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Clopidogrel

Clopidogrel is a platelet-blocking (antiplatelet) medicine used to lower the risk of heart attack and stroke in people with acute coronary syndrome, a recent heart attack, a recent stroke, or established peripheral arterial disease.

Brand names PlavixClopidogrel bisulfate
Drug classes Cytochrome P450 2c8 Inhibitors
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 67 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Clopidogrel at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Clopidogrel (Plavix) is an antiplatelet medicine that makes platelets less sticky, used to prevent heart attacks and strokes in people who have had one or have peripheral arterial disease (narrowed leg arteries); around since about 1997 and available generically, it is often paired with aspirin after a stent. Most people tolerate it well, but bleeding is its main risk, and easier bruising and slow-to-stop nosebleeds are common. Its boxed warning says it works less well in CYP2C19 poor metabolizers, people whose liver cannot activate it properly, which a genetic test can detect. Never stop it on your own, because stopping early raises the risk of heart attack and stroke.

Clinical pearls

  • Avoid omeprazole (Prilosec) and esomeprazole (Nexium) for heartburn, since they significantly weaken clopidogrel’s effect.
  • Tell your surgeon and dentist you take it, since it may need pausing about 5 days before, then restarting promptly.
  • NSAIDs like ibuprofen raise stomach bleeding risk with it, so acetaminophen is usually the better choice for everyday pain.
  • Combining it with warfarin, other antiplatelets or SSRI antidepressants adds bleeding risk, so every prescriber should know you take it.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Clopidogrel may not work as well if your body cannot convert it into its active form. This happens in people who are CYP2C19 poor metabolizers, a genetic difference in how the liver processes the drug.

Poor metabolizers who have acute coronary syndrome or a stent or other procedure (PCI) had higher rates of heart and blood vessel events at recommended doses. Genetic tests can identify this, and your doctor may consider a different treatment. Never stop clopidogrel on your own; talk with your prescriber about any concerns.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record1997
Companies listing it with the FDA35
FDA label last updatedMay 30, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Clopidogrel, written from its FDA label.

What Clopidogrel is used for

▾

Clopidogrel tablets are used to lower the risk of heart attack and stroke in these situations:

  • Non-ST-elevation acute coronary syndrome (unstable angina or non-ST-elevation heart attack)
  • ST-elevation heart attack (STEMI)
  • Recent heart attack
  • Recent stroke
  • Established peripheral arterial disease

Some product labels, including Plavix and certain clopidogrel tablets, say to use it together with aspirin for acute coronary syndrome.

How Clopidogrel works

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Clopidogrel is a prodrug, so the body must first convert it to an active form. That active form binds permanently to the P2Y12 receptor on platelets and blocks the ADP signal that tells platelets to activate and clump.

Because this binding is irreversible, affected platelets stay blocked for the rest of their lifespan.

Clopidogrel dosage

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Clopidogrel is taken by mouth, usually once daily, with or without food. For acute coronary syndrome, a one-time loading dose is often used to start the effect faster. Starting without one delays the full effect by several days. For recent heart attack, recent stroke or peripheral arterial disease, it is taken once daily without a loading dose. Follow your prescriber and label directions.

