Clopidogrel

Generic name: clopidogrel bisulfate tablets, USP · Brand names: Plavix (Sanofi-Aventis U.S. LLC)

Quick facts

Drug class

Clopidogrel is a P2Y12 platelet inhibitor (an antiplatelet, sometimes called a blood thinner in the Medication Guide).

Section

Highlights

Source text (exact source wording)

Clopidogrel tablets is a P2Y12 platelet inhibitor indicated for:

Rx or otc

Prescription (prescribing information with Medication Guide)

Forms and strengths

75 mg tablets: Pink colored, biconvex, round shaped, beveled edge, film coated tablets printed "CL 75" on one side and plain on other side (Ascend label)

Generic available

Value

Yes, this is a generic label (clopidogrel bisulfate tablet, Ascend Laboratories, LLC). ANDA status not displayed in text read.

Source

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=db1161c9-6efd-4361-a766-6a37c241ccee&type=display

Common use one line

Lowers the chance of heart attack and stroke in people with acute coronary syndrome, a recent heart attack or stroke, or peripheral artery disease.

What it is used for

Clopidogrel lowers the chance of a heart attack (MI) and stroke in people with acute coronary syndrome, which includes unstable angina and heart attacks. For these uses it is given with aspirin. It also lowers that chance in people with peripheral arterial disease or a recent heart attack or stroke.

Section

1.1 and 1.2 Indications and Usage

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Clopidogrel tablets 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 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 is 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. In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets is indicated to reduce the rate of MI and stroke.

How it works

Clopidogrel keeps platelets from clumping together. Its active form binds to a receptor on platelets and the effect cannot be reversed.

Section

12.1 Mechanism of Action

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Clopidogrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.

Dosage: adults

For acute coronary syndrome, treatment starts with a single 300 mg loading dose, then 75 mg once daily. Without the loading dose it takes several days for the effect to start. For recent heart attack, recent stroke or peripheral arterial disease, the dose is 75 mg once daily with no loading dose.

Section

2.1 and 2.2 Dosage and Administration

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

In patients who need an antiplatelet effect within hours, initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiating clopidogrel tablets without a loading dose will delay establishment of an antiplatelet effect by several days. [2.1 Acute Coronary Syndrome] 75 mg once daily orally without a loading dose [2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease]

Dosage: children

Safety and effectiveness in children have not been established.

Section

8.4 Pediatric Use

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Safety and effectiveness in pediatric populations have not been established.

Dosage adjustments

Drug interaction caps

Avoid omeprazole and esomeprazole. Avoid repaglinide; if it must be used, the label limits repaglinide to 0.5 mg before each meal and a total of 4 mg a day.

Section

7.2 and 7.8 Drug Interactions

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Avoid concomitant use of clopidogrel tablets with omeprazole or esomeprazole. [7.2] Avoid concomitant use of repaglinide with clopidogrel tablets. If concomitant use cannot be avoided, initiate repaglinide at 0.5 mg before each meal and do not exceed a total daily dose of 4 mg. [7.8]

Kidney

The label says experience is limited in people with moderate or severe kidney problems.

Section

8.6 Renal Impairment

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Experience is limited in patients with severe and moderate renal impairment [see Clinical Pharmacology (12.2)].

Liver

No dose change is needed for liver impairment.

Section

8.7 Hepatic Impairment

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

No dosage adjustment is necessary in patients with hepatic impairment [see Clinical Pharmacology (12.2)].

Elderly

No dose change is needed for older adults.

Section

8.5 Geriatric Use

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

No dosage adjustment is necessary in elderly patients.

Missed dose

Section

n/a

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Overdose

An overdose may cause bleeding. The effect on platelets lasts for the life of the platelet. Platelet transfusion may restore clotting. Poison control: 1-800-222-1222 (RxDiff rule, not from label).

Section

10 OVERDOSAGE

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Platelet inhibition by clopidogrel tablets is irreversible and will last for the life of the platelet. Overdose following clopidogrel administration may result in bleeding complications. A single oral dose of clopidogrel at 1500 or 2000 mg/kg was lethal to mice and to rats and at 3000 mg/kg to baboons. Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage in animals. Based on biological plausibility, platelet transfusion may restore clotting ability.

