Mycophenolate Side Effects
Please note - some side effects for Mycophenolate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects by Body System - for Healthcare Professionals
Applies to: intravenous powder for injection; oral capsule; oral suspension; oral tablet
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.
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 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 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.
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 side effects have included edema (12% to 28%), hyperphosphatemia (13%), hypokalemia (10%), hyperglycemia (10%), and hyperkalemia (9%).
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 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 side effects including a case of mycophenolate mofetil induced myopathy have been reported.
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 side effects including a case of mycophenolate sodium-induced hepatotoxicity have been reported.Top
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