Dapagliflozin, Saxagliptin, and Metformin: Warning
Dapagliflozin, Saxagliptin, and Metformin: Warning
Dapagliflozin, Saxagliptin, and Metformin: Warning
Patient Education
What are some things I need to know or do while I take this drug?
Tell all of your health care providers that you take this drug. This includes your doctors,
nurses, pharmacists, and dentists. This drug may need to be stopped before certain types
of surgery as your doctor has told you. If this drug is stopped, your doctor will tell you
when to start taking this drug again after your surgery or procedure.
To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child
has been sitting or lying down. Have your child be careful going up and down stairs.
Do not drive if your blood sugar has been low. There is a greater chance of you having a
crash.
High cholesterol has happened with this drug. If you have questions, talk with the doctor.
Talk with your doctor before you drink alcohol.
It may be harder to control blood sugar during times of stress such as fever, infection,
injury, or surgery. A change in physical activity, exercise, or diet may also affect blood
sugar.
Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
You may see something that looks like the tablet in your stool. This is normal and not a
cause for concern. If you have questions, talk with your doctor.
Bladder cancer has happened in a few more people taking this drug than in those taking
other drugs for diabetes. It is not known if this drug led to these cases of bladder cancer.
Talk with your doctor.
Kidney problems have happened. Sometimes, these may need to be treated in the hospital
or with dialysis.
A severe and sometimes deadly pancreas problem (pancreatitis) has happened with other
drugs like this one.
A rare but very bad infection has happened with drugs like this one. This infection may be
deadly. Get medical help right away if your genitals or the area between your genitals and
rectum becomes tender, red, or swollen, and you have a fever or do not feel well.
Too much acid in the blood or urine (ketoacidosis) and severe urinary tract infections (UTIs)
have happened. Ketoacidosis can be deadly. Both of these may need to be treated in a
hospital.
A skin reaction called bullous pemphigoid has happened with drugs like this one.
Sometimes, people have had to go to the hospital. Call your doctor right away if you have
blisters or if your skin starts to break down.
Heart failure has happened in people taking this drug. Tell your doctor if you have ever had
heart failure or kidney problems. Call your doctor right away if you feel very tired or you
have shortness of breath, a big weight gain, or swelling in the arms or legs.
If you are 65 or older, use this drug with care. You could have more side effects.
There is a chance of pregnancy in women of childbearing age who have not been ovulating.
If you want to avoid pregnancy, use birth control while taking this drug.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly
side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following
signs or symptoms that may be related to a very bad side effect:
Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin
with or without fever; wheezing; tightness in the chest or throat; trouble breathing,
swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or
throat.
Signs of dehydration like dry skin, mouth, or eyes; thirst; fast heartbeat; dizziness; fast
breathing; or confusion.
Signs of kidney problems like unable to pass urine, change in how much urine is passed,
blood in the urine, or a big weight gain.
Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain,
or very bad upset stomach or throwing up.
Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing
urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or
pelvic pain.
Strong odor to urine.
For females, vaginal yeast infection. Report itching or discharge.
For men, yeast infection of the penis. Report pain, swelling, rash, or discharge.
Low blood sugar can happen. The chance may be raised when this drug is used with other
drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast
heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of
these signs. Follow what you have been told to do for low blood sugar. This may include
taking glucose tablets, liquid glucose, or some fruit juices.
Drugs like this one may cause joint pain that can be very bad and disabling. Call your
doctor right away if you have very bad joint pain or any joint pain that does not go away.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects.
Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not
go away:
Signs of a common cold.
Headache.
It is common to have stomach problems like upset stomach, throwing up, or diarrhea when
you start taking this drug. If you have stomach problems later during treatment, call your
doctor right away. This may be a sign of an acid health problem in the blood (lactic
acidosis).
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor.
Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at
https://www.fda.gov/medwatch.