Storage

Store at 25 degrees C (77 degrees F). Trips between 15 and 30 degrees C (59 and 86 degrees F) are allowed. Ascend label; other labelers may differ.

Section

16 HOW SUPPLIED/STORAGE AND HANDLING

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Store at 25°C (77°F); excursions permitted to 15° C to 30°C (59°F to 86° F) [see USP Controlled Room Temperature].

Boxed warning

Clopidogrel has to be changed by the body into its active form, mostly by an enzyme called CYP2C19. People who have two nonworking copies of the CYP2C19 gene make less of the active form and get less benefit. Tests can find these people, and the label says to consider another P2Y12 inhibitor for them.

Title

WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE

Section

Boxed Warning

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

The effectiveness of clopidogrel tablets 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 tablets 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 P2Y12 inhibitor in patients identified as CYP2C19 poor metabolizers.

Contraindications

Do not use it if you have active, harmful bleeding such as a stomach ulcer or bleeding in the brain.

Section

4.1 Active Bleeding

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Clopidogrel tablets is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Do not use it if you are allergic to clopidogrel or any ingredient.

Section

4.2 Hypersensitivity

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Clopidogrel tablets is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2)].

Warnings and precautions

Omeprazole and esomeprazole reduce how well clopidogrel works. Avoid them.

Heading

5.1 Diminished Antiplatelet Activity in Patients with Impaired CYP2C19 Function

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

The metabolism of clopidogrel can also be impaired by drugs that inhibit CYP2C19, such as omeprazole or esomeprazole. Avoid concomitant use of clopidogrel tablets with omeprazole or esomeprazole because both significantly reduce the antiplatelet activity of clopidogrel tablets [see Drug Interactions (7.1)].

Clopidogrel raises the risk of bleeding, more so with other blood thinners, antiplatelets or regular NSAID use.

Heading

5.2 General Risk of Bleeding

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

P2Y12 inhibitors (thienopyridines), including clopidogrel tablets, increase the risk of bleeding. Risk factors for bleeding include concomitant use of other drugs that increase the risk of bleeding (e.g., anticoagulants, antiplatelet agents, and chronic use of NSAIDs) [see Drug Interactions (7.4, 7.5, 7.6, 7.7)].

Stopping raises the risk of heart and blood vessel events. When possible, therapy is paused for five days before surgery with major bleeding risk and restarted as soon as bleeding is controlled.

Heading

5.3 Discontinuation of clopidogrel tablets

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Discontinuation of clopidogrel tablets increases the risk of cardiovascular events. If clopidogrel tablets must be temporarily discontinued (e.g., to treat bleeding or for surgery with a major risk of bleeding), restart it as soon as possible. When possible, interrupt therapy with clopidogrel tablets for five days prior to such surgery. Resume clopidogrel tablets as soon as hemostasis is achieved.

A rare, serious blood condition called TTP, sometimes fatal, has been reported, sometimes in under 2 weeks. It needs urgent treatment.

Heading

5.4 Thrombotic Thrombocytopenic Purpura (TTP)

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

TTP, sometimes fatal, has been reported following use of clopidogrel tablets, sometimes after a short exposure (less than 2 weeks). TTP is a serious condition that requires urgent treatment including plasmapheresis (plasma exchange).

Allergic or blood reactions have been reported, including in people who reacted to similar medicines.

Heading

5.5 Cross-Reactivity among Thienopyridines

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel tablets, including patients with a history of hypersensitivity or hematologic reaction to other thienopyridines [see Contraindications (4.2) and Adverse Reactions (6.2)].

Pregnancy and breastfeeding

Available data have not shown a risk of major birth defects or miscarriage. Use during labor or delivery raises bleeding risk, so when possible it is stopped 5 to 7 days before. There are no data on milk, and no harm to breastfed infants was seen in a small number of cases.

