Clopidogrel Aliud

Antiplatelet agent for prevention of atherothrombotic events

Rx – Prescription Only P2Y12 Inhibitor ATC: B01AC04
Active Ingredient
Clopidogrel (as hydrogen sulfate)
Form
Film-coated tablet
Strength
75 mg
Manufacturer
Aliud Pharma
Medically reviewed by iMedic Medical Review Board

Clopidogrel Aliud is a prescription antiplatelet medicine containing clopidogrel 75 mg. It is used to prevent blood clots in patients who have experienced a heart attack, ischemic stroke, or have peripheral arterial disease. This guide provides comprehensive, evidence-based information about its uses, dosage, side effects, and drug interactions.

Quick Facts

Active Ingredient
Clopidogrel
Drug Class
P2Y12 Inhibitor
ATC Code
B01AC04
Common Uses
Atherothrombosis Prevention
Available Forms
Film-coated Tablet 75 mg
Prescription Status
Prescription Only (Rx)

Key Takeaways

  • Clopidogrel Aliud is a generic antiplatelet medicine containing clopidogrel 75 mg, bioequivalent to the original brand Plavix.
  • It works by irreversibly inhibiting the P2Y12 ADP receptor on platelets, preventing blood clot formation for the lifespan of the platelet (7–10 days).
  • Commonly prescribed after heart attack, ischemic stroke, or with coronary stents as part of dual antiplatelet therapy (DAPT) with aspirin.
  • Certain proton pump inhibitors (omeprazole, esomeprazole) should be avoided as they reduce clopidogrel’s effectiveness by inhibiting CYP2C19.
  • Genetic variation in CYP2C19 can affect how well clopidogrel works — approximately 2–14% of people are poor metabolizers with reduced antiplatelet response.

What Is Clopidogrel Aliud and What Is It Used For?

Clopidogrel Aliud contains the active substance clopidogrel, an antiplatelet medicine that prevents blood clots (thrombi) from forming. It is prescribed for adults to reduce the risk of heart attack, stroke, and other cardiovascular events in patients with atherosclerotic disease.

Clopidogrel belongs to the thienopyridine class of antiplatelet agents. It is a prodrug, meaning it must be converted into its active form by liver enzymes (primarily cytochrome P450 2C19, or CYP2C19) before it can exert its therapeutic effect. Once activated, clopidogrel irreversibly binds to the P2Y12 adenosine diphosphate (ADP) receptor on the surface of platelets, blocking ADP-mediated platelet activation and aggregation. This effect lasts for the entire remaining lifespan of the affected platelet, approximately 7 to 10 days.

Clopidogrel Aliud is a generic medicine manufactured by Aliud Pharma. It contains the same active ingredient and is bioequivalent to the original brand-name product Plavix, which was developed by Sanofi and Bristol-Myers Squibb and first approved in 1997. Generic clopidogrel products have been available since the expiry of the original patent and must meet the same rigorous quality, safety, and efficacy standards set by regulatory authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

The clinical evidence supporting clopidogrel’s efficacy is extensive. The landmark CAPRIE trial (Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events) demonstrated that clopidogrel 75 mg daily was more effective than aspirin 325 mg daily in reducing the combined risk of ischemic stroke, myocardial infarction, and vascular death in patients with atherosclerotic disease. Subsequent trials, including CURE, COMMIT, and CLARITY-TIMI 28, established the benefit of adding clopidogrel to aspirin (dual antiplatelet therapy) in patients with acute coronary syndromes and after percutaneous coronary intervention (PCI) with stent placement.

Approved Indications

Clopidogrel Aliud is indicated for the prevention of atherothrombotic events in adults with the following conditions:

How clopidogrel differs from aspirin

While both clopidogrel and aspirin are antiplatelet agents, they work through entirely different mechanisms. Aspirin inhibits cyclooxygenase (COX-1), blocking thromboxane A2 production. Clopidogrel blocks the P2Y12 ADP receptor. Because they target different pathways, combining them (dual antiplatelet therapy, DAPT) provides more comprehensive platelet inhibition than either drug alone. This is why DAPT is the standard of care after acute coronary syndromes and coronary stenting.

What Should You Know Before Taking Clopidogrel Aliud?

Do not take Clopidogrel Aliud if you are allergic to clopidogrel, have active pathological bleeding (such as a peptic ulcer or intracranial hemorrhage), or have severe liver disease. Tell your doctor about all other medicines you take, especially proton pump inhibitors, anticoagulants, and NSAIDs.

Before starting treatment with clopidogrel, your doctor needs a complete picture of your medical history and current medications. This is essential because clopidogrel interacts with several common medicines and is contraindicated in certain conditions. The following sections detail the most important safety information.

