Table of Contents

I. What is Jardiance?

II. FDA Approval of Jardiance

III. Jardiance Side Effects

IV. Jardiance Drug interactions

V. Conclusion

Jardiance, known generically as empagliflozin, received FDA approval in 2014 to treat type 2 diabetes. Studies have found that Jardiance can lower blood sugar levels, reduce the risk of cardiovascular events, and even promote modest weight loss. [1]

But before starting any new medication, it's essential to understand its potential risks and benefits. In this article, we'll discuss Jardiance's safety information, including its FDA-approval process and common side effects. We'll also explore how Jardiance interacts with other drugs so you can be fully informed about your treatment options.

What is Jardiance?

Approved by the FDA in 2014, Jardiance comes as a convenient once-daily pill that can provide the following benefits:

• Lowers blood sugar levels in people with type 2 diabetes
• Reduces the risk of cardiovascular death in those with type 2 diabetes and heart disease
• Reduces the likelihood of hospitalization and death in people with heart failure
• Treats chronic kidney disease in adults. [1]

The active component in Jardiance is empagliflozin, which belongs to a new class of medications known as SGLT2 inhibitors. These drugs work by blocking a protein called SGLT2 in the kidneys.  [1]

Under normal circumstances, the SGLT2 protein reabsorbs glucose from the kidneys back into the body. However, for people with type 2 diabetes, excess glucose in the body can be problematic. By inhibiting SGLT2, Jardiance removes extra glucose from the body through urination, which helps lower blood sugar levels. [1]

FDA Approval of Jardiance

Before a new medication can be made available to patients, it must pass through a rigorous approval process by the Food and Drug Administration (FDA). This ensures the medication is safe and effective for its intended use. The approval process involves several phases of clinical trials, each with a specific focus.

• Phase 1 trials focus on the safety and dosage of the medication.

• Phase 2 trials determine the medication’s effectiveness in individuals with the condition the medication is treating.

• Phase 3 trials generate most data for the medication's labeling and package insert.  {{2}

Jardiance was FDA-approved in 2014 after successfully completing multiple clinical trial phases. [1] In the following sections, we'll explore some of the most important findings from these phases.

Jardiance Safety

In 2017, a review was conducted to evaluate the safety of empagliflozin based on clinical trials in phases 1 to 3. The review consisted of 12,620 participants who were given one of three medications: empagliflozin 10 mg, empagliflozin 25 mg, or a placebo medication. [2]

Overall, the review found that empagliflozin was generally safe and well-tolerated. The incidences of severe and fatal side effects were higher in the placebo group than in the empagliflozin group. [2]

However, there were some side effects that were more common in the empagliflozin groups than in the placebo group.

• Hypoglycemia (low blood sugar) was more common when empagliflozin was combined with sulfonylurea medications. No increased hypoglycemia risk occurred in empagliflozin patients not on sulfonylureas.

• Genital infections: The incidence of genital infections was higher in the empagliflozin groups than in the placebo group.

• Volume depletion: Older adults (above 75) using empagliflozin had higher rates of volume depletion.

• Increased red blood cells: the empagliflozin group experienced increased red blood cells, while the placebo group did not.

• Diabetic ketoacidosis: The cases of diabetic ketoacidosis were similar between the empagliflozin and placebo groups. However, ketone levels rose higher in the empagliflozin groups, leading to two participants discontinuing treatment.  [2]

In summary, the review found that empagliflozin (Jardiance) is a safe and well-tolerated medication for managing diabetes. [2] If you have any concerns or questions about the safety of empagliflozin, it's important to speak with your healthcare provider.

Jardiance Effectiveness

In 2013, researchers conducted a study to evaluate the effectiveness of Jardiance for type 2 diabetes. A total of 986 patients with inadequately controlled diabetes were given one of three medications:

• Jardiance 10 mg once daily
• Jardiance 25 mg once daily
• Placebo medication once daily [1]

After 24 weeks, the results showed clear benefits for those taking Jardiance compared to placebo:

• HbA1c reduced to less than 7% in 35% of patients taking 10 mg of Jardiance and 44% of patients taking 25 mg of Jardiance.

• Fasting plasma glucose (FPG) reduced by 19 mg/dL in patients taking Jardiance 10 mg and 25 mg/dL in patients taking Jardiance 25 mg.

