
Lymphomas/Malignancies: Patients receiving mycophenolate alone or as part of an Immunosuppressants regimen are at increased risk of developing Lymphomas and other malignancies.
Neutropenia: Severe neutropenia (ANC less than 0.5 x 103/mcL) developed in up to 2% of renal transplant patients, up to 2.8% of cardiac transplant patients, and up to 3.6% of hepatic transplant patients receiving Mycophenolate 3 g daily.
Infections: All transplant patients are at increased risk of opportunistic infections.
Children: The type and frequency of adverse reactions in a clinical study of 100 pediatric patients 3 months to 18 years of age were generally similar to those observed in adult patients with the exception of abdominal pain, anemia, diarrhea, fever, hypertension, infection, leukopenia, pain, pharyngitis, respiratory tract infection, sepsis, and vomiting, which were observed in a higher proportion in pediatric patients.
Elderly: Elderly patients (65 years or older), may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly GI hemorrhage and pulmonary edema compared with younger individuals.
Post marketing: GI: Colitis, isolate cases of intestinal villous atrophy, pancreatitis.
Hematologic/Lymphatic: Cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia.
Respiratory: Interstitial lung disorders, including fatal pulmonary fibrosis.
Miscellaneous: Serious life-threatening infections, such as meningitis and infectious endocarditis. Congenital malformations, including ear, facial, cardiac, and nervous system malformations, and an increased incidence of first trimester pregnancy loss have been reported following exposure to mycophenolate during pregnancy.
View ADR Reporting Link