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Generic Name: clopidogrel (kloe PID oh grel)
Brand Name: Plavix
Clopidogrel is used to lower your risk of having a stroke, blood clot, or serious heart problem after you've had a heart attack, severe chest pain (angina), or circulation problems.
Clopidogrel may also be used for purposes not listed in this medication guide.
You should not use clopidogrel if you have any active bleeding such as a stomach ulcer or bleeding in the brain.
Clopidogrel increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have blood in your urine, black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.
Do not stop taking clopidogrel without first talking to your doctor, even if you have signs of bleeding. Stopping clopidogrel may increase your risk of a heart attack or stroke.
You should not use clopidogrel if you are allergic to it, or if you have:
any active bleeding; or
a stomach ulcer or bleeding in the brain (such as from a head injury).
Tell your doctor if you have ever had:
an ulcer in your stomach or intestines; or
a bleeding disorder or blood clotting disorder.
Clopidogrel may not work as well if you have certain genetic factors that affect the breakdown of this medicine in your body. Your doctor may perform a blood test to make sure clopidogrel is right for you.
This medicine is not expected to harm an unborn baby. However, taking clopidogrel within 1 week before childbirth can cause bleeding in the mother. Tell your doctor if you are pregnant or plan to become pregnant.
You should not breast-feed while using this medicine.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use these medicines exactly as directed.
Clopidogrel can be taken with or without food.
Clopidogrel is sometimes taken together with aspirin. Take aspirin only if your doctor tells you to.
Clopidogrel keeps your blood from coagulating (clotting) and can make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.
You may need to stop using clopidogrel for a short time before a surgery, medical procedure, or dental work. Any healthcare provider who treats you should know that you are taking clopidogrel.
Do not stop taking clopidogrel without first talking to your doctor, even if you have signs of bleeding. Stopping the medicine could increase your risk of a heart attack or stroke.
Store at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose can cause excessive bleeding.
Avoid alcohol. It can increase your risk of stomach bleeding.
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
If you also take aspirin: Ask a doctor or pharmacist before using medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to aspirin (such as salicylates, ibuprofen, ketoprofen, or naproxen). Taking these products together can increase your risk of bleeding.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Clopidogrel increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have blood in your urine, black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.
Also call your doctor at once if you have:
pale skin, easy bruising, purple spots under your skin or in your mouth;
jaundice (yellowing of your skin or eyes);
fast heartbeats, shortness of breath;
headache, fever, weakness, feeling tired;
little or no urination;
a seizure; or
signs of a blood clot--sudden numbness or weakness, confusion, problems with vision or speech.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Acute Coronary Syndrome:
Unstable Angina (UA)/Non-ST-Elevation Myocardial Infarction (NSTEMI):
-Loading dose: 300 mg orally once
-Maintenance dose: 75 mg orally once a day
-Duration of therapy: Optimal duration unknown.
ST-Elevation Myocardial Infarction (STEMI):
-Loading dose: 300 mg orally once (OPTIONAL)
-Maintenance dose: 75 mg orally once a day, with or without thrombolytics
-Duration of therapy: Optimal duration unknown.
Comments:
-Administer this drug in combination with aspirin 75 mg to 325 mg orally once a day.
-The benefit of this drug for patients who undergo primary percutaneous coronary intervention is unknown.
Uses: Prevention of atherothrombotic events in patients with non-ST-segment elevation acute coronary syndrome (UA, NSTEMI, those who are to be managed medically, those who are to be managed with coronary revascularization) and STEMI.
Usual Adult Dose for Ischemic Stroke:
75 mg orally once a day
Uses: Prevention of atherothrombotic events in patients with a history of recent myocardial infarction, recent stroke, or established peripheral arterial disease.
Usual Adult Dose for Myocardial Infarction:
75 mg orally once a day
Uses: Prevention of atherothrombotic events in patients with a history of recent myocardial infarction, recent stroke, or established peripheral arterial disease.
Usual Adult Dose for Peripheral Arterial Disease:
75 mg orally once a day
Uses: Prevention of atherothrombotic events in patients with a history of recent myocardial infarction, recent stroke, or established peripheral arterial disease.
Certain other medicines may increase your risk of bleeding, including aspirin. Avoid taking aspirin unless your doctor tells you to.
Tell your doctor about all your other medicines, especially:
any other medicines to treat or prevent blood clots;
a stomach acid reducer such as omeprazole, Nexium, or Prilosec;
an antidepressant;
an opioid medication;
a blood thinner--warfarin, Coumadin, Jantoven; or
NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may affect clopidogrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Clopidogrel (www.drugs.com/mtm/clopidogrel.html).
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 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:
More common
Less common
Rare
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
For Healthcare Professionals
Applies to clopidogrel: oral tablet
GeneralThe most commonly reported adverse effect was bleeding, including life threatening and fatal bleeding.
HematologicIn 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.
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
GastrointestinalIn 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.
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
HypersensitivityPostmarketing reports: Angioedema, anaphylactic reactions, cross reactive hypersensitivity among thienopyridines (e.g. ticlopidine, prasugrel), hypersensitivity reactions
CardiovascularCommon (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
Nervous systemCommon (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
MusculoskeletalCommon (1% to 10%): Arthralgia, back pain
Postmarketing reports: Arthritis, myalgia, musculoskeletal bleeding
PsychiatricCommon (1% to 10%): Depression
Postmarketing reports: Hallucinations, confusion
RespiratoryCommon (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)
DermatologicCommon (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.
HepaticPostmarketing reports: Hepatitis (noninfectious), acute liver failure, abnormal liver function tests
MetabolicCommon (1% to 10%): Hypercholesterolemia
GenitourinaryCommon (1% to 10%): Urinary tract infection
Postmarketing reports: Hematuria
OcularPostmarketing reports: Eye bleeds (conjunctival, ocular, retinal)
OtherCommon (1% to 10%): Accidental/inflicted injury, influenza-like symptoms, pain, fatigue, infection
Postmarketing reports: Fever
RenalUncommon (0.1% to 1%): Hematuria
Postmarketing reports: Glomerulopathy, serum creatinine increase
ImmunologicPostmarketing reports: Serum sickness
EndocrinePostmarketing reports: Gynecomastia
LocalCommon (1% to 10%): Puncture site bleeding
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Clopidogrel (www.drugs.com/mtm/clopidogrel.html).
August 31, 2020
August 17, 2020
August 1, 2020
July 14, 2020
May 12, 2020
May 11, 2020
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