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Does Jardiance (empagliflozin) cause side effects?
Common side effects of Jardiance include urinary tract infections (UTIs), female genital fungal infections, upper respiratory tract infection, increased cholesterol, joint pain, nausea, increased creatinine, increased urination, and volume depletion and associated conditions, which include dehydration, fainting, thirst, low blood pressure, and dizziness on standing (orthostatic hypotension).
Serious side effects of Jardiance include low blood pressure (hypotension), kidney failure, ketoacidosis, kidney infections (pyelonephritis), and low blood sugar (hypoglycemia) (when combined with insulin or sulfonylureas).
Drug interactions of Jardiance include diuretics, insulin or drugs that increase insulin secretion, and other SGLT2 inhibitors. Use of Jardiance has not been adequately evaluated in pregnant women. Jardiance is not recommended during the second and third trimesters of pregnancy. It is unknown if Jardiance is excreted in human breast milk. Jardiance is secreted in the milk of lactating rats, and exposure damages the developing kidneys in the rat fetus. Currently, the manufacturer does not recommend use of Jardiance while nursing.
What are the important side effects of Jardiance (empagliflozin)?
The most common side effects of Jardiance (empagliflozin) are:
- Urinary tract infections
- Female genital fungal infections
- Upper respiratory tract infection
- Increased cholesterol
- Joint pain
- Increased creatinine
- Increased urination
Other possible side effects of Jardiance include:
Volume depletion and associated conditions, which include:
Serious side effects of Jardiance include:
Jardiance (empagliflozin) side effects list for healthcare professionals
The following important adverse reactions are described below and elsewhere in the labeling:
- Acute Kidney Injury and Impairment in Renal Function
- Urosepsis and Pyelonephritis
- Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
- Genital Mycotic Infections
- Hypersensitivity Reactions
- Increased Low-Density Lipoprotein Cholesterol (LDL-C)
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.
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|
|Jardiance 10 mg
|Jardiance 25 mg
|Urinary tract infectiona||7.6%||9.3%||7.6%|
|Female genital mycotic infectionsb||1.5%||5.4%||6.4%|
|Upper respiratory tract infection||3.8%||3.1%||4.0%|
|Male genital mycotic infectionsd||0.4%||3.1%||1.6%|
aPredefined adverse event grouping, including, but not limited to, urinary tract infection, asymptomatic bacteriuria, cystitis
b Female 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).
c Predefined adverse event grouping, including, but not limited to, polyuria, pollakiuria, and nocturia
d Male 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.
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.
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.
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|
|Placebo||Jardiance 10 mg||Jardiance 25 mg|
|eGFR (mL/min/1.73 m2)||87.3||87.1||87.8|
|Week 12 Change||N||771||797||783|
|eGFR (mL/min/1.73 m2)||-0.3||-1.3||-1.4|
|Week 24 Change||N||708||769||754|
|eGFR (mL/min/1.73 m2)||-0.3||-0.6||-1.4|
|Moderate Renal Impairmentb|
|Placebo||Jardiance 25 mg|
|eGFR (mL/min/1.73 m2)||44.3||-||45.4|
|Week 12 Change||N||176||-||179|
|eGFR (mL/min/1.73 m2)||0.1||-||- 3.8|
|Week 24 Change||N||170||-||171|
|eGFR (mL/min/1.73 m2)||0.2||-||- 3.2|
|Week 52 Change||N||164||-||162|
|eGFR (mL/min/1.73 m2)||-0.3||-||- 2.8|
|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.
The incidence of hypoglycemia by study is shown in Table 3. The incidence of hypoglycemia increased when Jardiance was administered with insulin or sulfonylurea.
Table 3 Incidence of Overalla and Severeb Hypoglycemic Events in Placebo-Controlled Clinical Studiesc
|Jardiance 10 mg
|Jardiance 25 mg
|In Combination with Metformin
|Placebo + Metformin
|Jardiance 10 mg + Metformin
|Jardiance 25 mg + Metformin
|In Combination with Metformin + Sulfonylurea
|Jardiance 10 mg + Metformin + Sulfonylurea
|Jardiance 25 mg + Metformin + Sulfonylurea
|In Combination with Pioglitazone +/- Metformin
| Jardiance 10 mg + Pioglitazone +/- Metformin
|Jardiance 25 mg + Pioglitazone +/- Metformin
|In Combination with Basal Insulin +/- Metformin
|Jardiance 10 mg
|Jardiance 25 mg
|In Combination with MDI Insulin +/-Metformin
|Jardiance 10 mg
|Jardiance 25 mg
|a Overall hypoglycemic events: plasma or capillary glucose of less than or equal to 70 mg/dL
b Severe hypoglycemic events: requiring assistance regardless of blood glucose
c Treated set (patients who had received at least one dose of study drug)
d Insulin 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.
