Clopidogrel Aurobindo

Quick links to important sections

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Clopidogrel Aurobindo

Property Description
Active ingredient Clopidogrel (INN)
Form Film-coated tablet
Pharmacological class Antiplatelet agent (P2Y12 inhibitor)
General purpose Reduces the risk of blood clot formation
Origin Synthetic organic compound (Thienopyridine class)

What is the Drug Type and Classification of Clopidogrel Aurobindo?

Clopidogrel Aurobindo is a synthetic, prescription-only medication classified as an antiplatelet agent. The active compound, clopidogrel (INN), belongs to the chemical class of thienopyridines and is known as an irreversible P2Y12 receptor antagonist. This classification means the drug's primary function is to modify the behavior of blood components to prevent clotting. Clopidogrel is a single-product formulation and acts as a prodrug, a key characteristic requiring transformation by the liver into an active metabolite to initiate its therapeutic effect.

Composition and Physical Form of Clopidogrel Tablets

The medicine is supplied as an oral dosage form, specifically a film-coated tablet, which is the standardized preparation for systemic delivery of the compound. Each unit contains the active substance, typically prepared as clopidogrel bisulfate, combined with a solid base matrix and covered by a protective coating. This coating facilitates the administration process and ensures stability of the active ingredient. Structurally, clopidogrel’s synthetic origin and its characteristic formulation as a tablet contrast with older, liquid forms of similar blood modifiers.

What is the General Purpose of this Antiplatelet Agent?

The general purpose of Clopidogrel Aurobindo is to act as an antithrombotic agent, aiming to reduce the risk of blockages in the circulatory system. This is achieved through the inhibition of platelet aggregation, the initial step where platelets stick together to form a clot. By suppressing this action, the medication helps ensure consistent blood flow. Clopidogrel is recognized as an essential medicine, acknowledging its vital role in preventing clotting events.

Regulatory References

  1. Clopidogrel on the WHO Essential Medicines List

What side effects are possible with Clopidogrel Aurobindo?

Possible Side Effects and Safety Information

The safety profile of Clopidogrel Aurobindo, as documented in official regulatory sources, centers on the risk of bleeding and haemorrhagic events due to its antiplatelet activity. Adverse reactions are classified by frequency and associated System-Organ-Classes (SOC).


Officially Documented Adverse Reactions

Common side effects, occurring in between 1 in 10 and 1 in 100 people, include manifestations such as diarrhoea, abdominal pain, dyspepsia (indigestion), bruising (contusion), and epistaxis (nosebleeds).

Uncommon effects include headache, dizziness, gastrointestinal haemorrhage, purpura, and blood disorders like a reduction in platelets (thrombocytopenia) or white blood cells (leukopenia).

Serious adverse reactions are formally documented in regulatory labeling. These include major bleeding events, such as intracranial haemorrhage and fatal gastrointestinal haemorrhage. The rare, life-threatening blood disorder Thrombotic Thrombocytopenic Purpura (TTP) and severe blood dyscrasias like Aplastic Anaemia are also officially noted. TTP has been reported to occur rarely, sometimes shortly after the start of treatment.


Safety Restrictions and Limitations

The medicine is contraindicated (should not be used) in the presence of active pathological bleeding, such as an active peptic ulcer or existing intracranial haemorrhage, and in individuals with severe hepatic impairment. Furthermore, the official label notes that use during breastfeeding is contraindicated due to the potential for serious adverse reactions in the infant.

Overdose and Emergency Response

The official regulatory documentation for Clopidogrel describes overdose primarily through its most severe outcome: an exaggeration of the antiplatelet effect, leading to a heightened risk of bleeding complications and a prolonged bleeding time. This condition poses a risk of severe or life-threatening hemorrhage.

Non-clinical findings associated with acute toxicity, which are cited in the regulatory labels, have included signs such as vomiting, difficult breathing, prostration, and gastrointestinal hemorrhage.

Immediate medical attention is mandated in the event of suspected overdose. Regulatory labels require contacting emergency services or a poison control center without delay. Urgent medical help must be sought if the individual exhibits severe symptoms, including collapse, seizures, trouble breathing, or an inability to be awakened. These actions are required due to the severity of the documented manifestations.

No specific pharmacological antidote for Clopidogrel is officially known or documented in the regulatory prescribing information. The official management guidance emphasizes supportive measures and clinical monitoring. Based on biological plausibility, the labels describe the use of platelet transfusion as a possible measure to restore clotting ability when bleeding is observed. Appropriate therapy is deemed essential for the management of these severe bleeding complications.

Therapeutic Uses of Clopidogrel Aurobindo

What Clopidogrel Aurobindo Treats: Main Uses and Benefits

Clopidogrel Aurobindo is commonly used across therapeutic domains where additional symptomatic support is needed to address the risk of acute arterial blockages. This medication is primarily relevant in conditions associated with recurrent or episodic manifestations of thrombosis, including in patients with a history of myocardial infarction (heart attack), ischemic stroke, or established Peripheral Arterial Disease (PAD). It is also applied in scenarios where short-term symptomatic assistance is needed, such as following the implantation of a coronary stent.

The main benefit provided is supportive relief relevant to the management of conditions marked by vascular events, helping to maintain a sense of stability when symptoms are more noticeable. This provides support that helps with the management of the underlying conditions and the risk of acute episodes.

“This medication is considered relevant in contexts involving heightened systemic burden and is used when groups of symptoms related to vascular strain appear suddenly or fluctuate.”

Quick Fact: Management of Arterial Risk Clopidogrel Aurobindo helps manage the risk of acute events associated with heightened physiological activity, assisting with supporting functional stability for patients with established arterial disease.

Regulatory References

  1. NIH DailyMed overview

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Clopidogrel Aurobindo — Official Regulatory Information

Clopidogrel Aurobindo is contraindicated and must not be used in patients with a known hypersensitivity to clopidogrel or any component of the product. It is also strictly contraindicated for anyone with active pathological bleeding, such as an intracranial hemorrhage or peptic ulcer, or with severe hepatic impairment.

Restricted or Conditional Use

The medicine should be used with caution in patients with a heightened risk of bleeding from trauma or surgery, or in those with renal impairment or moderate hepatic disease, due to limited therapeutic experience in these populations. Individuals identified as poor CYP2C19 metabolizers may experience a diminished therapeutic effect, and physicians may consider alternative treatments.

Age- and Condition-Related Exclusions

The drug is not recommended for the pediatric population, as safety and efficacy have not been established. For patients who have had a recent ischaemic stroke, use cannot be recommended during the first seven days after the acute event. During pregnancy and breastfeeding, use is generally not recommended.

What should I know about interactions with other medicines?

Clopidogrel Aurobindo is an antiplatelet medication, and its effectiveness or safety can be impacted by other medicines and certain substances. It is important to inform your healthcare provider about all prescription drugs, over-the-counter medicines, and herbal supplements you are taking.

Medicines that Increase Bleeding Risk

Because Clopidogrel works to prevent blood clots, taking it with other medications that affect blood clotting increases the risk of serious bleeding, including gastrointestinal bleeds. These include:

  • Oral Anticoagulants: Such as warfarin, rivaroxaban, apixaban, and dabigatran (often referred to as 'blood thinners'). Concomitant use is generally not recommended.
  • Other Antiplatelet Agents: Including high doses of aspirin for pain relief (except for the low-dose aspirin prescribed by your doctor), prasugrel, or ticagrelor.
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Such as ibuprofen and naproxen, which should be avoided unless approved by a physician.
  • SSRIs and SNRIs: Certain antidepressants, including Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), may also increase bleeding risk.

Medicines that Reduce Clopidogrel's Effectiveness

Clopidogrel is a prodrug that must be metabolized into an active form by the liver enzyme CYP2C19. Medications that inhibit this enzyme can significantly reduce Clopidogrel's antiplatelet activity, potentially increasing the risk of cardiovascular events. These include the Proton Pump Inhibitors (PPIs):

Interaction Type Examples of Affected Medicines
Reduced Efficacy Omeprazole and Esomeprazole

If a PPI is needed for stomach protection, alternatives like pantoprazole or lansoprazole may be considered by your doctor, as they may have less impact on Clopidogrel's activity.

