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The following adverse reactions have been identified during post-approval use of clopidogrel bisulfate. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: Agranulocytosis; aplastic anemia/pancytopenia; thrombotic thrombocytopenic purpura (TTP); acquired hemophilia A.
Eye disorders: Eye (conjunctival, ocular, retinal) bleeding.
Gastrointestinal disorders: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome; colitis (including ulcerative or lymphocytic colitis); pancreatitis; stomatitis; gastric/duodenal ulcer; diarrhea.
General disorders and administration site condition: Fever; hemorrhage of operative wound.
Hepato-biliary disorders: Acute liver failure; hepatitis (non-infectious); abnormal liver function test.
Immune system disorders: Hypersensitivity reactions; anaphylactoid reactions; serum sickness.
Musculoskeletal, connective tissue and bone disorders: Musculoskeletal bleeding; myalgia; arthralgia; arthritis.
Nervous system disorders: Taste disorders; fatal intracranial bleeding; headache.
Psychiatric disorders: Confusion, hallucinations.
Respiratory, thoracic and mediastinal disorders: Bronchospasm; interstitial pneumonitis; respiratory tract bleeding; eosinophilic pneumonia.
Renal and urinary disorders: Increased creatinine levels.
Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash; urticaria; bullous dermatitis; eczema; toxic epidermal necrolysis; Stevens-Johnson syndrome; acute generalized exanthematous pustulosis (AGEP); angioedema; drug-induced hypersensitivity syndrome; drug rash with eosinophilia and systemic symptoms (DRESS); erythema multiforme; skin bleeding; lichen planus; generalized pruritus.
Vascular disorders: Vasculitis, hypotension.
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