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Advagraf 0.5mg, 1mg, 3mg and 5mg Prolonged-release hard caps(九)
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labyrinth disorderscommon:tinnitusuncommon:hypoacusisrare:deafness neurosensoryvery rare:hearing impairedRespiratory, thoracic and mediastinal disorderscommon:parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammationsuncommon:respiratory failures, respiratory tract disorders, asthmarare:acute respiratory distress syndromeGastrointestinal disordersvery common:diarrhoea, nauseacommon:gastrointestinal signs and symptoms, vomiting, gastrointestinal and abdominal pains, gastrointestinal inflammatory conditions, gastrointestinal haemorrhages, gastrointestinal ulceration and perforation, ascites, stomatitis and ulceration, constipation, dyspeptic signs and symptoms, flatulence, bloating and distension, loose stoolsuncommon:acute and chronic pancreatitis, peritonitis, blood amylase increased, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptyingrare:pancreatic pseudocyst, subileusRenal and urinary disordersvery common:renal impairmentcommon:renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptomsuncommon:haemolytic uraemic syndrome, anuriavery rare:nephropathy, cystitis haemorrhagicSkin and subcutaneous tissue disorderscommon:rash, pruritus, alopecias, acne, sweating increaseduncommon:dermatitis, photosensitivityrare:toxic epidermal necrolysis (Lyell's syndrome)very rare:Stevens Johnson syndromeMusculoskeletal and connective tissue disorderscommon:arthralgia, back pain, muscle cramps, pain in limbuncommon:joint disordersEndocrine disordersrare:hirsutismMetabolism and nutrition disordersvery common:diabetes mellitus, hyperglycaemic conditions, hyperkalaemiacommon:anorexia, metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemiauncommon:dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemiaInfections and infestationsAs is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal). The course of pre-existing infections may be aggravated. Both generalised and localised infections can occur.Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Advagraf.Injury, poisoning and procedural complicationscommon:primary graft dysfunctionMedication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed. A number of associated cases of transplant rejection have been reported (frequency cannot be estimated from available data).Neoplasms benign, malignant and unspecifiedPatients receiving immunosuppressive therapy are at increased risk of developing malignancies. Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.Vascular disordersvery com |
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