Dosing details from the FDA-approved label

From the Clopidogrel prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Acute coronary syndrome: UA/NSTEMI (non-ST-elevation ACS)
    • Single 300 mg oral loading dose, then 75 mg once daily, in combination with aspirin (75 to 325 mg once daily)
    • Can be administered with or without food
  • Acute coronary syndrome: STEMI
    • 75 mg once daily orally, in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics
    • May be initiated with or without a loading dose
    • Can be administered with or without food
  • Acute coronary syndrome (patients who need an antiplatelet effect within hours)
    • Single 300 mg oral loading dose, then 75 mg once daily
    • Initiating without a loading dose will delay establishment of an antiplatelet effect by several days
  • Recent MI, recent stroke, or established peripheral arterial disease
    • 75 mg once daily orally
    • With or without food; some labels state without a loading dose
  • CYP2C19 poor metabolizers
    • An appropriate dose regimen for this patient population has not been established
    • Poor metabolizer status is associated with diminished antiplatelet response
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 2. Acute coronary syndrome ( 2.1 ) - UA/NSTEMI: 300 mg loading dose followed by 75 mg once daily, in combination with aspirin (75 to 325 mg once daily) - STEMI: 75 mg once daily, in combination with aspirin (75-325 mg once daily), with or without a loading dose 2. Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily ( 2.2 ) 2.1 Acute Coronary Syndrome Clopidogrel can be administered with or without food [see Clinical Pharmacology (12.3) ] 1. For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel [see Clinical Studies (14.1) ]. 2. For patients with STEMI, the recommended dose of clopidogrel is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel may be initiated with or without a loading dose [see Clinical Studies (14.1) ]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease The recommended daily dose of clopidogrel is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3 ) ]. 2.3 CYP2C19 Poor Metabolizers CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5 ) ], an appropriate dose regimen for this patient population has not been established. 2.4 Use with Proton Pump Inhibitors (PPI) Avoid using omeprazole or esomeprazole with clopidogrel. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. When concomitant administration of a PPI is required, consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of clopidogrel active metabolite [see Warnings and Precautions (5.1) , Drug Interactions (7.1) and Clinical Pharmacology ( 12.3 ) ].

Read the full Dosage and Administration section on DailyMed →

Clopidogrel side effects

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Bleeding is the most commonly reported side effect.

Common side effects

  • Bleeding, which is the most commonly reported side effect
  • Nosebleeds
  • Blood in the urine
  • Bruising
  • Stomach or intestinal bleeding

When to get medical help

  • Call your doctor or get emergency help for bleeding that is severe, unusual or won't stop, including black or bloody stools or bleeding in the brain
  • Get help right away for signs of a serious allergic reaction (anaphylaxis)
  • Tell your doctor right away about any possible signs of thrombotic thrombocytopenic purpura (TTP), a rare blood clotting problem that has sometimes been fatal
  • Contact your doctor before stopping clopidogrel, since stopping early raises the risk of heart attack and stroke
  • Tell your doctor about signs of blood loss if you also take other antiplatelet medicines

Clopidogrel warnings and precautions

▾
  • Poor metabolizers: clopidogrel may be less effective if you have reduced CYP2C19 function.
  • Bleeding: risk is higher with anticoagulants, other antiplatelets and chronic NSAID use.
  • Stopping early: raises the risk of heart attack and stroke. If a pause is needed for surgery with major bleeding risk, it is usually about 5 days.
  • TTP: a rare, sometimes fatal blood disorder that has been reported.
  • Cross-reactivity: allergic cross-reactions among related medicines (thienopyridines) have been reported.

Clopidogrel interactions

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These can change how well clopidogrel works or raise bleeding risk:

  • Omeprazole and esomeprazole: reduce clopidogrel's effect
  • Opioids: reduce and delay absorption
  • NSAIDs, warfarin, SSRIs, SNRIs and other antiplatelets: raise bleeding risk
  • Strong CYP2C19 inducers such as rifampin: raise active drug levels and bleeding risk
  • Repaglinide: levels rise sharply

Interactions listed in the FDA-approved label

From the Clopidogrel prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • CYP2C19 inducers (e.g., rifampin): Increases levels of clopidogrel active metabolite and increases platelet inhibition, which might potentiate the risk of bleeding. As a precaution, avoid concomitant use of strong CYP2C19 inducers.
  • CYP2C19 inhibitors: omeprazole or esomeprazole: Significantly reduce the antiplatelet activity of clopidogrel, including when given 12 hours apart. Avoid concomitant use; if a PPI is required, consider another acid-reducing agent with minimal or no CYP2C19 inhibitory effect.
  • Opioids: Coadministration delays and reduces absorption of clopidogrel, resulting in reduced exposure to its metabolites. Consider a parenteral antiplatelet agent in acute coronary syndrome patients requiring morphine or other opioid agonists.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs): Coadministration increases the risk of gastrointestinal bleeding.
  • Warfarin (CYP2C9 substrates): Coadministration increases the risk of bleeding because of independent effects on hemostasis.
  • SSRIs and SNRIs: Concomitant administration may increase the risk of bleeding.
  • Other antiplatelet agents: Coadministration increases the risk of bleeding due to an additive effect. Promptly evaluate any signs or symptoms of blood loss.
  • Repaglinide (CYP2C8 substrates): Clopidogrel increased repaglinide exposures by 3.9-fold to 5.1-fold. Avoid concomitant use; if it cannot be avoided, initiate repaglinide at 0.5 mg before each meal, do not exceed a total daily dose of 4 mg, and increase glucose monitoring as needed.
Read the label’s full interactions text

7 DRUG INTERACTIONS • CYP2C19 inducers: Increases levels of clopidogrel active metabolite and increases platelet inhibition. ( 7.1 ) • Opioids: Decreased exposure to clopidogrel. Consider use of parenteral antiplatelet agent. ( 7.3 ) • Nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): 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): Increases substrate plasma concentrations. ( 7.8 ) 7.1 CYP2C19 Inducers Since clopidogrel is metabolized to its active metabolite partly by CYP2C19, use of drugs that induce the activity of this enzyme would be expected to result in increased drug levels of the active metabolite of clopidogrel. 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. As a precaution, avoid concomitant use of strong CYP2C19 inducers [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] . 7.2 CYP2C19 Inhibitors Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of drugs that inhibit the activity of this enzyme results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see Warnings and Precautions ( 5.1 )]. Omeprazole or Esomeprazole Avoid concomitant use of clopidogrel with omeprazole or esomeprazole. In clinical studies, omeprazole was shown to reduce significantly the antiplatelet activity of clopidogrel when given concomitantly or 12 hours apart. A similar reduction in antiplatelet activity was observed with esomeprazole when given concomitantly with clopidogrel.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Clopidogrel

▾
  • Do not use with active bleeding or a known allergy to clopidogrel
  • Tell your doctor about any known CYP2C19 poor metabolizer status
  • Tell your care team before surgery, labor or delivery, or spinal anesthesia procedures
  • Pregnancy: no drug-linked birth defect or miscarriage risk was identified in available data
  • Breastfeeding: discuss with your doctor
  • Children: safety and effectiveness not established
  • Older adults: no dose change needed
  • Kidney impairment: experience is limited; liver impairment: no dose change needed

Clopidogrel overdose

▾

Too much clopidogrel can cause bleeding complications, and its platelet effect lasts for the life of the platelet. A platelet transfusion may help restore clotting. Seek emergency help or call poison control after any overdose.

What Clopidogrel does in the body

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Clopidogrel's active form blocks platelets from clumping. Effects begin within about 2 hours of a dose, and with daily use the effect reaches steady state in about 3 to 7 days. Platelet function and bleeding time return to baseline about 5 days after stopping.

How your body processes Clopidogrel

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Clopidogrel is absorbed quickly and then converted by the liver into an active form, mainly by CYP2C19. The active form peaks about 30 to 60 minutes after dosing. Clopidogrel's half-life is about 6 hours, and the active form's is about 30 minutes. It leaves the body through urine and feces.

How to store Clopidogrel

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Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

309

Supplements & herbs that interact with Clopidogrel

309 supplements and herbal products have documented interactions with Clopidogrel in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 258
  • Minor · 46
Every supplement checked against Clopidogrel — ranked by severity The full interaction hub: 5 major · 258 moderate · 46 minor · every one linked to its full report. Check Clopidogrel against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Clopidogrel: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Clopidogrel — the kind of thing our pharmacy team would talk through with you at the counter.

What is clopidogrel for?

▾
It helps prevent heart attacks and strokes in people with acute coronary syndrome, a recent heart attack, a recent stroke or peripheral arterial disease. It works by keeping platelets from clumping into clots.

How should I take it?

▾
Take it by mouth, usually once a day, with or without food. Your doctor may start with a one-time loading dose. Follow your label and don't stop it unless your prescriber says so.

Why shouldn't I stop it suddenly?

