Possible Side Effects of INVOKAMET®/INVOKAMET® XR
INVOKAMET®/INVOKAMET® XR may cause serious side effects, including:
Dehydration: INVOKAMET®/INVOKAMET® XR can cause some people to become dehydrated (the loss of too much body water). This may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk if you have low blood pressure, take medicines to lower blood pressure, are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older. Talk to your doctor about ways to prevent dehydration
Ketoacidosis (increased ketones in your blood or urine) has happened in people who have type 1 or type 2 diabetes, during treatment with canagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKAMET®/INVOKAMET® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing
Kidney problems. Sudden kidney injury has happened to people taking INVOKAMET®/INVOKAMET® XR. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long.
A high amount of potassium in your blood (hyperkalemia)
Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking canagliflozin, one of the medicines in INVOKAMET®/INVOKAMET® XR. Tell your doctor if you have signs or symptoms of a urinary tract infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have high fever, back pain, nausea, or vomiting
Low blood sugar (hypoglycemia). If you take INVOKAMET®/INVOKAMET® XR 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 taking INVOKAMET®/INVOKAMET® XR.
Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.
Vaginal yeast infection: Women taking INVOKAMET®/INVOKAMET® XR may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish discharge, or vaginal itching.
Yeast infection of the penis (balanitis or balanoposthitis): Men taking INVOKAMET®/INVOKAMET® XR may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash; foul smelling discharge; or pain in the skin around penis.
Serious allergic reaction: If you have any symptoms of a serious allergic reaction, stop taking INVOKAMET®/INVOKAMET® XR and call your doctor right away or go to the nearest hospital emergency room.
Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKAMET®/INVOKAMET® XR. Talk to your doctor about factors that may increase your risk of bone fracture.
Low vitamin B12 (vitamin B12 deficiency): Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood. Your doctor may do blood tests to check your levels.
The most common side effects of INVOKAMET®/INVOKAMET® XR include: changes in urination, including urgent need to urinate more often, in larger amounts, or at night; diarrhea, nausea and vomiting, gas, weakness, indigestion, upset stomach, or headache.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.