Clopidogrel: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Clopidogrel. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Minor bleeding ¶5.1%
Any noncerebral bleeding3.9%
Other noncerebral bleeding (non-major)3.6%
Life-threatening bleeding2.2%
Other major bleeding1.6%
Requiring 2 to 3 units of blood1.3%
Requiring transfusion (≥4 units)1.2%
Hemorrhagic stroke0.91%
5 g/dl hemoglobin drop0.9%
Requiring surgical intervention0.7%
Requiring inotropes0.5%
Major noncerebral0.48%
Significantly disabling0.4%
Intracranial hemorrhage0.4%
Fatal0.2%
Hemorrhagic strokes0.1%
Significant loss of vision0.05%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

1.1 Acute Coronary Syndrome (ACS) For 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, USP have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets, USP have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown. The optimal duration of clopidogrel tablets, USP therapy in ACS is unknown. 1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets, USP have been shown to reduce the rate of a combined endpoint of new ische…

Source: FDA labeling via NIH DailyMed (set 98a83879…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.