|For this product there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on the dose received and also when given in combination with other therapeutic agents.The frequency categories assigned to the adverse drug reactions below are estimates: for most reactions, suitable data for calculating incidence are not available. Adverse drug reactions identified through post-marketing surveillance were considered to be rare or very rare. The following convention has been used for the classification of frequency:|
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.
|Very common||≥1/10 (≥10%)|
|Common ||≥1/100 and <1/10 (≥1% and <10%)|
|Uncommon||≥1/1000 and <1/100 (≥0.1% and <1%)|
|Rare ||≥1/10,000 and <1/1000 (≥0.01% and <0.1%)|
|Very rare|| <1/10,000 (<0.01%)|
Very rare reports have been received of thrombocytopenia, agranulocytosis and aplastic anaemia, particularly in individuals with impaired renal and/or hepatic function, reinforcing the need for particular care in this group of patients.
|Infections and infestations|
|Very rare ||Furunculosis|
|Blood and lymphatic system disorders|
|Very rare|| Agranulocytosis, aplastic anaemia, thrombocytopenia
Serious hypersensitivity reactions, including skin reactions associated with exfoliation, fever, lymphadenopathy, arthralgia and/or eosinophilia including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis occur rarely (see Skin and subcutaneous tissue disorders). Associated vasculitis and tissue response may be manifested in various ways including hepatitis, renal impairment and very rarely, seizures. Very rarely acute anaphylactic shock has been reported. If such reactions do occur, it may be at any time during treatment, Zyloric should be withdrawn immediately and permanently.A delayed multi-organ hypersensitivity disorder (known as hypersensitivity syndrome or DRESS) with fever, rashes, vasculitis,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, and colon). If such reactions do occur, it may be at any time during treatment, allopurinol should be withdrawn immediately and permanently When generalised hypersensitivity reactions have occurred, renal and/or hepatic disorder has usually been present particularly when the outcome has been fatal. (See section 4.4) Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions.Angioimmunoblastic lymphadenopathy has been described very rarely following biopsy of a generalised lymphadenopathy. It appears to be reversible on withdrawal of Zyloric.
|Immune system disorders|
|Uncommon|| Hypersensitivity reactions|
|Very rare|| Angioimmunoblastic lymphadenopathy|
Skin reactions 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, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN). Zyloric should be withdrawn immediately should such reactions occur. After recovery from mild reactions, Zyloric may, if desired, be re-introduced at a small dose (e.g. 50mg/day) and gradually increased. If the rash recurs, Zyloric should be permanently withdrawn as more severe hypersensitivity may occur (see Immune system disorders).
The clinical diagnosis of SJS/TEN remains the basis for decision making. If such reactions occur at any time during treatment, allopurinol should be withdrawn immediately and permanently.Angioedema has been reported to occur with and without signs and symptoms of a more generalised hypersensitivity reaction.
|Metabolism and nutrition disorders|
|Very rare|| Diabetes mellitus, hyperlipidaemia|
|Nervous system disorders|
|Very rare|| Coma, paralysis, ataxia, neuropathy, paraesthesiae, somnolence, headache, taste perversion|
|Very rare|| Cataract, visual disorder, macular changes|
|Ear and labyrinth disorders|
|Very rare|| Vertigo|
|Very rare|| Angina, bradycardia|
|Very rare|| Hypertension|
|Uncommon|| Vomiting, nausea|
|Very rare|| Recurrent haematemesis, steatorrhoea, stomatitis, changed bowel habit|
|In early clinical studies, nausea and vomiting were reported. Further reports suggest that this reaction is not a significant problem and can be avoided by taking Zyloric after meals.|
|Uncommon|| Asymptomatic increases in liver function tests|
|Rare|| Hepatitis (including hepatic necrosis and granulomatous hepatitis)|
|Hepatic dysfunction has been reported without overt evidence of more generalised hypersensitivity.|
|Skin and subcutaneous tissue disorders|
|Rare|| Stevens-Johnson syndrome/toxic epidermal necrolysis|
|Very rare|| Angioedema, fixed drug eruption, alopecia, discoloured hair|
Fever has been reported to occur with and without signs and symptoms of a more generalised Zyloric hypersensitivity reaction (see Immune system disorders).
|Renal and urinary disorders|
|Very rare|| Haematuria, uraemia|
|Reproductive system and breast disorders|
|Very rare|| Male infertility, erectile dysfunction, gynaecomastia|
|General disorders and administration site conditions|
|Very rare|| Oedema, general malaise, asthenia, fever|