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 Modigraf.
Neoplasms benign, malignant and unspecified (inl. cysts and polyps)
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.
Blood and lymphatic system disorders
common:  anaemia, thrombocytopenia, leukopenia, red blood cell analyses abnormal, leukocytosis
uncommon:  coagulopathies, pancytopenia, neutropenia, coagulation and bleeding analyses abnormal
rare: thrombotic thrombocytopenic purpura, hypoprothrombinaemia
not known: pure red cell aplasia, agranulocytosis, haemolytic anaemia
Immune system disorders
Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).
Endocrine disorders
rare: hirsutism
Metabolism and nutrition disorders
very common: diabetes mellitus, hyperglycaemic conditions, hyperkalaemia
common: metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia
uncommon: dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia
Psychiatric disorders
very common: insomnia
common: confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare
uncommon: psychotic disorder
Nervous system disorders
very common: headache, tremor
 
common:
 nervous system disorders, seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired
 
uncommon:
 encephalopathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language abnormalities, paralysis and paresis, amnesia
 
rare:  hypertonia
very rare:  Myasthenia
Eye disorders
common:  eye disorders, vision blurred, photophobia
uncommon:  cataract
rare:  blindness
Ear and labyrinth disorders
common: tinnitus
uncommon: hypoacusis
rare: deafness neurosensory
very rare: hearing impaired
Cardiac disorders
common: ischaemic coronary artery disorders, tachycardia
uncommon: heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations
rare: pericardial effusion
very rare: Torsades de Pointes
Vascular disorders
very common: hypertension
common: thromboembolic and ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders
uncommon: venous thrombosis deep limb, shock, infarction
Respiratory, thoracic and mediastinal disorders
common: parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis