actions from clinical trials are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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).
Blood and lymphatic system disorders
Very common:
leucopenia.
Common:
thrombocytopenia, eosinophilia.
Rare:
leucocytosis, lymphadenopathy.
Very rare:
agranulocytosis, aplastic anaemia, pancytopenia, aplasia pure red cell, anaemia, anaemia megaloblastic, reticulocytosis, haemolytic anaemia.
Not known:
bone marrow depression.
Immune system disorders
Rare:
a delayed multi-organ hypersensitivity disorder with fever, rashes, vasculitis, lymphadenopathy, pseudo lymphoma, arthralgia, leucopenia, eosinophilia, hepato-splenomegaly, abnormal liver function tests and vanishing bile duct syndrome (destruction and disappearance of the intrahepatic bile ducts) occurring in various combinations. Other organs may also be affected (e.g. liver, lungs, kidneys, pancreas, myocardium, colon).
Very rare:
anaphylactic reaction, oedema angioedema, hypogammaglobulinaemia.
Not known**:
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Infections and infestations
Not known**:
reactivation of Human herpesvirus 6 infection.
Endocrine disorders
Common:
Oedema, fluid retention, weight increase, hyponatraemia and blood osmolarity decreased due to an antidiuretic hormone (ADH)-like effect, leading in rare cases to water intoxication accompanied by lethargy, vomiting, headache, confusional state, neurological disorders.
Very rare:
galactorrhoea, gynaecomastia,
Metabolism and nutrition disorders
Rare:
folate deficiency, decreased appetite.
Very rare:
porphyria acute (acute intermittent porphyria and variegate porphyria), porphyria non-acute (porphyria cutanea tarda).
Psychiatric disorders
Rare:
hallucinations (visual or auditory), depression, aggression, agitation, restlessness, confusional state.
Very rare:
activation of psychosis.
Nervous system disorders
Very common:
ataxia, dizziness, somnolence.
Common:
diplopia, headache.
Uncommon:
abnormal involuntary movements (e.g. tremor, asterixis, dystonia, tics), nystagmus.
Rare:
dyskinesia, eye movementdisorder, speech disorders (e.g. dysarthria or slurred speech), choreoathetosis, neuropathy peripheral, paraesthesia, and paresis.
Very rare:
neuroleptic malignant syndrome, aseptic meningitis with myoclonus and peripheral eosinophilia, dysgeusia.
Not known**:
sedation