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. 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.
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.
What drugs interact with Jardiance (empagliflozin)?
Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
Insulin Or Insulin Secretagogues
Coadministration of empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.
Positive Urine Glucose Test
Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
Interference With 1,5-Anhydroglucitol (1,5-AG) Assay
Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
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Related Disease Conditions
Normal Blood Sugar Levels (Ranges) In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Diabetes Symptoms in Men
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Type 2 Diabetes
Type 2 diabetes is a chronic condition that may be reversible with diet and lifestyle changes. Symptoms include excessive thirst, frequent urination, weight loss, fatigue, and an unusual odor to your urine. Most people don't know they have type 2 diabetes until they have a routine blood test. Treatment options include medications, a type 2 diabetes diet, and other lifestyle changes.
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Having diabetes can mean early onset and increased severity of bladder symptoms (urinary incontinence and urinary tract infections) and changes in sexual function. Men may have erectile dysfunction; and women may have problems with sexual response and vaginal lubrication. Keep your diabetes under control, and you can lower your risk of sexual and urologic problems.
Eye Problems and Diabetes
Diabetes and eye problems are generally caused by high blood sugar levels over an extended period of time. Types of eye problems in a person with diabetes include glaucoma, cataracts, and retinopathy. Examples of symptoms include blurred vision, headaches, eye aches, pain, halos around lights, loss of vision, watering eyes. Treatment for eye problems in people with diabetes depend on the type of eye problem. Prevention of eye problems include reducing blood pressure, cholesterol levels, quitting smoking, and maintaining proper blood glucose levels.
Diabetes and Safe Medications for Colds and the Flu: OTC Medication Guide
If you have diabetes and catch a cold or the flu, can be more difficult to recover from infections and their complications, for example, pneumonia. Home remedies and over-the-counter (OTC) drugs used for the treatment of the signs and symptoms of colds and the flu may affect blood sugar levels in people with diabetes.Some medications are OK to take if you have diabetes get a cold or the flu include nonsteroidal anti-inflammatory drugs or NSAIDs, like acetaminophen (Tylenol) and ibuprofen (Motrin) to control symptoms of fever and pain. Most cough syrups are safe to take; however, check with your pediatrician to see what medications are safe to give your child if he or she has type 1 or 2 diabetes. If you have diabetes and are sick with a cold or flu, you need to check your blood sugar levels more frequently. Continue taking your regular medications. Eat a diabetic low-glycemic index diet rich in antioxidants. To prevent colds and the flu drink at least eight 8 ounce glasses of water a day. To replenish fluids, drink sports drinks like Gatorade and Pedialyte to replenish electrolytes. Avoid people who are sick, sneezing, coughing, or have other symptoms of a cold or flu.
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In the United States diabetes is the most common cause of kidney failure. High blood pressure and high levels of blood glucose increase the risk that a person with diabetes will eventually progress to kidney failure. Kidney disease in people with diabetes develops over the course of many years. albumin and eGFR are two key markers for kidney disease in people with diabetes. Controlling high blood pressure, blood pressure medications, a moderate protein diet, and compliant management of blood glucose can slow the progression of kidney disease. For those patients who's kidneys eventually fail, dialysis or kidney transplantation is the only option.
Type 2 Diabetes Medications (Side Effects, Differences)
Type 2 diabetes oral medications are prescribed to treat type 2 diabetes in conjuction with lifestyle changes like diet and exercise. There are nine classes of drugs approved for the treatment of type 2 diabetes. Examples of type 2 oral diabetes medications include acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Glucotrol XL), and metformin (Glucophage). Side effects, drug interactions, warnings and precautions, dosage, and breastfeeding and pregnancy safety information should be reviewed prior to taking any medication.
Tips for Managing Type 1 and 2 Diabetes at Home
Managing your diabetes is a full time commitment. The goal of diabetic therapy is to control blood glucose levels and prevent the complications of diabetes. Information about exercise, diet, and medication will help you manage your diabetes better. Blood glucose reagent strips, blood glucose meters, urine glucose tests, tests for urinary ketones, continuous glucose sensors, and Hemoglobin A1C testing information will enable you to mange your diabetes at home successfully.
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.