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Plavix Side Effects

Generic name: clopidogrel

Medically reviewed by Drugs.com. Last updated on Dec 21, 2021.

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.

For the Consumer

Applies to clopidogrel: oral tablets

Warning

    Diminished Antiplatelet Effect in Patients with 2 Loss-of-Function CYP2C19 Alleles
  • Clopidogrel is a prodrug; requires conversion to its active metabolite by the CYP enzyme system (primarily by CYP2C19).1 2 6 8 11 121

  • Genetic variations of CYP2C19 can result in impaired metabolism and reduced effectiveness of clopidogrel.1 121 (See Reduced Efficacy in Poor CYP2C19 Metabolizers under Cautions.) Patients who are homozygous for nonfunctional alleles of CYP2C19 have reduced levels of the active clopidogrel metabolite and reduced antiplatelet effects.1 121

  • Genetic tests are available to identify patients who are poor CYP2C19 metabolizers.1 20 121 122

  • Consider use of another P2Y12 receptor antagonist (e.g., prasugrel, ticagrelor) in patients identified as poor CYP2C19 metabolizers.1 121

Side effects include:

Bleeding.

For Healthcare Professionals

Applies to clopidogrel: oral tablet

General

The most commonly reported adverse effect was bleeding, including life threatening and fatal bleeding.[Ref]

Hematologic

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[Ref]

In the COMMIT study (n=45,852), the incidence of major non-cerebral or cerebral bleeding was 0.6% in clopidogrel 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.[Ref]

Gastrointestinal

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[Ref]

In the CAPRIE study (n=19,185), gastrointestinal hemorrhage occurred in 2% of patients taking clopidogrel compared to 2.7% taking aspirin. Bleeding requiring hospitalization occurred in 0.7% clopidogrel-treated and 1.1% aspirin-treated patients.[Ref]

Hypersensitivity

Postmarketing reports: Angioedema, anaphylactic reactions, cross reactive hypersensitivity among thienopyridines (e.g. ticlopidine, prasugrel), hypersensitivity reactions[Ref]

Cardiovascular

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[Ref]

Nervous system

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[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain

Postmarketing reports: Arthritis, myalgia, musculoskeletal bleeding[Ref]

Psychiatric

Common (1% to 10%): Depression

Postmarketing reports: Hallucinations, confusion[Ref]

Respiratory

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)[Ref]

Dermatologic

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[Ref]

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.[Ref]

Hepatic

Postmarketing reports: Hepatitis (noninfectious), acute liver failure, abnormal liver function tests[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Postmarketing reports: Hematuria[Ref]

Ocular

Postmarketing reports: Eye bleeds (conjunctival, ocular, retinal)[Ref]

Other

Common (1% to 10%): Accidental/inflicted injury, influenza-like symptoms, pain, fatigue, infection

Postmarketing reports: Fever[Ref]

Renal

Uncommon (0.1% to 1%): Hematuria

Postmarketing reports: Glomerulopathy, serum creatinine increase[Ref]

Immunologic

Postmarketing reports: Serum sickness, insulin autoimmune syndrome[Ref]

Endocrine

Postmarketing reports: Gynecomastia[Ref]

Local

Common (1% to 10%): Puncture site bleeding[Ref]

Frequently asked questions

References

1. "Product Information. Plavix (clopidogrel)." Bristol-Myers Squibb (2001):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.