Adverse reactions in association with Zyloric are rare in the overall-treated population and mostly of a minor nature.
The incidence is higher in the presence of renal and/or hepatic disorder.
These are the most common reactions and may occur at any time during treatment. They may be pruritic, maculopapular, sometimes scaly, sometimes purpuric and rarely, exfoliative.
Zyloric should be withdrawn immediately if reactions occur. After recovery from mild reactions, Zyloric may, if desired, be reintroduced at a small dose (eg, 50 mg/day) and gradually increased. If the rash recurs, Zyloric should be permanently withdrawn.
Skin reactions associated with exfoliation, fever, lymphadenopathy, arthralgia and/or eosinophilia resembling Stevens-Johnson and/or Lyell's syndrome, occur rarely. Associated vasculitis and tissue response may be manifested in various ways including hepatitis, interstitial nephritis and very rarely, epilepsy.
If such reactions do occur, which may be at any time during treatment, Zyloric should be withdrawn immediately and permanently.
Corticosteroids may be beneficial in overcoming them. When generalised hypersensitivity reactions have occurred, renal and/or hepatic disorder has usually been present particularly when the outcome has been fatal.
Has been described rarely following biopsy of a generalised lymphadenopathy. It appears to be reversible on withdrawal of Zyloric.
Very rarely, granulomatous hepatitis, without overt evidence of more generalised hypersensitivity, has been described. It appears to be reversible on withdrawal of Zyloric.
In early clinical studies, nausea and vomiting were reported. Further reports suggest that these reactions are not a significant problem and can be avoided by taking Zyloric after meals. Recurrent haematemesis has been reported as an extremely rare event as has steatorrhoea.
Blood and Lymphatic System:
There have been occasional reports of transient reduction in the numbers of thrombocytopenia, agranulocytosis and aplastic anaemia, particularly in individuals with impaired renal function, reinforcing the need for particular care in this group of patients.
The following complaints have been reported occasionally: Fever, general malaise, asthenia, headache, vertigo, ataxia, somnolence, coma, depression, paralysis, paraesthesiae, neuropathy, visual disorder, cataract, macular changes, taste perversion, stomatitis, changed bowel habit, infertility, impotence, nocturnal emission, diabetes mellitus, hyperlipaemia, furunculosis, alopecia, discoloured hair, angina, hypertension, bradycardia, oedema, uraemia, haematuria, gynaecomastia.