Mycophenolate Mofetil Tablets

• Tell all of your health care providers that you take this medicine (mycophenolate mofetil tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• There is a chance of skin cancer. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with this medicine (mycophenolate mofetil tablets). It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
• Some people treated with this medicine have had very bad kidney problems caused by a certain viral infection (BK virus). In people who have had a kidney transplant, BK virus infection may cause loss of the kidney. Call your doctor right away if you have signs of kidney problems like change in the amount of urine passed, difficulty or pain when passing urine, or blood in the urine.
• Hepatitis B or C testing may be done. A hepatitis B or C infection may get worse during care. Talk with the doctor.
• Bleeding, holes, and ulcers in the GI (gastrointestinal) tract have happened with this medicine (mycophenolate mofetil tablets). Sometimes, people have had to go to the hospital. Talk with the doctor.
• This medicine may cause loose stools (diarrhea). If you get loose stools (diarrhea), talk with your doctor about ways to lower this effect. Do not stop taking this medicine without talking with your doctor.
• If you are 65 or older, use this medicine (mycophenolate mofetil tablets) with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• If you are a man and have sex with a female who could get pregnant, you may need to protect her from pregnancy during care and for some time after care ends. Talk with your doctor.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use 2 kinds of birth control while taking this medicine.
• Use 2 kinds of birth control that you can trust during care and for 6 weeks after care ends.
• If you get pregnant while taking this medicine (mycophenolate mofetil tablets) or within 6 weeks after your last dose, call your doctor 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Chest pain or pressure.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Throwing up blood or throw up that looks like coffee grounds.
• Black, tarry, or bloody stools.
• A burning, numbness, or tingling feeling that is not normal.
• Muscle cramps.
• Very bad belly pain.
• Swelling.
• Pale skin.
• White patches in mouth.
• Vaginal itching or discharge.
• Yellow skin or eyes.
• Very bad and sometimes deadly lung problems have happened with this medicine. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.

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:

• Back pain.
• Hard stools (constipation).
• Headache.
• Dizziness.
• Loose stools (diarrhea).
• Not hungry.
• Belly pain.
• Gas.
• Feeling tired or weak.
• Shakiness.
• Upset stomach or throwing up.
• Not able to sleep.
• Joint pain.

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 the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (mycophenolate mofetil tablets) is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017