Section

8.1 Pregnancy and 8.2 Lactation

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see Data]. [8.1] Clopidogrel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage. Avoid neuraxial blockade during clopidogrel use because of the risk of spinal hematoma. When possible, discontinue clopidogrel 5 to 7 days prior to labor, delivery, or neuraxial blockade. [8.1] There are no data on the presence of clopidogrel in human milk or the effects on milk production. No adverse effects on breastfed infants have been observed with maternal clopidogrel use during lactation in a small number of postmarketing cases. [8.2]

Side effects

Common

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported side effect.

Threshold

Label gives no percentage threshold; Highlights state this single most commonly reported reaction.

Section

Highlights, Adverse Reactions

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. (6.1)

Less common

In the CURE trial, major bleeding was 3.7% with clopidogrel plus aspirin versus 2.7% with placebo plus aspirin, and minor bleeding was 5.1% versus 2.4%. Nosebleeds, blood in urine and bruising were reported more often. Itching was reported more often than with aspirin in the CAPRIE trial.

Section

6.1 Clinical Trials Experience, Table 1

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

In CURE, clopidogrel tablets 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). Table 1 (clopidogrel + aspirin vs placebo + aspirin, % patients): Major bleeding 3.7 vs 2.7; Life-threatening bleeding 2.2 vs 1.8; Fatal 0.2 vs 0.2; Minor bleeding 5.1 vs 2.4. Other bleeding events that were reported more frequently in the clopidogrel group were epistaxis, hematuria, and bruise. In CAPRIE, which compared clopidogrel tablets to aspirin, pruritus was more frequently reported in those taking clopidogrel tablets.

Serious

Serious problems reported include fatal bleeding, TTP, severe drops in blood cells, liver failure, and severe allergic and skin reactions.

Label source text (exact source wording)

TTP, sometimes fatal, has been reported following use of clopidogrel tablets, sometimes after a short exposure (less than 2 weeks). [5.4] Hemorrhages, including those with fatal outcome, have been reported in patients treated with clopidogrel tablets. [6.2] Postmarketing includes: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura (TTP), acquired hemophilia A; Acute liver failure; Hypersensitivity reactions, anaphylactoid reactions; toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema (partial copy of 6.2)

Medlineplus source text (exact source wording)

not retrieved (MedlinePlus not opened in this run)

Interactions

Drugs

Avoid. They reduce how well clopidogrel works, even when taken 12 hours apart.

Name

Omeprazole or esomeprazole

Section

7.2 CYP2C19 Inhibitors

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Avoid concomitant use of clopidogrel tablets with omeprazole or esomeprazole. In clinical studies, omeprazole was shown to reduce significantly the antiplatelet activity of clopidogrel tablets when given concomitantly or 12 hours apart.

Avoid strong CYP2C19 inducers such as rifampin; bleeding risk can rise.

Name

Strong CYP2C19 inducers (rifampin)

Section

7.1 CYP2C19 Inducers

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

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

Opioids can slow and reduce absorption of clopidogrel.

Name

Opioids

Section

7.3 Opioids

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

coadministration of opioid agonists delay and reduce the absorption of clopidogrel, presumably because of slowed gastric emptying, resulting in reduced exposure to its metabolites. Consider the use of a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists.

Taking NSAIDs with clopidogrel raises the risk of stomach and gut bleeding.

Name

NSAIDs

Section

7.4 NSAIDs

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Coadministration of clopidogrel tablets and NSAIDs increases the risk of gastrointestinal bleeding.

Using it with warfarin raises the risk of bleeding.

Name

Warfarin

Section

7.5 Warfarin

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

coadministration of clopidogrel tablets with warfarin increases the risk of bleeding because of independent effects on hemostasis.

SSRI and SNRI antidepressants may raise bleeding risk.

Name

SSRIs and SNRIs

Section

7.6 SSRIs and SNRIs

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

the concomitant administration of SSRIs and SNRIs with clopidogrel may increase the risk of bleeding.

Other antiplatelet medicines add to bleeding risk.

Name

Other antiplatelet agents

Section

7.7 Other Antiplatelet Agents

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Coadministration of antiplatelet agents increase the risk of bleeding due to an additive effect.

Clopidogrel raises repaglinide levels 3.9-fold to 5.1-fold. Avoid the combination.