Contraindications

You must not take Clopidogrel Aliud if any of the following apply to you:

Warnings and Precautions

Talk to your doctor or pharmacist before taking Clopidogrel Aliud if any of the following apply:

Pregnancy and Breastfeeding

There are no adequate and well-controlled studies of clopidogrel in pregnant women. Animal studies have not shown direct harmful effects on pregnancy, embryo-fetal development, parturition, or postnatal development, but the potential risks in humans are not fully characterized. As a precaution, clopidogrel should not be used during pregnancy unless clearly necessary and your doctor determines that the benefit outweighs the potential risk.

It is not known whether clopidogrel or its metabolites are excreted in human breast milk. Animal studies have shown that clopidogrel and its metabolites pass into breast milk. Breastfeeding should be discontinued during treatment with clopidogrel, as a risk to the newborn or infant cannot be excluded.

Important: Do not stop clopidogrel without medical advice

If you have had a coronary stent implanted, stopping clopidogrel prematurely can dramatically increase the risk of stent thrombosis — a potentially life-threatening event. Even if you need to undergo surgery, do not stop clopidogrel on your own. Your cardiologist and surgeon must jointly decide on the appropriate management strategy.

How Does Clopidogrel Aliud Interact with Other Drugs?

Clopidogrel has clinically significant interactions with several commonly used medicines. The most important interactions are with certain proton pump inhibitors (omeprazole, esomeprazole) that reduce clopidogrel’s effectiveness, and with anticoagulants and NSAIDs that increase bleeding risk.

Clopidogrel is a prodrug that depends on hepatic CYP450 enzymes — particularly CYP2C19 — for conversion to its active metabolite. Medicines that inhibit CYP2C19 can significantly reduce clopidogrel’s antiplatelet effect, potentially increasing the risk of cardiovascular events. Additionally, because clopidogrel inhibits platelet aggregation, combining it with other agents that affect hemostasis increases the risk of bleeding. Always inform your doctor and pharmacist about all medicines you are taking, including over-the-counter products and herbal supplements.

Major Interactions

Major Drug Interactions – Clopidogrel Aliud
Drug / Class Interaction Clinical Significance
Omeprazole Strong CYP2C19 inhibitor that reduces formation of clopidogrel’s active metabolite by 40–50% Avoid combination; use pantoprazole instead
Esomeprazole Strong CYP2C19 inhibitor with similar effect to omeprazole on clopidogrel activation Avoid combination; use pantoprazole instead
Warfarin Dual inhibition of hemostasis: clopidogrel inhibits platelet aggregation while warfarin inhibits coagulation factors Significantly increased bleeding risk; use only under close supervision with regular INR monitoring
Heparin (LMWH) Additive anticoagulant and antiplatelet effects Increased bleeding risk; monitor closely
Fluconazole Moderate CYP2C19 inhibitor that can reduce clopidogrel’s active metabolite levels Use with caution; consider platelet function testing if prolonged co-administration
Repaglinide Clopidogrel’s active metabolite inhibits CYP2C8, increasing repaglinide exposure (up to 3–5 fold) Avoid combination; risk of severe hypoglycemia

Minor Interactions

Additional Drug Interactions – Clopidogrel Aliud
Drug / Class Interaction Clinical Significance
Aspirin Additive antiplatelet effects via complementary pathways (COX-1 + P2Y12) Intended combination in DAPT; increased bleeding risk but established clinical benefit
NSAIDs (ibuprofen, naproxen) Additive effects on gastrointestinal mucosal injury and bleeding time prolongation Increased risk of GI bleeding; avoid if possible or use gastroprotection
SSRIs (fluoxetine, sertraline) SSRIs deplete platelet serotonin, which independently impairs hemostasis Increased risk of bleeding; monitor for signs of bleeding
Phenytoin, carbamazepine CYP2C19 inducers that may theoretically increase clopidogrel activation, but clinical significance is uncertain Monitor; clinical impact likely minimal
Pantoprazole Weak CYP2C19 inhibitor with minimal effect on clopidogrel activation Preferred PPI for co-administration with clopidogrel
Morphine Morphine slows gastric absorption, delaying clopidogrel’s onset of action Consider crushed loading dose or alternative antiplatelet in acute MI
Proton Pump Inhibitors (PPIs) and Clopidogrel

The interaction between PPIs and clopidogrel has been one of the most studied drug interactions in cardiovascular medicine. Both the FDA and EMA have issued guidance recommending avoidance of omeprazole and esomeprazole in patients taking clopidogrel. If you require gastroprotection (to protect the stomach from aspirin or NSAID use), pantoprazole is the preferred PPI, as pharmacokinetic studies have shown it has minimal impact on clopidogrel’s antiplatelet activity. H2 receptor antagonists (such as famotidine) are another alternative with no known interaction.

What Is the Correct Dosage of Clopidogrel Aliud?

The standard dose of Clopidogrel Aliud is 75 mg once daily, with or without food. In acute coronary syndromes, a loading dose of 300 mg (or 600 mg before PCI) is typically given first, followed by 75 mg daily. Always follow your doctor’s instructions regarding dosage and duration.

The dosage and duration of clopidogrel treatment depend on the clinical indication and the patient’s individual risk profile. The following recommendations are based on current European Society of Cardiology (ESC), American Heart Association (AHA), and European Medicines Agency (EMA) guidelines. Your doctor will determine the most appropriate regimen for your specific situation.

Adults

Recent Myocardial Infarction, Ischemic Stroke, or PAD

The recommended dose is 75 mg once daily, taken at approximately the same time each day. No loading dose is required for these chronic indications. Treatment can be initiated from a few days (MI) or 7 days (stroke) after the acute event.

Acute Coronary Syndrome (Non-ST Elevation)

A loading dose of 300 mg is given as a single dose, followed by 75 mg once daily in combination with aspirin (75–100 mg daily). The recommended duration of dual antiplatelet therapy is up to 12 months, after which aspirin alone is typically continued. The optimal duration is individualized based on ischemic and bleeding risk.

Percutaneous Coronary Intervention (PCI) with Stent

A loading dose of 300–600 mg is given before or at the time of the procedure. Higher loading doses (600 mg) achieve faster platelet inhibition and are generally preferred when PCI is planned. This is followed by 75 mg once daily in combination with aspirin. Duration of DAPT: 6–12 months after drug-eluting stent (DES), or 1–3 months in patients at high bleeding risk, as determined by your cardiologist.

ST-Elevation Myocardial Infarction (STEMI)

A loading dose of 300 mg is given in combination with aspirin and, if applicable, thrombolytic therapy. This is followed by 75 mg once daily in combination with aspirin. In patients over 75 years of age, the loading dose should be omitted and treatment started at 75 mg daily.

Children

Clopidogrel Aliud is not recommended for use in children and adolescents below 18 years of age. The efficacy and safety of clopidogrel have not been established in the pediatric population. A clinical trial (CLARINET) in neonates and infants with congenital heart disease found no clinical benefit of clopidogrel over placebo, with a trend toward increased bleeding events.

Elderly

No dose adjustment is required for elderly patients. However, elderly patients are at increased risk of bleeding and may have reduced hepatic function. Treatment should be monitored more closely, and the benefit-risk balance should be regularly reassessed by the treating physician.

Missed Dose

If you forget to take your daily dose of Clopidogrel Aliud, take it as soon as you remember. If it is nearly time for the next scheduled dose, skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for the forgotten one. Because clopidogrel irreversibly inhibits platelets, missing a single dose is unlikely to have a significant clinical impact, as previously affected platelets remain inhibited for their full lifespan. However, consistent daily dosing is important to ensure that newly formed platelets are adequately inhibited.

Overdose

Clopidogrel Overdose – Seek Emergency Help

If you have taken too much clopidogrel, seek emergency medical attention immediately or call your local poison control center. Show any remaining tablets or the empty packaging to the medical team.

Symptoms of clopidogrel overdose may include:

  • Prolonged bleeding time and excessive bruising
  • Gastrointestinal bleeding (vomiting blood, black tarry stools)
  • Nosebleeds that do not stop
  • Blood in urine

There is no specific antidote for clopidogrel. Platelet transfusion may be used to restore hemostatic function if clinically necessary. The active metabolite cannot be removed by dialysis.

What Are the Side Effects of Clopidogrel Aliud?

Like all medicines, clopidogrel can cause side effects, although not everybody gets them. The most common side effect is bleeding (hemorrhage), which occurs in approximately 1 in 10 patients. Serious side effects requiring immediate medical attention include signs of severe bleeding, thrombotic thrombocytopenic purpura (TTP), and severe allergic reactions.

The side effect profile of clopidogrel is primarily related to its antiplatelet mechanism of action. By inhibiting platelet aggregation, clopidogrel inherently increases the risk of bleeding events. The risk is further increased when clopidogrel is used in combination with aspirin (dual antiplatelet therapy). The side effects listed below are based on data from large clinical trials (CAPRIE, CURE, CLARITY, COMMIT) and post-marketing surveillance. If you experience any side effects, particularly signs of bleeding, contact your doctor promptly.

