Prescription medicine
Clopidogrel Brand names: Plavix
Clopidogrel (Plavix) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 35 generic labelers, and pharmacies paid $0.0472 per clopidogrel 75 mg tablet in the October 7, 2026 NADAC survey.
- 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 NDA 20839 record on Drugs@FDA; every clopidogrel label on DailyMed.
Highlights of the record
FDA label of May 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE 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 Plavix 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 ) The effectiveness of Plavix 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) ]. Plavix 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.
Used for
From the label: indications and usagePlavix is 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]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke.
Forms and strengths
- 75 mg
- 300 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- November 17, 1997 Plavix, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first January 14, 2008; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 36 of which 35 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0472 per tablet Clopidogrel 75 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2018 1 Class I among all firms' recalls; latest March 23, 2023
- FAERS reports
- 211,001 through July 30, 2026
What is clopidogrel used for?
From the label: indications and usagePlavix is 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]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. ( 1.1 ) Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke. […]
Conditions named in the indications of clopidogrel's FDA labels, with every medicine labeled for each:
From other clopidogrel labelsAngina: Syndrome (ACS) Plavix is 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 …
FDA pharmacologic class: P2Y12 Platelet Inhibitor.
Source: FDA drug label (Plavix), 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 patient leaflet for clopidogrel say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Plavix?Plavix may not work as well in people who: have certain genetic factors that affect how the body breaks down Plavix. Your doctor may do genetic tests to make sure Plavix is right for you. take certain medicines, especially omeprazole (Prilosec ® ) or esomeprazole (Nexium ® ). Your doctor may change the medicine you take for stomach acid problems while you take Plavix. Plavix can cause bleeding which can be serious and can sometimes lead to death. Plavix is a blood thinner medicine that lowers the chance of blood clots forming in your body. While you take Plavix: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer for any bleeding to stop Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time blood in your urine (pink, red or brown urine) red or black stools (looks like tar) bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like coffee grounds Do not stop taking Plavix without talking to the doctor who prescribes it for you. People who stop taking Plavix too soon have a higher risk of having a heart attack or dying. If you must stop Plavix because of bleeding, your risk of a heart attack may be higher.
From the patient leaflet: How should I store Plavix?Store Plavix at 59°F to 86°F (15°C to 30°C). Keep Plavix and all medicines out of the reach of children.
Source: FDA drug label (Plavix), Sanofi-Aventis U.S. LLC, effective May 30, 2025 (SPL set de8b0b67-eb25-4684-83b5-7ad785314227), via openFDA; the full label on DailyMed
Is there a generic for clopidogrel (Plavix)?
The FDA approved the first generic clopidogrel on January 14, 2008. 25 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clopidogrel from 35 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clopidogrel (Plavix)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0472 per Clopidogrel 75 mg tablet, down 15% from $0.0557 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clopidogrel 75 mg tablet (generic)
- Plavix 75 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clopidogrel 300 mg tablet | Generic | $5.29 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $158.73 | -43% |
| Clopidogrel 75 mg tablet | Generic | $0.0472 per tablet | $1.42 | -15% |
| Plavix 75 mg tablet | Brand | $8.23 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $246.88 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clopidogrel been recalled?
The FDA's Enforcement Report lists 6 recalls naming clopidogrel since 2018: 1 Class I (the most serious), 5 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| August 2, 2021 | Class II | Macleods Pharma Usa Inc | Presence of foreign matter |
| December 10, 2018 | Class II | Dr. Reddy's Laboratories, Inc. | Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability … |
| November 7, 2018 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing. |
| January 4, 2018 | Class I | International Laboratories, LLC | LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clopidogrel label say about other medicines?
The clopidogrel label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 38 other medicines name clopidogrel. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dexlansoprazole | drug interactions | Dexlansoprazole, lansoprazole, and pantoprazole had less effect on the antiplatelet activity of Plavix than did omeprazole or esomeprazole [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. |
| Esomeprazole | drug interactions | Omeprazole or Esomeprazole Avoid concomitant use of Plavix with omeprazole or esomeprazole. |
| Lansoprazole | drug interactions | Dexlansoprazole, lansoprazole, and pantoprazole had less effect on the antiplatelet activity of Plavix than did omeprazole or esomeprazole [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. |
| Morphine | drug interactions | Consider the use of a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists. |
| Omeprazole | drug interactions | Omeprazole or Esomeprazole Avoid concomitant use of Plavix with omeprazole or esomeprazole. |
| Pantoprazole | drug interactions | Dexlansoprazole, lansoprazole, and pantoprazole had less effect on the antiplatelet activity of Plavix than did omeprazole or esomeprazole [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. |
| Repaglinide | drug interactions | Increases risk of bleeding. ( 7.4 , 7.5 , 7.6 ) Other Antiplatelet Agents: Increases the risk of bleeding due to an additive effect. ( 7.7 ) Repaglinide (CYP2C8 substrates): |
| Rifampin | drug interactions | Rifampin strongly induces CYP2C19 resulting to both an increase level of clopidogrel active metabolite and platelet inhibition, which in particular might potentiate the risk of bleeding. |
| Warfarin | drug interactions | Consider use of parenteral antiplatelet agent. ( 7.3 ) Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): |
Other labels that name clopidogrel
Source: FDA drug label (Plavix), 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 for clopidogrel?
The FDA Adverse Event Reporting System holds 211,001 reports that list clopidogrel among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as clopidogrel?
2 other medicines are given the same way (oral) and in the same FDA class as clopidogrel or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ticagrelor | Heart attack and coronary artery disease | 28 labelers | $0.253 per tablet 90 mg tablet | No current entry |
| Prasugrel | Angina, Heart attack and coronary artery disease | 10 labelers | $0.263 per tablet 10 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does clopidogrel compare with medicines for the same use?
6 side-by-side pages set clopidogrel beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other p2y12 inhibitors
- the pharmacologic class, with prices and generics
- Clopidogrel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other