Possible risks and side effects of JANUVIA

What is the most important information you should know about JANUVIA?

Serious side effects can happen in people taking JANUVIA, including:

  • Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
    Before you start taking JANUVIA, tell your doctor if you have ever had:
    • pancreatitis
    • high blood triglyceride levels
    • stones in your gallbladder (gallstones)
    • kidney problems
    • a history of alcoholism

Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

  • Heart failure. Heart failure means your heart does not pump blood well enough.
    Before you start taking JANUVIA, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms:
    • increasing shortness of breath or trouble breathing, especially when you lie down
    • swelling or fluid retention, especially in the feet, ankles or legs
    • an unusually fast increase in weight
    • unusual tiredness

These may be symptoms of heart failure.

Who should not take JANUVIA?

JANUVIA should not be used in patients with type 1 diabetes. If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUVIA.

Do not take JANUVIA if you are allergic to any of the ingredients in JANUVIA. See the Medication Guide for a complete list of ingredients in JANUVIA.

Symptoms of a serious allergic reaction to JANUVIA may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

What are the possible side effects of JANUVIA?

JANUVIA may cause serious side effects, including:

  • See above “What is the most important information you should know about JANUVIA?”
  • Kidney problems, sometimes requiring dialysis.
  • Low blood sugar (hypoglycemia). If you take JANUVIA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include:
    • headache
    • drowsiness
    • irritability
    • hunger
    • dizziness
    • confusion
    • sweating
    • feeling jittery
    • weakness
    • fast heart beat
  • Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away or get emergency medical help. See above “Who should not take JANUVIA?”. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
  • Joint pain. Some people who take medicines called DPP-4 inhibitors like JANUVIA may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
  • Skin reaction. Some people who take medicines called DPP-4 inhibitors like JANUVIA may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking JANUVIA.

The most common side effects of JANUVIA include upper respiratory infection, stuffy or runny nose and sore throat, and headache.

JANUVIA may have other side effects, including stomach upset and diarrhea, swelling of the hands or legs, when JANUVIA is used with metformin and rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of JANUVIA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is JANUVIA?

JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes.

JANUVIA should not be used in patients with type 1 diabetes. If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUVIA.

Selected Risk Information About JANUVIA

Before you take JANUVIA, tell your doctor about all of your medical conditions. JANUVIA can cause serious side effects, including pancreatitis, which may be severe and lead to death. Before you start taking JANUVIA, tell your doctor if you’ve ever had pancreatitis. Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Before you start taking JANUVIA, tell your doctor if you have ever had heart failure (your heart does not pump blood well enough) or have problems with your kidneys. Contact your doctor right away if you have increasing shortness of breath or trouble breathing (especially when you lie down); swelling or fluid retention (especially in the feet, ankles, or legs); an unusually fast increase in weight; or unusual tiredness. These may be symptoms of heart failure.

Kidney problems, sometimes requiring dialysis, have been reported.

Do not take JANUVIA if you are allergic to any of its ingredients, including sitagliptin. Symptoms of serious allergic reactions to JANUVIA, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away or get emergency medical help.

Some people who take medicines called DPP-4 inhibitors like JANUVIA, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.

Some people who take medicines called DPP-4 inhibitors like JANUVIA may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking JANUVIA.

If you take JANUVIA with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include headache, drowsiness, irritability, hunger, dizziness, confusion, sweating, feeling jittery, weakness, and fast heart beat.

Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with JANUVIA. The most common side effects of JANUVIA are upper respiratory tract infection, stuffy or runny nose and sore throat, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for JANUVIA® (sitagliptin) tablets and discuss it with your doctor. The physician Prescribing Information also is available.

Having trouble paying for your Merck medicine? Merck may be able to help. Visit merckhelps.com.

What is JANUVIA® (sitagliptin)?

JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes.

JANUVIA should not be used in patients with type 1 diabetes. If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUVIA.

JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that,

JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes.

JANUVIA should not be used in patients with type 1 diabetes.

Selected Risk Information About JANUVIA® (sitagliptin)

Before you take JANUVIA, tell your doctor about all of your medical conditions. JANUVIA can cause serious side effects, including pancreatitis, which may be severe and lead to death. Before you start taking JANUVIA, tell your doctor if you’ve ever had pancreatitis. Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Before you start taking JANUVIA, tell your doctor if you have ever had heart failure (your heart does not pump blood well enough) or have problems with your kidneys. Contact your doctor right away if you have increasing shortness of breath or trouble breathing (especially when you lie down); swelling or fluid retention (especially in the feet, ankles, or legs); an unusually fast increase in weight; or unusual tiredness. These may be symptoms of heart failure.

Kidney problems, sometimes requiring dialysis, have been reported.

Do not take JANUVIA if you are allergic to any of its ingredients, including sitagliptin. Symptoms of serious allergic reactions to JANUVIA, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away or get emergency medical help.

Some people who take medicines called DPP-4 inhibitors like JANUVIA, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.

Some people who take medicines called DPP-4 inhibitors like JANUVIA may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking JANUVIA.

If you take JANUVIA with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include headache, drowsiness, irritability, hunger, dizziness, confusion, sweating, feeling jittery, weakness, and fast heart beat.

Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with JANUVIA. The most common side effects of JANUVIA are upper respiratory tract infection, stuffy or runny nose and sore throat, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for JANUVIA® (sitagliptin) tablets and discuss it with your doctor. The physician Prescribing Information also is available.

Having trouble paying for your Merck medicine? Merck may be able to help. Visit merckhelps.com.

Before you take JANUVIA, tell your doctor about all of your medical conditions. JANUVIA can cause serious side effects, including pancreatitis,

Before you take JANUVIA, tell your doctor about all of your medical conditions. JANUVIA can cause serious side effects, including pancreatitis, which may be severe and lead to death. Before you start taking JANUVIA, tell your doctor if you’ve ever had pancreatitis. Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.