Clopidogrel Side effects

Rating: 5 - 1 review(s)
Did you have any side effects with this medicine?
sponsored

What are the possible side effects of Clopidogrel?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Clopidogrel and call your doctor at once if you have any of these serious side effects:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Clopidogrel in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
sponsored

The following serious adverse reactions are discussed below and elsewhere in the labeling:

Bleeding
Thrombotic thrombocytopenic purpura

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions and durations of follow up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clopidogrel has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for 1 year or more. The clinically important adverse reactions observed in trials comparing Clopidogrel plus aspirin to placebo plus aspirin and trials comparing Clopidogrel alone to aspirin alone are discussed below.

Bleeding

CURE

In CURE, Clopidogrel use with aspirin was associated with an increase in major bleeding (primarily gastrointestinal and at puncture sites) compared to placebo with aspirin. The incidence of intracranial hemorrhage (0.1%) and fatal bleeding (0.2%) were the same in both groups. Other bleeding events that were reported more frequently in the Clopidogrel group were epistaxis, hematuria, and bruise.

The overall incidence of bleeding is described in Table 1.

Table 1: CURE Incidence of Bleeding Complications (% Patients)
*
Other standard therapies were used as appropriate.
Life-threatening and other major bleeding.
Major bleeding event rate for Clopidogrel + aspirin was dose-dependent on aspirin: < 100mg = 2.6%; 100 mg to 200 mg = 3.5%; >200 mg = 4.9%

Major bleeding event rates for Clopidogrel + aspirin by age were: <65 years = 2.5%,≥ 65 to <75 years = 4.1%, ≥75 years = 5.9%

§
Major bleeding event rate for placebo + aspirin was dose-dependent on aspirin: <100 mg = 2.0%; 100 mg to 200 mg = 2.3%; >200 mg = 4.0%

Major bleeding event rates for placebo + aspirin by age were: <65 years = 2.1%, ≥65 to <75 years = 3.1%, ≥75 years = 3.6%

Led to interruption of study medication

Event

Clopidogrel

(+ aspirin)*

(n=6259)

Placebo

(+ aspirin)*

(n=6303)

Major Bleeding†

3.7‡

2.7§

Life-threatening bleeding

2.2

1.8

Fatal

0.2

0.2

5 g/dL hemoglobin drop

0.9

0.9

Requiring surgical intervention

0.7

0.7

Hemorrhagic strokes

0.1

0.1

Requiring inotropes

0.5

0.5

Requiring transfusion (≥4 units)

1.2

1.0

Other major bleeding

1.6

1.0

Significantly disabling

0.4

0.3

Intraocular bleeding with significant loss of vision

0.05

0.03

Requiring 2-3 units of blood

1.3

0.9

Minor bleeding¶

5.1

2.4

Ninety-two percent (92%) of the patients in the CURE study received heparin or low molecular weight heparin (LMWH), and the rate of bleeding in these patients was similar to the overall results.

COMMIT

In COMMIT, similar rates of major bleeding were observed in the Clopidogrel and placebo groups, both of which also received aspirin.

Table 2: Incidence of Bleeding Events in COMMIT (% Patients)

Type of bleeding

Clopidogrel

(+ aspirin)

(n=22,961)

Placebo

(+ aspirin)

(n=22,891)

p-value

Major* noncerebral or cerebral bleeding**

0.6

0.5

0.59

Major noncerebral

0.4

0.3

0.48

Fatal

0.2

0.2

0.90

Hemorrhagic stroke

0.2

0.2

0.91

Fatal

0.2

0.2

0.81

Other noncerebral bleeding (non-major)

3.6

3.1

0.005

Any noncerebral bleeding

3.9

3.4

0.004

* Major bleeds were cerebral bleeds or non-cerebral bleeds thought to have caused death or that required transfusion.

** The relative rate of major noncerebral or cerebral bleeding was independent of age. Event rates for Clopidogrel + aspirin by age were: <60 years = 0.3%, ≥60 to <70 years = 0.7%,≥ 70 years = 0.8%. Event rates for placebo + aspirin by age were: <60 years = 0.4%, ≥60 to <70 years = 0.6%, ≥70 years = 0.7%.

CAPRIE (Clopidogrel vs. Aspirin)

In CAPRIE, gastrointestinal hemorrhage occurred at a rate of 2.0% in those taking Clopidogrel vs. 2.7% in those taking aspirin; bleeding requiring hospitalization occurred in 0.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for Clopidogrel compared to 0.5% for aspirin.

Other bleeding events that were reported more frequently in the Clopidogrel group were epistaxis and hematoma.

Other Adverse Events

In CURE and CHARISMA, which compared Clopidogrel plus aspirin to aspirin alone, there was no difference in the rate of adverse events (other than bleeding) between Clopidogrel and placebo.

In CAPRIE, which compared Clopidogrel to aspirin, pruritus was more frequently reported in those taking Clopidogrel. No other difference in the rate of adverse events (other than bleeding) was reported.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Clopidogrel. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura (TTP), acquired hemophilia A
Eye disorders: Eye (conjunctival, ocular, retinal) bleeding
Gastrointestinal disorders: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome, colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea
General disorders and administration site condition: Fever, hemorrhage of operative wound
Hepato-biliary disorders: Acute liver failure, hepatitis (non-infectious), abnormal liver function test
Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness
Musculoskeletal, connective tissue and bone disorders: Musculoskeletal bleeding, myalgia, arthralgia, arthritis
Nervous system disorders: Taste disorders, fatal intracranial bleeding, headache
Psychiatric disorders: Confusion, hallucinations
Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, respiratory tract bleeding, eosinophilic pneumonia
Renal and urinary disorders: Increased creatinine levels
Skin and subcutaneous tissue disorders: Maculopapular, erythematous or exfoliative rash, urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome,acute generalized exanthematous pustulosis (AGEP), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, skin bleeding, lichen planus, generalized pruritus
Vascular disorders: Vasculitis, hypotension

What is the most important information I should know about Clopidogrel?

Clopidogrel contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
sponsored

Active Bleeding

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

Hypersensitivity

Clopidogrel is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to Clopidogrel or any component of the product.

References

  1. DTP/NCI. "clopidogrel: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  2. European Chemicals Agency - ECHA. "Thieno[3,2-c]pyridine-5(4H)-acetic acid, α-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (αS)-: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  3. HSDB. "CLOPIDOGREL". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Clopidogrel are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Clopidogrel. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported side effects

No survey data has been collected yet


Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 26 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2022 ndrugs.com All Rights Reserved