stinal disorders
very common:
diarrhoea, nausea
common:
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 stools
uncommon:
acute and chronic pancreatitis, peritonitis, blood amylase increased, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying
rare:
pancreatic pseudocyst, subileus
Renal and urinary disorders
very common:
renal impairment
common:
renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms
uncommon:
haemolytic uraemic syndrome, anuria
very rare:
nephropathy, cystitis haemorrhagic
Skin and subcutaneous tissue disorders
common:
rash, pruritus, alopecias, acne, sweating increased
uncommon:
dermatitis, photosensitivity
rare:
toxic epidermal necrolysis (Lyell's syndrome)
very rare:
Stevens Johnson syndrome
Musculoskeletal and connective tissue disorders
common:
arthralgia, back pain, muscle cramps, pain in limb
uncommon:
joint disorders
Endocrine disorders
rare:
hirsutism
Metabolism and nutrition disorders
very common:
diabetes mellitus, hyperglycaemic conditions, hyperkalaemia
common:
anorexia, metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia
uncommon:
dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia
Infections and infestations
As 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 complications
common:
primary graft dysfunction
Medication 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 unspecified
Patients 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 disorders
very common:
hypertension
common:
thromboembolic and ischaemic events, vascular hyp |
