Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Jardiance

Last reviewed on RxList: 8/4/2020
Jardiance Side Effects Center

What Is Jardiance?

Jardiance (empagliflozin) is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2) used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Jardiance is also indicated to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.

What Are Side Effects of Jardiance?

Common side effects of Jardiance include:

Dosage for Jardiance

The recommended dose of Jardiance is 10 mg once daily in the morning, taken with or without food.

What Drugs, Substances, or Supplements Interact with Jardiance?

Jardiance may interact with diuretics, insulin or insulin secretagogues. Tell your doctor all medications and supplements you use.

Jardiance During Pregnancy and Breastfeeding

During pregnancy, Jardiance should be taken only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Jardiance (empagliflozin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Type 2 Diabetes: Signs, Symptoms, Treatments See Slideshow
Jardiance Consumer Information

3 pharmacies near 20147 have coupons for Jardiance (Brand Names:Jardiance for 10MG)

CVS Pharmacy
CVS Pharmacy
$662.09

Est. Regular Price

$372.5

with free coupon

View Coupon
Walgreens
Walgreens
$662.09

Est. Regular Price

$380.99

with free coupon

View Coupon
Walmart Pharmacy
Walmart Pharmacy
$662.09

Est. Regular Price

$433.77

with free coupon

View Coupon

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Call your doctor at once if you have:

  • little or no urination;
  • dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out);
  • ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
  • signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back.

Older adults may be more likely to have side effects from this medicine.

Common side effects may include:

  • bladder infection; or
  • vaginal yeast infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Jardiance (Empagliflozin Tablets)

QUESTION

______________ is another term for type 2 diabetes. See Answer
Jardiance Professional Information

SIDE EFFECTS

The following important adverse reactions are described below and elsewhere in the labeling:

  • Hypotension [see WARNINGS AND PRECAUTIONS]
  • Ketoacidosis [see WARNINGS AND PRECAUTIONS]
  • Acute Kidney Injury and Impairment in Renal Function [see WARNINGS AND PRECAUTIONS]
  • Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS]
  • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see WARNINGS AND PRECAUTIONS]
  • Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see WARNINGS AND PRECAUTIONS]
  • Genital Mycotic Infections [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Increased Low-Density Lipoprotein Cholesterol (LDL-C) [see WARNINGS AND PRECAUTIONS]

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.

Pool Of Placebo-Controlled Trials Evaluating JARDIANCE 10 And 25 mg

The data in Table 1 are derived from a pool of four 24-week placebo-controlled trials and 18-week data from a placebo-controlled trial with insulin. JARDIANCE was used as monotherapy in one trial and as add-on therapy in four trials [see Clinical Studies].

These data reflect exposure of 1976 patients to JARDIANCE with a mean exposure duration of approximately 23 weeks. Patients received placebo (N=995), JARDIANCE 10 mg (N=999), or JARDIANCE 25 mg (N=977) once daily. The mean age of the population was 56 years and 3% were older than 75 years of age. More than half (55%) of the population was male; 46% were White, 50% were Asian, and 3% were Black or African American. At baseline, 57% of the population had diabetes more than 5 years and had a mean hemoglobin A1c (HbA1c) of 8%. Established microvascular complications of diabetes at baseline included diabetic nephropathy (7%), retinopathy (8%), or neuropathy (16%). Baseline renal function was normal or mildly impaired in 91% of patients and moderately impaired in 9% of patients (mean eGFR 86.8 mL/min/1.73 m²).

Table 1 shows common adverse reactions (excluding hypoglycemia) associated with the use of JARDIANCE. The adverse reactions were not present at baseline, occurred more commonly on JARDIANCE than on placebo and occurred in greater than or equal to 2% of patients treated with JARDIANCE 10 mg or JARDIANCE 25 mg.

Table 1 : Adverse Reactions Reported in ≥2% of Patients Treated with JARDIANCE and Greater than Placebo in Pooled Placebo-Controlled Clinical Studies of JARDIANCE Monotherapy or Combination Therapy