• Body weight decreased by 2.8% in patients taking 10 mg of Jardiance and 3.2% in patients taking 25 mg of Jardiance. [1]

Overall, the study found that Jardiance helped significantly improve multiple measures of diabetes management compared to a placebo. [1]

Jardiance Side Effects

When taking Jardiance, it's important to be aware of potential side effects, monitor your health, and get medical care if needed. Like any prescription medication, Jardiance may cause some unwelcome effects. Being informed and attentive to your body's signals is critical.

• Diabetic ketoacidosis: This life-threatening condition requires immediate treatment. Stop taking Jardiance and call your doctor right away if you notice symptoms like nausea, vomiting, stomach pain, excessive fatigue, difficulty breathing, or ketones in your urine or blood. Getting prompt medical care can prevent complications from diabetic ketoacidosis.

• Dehydration: Jardiance causes the body to expel more fluids. Be sure to drink plenty of water while taking this medication. Contact your doctor if you have trouble staying hydrated or experience dizziness, weakness, or excessive thirst. Drinking enough fluids will help prevent dehydration.

• Urinary tract infections (UTIs): If left untreated, UTIs can become severe and lead to hospitalization. Pay attention to signs of a UTI, such as a burning feeling when urinating, needing to urinate frequently, pelvic pain, or blood in the urine. Let your healthcare provider know right away if you suspect a UTI. With proper treatment, most UTIs can be resolved quickly.

• Hypoglycemia or low blood sugar: You may have an increased risk of hypoglycemia if you’re taking Jardiance with insulin. Look out for telltale signs of hypoglycemia like headaches, sleepiness, weakness, dizziness, confusion, hunger, rapid heartbeat, sweating, and feeling shaky. 

• Allergic reactions: In rare cases, Jardiance can trigger allergic reactions in those sensitive to the medication. Seek emergency care if you develop any signs of a severe allergic reaction, such as a rash, raised red bumps on the skin, or swelling of the lips, face, mouth, or throat that makes breathing difficult. Stopping the medication and getting medical treatment can ease allergic reaction symptoms.

• Yeast infections: For women, watch for vaginal odor, abnormal discharge, or itching. Men should look for redness, itching, or swelling of the penis, rash, foul-smelling discharge, or penile pain. Prescription antifungal medication from your doctor can clear up a yeast infection. [3]

Being aware of potential side effects allows you to monitor your health closely while taking Jardiance. Reach out to your healthcare provider if any symptoms concern you—getting timely treatment can help prevent side effects from becoming serious. Your doctor is there to help you use Jardiance safely and effectively.

Jardiance Drug interactions

When you decide to incorporate Jardiance into your medication routine, it is crucial to inform your doctor about all other medications you are currently taking. This includes prescription drugs, over-the-counter medications, vitamins, and supplements. By doing so, you can avoid any potential drug interactions.

There are a few common drug interactions that you should be aware of when taking Jardiance:

• Diuretics: Taking Jardiance with diuretics can increase your urine volume and frequency. While this is a normal effect of both medications, staying mindful of your hydration levels is essential to prevent dehydration. Your doctor will evaluate your blood volume and renal function before starting you on Jardiance. Additionally, they will monitor you closely for any signs of decreased blood volume and renal function once you begin the medication.

• Insulin or insulin secretagogues: Jardiance combined with insulin or insulin secretagogues has been associated with a higher risk of hypoglycemia or low blood sugar. Your doctor may adjust your insulin dosage after you start Jardiance to reduce this risk. It's essential to follow your doctor's guidance and make the recommended changes to your insulin regimen.

• Lithium: Jardiance can speed up how quickly the kidneys remove lithium from the body. This may lower lithium levels to subtherapeutic concentrations. If you're on lithium, your doctor will likely check your lithium blood levels more often after starting Jardiance or changing your dosage. This allows them to ensure your lithium levels remain in the effective range. [1]

Remember, it is always important to have open and honest communication with your doctor about any medications you are taking. By reviewing all your medications with your doctor, you can work together to manage drug interactions safely. 

Conclusion

Jardiance can be a helpful medication for managing type 2 diabetes by improving blood sugar levels and reducing the risks of diabetes complications.

However, as with starting any new medication, discuss potential side effects and any other medications you take with your doctor to prevent problems. Staying informed and communicating with your healthcare team allows you to get the most out of your treatment.

To learn more about Jardiance, visit our dedicated Jardiance blog.

The content in this article is intended for informational purposes only. This website does not provide medical advice. In all circumstances, you should always seek the advice of your physician and/or other qualified health professionals(s) for drug, medical condition, or treatment advice. The content provided on this website is not a substitute for professional medical advice, diagnosis, or treatment.