Clopidogrel Side Effects: Common, Serious & FDA Warnings
Based on 208,000+ FDA adverse event reports, the most-reported clopidogrel reactions include dyspnoea, myocardial infarction, and fatigue. No active recalls are on record. The FDA-approved label carries a boxed warning.
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 of Clopidogrel
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for clopidogrel. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Dyspnoea | 10,782 | 5.2% |
| Myocardial Infarction | 10,185 | 4.9% |
| Fatigue | 9,281 | 4.4% |
| Gastrointestinal Haemorrhage | 8,711 | 4.2% |
| Nausea | 8,560 | 4.1% |
| Dizziness | 8,382 | 4.0% |
| Diarrhoea | 8,032 | 3.8% |
| Asthenia | 7,327 | 3.5% |
| Cerebrovascular Accident | 6,788 | 3.3% |
| Anaemia | 6,665 | 3.2% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
| Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established. | 6,501 | 3.1% |
From the FDA-approved label, Section 5.1: Diminished Antiplatelet Activity in Patients with Impaired CYP2C19 Function
Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in CYP2C19 [see Boxed Warning ] . The metabolism of clopidogrel can also be impaired by drugs that inhibit CYP2C19, such as omeprazole or esomeprazole. Avoid concomitant use of clopidogrel with omeprazole or esomeprazole because both significantly reduce the antiplatelet activity of clopidogrel [see Drug Interactions (7.2) ] .
From the FDA-approved label, Section 5.4: Thrombotic Thrombocytopenic Purpura (TTP)
TTP, sometimes fatal, has been reported following use of clopidogrel, sometimes after a short exposure (<2 weeks). TTP is a serious condition that requires urgent treatment including plasmapheresis (plasma exchange). It is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragmented RBCs] seen on peripheral smear), neurological findings, renal dysfunction, and fever [see Adverse Reactions (6.2) ].
Clopidogrel Recalls
FDA enforcement actions matched to clopidogrel via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →).
No recalls are on record for this drug in the FDA enforcement database.
Clopidogrel Shortages
FDA-listed shortages of clopidogrel products. Strength and dosage-form level detail.
Is Clopidogrel Safe?
Clopidogrel is FDA-approved. The label's Warnings and Precautions section covers diminished antiplatelet activity in patients with impaired cyp2c19 function (Section 5.1), general risk of bleeding (Section 5.2), discontinuation of clopidogrel (Section 5.3), thrombotic thrombocytopenic purpura (ttp) (Section 5.4), cross-reactivity among thienopyridines (Section 5.5).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Clopidogrel is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
Clopidogrel tablets are a P2Y 12 platelet inhibitor indicated for: Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) – For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease.Show full Indications and Usage
Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2) 1.1 Acute Coronary Syndrome (ACS) Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin. Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin. 1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.
Frequently Asked Questions
What are the most-reported side effects of clopidogrel?
Is clopidogrel the same as Clopidogrel Bisulfate?
Has clopidogrel been recalled?
Does clopidogrel have an FDA boxed warning?
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.