ist of adverse reactions
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 tacrolimus.
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.
Immune system disorders
Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).
System Organ Class
Frequency of adverse reactions
Very common
Common
Uncommon
Rare
Very rare
Not known
Blood and lymphatic system disorders
anaemia, thrombocyte-penia, leukopenia, red blood cell analyses abnormal, leukocytosis
coagulo-pathies, pancytopenia, neutropenia, coagulation and bleeding analyses, abnormal
thrombotic thrombocytopenic purpura, hypopro-thrombinaemia
pure red cell aplasia, agranulo-cytosis, haemolytic anaemia
Endocrine disorders
hirsutism
Metabolism and nutrition disorders
diabetes mellitus, hyper-glycaemic conditions, hyper-kalaemia
anorexia, metabolic acidoses, other electrolyte ab-normalities, hyponatraemia, fluid overload, hyperuricaemia, hypo-magnes-aemia, hypo-kalaemia, hypocalcemia, appetite decreased, hypercholest-erolaemia, hyperlipidaemia, hypertri-glycerid-aemia, hypophos-phateaemia
dehydration, hypo-glycaemia, hypoprotein-aemia, hyperphos-phataemia
Psychiatric disorders
insomnia
confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare
psychotic disorder
Nervous system disorders
headache, tremor
nervous system disorders seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias and dysaesthesias, writing impaired
encephalo-pathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language abnormalities, paralysis and paresis, amnesia
hypertonia
myasthenia
Eye disorders
eye disorders, vision blurred, photophobia
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