Summary of the safety profile:
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the first month of treatment.
List of adverse reactions:
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented as follows. Their frequency is defined using the following conventions: Common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
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.
Very rare, not known: Kounis syndrome (vasospastic allergic angina/allergic myocardial infarction) in the context of a hypersensitivity reaction due to clopidogrel.
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).
Very rare, not known: Hallucinations, confusion.
Nervous system disorders:
Uncommon: Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness; Very rare, not known: Taste disturbances, ageusia.
Uncommon: Eye bleeding (conjunctival, ocular, retinal).
Ear and labyrinth 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.
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.
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.
Reproductive systems and breast disorders:
Musculoskeletal, connective tissue and bone disorders:
Very rare, not known: Musculo-skeletal 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; Very rare, not known: Fever.
Uncommon: Bleeding time prolonged, neutrophil count decreased, platelet count decreased.