Number (%) of Patients
Placebo
N=995
JARDIANCE 10 mg
N=999
JARDIANCE 25 mg
N=977
Urinary tract infectiona7.6%9.3%7.6%
Female genital mycotic infectionsb1.5%5.4%6.4%
Upper respiratory tract infection3.8%3.1%4.0%
Increased urinationc1.0%3.4%3.2%
Dyslipidemia3.4%3.9%2.9%
Arthralgia2.2%2.4%2.3%
Male genital mycotic infectionsd0.4%3.1%1.6%
Nausea1.4%2.3%1.1%
aPredefined adverse event grouping, including, but not limited to, urinary tract infection, asymptomatic bacteriuria, cystitis
bFemale genital mycotic infections include the following adverse reactions: vulvovaginal mycotic infection, vaginal infection, vulvitis, vulvovaginal candidiasis, genital infection, genital candidiasis, genital infection fungal, genitourinary tract infection, vulvovaginitis, cervicitis, urogenital infection fungal, vaginitis bacterial. Percentages calculated with the number of female subjects in each group as denominator: placebo (N=481), JARDIANCE 10 mg (N=443), JARDIANCE 25 mg (N=420).
cPredefined adverse event grouping, including, but not limited to, polyuria, pollakiuria, and nocturia
dMale genital mycotic infections include the following adverse reactions: balanoposthitis, balanitis, genital infections fungal, genitourinary tract infection, balanitis candida, scrotal abscess, penile infection. Percentages calculated with the number of male subjects in each group as denominator: placebo (N=514), JARDIANCE 10 mg (N=556), JARDIANCE 25 mg (N=557).

Thirst (including polydipsia) was reported in 0%, 1.7%, and 1.5% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.

Volume Depletion

JARDIANCE causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion. In the pool of five placebo-controlled clinical trials, adverse reactions related to volume depletion (e.g., blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope) were reported by 0.3%, 0.5%, and 0.3% of patients treated with placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively. JARDIANCE may increase the risk of hypotension in patients at risk for volume contraction [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Increased Urination

In the pool of five placebo-controlled clinical trials, adverse reactions of increased urination (e.g., polyuria, pollakiuria, and nocturia) occurred more frequently on JARDIANCE than on placebo (see Table 1). Specifically, nocturia was reported by 0.4%, 0.3%, and 0.8% of patients treated with placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.

Acute Impairment In Renal Function

Treatment with JARDIANCE was associated with increases in serum creatinine and decreases in eGFR (see Table 2). Patients with moderate renal impairment at baseline had larger mean changes [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

In a long-term cardiovascular outcome trial, the acute impairment in renal function was observed to reverse after treatment discontinuation suggesting acute hemodynamic changes play a role in the renal function changes observed with empagliflozin.

Table 2 : Changes from Baseline in Serum Creatinine and eGFRa in the Pool of Four 24-week Placebo-Controlled Studies and Renal Impairment Study

Pool of 24-Week Placebo-Controlled Studies
PlaceboJARDIANCE 10 mgJARDIANCE 25 mg
Baseline MeanN825830822
Creatinine (mg/dL)0.840.850.85
eGFR (mL/min/1.73 m²)87.387.187.8
Week 12 ChangeN771797783
Creatinine (mg/dL)0.000.020.01
eGFR (mL/min/1.73 m²)-0.3-1.3-1.4
Week 24 ChangeN708769754
Creatinine (mg/dL)0.000.010.01
eGFR (mL/min/1.73 m²)-0.3-0.6-1.4
Moderate Renal Impairmentb
PlaceboJARDIANCE 25 mg
Baseline MeanN187--187
Creatinine (mg/dL)1.49--1.46
eGFR (mL/min/1.73 m²)44.3--45.4
Week 12 ChangeN176--179
Creatinine (mg/dL)0.01--0.12
eGFR (mL/min/1.73 m²)0.1---3.8
Week 24 ChangeN170--171
Creatinine (mg/dL)0.01--0.10
eGFR (mL/min/1.73 m²)0.2---3.2
Week 52 ChangeN164--162
Creatinine (mg/dL)0.02--0.11
eGFR (mL/min/1.73 m²)-0.3---2.8
Post-treatment ChangecN98--103
Creatinine (mg/dL)0.03--0.02
eGFR (mL/min/1.73 m²)0.16--1.48
aObserved cases on treatment.
bSubset of patients from renal impairment study with eGFR 30 to less than 60 mL/min/1.73 m²
cApproximately 3 weeks after end of treatment.

Hypoglycemia

The incidence of hypoglycemia by study is shown in Table 3. The incidence of hypoglycemia increased when JARDIANCE was administered with insulin or sulfonylurea [see WARNINGS AND PRECAUTIONS].