Other Interactions

Strong inducers of the CYP2C19 enzyme, such as rifampicin, may increase the active metabolite level of Clopidogrel and potentially increase the bleeding risk. Certain substances like grapefruit juice and some herbal remedies (e.g., Ginkgo biloba, St. John's wort) may also interact, requiring discussion with a healthcare professional.

Mechanism of Action

Prodrug Activation and Irreversible P2Y12 Receptor Blockade

Clopidogrel is an inactive prodrug that must be metabolized by liver enzymes, primarily CYP2C19, to create its active form. This active metabolite exerts its effect by forming a permanent, covalent bond with the P2Y12 receptor on the surface of blood platelets. This interaction is classified as an irreversible non-competitive antagonism, permanently inactivating the receptor.

Signal Blockade and Sustained Anti-Thrombotic Activity

The irreversible blockade of the P2Y12 receptor prevents the natural agonist, ADP, from transmitting its signal within the platelet. This action blocks the internal cascade that would otherwise lead to the activation of the GPIIb/IIIa receptor complex, which is essential for platelets to stick together (aggregate). The physiological consequence is a sustained anti-thrombotic effect, meaning the drug significantly reduces the capacity of treated platelets to aggregate and form thrombi, and contributes to the physiological outcome of unimpeded blood flow.

Mechanism Limitation via Genetic Variability

The efficiency of this entire process is subject to a significant mechanism limitation tied to genetic variability. Individuals who are CYP2C19 poor metabolizers produce reduced levels of the active metabolite, leading to inadequate receptor blockade, which results in sub-therapeutic levels of P2Y12 receptor blockade and reduced anti-thrombotic activity at the systemic level.

Dosage and Administration Information

Clopidogrel Aurobindo is an antiplatelet medication that should be taken exactly as prescribed by your healthcare provider. It is important to read the accompanying Medication Guide before starting treatment and with every refill.

Administration and Dosage

  • Take by mouth once daily, with or without food, as an oral tablet. For optimal consistency, try to take the dose around the same time every day.
  • Do not stop taking Clopidogrel Aurobindo without consulting your doctor, even if you feel well. Stopping the medication too soon significantly increases the risk of serious cardiovascular events, such as heart attack or stroke.
  • Your prescribed dosage will depend on your specific medical condition (e.g., recent heart attack, stroke, or acute coronary syndrome). For certain acute conditions, a high initial loading dose may be prescribed, followed by a lower maintenance dose.

Missed Dose Instructions

  • If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose (generally within 12 hours of the usual time). In this case, skip the missed dose and resume your regular schedule.
  • Do not take two doses at the same time to make up for a missed dose.

Precautions for Surgery

  • If you are scheduled for any surgery, including dental procedures, inform your doctor or dentist that you are taking this medication.
  • Your healthcare provider may instruct you to temporarily stop taking Clopidogrel at least 5 days before the procedure to minimize the risk of excessive bleeding. Do not stop without medical advice.

Important Drug Interactions

  • Certain medications, such as the proton pump inhibitors omeprazole and esomeprazole, can reduce the effectiveness of clopidogrel. Avoid using them together unless directed otherwise by your doctor, who may recommend an alternative acid-reducing agent.

Recent Clinical Evidence

Research evidence / Overview of studies for Clopidogrel Aurobindo


Evidence for Long-Term Prevention After a Vascular Event

Research has explored the use of clopidogrel in adults who have conditions associated with acute episodes, such as a recent heart attack, ischemic stroke, or established Peripheral Arterial Disease (PAD). These studies were structured as large-scale Randomized Controlled Trials (RCTs), where researchers monitored the frequency of major outcomes, including heart attack, stroke, or vascular death, over long-term observation periods, typically extending up to three years.

Studies explored how outcomes evolved in the observed populations. When compared to the aspirin group in the overall study population, data describe patterns related to the tracking of the composite endpoint in the group receiving clopidogrel monotherapy. Research also explores whether genetic factors may affect how a patient responds to the medication, and this area remains a subject of continued scientific inquiry.


Evidence for Acute Coronary Syndrome (ACS) Management

This research base primarily utilized double-blind, placebo-controlled RCTs to explore clopidogrel in combination with aspirin compared to aspirin plus a placebo in patients experiencing an acute coronary syndrome event. The studies typically observed responses over defined time intervals up to one year.

The clinical research monitored the frequency of major events, and findings describe that the combination was associated with differences in the tracking of cardiovascular events compared to aspirin alone. However, the studies consistently describe that the combination therapy was also associated with tracking differences in bleeding events compared to aspirin alone. Research contributes to understanding the balance between these two sets of outcomes.


Long-Term Research and Follow-up Durations

While research provides insight into short-term and intermediate outcomes, detailed data for outcomes that continue past the initial study periods are still emerging, as long-term effects are not fully established beyond the observation window of the largest trials. Continuing research is ongoing to provide more context regarding the long-term patterns over extended periods.

Key Studies & References

  1. PLAVIX (clopidogrel bisulfate) tablets Prescribing Information - FDA Labeling.

Frequently Asked Questions (FAQ)

Common questions about Clopidogrel Aurobindo (FAQ)

Q: What is the main difference between Clopidogrel and Clopidogrel Aurobindo?

A: Clopidogrel is the active medicinal ingredient prescribed to reduce the risk of certain cardiovascular events. Clopidogrel Aurobindo is the specific version of this medication, which is manufactured by the pharmaceutical company Aurobindo. This version contains the same active drug substance as other products with clopidogrel.

Q: Does this medicine prevent a heart attack?

A: Official information indicates that the medicine is indicated for the reduction of atherothrombotic events, which includes both heart attack and stroke, in certain adult patient populations. Regulatory documents state that studies were structured to track the frequency of these events in the observed populations.

Q: How long does it take for Clopidogrel Aurobindo to start working?

A: Studies on the drug’s pharmacology indicate that the antiplatelet effect of the active form of clopidogrel begins approximately two hours after a person takes an oral dose. This is when the effect on platelet function is described as beginning, according to official pharmacology data.

Q: What is the difference between Clopidogrel and aspirin?

A: Clopidogrel is specifically classified as a P2Y12 platelet inhibitor, meaning it works by permanently blocking a specific receptor on blood platelets. Aspirin, while also affecting clotting, is a different type of drug that works by inhibiting a different enzyme to reduce platelet stickiness. Both classes of drugs have been explored in research to reduce the likelihood of certain thrombotic events.

Q: Is it true that some people are 'non-responders' to Clopidogrel?

A: Regulatory documents include warnings that patients who have certain genetic variations in the CYP2C19 liver enzyme may produce reduced levels of the active medication. This genetic difference, which is tied to the metabolism of the drug, is described as resulting in a reduced antiplatelet effect in those individuals.

Q: Can Clopidogrel Aurobindo cause stomach problems?

A: Official documentation lists several common adverse reactions related to the digestive system, including diarrhea, abdominal pain, and dyspepsia (indigestion). Because of the antiplatelet effect, the risk of serious issues such as gastrointestinal bleeding is also listed as a known risk.

Q: How does the medicine affect the blood platelets?

A: The medicine works by causing the irreversible blockade of the P2Y12 receptor on the surface of blood platelets. This action is described as preventing the platelets from receiving signals that would otherwise cause them to clump together and form a blood clot, which contributes to the overall reduction in platelet aggregation.

Q: Is it normal to have mild nosebleeds while taking this drug?

A: Official documents classify epistaxis (nosebleeds) as a common side effect, meaning it may affect between 1 in 10 and 1 in 100 people taking the medication. Because of the drug's effect on platelets, an increased tendency to bleed is noted, and mild nosebleeds are documented as a common occurrence.

Q: What is the long-term safety profile of Clopidogrel as described in official documents?

A: Clinical studies have provided data for outcomes for periods typically extending up to three years. However, official regulatory documents note that the long-term effects of the medicine are not fully established beyond the observation periods of the largest clinical trials.

Q: Can this medication affect my ability to drive or operate machinery?

A: Official documents list central nervous system adverse reactions such as dizziness, headache, and vertigo. Official guidance notes that these effects, if present, may potentially impair the user's ability to drive or operate machinery.

Q: Is Clopidogrel Aurobindo safe for people with kidney problems?

A: Official product information notes that therapeutic experience with clopidogrel is described as limited in patients who have renal impairment. Official documentation notes that the use of clopidogrel in these patients is described as requiring caution.

Q: Is Clopidogrel Aurobindo safe for older adults?

A: Regulatory documents state that studies performed to date in geriatric populations have generally not demonstrated age-specific issues that would limit the usefulness of the medicine in the elderly. Official information also notes that the risk of bleeding may be increased in the elderly population.

Q: What is the purpose of the 'Aurobindo' part of the name?

A: The name Aurobindo identifies the pharmaceutical company that manufactures and markets this specific version of the medicine. The term 'Clopidogrel' is the universally recognized name of the active drug ingredient itself.

Q: Are there any known issues with taking Clopidogrel Aurobindo while pregnant (informational only)?

A: Available data from literature and postmarketing surveillance of clopidogrel use during human pregnancy have not identified an association with major birth defects, miscarriage, or adverse fetal outcomes. The use of the drug during pregnancy requires a medical assessment of the potential benefits and risks.

Q: Do studies suggest any specific time of day is best for taking Clopidogrel Aurobindo?

A: Official guidance is to take the prescribed dose once daily with or without food. While a specific time of day is not determined as optimal, the administration guidance in the product labeling emphasizes the importance of taking the dose around the same time every day to maintain consistency.

Q: Are there any known interactions with herbal supplements?

A: Official labeling notes that certain substances like herbal remedies, specifically citing examples such as Ginkgo biloba and St. John's wort, may interact with clopidogrel. Official documents describe that the use of herbal supplements should be discussed with a healthcare professional.

Q: What is the main reason why a person might be told to stop Clopidogrel Aurobindo?

A: Official documentation describes serious risks that may require immediate discontinuation of the medication. These include developing severe or active pathological bleeding (such as bleeding from a peptic ulcer) or the onset of the rare, life-threatening blood disorder Thrombotic Thrombocytopenic Purpura (TTP).

Q: Is Clopidogrel Aurobindo associated with any long-term muscle or joint pain?

A: Official documents describe certain musculoskeletal effects, with arthralgia (joint pain) and myalgia (muscle pain) listed as postmarketing or rare adverse reactions. In regulatory documents, these effects are typically documented in postmarketing reports and are not classified as common adverse reactions.

Q: What is the potential for an allergic reaction to Clopidogrel Aurobindo?

A: The medicine is formally contraindicated if a person has a known allergy to the active substance or any other component (excipients). Allergic reactions that have been documented in postmarketing reports include reactions such as skin rash, itching, and swelling (angioedema).

Q: Does Clopidogrel Aurobindo contain lactose or gluten?

A: Official documentation notes that excipients (inactive ingredients) for the reference product include lactose monohydrate. Confirmation of excipients for the specific Aurobindo product is detailed in its official product labeling.

Q: Do regulatory documents mention any risk of depression or mood changes with clopidogrel?

A: Regulatory documents list certain central nervous system effects, such as confusion (less common) and hallucinations (documented in postmarketing reports). However, depression or mood changes are not explicitly listed among the common or uncommon adverse reactions in official safety data.

Q: What are the typical storage conditions for this medication?

A: Official documents advise that the medicine should be kept in its original packaging and stored at a controlled room temperature, typically between 68 F and 77 F (20 C to 25 C). Official product information also states that the medication must be stored out of the reach of children.

How should Clopidogrel Aurobindo be stored and disposed of?

How to Store and Dispose of Clopidogrel Aurobindo

Official regulatory documents define specific conditions for storing Clopidogrel tablets to maintain product stability. The medicine must be stored at a temperature below 30°C and should be kept from freezing.

Storage Requirements

Condition Requirement
Temperature Store below 30°C; do not freeze.
Container Keep in the original container with the cap tightly closed to protect from moisture and light.
Child Safety Keep out of the sight and reach of children.
Stability For tablets in the HDPE bottle pack, the shelf-life is 6 months after the bottle is first opened.

Disposal

Disposal of unused or expired tablets must be done according to local requirements. Consult a healthcare professional on how to properly discard any medicine no longer needed, especially considering the active substance is classified as toxic to aquatic organisms.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Clopidogrel Aurobindo found in:

A-Z Index: