| Document Date: 2013-10-01 08:25:54
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City Disorder Reference / Reference / / Company Either Treatment Group / SUSPECTED ADVERSE REACTIONS / Pregnancy Exposure Prevention and Planning / Novartis Pharmaceuticals Corporation / / Country United States / / Event FDA Phase / / IndustryTerm healthcare / food intake / / MedicalCondition fetal resorptions / chest pain / Lymphoma / mumps / HBV / yellow fever / herpes zoster / lymphoproliferative disorder / leukopenia / arthritis / Reactivated Viral Infections / esophagitis / measles / urinary tract infection / wound infection / skin cancer / active digestive system disease / osteomyelitis / nausea / SERIOUS INFECTIONS / alopecia / infectious / hepatitis C / digestive system disease / carcinoma / hepatitis B / Known hypersensitivity / pulmonary fibrosis / colitis / Hereditary Deficiency / spontaneous abortions / duodenal ulcers / gout / Intestinal perforation / peritonitis / gastrointestinal hemorrhage / hemiparesis / progressive multifocal leukoencephalopathy / lymphadenopathy / gastritis / pulmonary edema / lymphopenia / renal disease / intestinal perforations / Hypersensitivity / diarrhea / gastric ulcers / cleft lip / sinusitis / muscle cramps / constipation / gastroesophageal reflux disease / pruritus / Infections / influenza / nephrolithiasis / agranulocytosis / wheezing / hypotension / ataxia / Abdominal pain / hyperkalemia / insomnia / pneumonia / necrosis / hereditary / Hypertension / Acne / opportunistic infections / umbilical hernia / disease / Arthralgia / dyspnea / urolithiasis / hematuria / Carcinogenesis / CMV infection / neutropenia / vertigo / ileus / lymphomas / upper respiratory infection / HCV / polio / Viral Infections / oral candidiasis / sarcoma / pain / vomiting / rubella / protozoal infections / diabetes mellitus / pancreatitis / endocarditis / Blood Dyscrasias Including Pure Red Cell Aplasia / exencephaly / lymphoma and other malignancies / infection / deficiency / Dizziness / Lymphocele / Cough / renal failure / AND SERIOUS INFECTIONS / meningitis / rash / varicella / herpes simplex / anemia / Hypercholesterolemia / Pure Red Cell Aplasia / disorders / anophthalmia / tuberculosis / / MedicalTreatment oral contraceptives / birth control / Immunizations / kidney transplants / contraception / immunosuppression / kidney transplant / immunosuppressive therapy / antibody therapy / organ transplant / renal transplant / contraceptive methods / / Organization DOSAGE AND ADMINISTRATION / FDA / / Person Sevelamer Cyclosporine Norfloxacin / Metronidazole Rifampin Hormonal Contraceptives Acyclovir / Flora Drugs / / / Position physician / General / neurologist / / Product Myfortic 360 mg / cyclosporine / Norfloxacin / Acyclovir / Rifampin / Pantoprazole / Myfortic 180 mg / levonorgestrel / Metronidazole / Amoxicillin / MYFORTIC / Ganciclovir / Azathioprine / Ciprofloxacin / Valacyclovir / Cholestyramine / / Technology Transplantation / Pharmacokinetics / / URL www.fda.gov/medwatch / /
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Myfortic (mycophenolic acid) delayed-release tablets label