Valdorin Adverse Reactions

Clopidogrel: Hemorrhagic events: In CAPRIE patients receiving Clopidogrel, gastrointestinal hemorrhage occurred at a rate of 2.0%, and required hospitalization in 0.7%. In patients receiving aspirin, the corresponding rates were 2.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for Clopidogrel compared to 0.5% for aspirin.
In CURE, Clopidogrel use with aspirin was associated with an increase in bleeding compared to placebo with aspirin. There was an excess in major bleeding in patients receiving Clopidogrel plus aspirin compared with placebo plus aspirin, primarily gastrointestinal and at puncture sites. The incidence of intracranial hemorrhage (0.1%), and fatal bleeding (0.2%), were the same in both groups.
Adverse Events occurring in ≥2.5% of patients using Clopidogrel in CAPRIE trial: Body as a Whole - general disorders: Chest pain, Accidental/inflicted injury, Influenza like symptoms, Pain and fatigue.
Cardiovascular disorders, general: Oedema, Hypertension.
Central and peripheral nervous system disorders: Headache, Dizziness.
GIT disorders: Abdominal pain, Diarrhea, Dyspepsia, Nausea.
Metabolic and nutritional: Hypercholesterolemia.
Musculoskeletal system disorder: Arthralgia, Back pain.
Platelets/bleeding and clotting disorders: Bruise/purpura, Epistaxis.
Psychiatric disorders: Depression.
Respiratory system disorders: Upper respiratory tract infection, Dyspnea, Rhinitis, Bronchitis, Coughing.
Dermatological: Rash/pruritus.
Urinary system disorders: Urinary tract infection.
Aspirin: Side effects are generally mild and infrequent: Blood and the lymphatic system disorders: Aspirin prolongs bleeding time, decreases platelet adhesiveness and, in large doses, may cause hypoprothrombinaemia. Thrombocytopenia may also occur. Bleeding disorders such as epistaxis, haematuria, purpura, ecchymoses, haemoptysis, gastrointestinal bleeding, haematoma and cerebral haemorrhage have occasionally been reported. Fatalities have occurred. Haemolytic anaemia can occur in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Immune system disorder: Hypersensitivity reactions include skin rashes, urticaria, angioedema, asthma, bronchospasm, rhinitis and rarely, anaphylaxis.
Ear & Labyrinth disorder: Tinnitus.
Gastrointestinal disorders: Gastrointestinal irritation is common in patients taking aspirin preparations, and nausea, vomiting, dyspepsia, gastritis, gastrointestinal erosions and ulceration have been reported. Anaemia may occur following chronic gastrointestinal blood loss or acute haemorrhage.
Skin and subcutaneous tissue disorders: Skin reactions may occur in susceptible patients.
Renal and Urinary disorders: Urate kidney stones.