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Blood and lymphatic system disorders: Uncommon: Agranulocytosis occur about 0.3-0.6% of cases. It can still manifest weeks or months after the start of therapy and necessitate discontinuation of the medication. In most cases, it recedes spontaneously.
Very rare: Thrombocytopenia, pancytopenia, generalized lymphadenopathy.
Endocrine disease: Very rare: Insulin autoimmune syndrome (with pronounced decline in blood glucose level).
Nervous system disorders: Rare: Disturbances in the sense of taste (dysgeusia, ageusia) occur rarely; they can recede after discontinuation of therapy. A return to normal can take several weeks, however.
Very rare: Neuritis, polyneuropathia.
Vascular disorders: Frequency 'not known': Vasculitis.
Gastointestinal disorders: Very Rare: Acute salivary gland swelling.
Frequency 'not known': Acute pancreatitis.
Hepatobiliary disorders: Very rare: Individual cases of cholestatic jaundice or toxic hepatitis has been described. The symptoms generally recede after discontinuation of the medicinal product. Clinically inapparent signs of cholestasis during treatment have to be differentiated from disturbances caused by hyperthyroidism, such as an increase in GGT (gamma-glutamyl transferase) and alkaline phosphatase or its bone-specific isoenzyme.
Skin and subcutaneous disorders: Very common: Allergic skin reaction of varying degress (pruritus, rash, urticaria). They mostly take a mild course and frequently recede during continued therapy.
Very rare: Severe forms of allergic skin reactions including generalized dermatitis. Alopecia. Drug-induced lupus erythematosus.
Muscoskeletal and connective tissue disorders: Common: Arthralgia may develop gradually and occur even after several months of therapy.
General disorders and administration site conditions: Rare: Drug fever.
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