Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines to lower the body's natural immunity in patients who receive kidney transplants.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate prevents the white blood cells from rejecting the transplanted organ.

This medicine is available only with your doctor's prescription.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may lead to rejection of your transplanted organ.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine on an empty stomach, either 1 hour before or 2 hours after meals, unless your doctor tells you otherwise.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

If you are also using antacids that contain aluminum or magnesium (such as Maalox® or Mylanta®), do not use them at the same time as mycophenolate. If you have questions, talk with your doctor about the best times to use your medicines.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal or stomach pain or cramps

black, tarry stools

bladder pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blurred vision

body aches or pain

bone pain

burning or stinging of the skin

chest pain

cloudy urine

confusion

constipation

convulsions

cough

decrease in the amount of urine

decreased frequency or amount of urine

depression

difficult, burning, or painful urination

dizziness or lightheadedness

drowsiness

dry mouth

ear congestion

fainting

fast, pounding, or irregular heartbeat or pulse

fever or chills

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

incoherent speech

increase in heart rate

increased blood pressure

increased hunger

increased thirst

increased urination

joint pain, stiffness, or swelling

loss of appetite

loss of consciousness

loss of voice

lower back, side, or stomach pain

metallic taste

muscle cramps in the hands, arms, feet, legs, or face

muscle spasms or twitching

muscle weakness

nausea or vomiting

nervousness

noisy, rattling breathing

numbness and tingling around the mouth, fingertips, hands, or feet

painful blisters on the trunk of the body

painful cold sores or blisters on the lips, nose, eyes, or genitals

pale skin

pinpoint red spots on the skin

rapid breathing

red, tender, or oozing skin at incision

runny nose

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sunken eyes

sweating

swelling

swollen glands

thirst

tightness in the chest

tremor

trouble breathing at rest or with exertion

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

anxiety

back pain

belching

bleeding gums

blemishes on the skin

bruising

diarrhea

difficulty moving

excess air or gas in the stomach or intestines

facial hair growth in females

full feeling

full or round face, neck, or trunk

heartburn

increased hair growth, especially on the face

increased thirst or urination

indigestion

irritability

irritation in the mouth

itching skin

loose stools

loss of sexual desire or ability

menstrual irregularities

muscle pains or stiffness

pain

pain or tenderness around the eyes and cheekbones

passing gas

pimples

redness and swelling of the gums

shakiness in the legs, arms, hands, or feet

sleeplessness

sore mouth or tongue

stomach discomfort or upset

trouble sleeping

upper abdominal or stomach pain

white patches in the mouth or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that mycophenolate is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine and 8 to 10 days after using this medicine to make sure you are not pregnant. Your birth control pills may not work as well while you are using this medicine. You must use two forms of birth control together for the entire time that you are being treated, and for 6 weeks after you receive your last dose of this medicine. Use birth control pills together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

Mycophenolate can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

This medicine may increase your risk of developing rare and serious virus infections, such as shingles, herpes, cytomegalovirus (CMV) infection, BK virus-associated nephropathy (BKVAN), or polyoma virus-associated nephropathy (PVAN). CMV can cause serious tissue and blood infections. The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine, a decreased frequency or amount of urine, fever, increased thirst, loss of appetite, lower back or side pain, nausea, painful cold sores or blisters, sore throat, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

This medicine may cause reactivation of hepatitis B or C infection. Check with your doctor right away if you have the following symptoms while using this medicine: dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness.

While you are using this medicine, and after you stop, do not have any immunizations (vaccinations) without your doctor's approval. Mycophenolate will lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Do not stop taking this medicine without checking first with your doctor. Doing so may cause rejection of your transplanted organ. Your doctor will decide how long you should take this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.