Therodel Adverse Reactions

Bleeding: Some cases were reported with fatal outcome (especially intracranial, gastrointestinal and retroperitoneal haemorrhage); serious cases of skin bleeding (purpura), musculo-skeletal bleeding (haemarthrosis, haematoma), eye bleeding (conjuctival, ocular, retinal), epistaxis, respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), haematuria and haemorrhage of operative wound have been reported; cases of serious haemorrhage have been reported in patients taking Clopidogrel concomitantly with acetylsalicylic acid (ASA) or Clopidogrel with ASA and heparin.
Hematological disorders: Neutropenia, Thrombocytopenia, Aplastic anemia.
Central and peripheral nervous system disorders: Uncommon: Headache, Dizziness and Paraesthesia.
Rare: Vertigo.
Gastrointestinal system disorders: Common: Dyspepsia, Abdominal pain and Diarrhoea.
Uncommon: Gastric ulcer and Duodenal ulcer, Gastritis, Vomiting, Nausea, Constipation, Flatulence.
Platelet, bleeding and clotting disorders: Uncommon: Bleeding time increased and Platelets decreased.
Skin and appendages disorders: Uncommon: Rash and Pruritus.
White cell and RES disorders: Uncommon: Leucopenia, Eosinophilia, Neutrophils decreased.
Blood and lymphatic system disorders: Very rare: Thrombotic Thrombocytopenic Purpura (TTP) (1/200,000 exposed patients), severe Thrombocytopenia (platelet count ≤30 x 10⁹/L), Granulocytopenia, Agranulocytosis, Anaemia and Aplastic Anaemia/Pancytopenia.
Immune system disorders: Very rare: Anaphylactoid reactions, Serum sickness.
Psychiatric disorders: Very rare: Confusion, Hallucinations.
Nervous system disorders: Very rare: Taste disturbances.
Vascular disorders: Very rare: Vasculitis, Hypotension.
Respiratory, thoracic and mediastinal disorders: Very rare: Bronchospasm, Interstitial pneumonitis.
Gastrointestinal disorders: Very rare: Pancreatitis, Colitis (including ulcerative or lymphocytic colitis), Stomatitis.
Hepato-biliary disorders: Very rare: Acute liver failure, Hepatitis.
Skin and subcutaneous tissue disorders: Very rare: Angioderma, Bullous dermatitis (erythema multiforme, Stevens Johnson Syndrome), rash erythematous, urticaria, eczema and lichen planus.
Musculoskeletal, connective tissue and bone disorders: Very rare: Arthralgia, Arthritis, Myalgia.
Renal and urinary disorders: Very rare: Glomerulonephritis.
General disorders and administration site conditions: Very rare: Fever.
Investigations: Very rare: Abnormal liver function test, Blood creatinine increase.