n (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
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 Prograf.
Neoplasms benign, malignant and unspecified (incl. 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, leukopenia, thrombocytopenia, leukocytosis, red blood cell analyses abnormal
uncommon:
coagulopathies, coagulation and bleeding analyses abnormal, pancytopenia, neutropenia
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:
hyperglycaemic conditions, diabetes mellitus, hyperkalaemia
common:
hypomagnesaemia, hypophosphataemia, hypokalaemia, hypocalcaemia, hyponatraemia, fluid overload, hyperuricaemia, appetite decreased, metabolic acidoses, hyperlipidaemia, hypercholesterolaemia, hypertriglyceridaemia, other electrolyte abnormalities
uncommon:
dehydration, hypoproteinaemia, hyperphosphataemia, hypoglycaemia
Psychiatric disorders
very common:
insomnia
common:
anxiety symptoms, confusion and disorientation, depression, depressed mood, mood disorders and disturbances, nightmare, hallucination, mental disorders
uncommon:
psychotic disorder
Nervous system disorders
very common:
tremor, headache
common:
seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders
uncommon:
coma, central nervous system haemorrhages and cerebrovascular accidents, paralysis and paresis, encephalopathy, speech and language abnormalities, amnesia
rare:
hypertonia
very rare:
myasthenia
Eye disorders
common:
vision blurred, photophobia, eye disorders
uncommon:
cataract
rare:
blindness
&n
