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Clopidogrel

Plavix · P2Y12 inhibitor

An oral antiplatelet prodrug for selected coronary and atherosclerotic vascular indications. Bleeding risk, CYP2C19 activation and the prescribed treatment plan guide use.

Therapeutic class
P2Y12 platelet inhibitor
Representative brand
Plavix
Reference focus
U.S. tablets; selected stroke-guideline context
Essential safety

Do not stop without the prescribing team.

Stopping can increase cardiovascular-event risk. Report uncontrolled bleeding, black stools or TTP symptoms urgently; avoid omeprazole and esomeprazole.

Warnings and precautions
01

Indications

ACS, recent MI/stroke and established PAD.

Labeled uses

Non-ST-elevation ACS, including medical management or coronary revascularization, and medically managed STEMI: reduce MI/stroke with aspirin. Recent MI, recent stroke or established PAD: reduce MI/stroke.

Stroke guideline context

AHA/ASA recommends short-term dual antiplatelet therapy only in selected patients, such as early minor stroke/high-risk TIA or severe symptomatic intracranial stenosis. Routine long-term DAPT is not recommended for secondary stroke prevention. The indication-specific duration and stroke mechanism require clinician review.

02

Dosage and administration

Use the indication-specific loading decision.

Adult oral regimens

IndicationPlavix label directions
ACS needing effect within hours300 mg once as loading dose, then 75 mg once daily. Without loading, effect takes several days to establish.
Recent MI/stroke or established PAD75 mg once daily without loading.

Administration and treatment planning

May take with or without food. ACS uses aspirin as labeled; PCI, switching from another P2Y12 inhibitor and DAPT duration require an individualized cardiology/neurology plan. This profile supplies no universal switch, 600 mg loading or fixed DAPT-duration rule.

Organ impairment and procedures

Hepatic impairment and older age require no label dose adjustment. Moderate/severe renal experience is limited; individualize risk assessment. For surgery with major bleeding risk, interrupt 5 days beforehand when possible, then restart once hemostasis is achieved under the treating team.

03

Safety

Bleeding, loss of effect and rare TTP.

Warnings and precautions

Bleeding may be serious or fatal. CYP2C19 variants/inhibitors can reduce effect; avoid strong CYP2C19 inducers because of bleeding risk. Premature discontinuation raises cardiovascular-event risk. TTP can occur after short exposure and requires emergency treatment, including plasma exchange. Cross-reactivity with other thienopyridines is reported.

Contraindications

Active pathological bleeding, including peptic-ulcer or intracranial bleeding; hypersensitivity to clopidogrel or product components.

Boxed warning · CYP2C19 poor metabolizers

Patients with two nonfunctional CYP2C19 alleles form less active metabolite and have reduced platelet inhibition. Tests can identify poor metabolizers; consider another P2Y12 inhibitor. The label does not establish a universal dose escalation to overcome this.

Adverse reactions

Bleeding, bruising, epistaxis and hematoma are prominent; itching is reported. Serious postmarketing allergy, skin, blood, liver and lung disorders include insulin autoimmune syndrome with severe hypoglycemia. Overdose may cause bleeding; urgent medical assessment is required and platelet transfusion may restore clotting.

04

Drug interactions

Activation, absorption and bleeding interactions.

Clinically relevant interactions

  • Avoid omeprazole/esomeprazole; omeprazole reduces effect even 12 hours apart. Other listed PPIs had less effect; select gastroprotection with the prescriber.
  • Avoid strong CYP2C19 inducers such as rifampin.
  • Opioids delay/reduce absorption; consider a parenteral antiplatelet in ACS requiring opioids.
  • NSAIDs, warfarin, other antiplatelets and SSRIs/SNRIs increase bleeding risk.
  • Avoid repaglinide. If unavoidable, its label-directed start is 0.5 mg before meals, maximum 4 mg/day with more glucose monitoring.
05

Use in specific populations

Pregnancy and delivery bleeding assessment.

Pregnancy and lactation

Available pregnancy reports have not identified a major-birth-defect/miscarriage signal; emergency MI/stroke treatment should not be withheld solely for fetal concerns. Avoid neuraxial blockade during use; when possible stop 5–7 days before delivery/blockade. Milk data are limited; individualize breastfeeding benefit/risk.

Pediatric and geriatric considerations

Pediatric safety/effectiveness is not established. A neonatal/infant shunt trial showed no clinical benefit. Older adults do not need an age-only adjustment; bleeding context and comorbidities still matter.

06

Clinical pharmacology

Irreversible inhibition through an active metabolite.

Mechanism of action

The active metabolite binds platelet P2Y12 ADP receptors irreversibly, suppressing activation/aggregation for the platelet lifespan.

Pharmacokinetics

Activation
Hepatic CYP enzymes, principally CYP2C19; much drug becomes inactive metabolites.
Half-lives
Parent approximately 6 hours; active metabolite about 30 minutes.
Elimination
Radiolabeled dose: approximately 50% urinary and 46% fecal recovery over 5 days.
Platelet effect
Steady inhibition after 75 mg/day by days 3–7; recovery generally about 5 days after stopping.
07

Monitoring and counseling

Assess bleeding, adherence and clinical vascular response.

Monitoring parameters

  • Evaluate blood loss, bruising and unexplained anemia; CBC/platelets and organ tests follow clinical findings.
  • Assess TTP symptoms: low platelets/hemolysis, neurologic changes, renal dysfunction and fever.
  • Review CYP2C19 results when available and medicines affecting activation/bleeding.
  • Check adherence, ischemic symptoms and repaglinide-related hypoglycemia if combination unavoidable.

Patient counseling information

Read the Medication Guide. Do not stop independently. Tell clinicians/dentists before procedures; report prolonged bleeding or blood in stool/urine. Seek urgent help for unexplained fever with neurologic symptoms, weakness or unusual bruising. Review OTC acid reducers, NSAIDs and supplements.

08

Product identification

Verify exact tablet and loading-dose strength.

Representative product · Plavix 75 mg

Appearance
Pink round biconvex film-coated tablet.
Imprint
75 / 1171.
Manufacturer
Sanofi-aventis U.S. LLC.
Example NDC
0024-1171-90 · 90 tablets.
U.S. status
Prescription medicine.

Dosage forms and strengths

Selected oral tablets
75 mg and 300 mg.
300 mg appearance
Pink oblong, imprinted 300 / 1332; distinct loading strength.

Storage and handling

Store at 25°C; excursions 15–30°C. Keep the prescribed formulation/strength identified and dispense the Medication Guide.

09

References

Original sources for the clinical and product information.

  1. DailyMed / SanofiPlavix · Full prescribing information

    Clinical PI May 2025; SPL version 5/effective May 30, 2025; DailyMed archive publication June 11, 2025. Public current label accessed October 1, 2026.

  2. AHA / ASASecondary stroke prevention · Guideline summary

    Official 2021 guideline Top Things to Know, updated May 24, 2021; short-term DAPT selection, without a numeric-duration algorithm.

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