Table 3 : Incidence of Overalla and Severeb Hypoglycemic Events in Placebo-Controlled Clinical Studiesc

Monotherapy (24 weeks)Placebo
(n=229)
JARDIANCE 10 mg
(n=224)
JARDIANCE 25 mg
(n=223)
Overall (%)0.4%0.4%0.4%
Severe (%)0%0%0%
In Combination with Metformin (24 weeks)Placebo + Metformin
(n=206)
JARDIANCE 10 mg + Metformin
(n=217)
JARDIANCE 25 mg + Metformin
(n=214)
Overall (%)0.5%1.8%1.4%
Severe (%)0%0%0%
In Combination with Metformin + Sulfonylurea (24 weeks)Placebo
(n=225)
JARDIANCE 10 mg + Metformin + Sulfonylurea
(n=224)
JARDIANCE 25 mg + Metformin + Sulfonylurea
(n=217)
Overall (%)8.4%16.1%11.5%
Severe (%)0%0%0%
In Combination with Pioglitazone +/- Metformin (24 weeks)Placebo
(n=165)
JARDIANCE 10 mg + Pioglitazone +/- Metformin
(n=165)
JARDIANCE 25 mg + Pioglitazone +/-Metformin
(n=168)
Overall (%)1.8%1.2%2.4%
Severe (%)0%0%0%
In Combination with Basal Insulin +/- Metformin (18 weeksd)Placebo
(n=170)
JARDIANCE 10 mg
(n=169)
JARDIANCE 25 mg
(n=155)
Overall (%)20.6%19.5%28.4%
Severe (%)0%0%1.3%
In Combination with MDI Insulin +/-Metformin (18 weeksd)Placebo
(n=188)
JARDIANCE 10 mg
(n=186)
JARDIANCE 25 mg
(n=189)
Overall (%)37.2%39.8%41.3%
Severe (%)0.5%0.5%0.5%
aOverall hypoglycemic events: plasma or capillary glucose of less than or equal to 70 mg/Dl
bSevere hypoglycemic events: requiring assistance regardless of blood glucose
cTreated set (patients who had received at least one dose of study drug)
dInsulin dose could not be adjusted during the initial 18 week treatment period

Genital Mycotic Infections

In the pool of five placebo-controlled clinical trials, the incidence of genital mycotic infections (e.g., vaginal mycotic infection, vaginal infection, genital infection fungal, vulvovaginal candidiasis, and vulvitis) was increased in patients treated with JARDIANCE compared to placebo, occurring in 0.9%, 4.1%, and 3.7% of patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively. Discontinuation from study due to genital infection occurred in 0% of placebo-treated patients and 0.2% of patients treated with either JARDIANCE 10 or 25 mg.

Genital mycotic infections occurred more frequently in female than male patients (see Table 1).

Phimosis occurred more frequently in male patients treated with JARDIANCE 10 mg (less than 0.1%) and JARDIANCE 25 mg (0.1%) than placebo (0%).

Urinary Tract Infections

In the pool of five placebo-controlled clinical trials, the incidence of urinary tract infections (e.g., urinary tract infection, asymptomatic bacteriuria, and cystitis) was increased in patients treated with JARDIANCE compared to placebo (see Table 1). Patients with a history of chronic or recurrent urinary tract infections were more likely to experience a urinary tract infection. The rate of treatment discontinuation due to urinary tract infections was 0.1%, 0.2%, and 0.1% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.

Urinary tract infections occurred more frequently in female patients. The incidence of urinary tract infections in female patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg was 16.6%, 18.4%, and 17.0%, respectively. The incidence of urinary tract infections in male patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg was 3.2%, 3.6%, and 4.1%, respectively [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Laboratory Tests

Increase In Low-Density Lipoprotein Cholesterol (LDL-C)

Dose-related increases in low-density lipoprotein cholesterol (LDL-C) were observed in patients treated with JARDIANCE. LDL-C increased by 2.3%, 4.6%, and 6.5% in patients treated with placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively [see WARNINGS AND PRECAUTIONS]. The range of mean baseline LDL-C levels was 90.3 to 90.6 mg/dL across treatment groups.

Increase In Hematocrit

In a pool of four placebo-controlled studies, median hematocrit decreased by 1.3% in placebo and increased by 2.8% in JARDIANCE 10 mg and 2.8% in JARDIANCE 25 mg treated patients. At the end of treatment, 0.6%, 2.7%, and 3.5% of patients with hematocrits initially within the reference range had values above the upper limit of the reference range with placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively.

Postmarketing Experience

Additional adverse reactions have been identified during postapproval use of JARDIANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Ketoacidosis [see WARNINGS AND PRECAUTIONS]
  • Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS]
  • Necrotizing Fasciitis of the Perineum (Fournier's gangrene) [see WARNINGS AND PRECAUTIONS]
  • Angioedema [see WARNINGS AND PRECAUTIONS]
  • Skin Reactions (e.g., rash, urticaria)

Read the entire FDA prescribing information for Jardiance (Empagliflozin Tablets)

Related Resources for Jardiance

© Jardiance Patient Information is supplied by Cerner Multum, Inc. and Jardiance Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

SLIDESHOW

Type 2 Diabetes: Signs, Symptoms, Treatments See Slideshow

Health Solutions From Our Sponsors