▾
Stopping early raises your risk of a heart attack or stroke. If you need surgery, your doctor will tell you whether to pause it, often about 5 days before, and when to restart.

What side effects should I expect?

▾
Bleeding is the most common one, so you may notice nosebleeds or bruise more easily. Call your doctor for bleeding that is heavy, unusual or won't stop, or for black or bloody stools.

Can I take heartburn medicine with it?

▾
Avoid omeprazole and esomeprazole, since they weaken clopidogrel. Ask me or your doctor about other acid reducers. Also check before using NSAIDs, blood thinners or antidepressants, since they can raise bleeding risk.

Is it safe in pregnancy?

▾
Available data haven't shown a link to major birth defects or miscarriage. Treating a heart attack or stroke shouldn't be withheld because of pregnancy. Tell your doctor if you're pregnant or near delivery because of bleeding risk.

Is Clopidogrel available over the counter?

▾
No. Clopidogrel is a prescription medicine: every Clopidogrel product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Clopidogrel first available?

▾
The earliest FDA record we hold for Clopidogrel is from 1997: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Clopidogrel was first used.

Who makes Clopidogrel?

▾
35 companies currently list Clopidogrel products in the FDA's NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack, NuCare Pharmaceuticals,Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Clopidogrel on HelloPharmacist

Detailed data & references for Clopidogrel Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Clopidogrel forms and strengths (how it comes)

Clopidogrel is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Clopidogrel inactive ingredients by manufacturer.

Tablet

By mouth
Brands Clopidogrel Bisulfate Plavix
How this form is used
What it may be used for
  • Plavix is a P2Y12 platelet inhibitor used to reduce heart attack and stroke in acute coronary syndrome, recent heart attack, recent stroke or established peripheral arterial disease
  • Clopidogrel tablets are used for acute coronary syndrome, recent heart attack, recent stroke or established peripheral arterial disease
Important instructions
  • Plavix is taken by mouth once daily; for acute coronary syndrome it may be started with a one-time loading dose
  • Plavix should be given together with aspirin for acute coronary syndrome
  • Clopidogrel tablets can be taken with or without food
Available strengths 2 strengths
126 FDA-listed product records ⓘ

Clopidogrel on the U.S. market: products, makers and brands

How Clopidogrel appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

35 companies list 66 Clopidogrel product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1997. Brand names on the directory include Plavix, Clopidogrel bisulfate; the rest are generics.

1
Dose forms ⓘ
35
Labelers (makers, repackagers, distributors)
3
Brand names
66
FDA-listed product records ⓘ
1997
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (25) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions11%
Bryant Ranch Prepack6%
NuCare Pharmaceuticals,Inc.6%
Proficient Rx LP6%
Remedyrepack Inc.6%
American Health Packaging3%
Other makers62%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Clopidogrel is used (Medicaid data)

A general measure of how commonly Clopidogrel is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Clopidogrel is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,480,259
Medicaid prescriptions filled (Q1–Q4 2025)
$15.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Clopidogrel prescribed? Of the 1,601 medications we measure, Clopidogrel ranks #131 by Medicaid prescriptions — more than 92% of them.

Where Clopidogrel ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Clopidogrel product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 75 mg oral tablet is the most-dispensed Clopidogrel product — about 100% of these Medicaid prescriptions.

clopidogrel 75 MG Oral Tablet Most dispensed

1,480,174 Medicaid prescriptions (Q1–Q4 2025) 100% of Clopidogrel prescriptions shown $15.3M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 42 of 261 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309362

clopidogrel 300 MG Oral Tablet

85 Medicaid prescriptions (Q1–Q4 2025) <1% of Clopidogrel prescriptions shown $3,957 gross reimbursement (before rebates) ≈ $47 per prescription (gross)

Summed across the 2 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749196

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Clopidogrel, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 44 of 317 listed Clopidogrel NDCs with Medicaid activity.

