What the label lists and what reports show
Clopidogrel side effects
Clopidogrel's FDA label: “Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction.” FAERS holds 211,001 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (10,953 reports).
- Generic listed
- Boxed warning
Check it at the source: the clopidogrel FDA label on DailyMed (effective May 30, 2025, Sanofi-Aventis U.S. LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Plavix?Plavix can cause serious side effects including: See " What is the most important information I should know about Plavix? " A blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP). TTP can happen with Plavix, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where blood clots form in blood vessels; and can happen anywhere in the body. TTP needs to be treated in a hospital right away because it may cause death. […]
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective May 30, 2025 (SPL set de8b0b67-eb25-4684-83b5-7ad785314227), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsBleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction.
Table 1: CURE Incidence of Bleeding Complications (% patients)
| Event | Plavix (+ aspirin) (n=6259) | Placebo (+ aspirin) (n=6303) |
|---|---|---|
| Major bleeding Life-threatening and other major bleeding. | 3.7 | 2.7 |
| Life-threatening bleeding | 2.2 | 1.8 |
| Fatal | 0.2 | 0.2 |
| 5 g/dL hemoglobin drop | 0.9 | 0.9 |
| Requiring surgical intervention | 0.7 | 0.7 |
| Hemorrhagic strokes | 0.1 | 0.1 |
| Requiring inotropes | 0.5 | 0.5 |
| Requiring transfusion (≥4 units) | 1.2 | 1.0 |
| Other major bleeding | 1.6 | 1.0 |
| Significantly disabling | 0.4 | 0.3 |
| Intraocular bleeding with significant loss of vision | 0.05 | 0.03 |
| Requiring 2–3 units of blood | 1.3 | 0.9 |
| Minor bleeding Led to interruption of study medication. | 5.1 | 2.4 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed below and elsewhere in the labeling: Bleeding [see Warnings and Precautions (5.2) ] Thrombotic thrombocytopenic purpura [see Warnings and Precautions (5.4) ] Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and durations of follow-up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. The clinically important adverse reactions observed in trials comparing Plavix plus aspirin to placebo plus aspirin and trials comparing Plavix alone to aspirin alone are discussed below. Bleeding CURE In CURE, Plavix use with aspirin was associated with an increase in major bleeding (primarily gastrointestinal and at puncture sites) compared to placebo with aspirin (see Table 1 ). …
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective May 30, 2025 (SPL set de8b0b67-eb25-4684-83b5-7ad785314227), via openFDA; the full label on DailyMed
What do FAERS reports show?
211,001 reports list clopidogrel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 23,381 are coded as a death and 97,375 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Clopidogrel: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions