The most commonly reported adverse reactions (occurring in > 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.

The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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.

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.

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 an