Mycophenolate mofetil Side Effects

Some side effects of mycophenolate mofetil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to mycophenolate mofetil: oral capsule, oral powder for suspension, oral tablet

Along with its needed effects, mycophenolate mofetil 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 while taking mycophenolate mofetil:

More common
  • Abdominal or stomach cramps or pain
  • 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
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • confusion
  • convulsions
  • cough or hoarseness
  • decreased urine
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • fever or chills
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • irregular heartbeats
  • irregular pulse
  • irritability
  • lightheadedness
  • loss of appetite
  • lower back or side pain
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle pain or cramps
  • muscle spasms (tetany) or twitching
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid weight gain
  • rapid, shallow breathing
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain and bloating
  • sweating
  • swollen glands
  • tightness in the chest
  • tingling of the hands or feet
  • trembling
  • tremor
  • troubled breathing with exertion
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness or heaviness of the legs
Incidence not known
  • Back pain
  • constipation
  • coughing or spitting up blood
  • darkened urine
  • general feeling of illness
  • indigestion
  • night sweats
  • pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • severe headache
  • sudden high fever or low-grade fever for months
  • tenderness
  • watery or bloody diarrhea
  • yellow eyes or skin

Some side effects of mycophenolate mofetil 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
  • belching
  • fear
  • heartburn
  • lack or loss of strength
  • rash
  • trouble sleeping
  • weight loss

For Healthcare Professionals

Applies to mycophenolate mofetil: intravenous powder for injection, oral capsule, oral suspension, oral tablet

Gastrointestinal

Gastrointestinal side effects appear to have been dose related.

A well designed, placebo-controlled study of mycophenolate (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for prevention of acute renal allograft rejection reported a similar frequency of adverse events. There was a trend towards more diarrhea (16% vs. 12%), nausea (6% vs. 3%), gastroenteritis (4% vs. 1%), and vomiting (4% vs. 1%) in the mycophenolate group, especially with the higher dose. Gastrointestinal, rectal, and duodenal hemorrhage, hemorrhagic pancreatitis and large intestine perforation occurred rarely and only in the mycophenolate mofetil group. In general, adverse effects occurred with a higher frequency as the dose was increased above 2 grams per day. Mycophenolate mofetil should be used cautiously in patients with active gastrointestinal disease.

Gastrointestinal side effects including diarrhea (36%), nausea (20%), and vomiting (13%) have been the most common side effects. A case of mycophenolate mofetil-induced ischemic colitis also has been reported.

Hematologic

A well designed, placebo-controlled study noted that hematologic adverse events resolved within one week. Hematologic side effects tend to occur early in the course of treatment and be dose-related. Careful monitoring of hematologic parameters may be warranted early in the course of therapy.

A well designed, placebo-controlled study of mycophenolate mofetil (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for prevention of acute renal allograft rejection reported a similar frequency of adverse events. A trend towards higher frequencies of leukopenia (11% to 14%) and anemia (4% to 7%) were reported in the active groups. Pancytopenia and agranulocytosis occurred rarely. The proportion of patients with leukopenia between 31 and 180 days after transplantation was 3 times higher in the mycophenolate mofetil group. All observed hematologic effects resolved within one week. Adverse effects occur with a higher frequency as the dose exceeds 2 grams/day.

Hematologic side effects have included dose-related leukopenia (11% to 35%), anemia (25%), and thrombocytopenia (9%). Severe neutropenia has occurred in up to 2% of patients. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents. A case in of mycophenolate mofetil causing deep venous thrombosis has also been reported.

Immunologic

Immunologic side effects have included immunosuppression. Immunosuppression associated with therapy has resulted in sepsis (primarily cytomegalovirus viremia) in approximately 20% of patients. Other opportunistic infections have included herpes simplex virus (18%), herpes zoster (7%), and invasive candidal infections (1%).

On a positive note, mycophenolate has been found to delay the recurrence of hepatitis C in liver transplant recipients.

Immunosuppression appeared to be dose-related.

In three controlled studies for the prevention of rejection, similar rates of fatal infections/sepsis (less than 2%) occurred in patients receiving mycophenolate mofetil or the control drug (usually azathioprine) in addition to other immunosuppressives. A well designed, placebo-controlled study of mycophenolate mofetil (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for the prevention of acute renal allograft rejection reported a similar frequency of adverse events. Cytomegalovirus tissue-invasive disease (7%), herpes zoster (7%), and herpes simplex (15%) showed a trend towards a higher frequency in the mycophenolate mofetil group. In general, adverse effects occur with a higher frequency as the dose is increased above 2 grams per day.

Oncologic

Oncologic side effects including lymphoma and lymphoproliferative disease (1%) and non-melanoma skin carcinoma (2% to 4%) have been associated with therapy.

The incidence of new malignancies in patients receiving mycophenolate mofetil followed for greater than 1 year was similar to that reported in the literature for renal allograft recipients.

Renal

Epinette, et al reported a long-term follow up (to 13 years) of patients treated with mycophenolate mofetil on a compassionate-use basis for psoriasis. Dosages averaged between 3 and 4 grams daily (range 2 to 7 grams), higher than the currently recommended dose for renal transplant patients. Dysuria, urgency, and frequency occurred in 28% of patients during the first year and decreased to less than 5% thereafter. Subsequent dose reductions after the first year lessened renal adverse effects considerably.

Renal side effects have included urinary tract infections (37% to 45%), hematuria (13%), and kidney tubular necrosis (6% to 10%).

BK virus-associated nephropathy has been reported. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.

Metabolic

Metabolic side effects have included edema (12% to 28%), hyperphosphatemia (13%), hypokalemia (10%), hyperglycemia (10%), and hyperkalemia (9%).

Respiratory

Respiratory system side effects have included respiratory infection (23%), dyspnea (16%), and increased cough (16%). A case of primary tuberculosis one year after conversion from azathioprine to mycophenolate mofetil has also been reported.

Dermatologic

Dermatologic side effects including acne (10%) and rash (8%) have been reported in clinical trials. A case of dyshidrotic eczema has been reported. A case of papulosquamous psoriatic-like skin eruption has also been reported.

Musculoskeletal

Musculoskeletal side effects including a case of mycophenolate mofetil induced myopathy have been reported.

Other

Abdominal pain has been reported to be a critical complication of mycophenolate mofetil in renal transplant recipients.

Other side effects have included abdominal pain and postmarketing reports of congenital malformations and an increased incidence of first trimester pregnancy loss.

Hepatic

Hepatic side effects including a case of mycophenolate sodium-induced hepatotoxicity have been reported.

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