Mycophenolate mofetil is used to prevent organ rejection in people at least 3 months old who have received a liver, kidney, or heart transplant. Mycophenolate mofetil is also used with other medicines to prevent organ transplant rejection.

Mycophenolate mofetil may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to mycophenolate mofetil, mycophenolic acid, or polysorbate 80.

Talk with your doctor about the risks and benefits of mycophenolate mofetil. This medicine may increase your risk of cancer, serious or fatal infections, or a viral infection that can cause kidney transplant failure.

Tell your doctor if you have ever had:

• a stomach ulcer or problems with digestion, diabetes;
• hepatitis B or C or other viral infection (may become active or get worse while you are using mycophenolate mofetil);
• phenylketonuria, or PKU (the liquid form of this medicine may contain phenylalanine); or
• a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

This medicine can cause a miscarriage or birth defects, especially during the first 3 months of pregnancy. You will need to have a negative pregnancy test before and during treatment with this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolate mofetil, and for at least 6 weeks after your last dose. Sexually active men and their partners should use effective contraception during treatment and for at least 90 days after the last dose.

Mycophenolate mofetil can make birth control pills less effective. Ask your doctor about using an additional barrier form of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy.

You do not need to use additional birth control if you use an intrauterine device (IUD), if you have had a tubal ligation, or if your sexual partner has had a vasectomy.

This medicine comes with patient instructions about the most effective non-hormonal forms of birth control to use. Follow these directions carefully. Ask your doctor if you have any questions.

If a pregnancy occurs during treatment, do not stop taking mycophenolate mofetil. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).

Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are unable to use other needed transplant medications.

You should not breastfeed while using mycophenolate mofetil.

Use Mycophenolate Mofetil (Oral/Injection)(Intravenous,Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mycophenolate mofetil may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Mycophenolate mofetil affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have:

• fever of 100.5 degrees F or higher, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain, loss of smell or taste, stomach pain, vomiting, diarrhea, weight loss;
• weakness on one side of your body, loss of muscle control, confusion, thinking problems, loss of interest in things that normally interest you;
• pain around the transplanted kidney, pain or burning when you urinate, dark urine, jaundice (yellowing of the skin or eyes);
• tingly or painful blistering rash on one side of your body, swelling, warmth, redness, or oozing around a skin wound; or
• a new skin lesion, or a mole that has changed in size or color.

Also call your doctor at once if you have:

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, fever, joint stiffness and pain, and muscle pain; or
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

• stomach pain, nausea, vomiting, diarrhea, constipation, swelling in your ankles or feet, rash, pain anywhere in your body;
• headache, dizziness, tremors, fever, sore throat, cold symptoms, or other signs of infections; or
• abnormal blood tests, high blood sugar, high or low blood pressure, fast heart rate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Mycophenolate mofetil can make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a "live" vaccine while using mycophenolate mofetil. The vaccine may not work as well and may not fully protect you from disease.

You must not donate blood or sperm while using this medicine, and for at least 6 weeks (for blood) or 90 days (for sperm) after your last dose.