Name

Repaglinide

Section

7.8 Repaglinide

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Clopidogrel tablets increased repaglinide exposures by 3.9-fold to 5.1-fold [see Clinical Pharmacology (12.3)]. Avoid concomitant use of repaglinide with clopidogrel tablets.

Food and alcohol

It can be taken with or without food.

Name

Food

Section

12.3 Pharmacokinetics, Effect of food

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Clopidogrel tablets can be administered with or without food.

Name

Alcohol / grapefruit

Section

n/a

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Other

not applicable

Name

Liverpool HIV/HEP checkers

Section

n/a

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

not applicable: label interaction sections list no antiviral drugs

Patient tips

Label

Do not stop without talking to your prescriber. You will bruise and bleed more easily and bleeding takes longer to stop. Report unusual or long bleeding or blood in stool or urine. Tell doctors and dentists before any procedure. Do not take omeprazole or esomeprazole.

Section

17 PATIENT COUNSELING INFORMATION (Medication Guide only partly read)

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Source text (exact source wording)

Advise patients not to discontinue clopidogrel tablets without first discussing it with the healthcare provider who prescribed it. Advise patients that they: will bruise and bleed more easily; will take longer than usual to stop bleeding; must report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine. Advise patients to inform physicians and dentists that they are taking clopidogrel tablets before any surgery or dental procedure. Advise patients not to take omeprazole or esomeprazole while taking clopidogrel tablets.

Alternatives

Class source

Label Highlights: 'Clopidogrel tablets is a P2Y12 platelet inhibitor'. openFDA not checked.

Note

No recommendation made.

Frequently asked questions

Question

What is clopidogrel used for?

Answer

It lowers the chance of a heart attack (MI) and stroke in people with acute coronary syndrome, a recent heart attack or stroke, or peripheral arterial disease. In acute coronary syndrome it is given with aspirin.

Source section

1 Indications and Usage

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Question

How do I take it?

Answer

For recent heart attack, recent stroke or peripheral arterial disease the dose is 75 mg once daily. For acute coronary syndrome a single 300 mg loading dose may be given first, then 75 mg once daily. It can be taken with or without food.

Source section

2.1, 2.2; 12.3

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Question

What are the main side effects?

Answer

Bleeding is the most commonly reported side effect, including life-threatening and fatal bleeding. You will bruise and bleed more easily.

Source section

Highlights; 17

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Question

Can I take omeprazole or similar acid medicines with it?

Answer

Avoid omeprazole and esomeprazole because they significantly reduce how well clopidogrel works.

Source section

5.1; 7.2

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Question

What should I not combine with clopidogrel?

Answer

NSAIDs, warfarin, SSRIs, SNRIs and other antiplatelet medicines raise bleeding risk. Avoid repaglinide and strong CYP2C19 inducers such as rifampin.

Source section

7 Drug Interactions

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Question

Is it safe in pregnancy or breastfeeding?

Answer

Available data have not shown a risk of major birth defects or miscarriage. Use during labor raises bleeding risk. There are no data on milk, and no harm was seen in a small number of breastfed infants.

Source section

8.1; 8.2

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Question

Can I stop clopidogrel if I feel fine?

Answer

Do not stop without talking to your prescriber. Stopping raises the risk of cardiovascular events.

Source section

5.3; 17

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Question

Does my genetics matter?

Answer

Yes. People with two nonfunctional CYP2C19 gene alleles make less active drug. Tests are available and the label says to consider another P2Y12 inhibitor for them.

Source section

Boxed Warning; 12.5

Source

Ascend clopidogrel tablets label (db1161c9-6efd-4361-a766-6a37c241ccee)

Sources

DailyMed printer-friendly label, Ascend Laboratories, LLC (clopidogrel tablets)
Set id: db1161c9-6efd-4361-a766-6a37c241ccee · Label effective or revised date: Revised: 9/2025 · Dailymed version date: Jun 03, 2026 (DailyMed list publish date) · Fetched at: 2026-11-02 · Sections used: Boxed warning, 1-8, 10, 12.1, 12.3 (food), 16, 17, start of Medication Guide (text capped at 50,000 of 60,525 characters)

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug