Last reviewed 2026-04-20 · How we verify

CLOPIDOGREL BISULFATE

CLOPIDOGREL BISULFATE is a drug. It is currently FDA-approved (first approved 1997).

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE The effectiveness of clopidogrel results from its antiplatelet activity, which is dependent on its conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] . Clopidogrel 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 [see Clinical Pharmacology (12.5) ] . Consider use of another platelet P2Y 12 inhibitor in patients identified as CYP2C19 poor metabolizers. WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE See full prescribing information for complete boxed warning. Effectiveness of clopidogrel depends on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. ( 5.1 , 12.3 ) Tests are available to identify patients who are CYP2C19 poor metabolizers. (12.5) Consider use of another platelet P2Y 12 inhibitor in patients identified as CYP2C19 poor metabolizers. ( 5.1)

Common side effects

• Minor bleeding
• Major bleeding
• Other noncerebral bleeding (nonmajor)
• Any noncerebral bleeding
• Life-threatening bleeding
• Gastrointestinal hemorrhage
• Requiring transfusion (≥4 units)
• Other major bleeding
• Requiring 2-3 units of blood
• 5 g/dL hemoglobin drop
• Epistaxis
• Hematuria

Serious adverse events

• Fatal bleeding
• Hemorrhagic stroke
• Intracranial hemorrhage
• Requiring surgical intervention
• Requiring inotropes
• Significantly disabling bleeding
• Intraocular bleeding with significant loss of vision
• Bleeding requiring hospitalization

Key clinical trials

• The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis (PHASE4)
• Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure (PHASE4)
• Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR） (NA)
• PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years (PHASE3)
• Clopidogrel vs. Aspirin for Cardiovascular Risk Reduction in Patients With S. Aureus Bacteremia (PHASE4)
• Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window (PHASE3)
• SIMPLAAFY Clinical Trial (NA)
• INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT) (NA)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• CLOPIDOGREL BISULFATE CI brief — competitive landscape report
• CLOPIDOGREL BISULFATE updates RSS · CI watch RSS

Frequently asked questions about CLOPIDOGREL BISULFATE

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing