The following undesirable effects cover adverse reactions from clinical trials: The principal adverse reactions associated with the administration of mycophenolate mofetil in combination with cyclosporine and corticosteroids include diarrhea, leukopenia, sepsis, and vomiting, and there is evidence of a higher frequency of certain types of infections.
Malignancies: Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin. Lymphoproliferative disease or lymphoma developed in 0.4-1% of patients receiving mycophenolate mofetil capsules 250 mg (2 g or 3 g daily) in combination with other immunosuppressants in controlled clinical trials of renal (2 g), cardiac and hepatic transplant patients followed for at least 1 year. Non melanoma skin carcinomas occurred in 1.6-4.2% of patients; other types of malignancy occurred in 0.7-2.1% of patients. Three-year safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
Opportunistic infections: All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load. The most common opportunistic infections in patients receiving mycophenolate mofetil capsules 250 mg (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex. The proportion of patients with CMV viraemia/syndrome was 13.5%.
Children and adolescents (ages 2 to 18 years): The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patient given 1 g mycophenolate mofetil twice daily. However, the following treatment-related adverse events were more frequent in the paediatric population when compared to adults: abdominal pain, anemia, diarrhea, fever, hypertension, infection, leukopenia, pain, pharyngitis, respiratory tract infection, sepsis, and vomiting.
Elderly patients (≥ 65 years): Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression. Elderly patients receiving mycophenolate mofetil as part of a combination immunosuppressive regimen may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Other adverse reactions: Very common Adverse Reaction (>20%): Cardiovascular: Hypertension, hypotension, peripheral edema, edema, chest pain, tachycardia.
Central nervous system: Pain, headache, insomnia, fever, dizziness, anxiety.
Endocrine & metabolic: Hyperglycemia, hypercholesterolaemia, hypomagnesemia, hypokalemia, hypocalcemia, hyperkalemia.
Gastrointestinal: Abdominal pain, nausea, diarrhea, constipation, vomiting, anorexia, dyspepsia.
Genitourinary: Urinary tract infection.
Hematologic: Leucopenia, anemia, hypochromic, leukocytosis, thrombocytopenia.
Hepatic: Liver function tests abnormal, ascites.
Neuromuscular & skeletal: Back pain, weakness, tremor, paresthesia.
Renal: Creatinine increased, BUN increased, kidney function abnormal.
Respiratory: Dyspnea, respiratory tract infection, pleural effusion, cough, lung disorder, sinusitis.
Miscellaneous: Lactate dehydrogenase increased.
Common Adverse Reaction (3% to 20%): Cardiovascular: Angina, arrhythmia, arterial thrombosis, atrial fibrillation, atrial flutter, bradycardia, cardiac arrest, cardiac failure, CHF, extrasystole, facial edema, hyper/hypovolemia, pallor, palpitation, pericardial effusion, peripheral vascular disorder, postural hypotension, supraventricular tachycardia, syncope, thrombosis, vasospasm, venous pressure increased, ventricular extrasystole, ventricular tachycardia.
Central nervous system: Agitation, chills with fever, confusion, delirium, depression, emotional lability, hallucination, hypoesthesia, malaise, nervousness, seizure, somnolence, thinking abnormal, vertigo.
Dermatologic: Acne, alopecia, bruising, cellulitis, fungal dermatitis, hirsutism, petechia, pruritus, skin carcinoma, skin hypertrophy, skin ulcer, vesiculobullous rash.
Endocrine & metabolic: Acidosis, alkalosis, Cushing's syndrome, dehydration, diabetes mellitus, Gout, hypercalcemia, hyper/hypophosphataemia, hyperlipemia, hyperuricemia, hypochloremia, hypoglycemia, hyponatremia, hypothyroidism, parathyroid disorder.
Gastrointestinal: Abdomen enlarged, dysphagia, esophagitis, flatulence, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, gum hyperplasia, ileus, melena, mouth ulceration, oral moniliasis, stomach disorder, stomach ulcer, stomatitis, xerostomia, weight gain/loss.
Genitourinary: Impotence, nocturia, pelvic pain, prostatic disorder, scrotal edema, urinary frequency, urinary incontinence, urinary retention, urinary tract disorder.
Hematologic: Coagulation disorder, hemorrhage, neutropenia, pancytopenia, polycythemia, Prothrombin time increased, thromboplastin time increased.
Hepatic: Alkaline phosphatase increased, bilirubinemia, cholangitis, cholestatic jaundice, GGT increased, hepatitis, jaundice, liver damage, transaminases increased.
Neuromuscular and skeletal: Arthralgia, hypertonia, joint disorder, leg cramps, myalgia, myasthenia, neck pain, neuropathy.
Ocular: Amblyopia, cataract, conjunctivitis, eye hemorrhage, lacrimation disorder, vision abnormal.
Otic: Deafness, ear disorder, ear pain, tinnitus.
Renal: Albuminuria, creatinine increased, dysuria, hematuria, hydronephrosis, oliguria, Pyelonephritis, renal failure, renal tubular necrosis.
Respiratory: Apnea, asthma, atelectasis, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, hypoxia, respiratory acidosis, pharyngitis, pneumonia, pneumothorax, pulmonary edema, pulmonary hypertension, respiratory moniliasis, rhinitis, sputum increased, voice alteration.
Miscellaneous: Candida (mucocutaneous), CMV viremia/syndrome, CMV tissue invasive disease, Herpes zoster, cutaneous disease, cyst, diaphoresis, flu-like syndrome, healing abnormal, hernia, ileus infection, neoplasm, peritonitis, thirst.
Post-marketing and /or case report: Atypical mycobacterial infection, BK virus- associated-nephropathy, colitis, gastrointestinal perforation, infectious endocarditis, interstitial lung disorder, villous atrophy, lymphoma, lymphoproliferative disease, malignancy, meningitis, pancreatitis, progressive multifocal leukoencephalopathy (sometime fatal), pulmonary fibrosis (fatal), pure red cell aplasia, tuberculosis.