Axcel Clopidogrel

Axcel Clopidogrel Side Effects



Kotra Pharma


Kotra Pharma
Full Prescribing Info
Side Effects
Blood and the lymphatic system disorders: Uncommon: Thrombocytopenia, leucopenia, eosinophilia. Rare: Neutropenia, including severe neutropenia. Very rare, not known: Thrombotic thrombocytopenic purpura (TTP), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia.
Immune system disorders: Very rare, not known: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*.
Psychiatric disorders: Very rare, not known: Hallucinations, confusion.
Nervous system disorders: Uncommon: Intracranial bleeding, headache, paraesthesia, dizziness. Very rare, not known: Taste disturbances, ageusia.
Eye disorders: Uncommon: Eye bleeding (conjunctival, ocular, retinal).
Ear and labyrinth disorders: Rare: Vertigo.
Vascular disorders: Common: Haematoma. Very rare, not known: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension.
Respiratory, thoracic and mediastinal disorders: Common: Epistaxis; Very rare, not known: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, eosinophilic pneumonia.
Gastrointestinal disorders: Common: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia. Uncommon: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence. Rare: Retroperitoneal haemorrhage. Very rare, not known: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis.
Hepato-biliary disorders: Very rare, not known: Acute liver failure, hepatitis, abnormal liver function test.
Skin and subcutaneous tissue disorders: Common: Bruising. Uncommon: Rash, pruritus, skin bleeding (purpura). Very rare, not known: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus.
Musculoskeletal, connective tissue and bone disorders: Very rare, not known: Musculoskeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia.
Renal and urinary disorders: Uncommon: Haematuria. Very rare, not known: Glomerulonephritis, blood creatinine increased.
General disorders and administration site conditions: Common: Bleeding at puncture site, fever.
Cardiac disorders: Very rare, not known: Kounis syndrome (vasospastic allergic angina/allergic myocardial infarction) in the context of a hypersensitivity reaction due to clopidogrel*.
Reproductive systems and breast disorders: Rare: Gynaecomastia.
Investigations: Uncommon: Bleeding time prolonged, neutrophil count decreased, platelet count decreased.
*Information related to clopidogrel with frequency "not known".
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