Compare Clopidogrel products

A representative set of FDA-listed product records for Clopidogrel — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 66 of 66 products — FDA National Drug Code Directory. See every product, package size and price: browse all 66 Clopidogrel NDCs →

Clopidogrel side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Clopidogrel — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Clopidogrel are dyspnoea, myocardial infarction, fatigue; about 82% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

210,996
Reports mentioning it
82%
Reported as serious
12
Distinct effects shown
Most reported effects
Dyspnoea
10,954
Myocardial Infarction
10,229
Fatigue
9,429
Gastrointestinal Haemorrhage
8,773
Nausea
8,687
Dizziness
8,486
Diarrhoea
8,192
Asthenia
7,413
Fall
7,199
Cerebrovascular Accident
6,869
Age groups
Elderly · 26,051Adult · 14,147Child · 51Neonate · 50Adolescent · 39Infant · 32

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Clopidogrel in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Clopidogrel FDA approval history

How Clopidogrel went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Clopidogrel was first approved by the FDA in 1997 (Brand: PLAVIX · Sanofi Aventis Us); the first generic version was approved in 2008. It remains available in U.S. pharmacies today.

1997
Brand approved
Brand: PLAVIX · Sanofi Aventis Us
2008
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Clopidogrel recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Clopidogrel recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Aug 2, 2021 · Terminated · Macleods Pharma Usa Inc
Presence of foreign matter
  • Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh,… Lots: Lot # BCA82021A, Exp 06/2023 FDA record D-0787-2021 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Clopidogrel RxCUI 32968 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 374583 In current FDA listings
    Clinical drug / strength (SCD) 75 MG RxCUI 309362 300 MG RxCUI 749196

Look up RxCUI 32968 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Clopidogrel costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 75 mg $8.23 per tablet NDC details & price history
Tablet · Oral 75 mg $0.047 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Clopidogrel brand names

Clopidogrel is sold under 2 brand names in the FDA directory — Plavix, Clopidogrel bisulfate. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Plavix Clopidogrel bisulfate

Who makes Clopidogrel: manufacturers and labelers

35 companies list Clopidogrel products with the FDA. By number of product records, the largest are A-S Medication Solutions, Bryant Ranch Prepack, NuCare Pharmaceuticals,Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 7 Bryant Ranch Prepack 4 NuCare Pharmaceuticals,Inc. 4 Proficient Rx LP 4 Remedyrepack Inc. 4 American Health Packaging 2 Apotex Corp. 2 Camber Pharmaceuticals, Inc. 2 Dr.Reddy's Laboratories Inc 2 Dr.Reddy's Laboratories Limited 2 PD-Rx Pharmaceuticals, Inc. 2 Preferred Pharmaceuticals Inc. 2 Quallent Pharmaceuticals Health LLC 2 Radha Pharmaceuticals, Inc. 2 Sanofi-Aventis U.S. LLC 2 ScieGen Pharmaceuticals Inc 2 Vensun Pharmaceuticals, Inc. 2 Westminster Pharmaceuticals, LLC 2 Amneal Pharmaceuticals LLC 1 Aphena Pharma Solutions - Tennessee, LLC 1 Ascend Laboratories, LLC 1 Aurobindo Pharma Limited 1 AvPAK 1 Cardinal Health 107, LLC 1

…and 11 more on the FDA NDC directory.

Clopidogrel drug class (RxNorm)

Clopidogrel belongs to the P2Y12 Platelet Inhibitor class.

Pharmacologic class P2Y12 Platelet Inhibitor
Drug family (ATC) Platelet aggregation inhibitors excl. heparin
How it works P2Y12 Receptor Antagonists, Cytochrome P450 2C8 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Clopidogrel page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 30, 2025
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Clopidogrel.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Clopidogrel after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
67
Finished products in the current FDA directory
66
Companies listing them (makers, repackagers, distributors)
35
FDA labeler codes behind them ⓘ
39
Linked representative label ⓘ
sanofi-aventis U.S. LLC
Linked label effective
May 30, 2025
Composite sections available
25
Linked SPL Set ID
de8b0b67-eb25-4684-83b5-7ad785314227
Linked SPL Document ID
ed60a9e7-49f4-469c-bb7a-08e1bb6057e2
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. sanofi-aventis U.S. LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →