Note: This document contains side effect information about clopidogrel. Some of the dosage forms listed on this page may not apply to the brand name Plavix.
Applies to clopidogrel: oral tablet
Oral route (Tablet)
The effectiveness of clopidogrel hydrogen sulfate results from its antiplatelet activity, which is dependent on its conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. Clopidogrel hydrogen sulfate at recommended doses forms less of the active metabolite and so has a reduced effect on platelet activity in patients who are homozygous for nonfunctional alleles of the CYP2C19 gene, (termed “CYP2C19 poor metabolizers”). Tests are available to identify patients who are CYP2C19 poor metabolizers. Consider use of another platelet P2Y12 inhibitor in patients identified as CYP2C19 poor metabolizers..
Along with its needed effects, clopidogrel (the active ingredient contained in Plavix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking clopidogrel:
Incidence not known
Some side effects of clopidogrel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to clopidogrel: oral tablet
The most commonly reported adverse effect was bleeding, including life threatening and fatal bleeding.
In the COMMIT study (n=45,852), the incidence of major non-cerebral or cerebral bleeding was 0.6% in clopidogrel (the active ingredient contained in Plavix) plus aspirin treated patients, with 0.4% classified as major non-cerebral (0.2% fatal) and 0.2% as hemorrhagic stroke (0.2% fatal). Non-major noncerebral bleeding or any noncerebral bleeding occurred in 3.6% and 3.9% of patients receiving this drug plus aspirin, respectively. Major bleeds were defined as cerebral bleeds or non-cerebral bleeds thought to have caused death or that required transfusion.
In the CURE study (n=12,562), the incidence of fatal bleeding (0.2%) and intracranial hemorrhage (0.1%) was the same between clopidogrel with aspirin and placebo with aspirin groups.
Uncommon (0.1% to 1%): Fatal bleeding, eosinophilia, leucopenia, increased bleeding time, thrombocytopenia
Rare (0.01% to 0.1%): Neutropenia
Very rare (less than 0.01%): Decreased platelet count
Postmarketing reports: Serious cases of bleeding (mainly skin), hemarthrosis, hematoma, hemorrhage of operative wound, fatal hemorrhage (intracranial, gastrointestinal, and retroperitoneal), thrombotic thrombocytopenic purpura (TTP), acquired hemophilia A, aplastic anemia, pancytopenia, agranulocytosis, granulocytopenia, anemia
In the CAPRIE study (n=19,185), gastrointestinal hemorrhage occurred in 2% of patients taking clopidogrel (the active ingredient contained in Plavix) compared to 2.7% taking aspirin. Bleeding requiring hospitalization occurred in 0.7% clopidogrel-treated and 1.1% aspirin-treated patients.
Common (1% to 10%): Abdominal pain, gastrointestinal hemorrhage, dyspepsia, diarrhea, nausea, gastritis
Uncommon (0.1% to 1%): Vomiting, flatulence, constipation, gastric, peptic, or duodenal ulcer
Rare (0.01% to 0.1%): Retroperitoneal hemorrhage
Postmarketing reports: Colitis (ulcerative or lymphocytic), pancreatitis, stomatitis
Postmarketing reports: Angioedema, anaphylactic reactions, cross reactive hypersensitivity among thienopyridines (e.g. ticlopidine, prasugrel), hypersensitivity reactions
Common (1% to 10%): Chest pain, hypertension, angina pectoris, coronary artery disorder, peripheral ischemia
Very rare (less than 0.01%): Hematoma
Postmarketing reports: Hypotension, syncope, vasculitis
Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Paresthesia
Rare (0.01% to 0.1%): Vertigo, intracranial hemorrhage
Postmarketing reports: Taste disturbances, ageusia
Common (1% to 10%): Arthralgia, back pain
Postmarketing reports: Arthritis, myalgia, musculoskeletal bleeding
Common (1% to 10%): Depression
Postmarketing reports: Hallucinations, confusion
Common (1% to 10%): Upper respiratory tract infection, dyspnea, rhinitis, coughing, bronchitis, epistaxis
Postmarketing reports: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia, respiratory tract bleeding (hemoptysis, pulmonary hemorrhage)
Common (1% to 10%): Rash, purpura, pruritus, bruising
Postmarketing reports: Maculopapular, erythematous, or exfoliative rash, urticaria, bullous dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), eczema, lichen planus
In CAPRIE (n=19,185), 4.2% of patients receiving clopidogrel developed a rash compared to 3.5% in the aspirin group. In CURE (n=12,562), 1.3% treated with clopidogrel and aspirin compared to 1.1% placebo, as well as 0.7% of patients in CLARITY (n=3491) reported a rash. Drug discontinuation due to skin disorders in CAPRIE was 0.8% and in CURE 0.4% of patients.
Postmarketing reports: Hepatitis (noninfectious), acute liver failure, abnormal liver function tests
Common (1% to 10%): Hypercholesterolemia
Common (1% to 10%): Urinary tract infection
Postmarketing reports: Hematuria
Postmarketing reports: Eye bleeds (conjunctival, ocular, retinal)
Common (1% to 10%): Accidental/inflicted injury, influenza-like symptoms, pain, fatigue, infection
Postmarketing reports: Fever
Uncommon (0.1% to 1%): Hematuria
Postmarketing reports: Glomerulopathy, serum creatinine increase
Postmarketing reports: Serum sickness
Postmarketing reports: Gynecomastia
Common (1% to 10%): Puncture site bleeding
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Plavix