CellCept Side Effects

Generic name: mycophenolate mofetil

Note: This document contains side effect information about mycophenolate mofetil. Some of the dosage forms listed on this page may not apply to the brand name CellCept.

Some side effects of CellCept 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: intravenous powder for injection, oral capsule, oral suspension, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking mycophenolate mofetil (the active ingredient contained in CellCept) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms;

• pale skin, easy bruising or bleeding, unusual weakness, trouble breathing, fast heart rate;

• bloody, black, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• painful or difficult urination;

• chest pain;

• feeling like you might pass out;

• problems with vision, speech, balance, or memory; or

• weakness in your legs, lack of coordination.

Less serious side effects of mycophenolate mofetil may include:

• nausea, vomiting, stomach pain, diarrhea, or constipation;

• headache, mild weakness;

• swelling in your hands or feet;

• numbness or tingly feeling; or

• anxiety, sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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 (the active ingredient contained in CellCept) 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 (the active ingredient contained in CellCept) (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 (the active ingredient contained in CellCept) 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 (the active ingredient contained in CellCept) 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 (the active ingredient contained in CellCept) induced myopathy have been reported.

Other

Abdominal pain has been reported to be a critical complication of mycophenolate mofetil (the active ingredient contained in CellCept) 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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