspnoea445 reports
  • diarrhoea432 reports
  • urinary tract infection422 reports

Read these as a signal, not a rate. A report does not mean empagliflozin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

How long empagliflozin stays in your system

The elimination half-life of empagliflozin is about 12 hours (apparent terminal elimination half-life ~12.4 h). Not a prodrug and has no active metabolite — the label reports no major metabolites in human plasma; empagliflozin is cleared mainly by UGT glucuronidation (to inactive conjugates) plus fecal and urinary excretion. Drug exposure rises when the kidneys or liver are impaired, so it clears more slowly: AUC increases roughly 18%/20%/66% in mild/moderate/severe renal impairment (and ~48% in dialysis patients), and roughly 23%/47%/75% in mild/moderate/severe hepatic impairment.

JARDIANCE (empagliflozin) tablet, film coated — FDA label, DailyMed

Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.

Related calculators

Frequently asked questions

What is empagliflozin?

JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the sodium-glucose co-transporter 2 (SGLT2).

How long does empagliflozin stay in your system?

The elimination half-life of empagliflozin is about 12 hours (apparent terminal elimination half-life ~12.4 h) — that is how long the body takes to clear half of a dose. Not a prodrug and has no active metabolite — the label reports no major metabolites in human plasma; empagliflozin is cleared mainly by UGT glucuronidation (to inactive conjugates) plus fecal and urinary excretion. Drug exposure rises when the kidneys or liver are impaired, so it clears more slowly: AUC increases roughly 18%/20%/66% in mild/moderate/severe renal impairment (and ~48% in dialysis patients), and roughly 23%/47%/75% in mild/moderate/severe hepatic impairment. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take empagliflozin with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run empagliflozin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does empagliflozin come in?

Across the brands we track, empagliflozin is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic empagliflozin?

We do not currently list a generic-labelled empagliflozin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Has empagliflozin been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions empagliflozin. The most recent: Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release… (Jun 12, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

What are the most common side effects of empagliflozin, and do any of them go away?

The most common are genital yeast infections (itching, soreness, discharge, or irritation under the foreskin) and urinary tract infections, plus more urination and thirst. The extra urination usually eases over the first few weeks as your body adjusts. Genital infections respond to standard antifungal treatment, but they can come back while you keep taking the drug, because empagliflozin works by pushing sugar out in your urine and sugar feeds yeast. This answer is for the oral tablet (Jardiance and its combination pills), the only form sold; the label's usual dose is 10 mg once daily in the morning, with or without food.

Which empagliflozin side effects mean go to the emergency room?

Two stand out. First, ketoacidosis, which with this drug class can happen even when your blood sugar reads below the level usually expected for it (under 250 mg/dL), so a near-normal glucose does not rule it out; the label records fatal cases in type 2 diabetes, not only type 1. Warning signs: nausea, vomiting, belly pain, feeling generally unwell, unusual tiredness, and shortness of breath or deep rapid breathing. Second, Fournier's gangrene, a rare necrotizing infection of the perineum: pain, tenderness, redness, or swelling between the genitals and anus plus fever or malaise. It needs urgent surgery. Also urgent: fever with flank or back pain (the label warns of pyelonephritis and urosepsis needing hospitalization), and swelling of the face, lips, or tongue, which the label lists as serious hypersensitivity including angioedema.

What raises the risk of ketoacidosis on empagliflozin, and how do I lower it?

The label names the precipitants: insulin dose reduction or missed insulin doses, acute febrile illness, reduced calorie intake, ketogenic eating, surgery, volume depletion, and alcohol abuse. FDA labeling directs withholding empagliflozin for at least 3 days before scheduled surgery or any procedure involving prolonged fasting, and restarting only once you are eating normally and the other risk factors have resolved. Do not stop insulin on your own if you use it. On sick days, keep fluids up, and if you can test ketones, test when you feel unwell even with a normal glucose reading. Empagliflozin is not recommended for type 1 diabetes because it raises ketoacidosis risk in that group.

What day-to-day steps reduce the problems with empagliflozin?

Take it in the morning so the extra urination does not wake you at night. Rinse and dry the genital area after urinating and change out of damp clothing; the label notes that a history of chronic or recurrent genitourinary infection makes another one more likely, so report itching early rather than waiting. Check your feet: the label carries a lower limb amputation warning and instructs monitoring for foot infections or ulcers, so get any sore, blister, or non-healing spot looked at promptly. Dizziness on standing usually means volume depletion, more likely if you also take a loop diuretic, are elderly, or have reduced kidney function; keep fluids up and ask about adjusting the diuretic. Empagliflozin alone rarely causes low blood sugar, but when added to insulin or a sulfonylurea, those doses often need lowering.

Cite this page
APA
pharmaranks. (2026, July 24). Empagliflozin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/empagliflozin
MLA
“Empagliflozin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/empagliflozin.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for empagliflozin on DailyMed (NIH) ↗.