Stop clopidogrel and seek immediate medical attention if you experience:
  • Sudden severe headache, confusion, vision changes, or difficulty speaking (possible intracranial hemorrhage or TTP)
  • Coughing up blood, blood in vomit (looks like coffee grounds), or black tarry stools
  • Blood in urine or unusually heavy menstrual bleeding
  • Severe allergic reaction: rash, itching, swelling of face/lips/tongue, difficulty breathing
  • Unexplained fever, extreme fatigue, dark-colored urine, or jaundice (yellowing of skin/eyes)

Common Side Effects

May affect up to 1 in 10 people

  • Bleeding (hematoma, nosebleed, gastrointestinal hemorrhage, bruising)
  • Hematoma (collection of blood under the skin)

Uncommon Side Effects

May affect up to 1 in 100 people

  • Headache, dizziness, and paresthesia (tingling or numbness)
  • Gastric ulcer, duodenal ulcer, gastritis
  • Diarrhea, abdominal pain, indigestion (dyspepsia)
  • Rash, pruritus (itching), purpura (skin hemorrhages)
  • Blood in urine (hematuria)
  • Prolonged bleeding time, decreased platelet count
  • Intracranial bleeding (very serious – seek emergency help)

Rare Side Effects

May affect up to 1 in 1,000 people

  • Thrombotic thrombocytopenic purpura (TTP)
  • Severe reduction in blood cell counts (neutropenia, thrombocytopenia, pancytopenia)
  • Retroperitoneal hemorrhage (bleeding behind the abdominal cavity)
  • Severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
  • Vasculitis (inflammation of blood vessels)
  • Bronchospasm, interstitial pneumonitis
  • Hepatitis, acute liver failure
  • Serum sickness-like reaction

Frequency Not Known

Cannot be estimated from available data

  • Acquired hemophilia A
  • Drug-induced hypersensitivity syndrome (DRESS)
  • Insulin autoimmune syndrome (severe hypoglycemia)
  • Lichen planus-like dermatitis
  • Musculoskeletal bleeding (hemarthrosis, muscle hemorrhage)
  • Surgical wound bleeding
  • Eye hemorrhage (conjunctival, ocular, retinal)
Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to your national medicines regulatory authority (e.g., FDA MedWatch in the US, Yellow Card Scheme in the UK, or EMA EudraVigilance in the EU). Reporting helps to continuously monitor the benefit-risk balance of medicines.

How Should You Store Clopidogrel Aliud?

Store Clopidogrel Aliud in the original packaging at room temperature (below 25°C / 77°F), protected from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the packaging.

Proper storage is essential to maintain the quality, safety, and effectiveness of your medication. Follow these guidelines:

What Does Clopidogrel Aliud Contain?

Each film-coated tablet of Clopidogrel Aliud contains 75 mg of clopidogrel (as clopidogrel hydrogen sulfate, equivalent to 97.875 mg of clopidogrel hydrogen sulfate). The tablet also contains several inactive excipients and a film coating.

Active Ingredient

The active substance is clopidogrel. Each film-coated tablet contains clopidogrel hydrogen sulfate equivalent to 75 mg of clopidogrel base. Clopidogrel hydrogen sulfate (also known as clopidogrel bisulfate) is a white to off-white powder that is practically insoluble in water at neutral pH. The molecular formula is C16H16ClNO2S·H2SO4 and the molecular weight is 419.9 g/mol.

Inactive Ingredients (Excipients)

The excipients in Clopidogrel Aliud tablets typically include:

Tablet Appearance

Clopidogrel Aliud 75 mg film-coated tablets are typically round, biconvex, pink to light pink colored tablets. The exact appearance may vary slightly between batches. The tablets are supplied in PVC/PVDC-aluminum blister packs. Common pack sizes include 28, 30, 50, 84, 90, and 100 tablets, although not all pack sizes may be marketed in every country.

Allergy information

If you are allergic to any of the inactive ingredients listed above, inform your doctor or pharmacist before starting treatment. The film coating contains iron oxide (E172) and titanium dioxide (E171) as coloring agents. If you have known hypersensitivities to these excipients, discuss alternatives with your healthcare provider.

Frequently Asked Questions About Clopidogrel Aliud

Clopidogrel Aliud is a generic version of Plavix. Both contain exactly the same active ingredient — clopidogrel 75 mg — and have been proven to be bioequivalent, meaning they are absorbed and distributed in the body in essentially the same way. Generic medicines must meet the same rigorous quality, safety, and efficacy standards set by regulatory authorities such as the EMA and FDA. The main differences between Clopidogrel Aliud and Plavix are the manufacturer (Aliud Pharma versus Sanofi), the packaging, and the price. Generic clopidogrel is typically significantly less expensive than the branded product, without any compromise in clinical effectiveness.

Omeprazole and esomeprazole should be avoided while taking clopidogrel. These proton pump inhibitors (PPIs) are strong inhibitors of the CYP2C19 enzyme, which is essential for converting clopidogrel into its active metabolite. Studies have shown that omeprazole can reduce clopidogrel’s antiplatelet activity by 25–50%, which may increase the risk of cardiovascular events. If you need stomach acid suppression — for example, to prevent ulcers from aspirin — pantoprazole is the recommended alternative, as it has minimal impact on CYP2C19. H2 receptor antagonists such as famotidine are another option with no known pharmacokinetic interaction. Always discuss PPI use with your cardiologist or prescribing physician.

After coronary stent placement, clopidogrel is prescribed as part of dual antiplatelet therapy (DAPT) with aspirin. The standard duration for drug-eluting stents (DES) is 6 to 12 months. However, this duration is individualized by your cardiologist. Patients at high bleeding risk may receive a shorter course (1–3 months), while those at high ischemic risk but low bleeding risk may benefit from extended DAPT (beyond 12 months). After bare-metal stents (BMS), DAPT is typically given for at least 1 month. Never stop clopidogrel prematurely without consulting your cardiologist, as early discontinuation dramatically increases the risk of stent thrombosis, which can be fatal.

Clopidogrel is a prodrug that requires conversion to its active form by the liver enzyme CYP2C19. Approximately 2–14% of the population carries genetic variants that result in reduced or absent CYP2C19 activity (known as “poor metabolizers”). These individuals produce less of clopidogrel’s active metabolite and therefore have a weaker antiplatelet response, which has been associated with higher rates of cardiovascular events, particularly stent thrombosis. The prevalence of CYP2C19 poor metabolizer status varies by ethnicity: approximately 2–5% of Caucasians, 2–4% of African Americans, and 15–20% of people of Asian and Pacific Islander descent. Pharmacogenomic testing (a simple blood or saliva test) can identify poor metabolizers, allowing doctors to prescribe alternative antiplatelet agents such as ticagrelor or prasugrel, which do not depend on CYP2C19 for activation.

Clopidogrel should generally be discontinued 5 to 7 days before elective surgery to allow sufficient recovery of platelet function. This applies to all types of surgery, including dental procedures. However, this decision is not straightforward and must involve both your surgeon and your cardiologist. In patients with recent coronary stent placement, stopping clopidogrel carries a significant risk of stent thrombosis. Your medical team will weigh the surgical bleeding risk against the thrombotic risk and determine the optimal timing. In emergency surgery where clopidogrel cannot be stopped in advance, surgeons take additional hemostatic precautions, and platelet transfusions may be considered if clinically needed. Never stop clopidogrel on your own — always seek medical guidance.

If you suspect you have taken more clopidogrel than prescribed, seek emergency medical attention immediately. The primary concern with clopidogrel overdose is prolonged bleeding time and the associated risk of hemorrhagic complications. There is no specific antidote for clopidogrel. Treatment is symptomatic and supportive. If necessary, platelet transfusions can be administered to restore hemostatic function, though this is only partially effective because newly transfused platelets will also be exposed to any remaining active metabolite in the circulation. Dialysis is not effective in removing clopidogrel or its active metabolite from the body.

References

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  2. Yusuf S, Zhao F, Mehta SR, et al. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation (CURE trial). New England Journal of Medicine. 2001;345(7):494-502. doi:10.1056/NEJMoa010746
  3. Sabatine MS, Cannon CP, Gibson CM, et al. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation (CLARITY-TIMI 28). New England Journal of Medicine. 2005;352(12):1179-1189. doi:10.1056/NEJMoa050522
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  6. European Medicines Agency. Summary of Product Characteristics: Clopidogrel. EMA/H/C/000975. Last updated 2024.
  7. U.S. Food and Drug Administration. FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug. 2010. Updated 2016.
  8. World Health Organization. WHO Model List of Essential Medicines – 23rd list (2023). Geneva: World Health Organization; 2023.
  9. Gilard M, Arnaud B, Cornily JC, et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA study. Journal of the American College of Cardiology. 2008;51(3):256-260. doi:10.1016/j.jacc.2007.06.064
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This article was written and reviewed by iMedic’s medical editorial team, which includes board-certified physicians and clinical pharmacists with expertise in cardiovascular medicine, clinical pharmacology, and drug safety.

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