Clopidogrel

Applies to clopidogrel: oral tablet

Along with its needed effects, clopidogrel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clopidogrel:

More common

• Chest pain
• collection of blood under the skin
• deep, dark purple bruise
• itching, pain, redness, or swelling
• pain in general
• red or purple spots on the skin, varying in size from pinpoint to large bruises

Less common

• Nosebleed
• painful or difficult urination
• shortness of breath
• vomiting of blood or material that looks like coffee grounds

Rare

• Black, tarry stools
• blistering, flaking, or peeling of the skin
• blood in the urine or stools
• confusion
• fever, chills, or sore throat
• headache (sudden, severe)
• nausea or vomiting
• stomach pain (severe)
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• weakness (sudden)

Incidence not known

• Abdominal or stomach cramps or swelling
• back pain or backaches
• blurred vision
• change in mental status
• cough or hoarseness
• dark urine
• difficulty with breathing or swallowing
• difficulty with speaking
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• feeling of discomfort
• general feeling of tiredness or weakness
• hives
• inflammation of the joints
• itching
• light-colored stools
• lower back or side pain
• muscle aches
• pale color of the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• reddening of the skin, especially around the ears
• seizures
• sweating
• swelling of the eyes, face, or inside of the nose
• swollen lymph glands
• swollen or painful glands
• tightness in the chest
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• watery or bloody diarrhea
• wheezing
• yellow eyes or skin

Some side effects of clopidogrel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bad, unusual, or unpleasant (after) taste
• bloating
• change in taste
• constipation
• diarrhea
• difficulty with moving
• headache
• hives or welts
• indigestion
• loss of appetite
• muscle pain or stiffness
• noisy breathing
• pain in the joints
• pains in the stomach, side, or abdomen, possibly radiating to the back
• redness, soreness, or itching skin
• seeing, hearing, or feeling things that are not there
• skin blisters
• sores, welting, or blisters
• swelling or inflammation of the mouth

Applies to clopidogrel: oral tablet

The most commonly reported adverse effect was bleeding, including life threatening and fatal bleeding.

In the COMMIT study (n=45,852), the incidence of major non-cerebral or cerebral bleeding was 0.6% in clopidogrel plus aspirin treated patients, with 0.4% classified as major non-cerebral (0.2% fatal) and 0.2% as hemorrhagic stroke (0.2% fatal). Non-major noncerebral bleeding or any noncerebral bleeding occurred in 3.6% and 3.9% of patients receiving this drug plus aspirin, respectively. Major bleeds were defined as cerebral bleeds or non-cerebral bleeds thought to have caused death or that required transfusion.

In the CURE study (n=12,562), the incidence of fatal bleeding (0.2%) and intracranial hemorrhage (0.1%) was the same between clopidogrel with aspirin and placebo with aspirin groups.

Uncommon (0.1% to 1%): Fatal bleeding, eosinophilia, leucopenia, increased bleeding time, thrombocytopenia

Rare (0.01% to 0.1%): Neutropenia

Very rare (less than 0.01%): Decreased platelet count

Postmarketing reports: Serious cases of bleeding (mainly skin), hemarthrosis, hematoma, hemorrhage of operative wound, fatal hemorrhage (intracranial, gastrointestinal, and retroperitoneal), thrombotic thrombocytopenic purpura (TTP), acquired hemophilia A, aplastic anemia, pancytopenia, agranulocytosis, granulocytopenia, anemia

In the CAPRIE study (n=19,185), gastrointestinal hemorrhage occurred in 2% of patients taking clopidogrel compared to 2.7% taking aspirin. Bleeding requiring hospitalization occurred in 0.7% clopidogrel-treated and 1.1% aspirin-treated patients.

Common (1% to 10%): Abdominal pain, gastrointestinal hemorrhage, dyspepsia, diarrhea, nausea, gastritis

Uncommon (0.1% to 1%): Vomiting, flatulence, constipation, gastric, peptic, or duodenal ulcer

Rare (0.01% to 0.1%): Retroperitoneal hemorrhage

Postmarketing reports: Colitis (ulcerative or lymphocytic), pancreatitis, stomatitis

Postmarketing reports: Angioedema, anaphylactic reactions, cross reactive hypersensitivity among thienopyridines (e.g. ticlopidine, prasugrel), hypersensitivity reactions

Common (1% to 10%): Chest pain, hypertension, angina pectoris, coronary artery disorder, peripheral ischemia

Very rare (less than 0.01%): Hematoma

Postmarketing reports: Hypotension, syncope, vasculitis

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Paresthesia

Rare (0.01% to 0.1%): Vertigo, intracranial hemorrhage

Postmarketing reports: Taste disturbances, ageusia

Common (1% to 10%): Arthralgia, back pain

Postmarketing reports: Arthritis, myalgia, musculoskeletal bleeding

Common (1% to 10%): Depression

Postmarketing reports: Hallucinations, confusion

Common (1% to 10%): Upper respiratory tract infection, dyspnea, rhinitis, coughing, bronchitis, epistaxis

Postmarketing reports: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia, respiratory tract bleeding (hemoptysis, pulmonary hemorrhage)

Common (1% to 10%): Rash, purpura, pruritus, bruising

Postmarketing reports: Maculopapular, erythematous, or exfoliative rash, urticaria, bullous dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), eczema, lichen planus

In CAPRIE (n=19,185), 4.2% of patients receiving clopidogrel developed a rash compared to 3.5% in the aspirin group. In CURE (n=12,562), 1.3% treated with clopidogrel and aspirin compared to 1.1% placebo, as well as 0.7% of patients in CLARITY (n=3491) reported a rash. Drug discontinuation due to skin disorders in CAPRIE was 0.8% and in CURE 0.4% of patients.

Postmarketing reports: Hepatitis (noninfectious), acute liver failure, abnormal liver function tests

Common (1% to 10%): Hypercholesterolemia

Common (1% to 10%): Urinary tract infection

Postmarketing reports: Hematuria

Postmarketing reports: Eye bleeds (conjunctival, ocular, retinal)

Common (1% to 10%): Accidental/inflicted injury, influenza-like symptoms, pain, fatigue, infection

Postmarketing reports: Fever

Uncommon (0.1% to 1%): Hematuria

Postmarketing reports: Glomerulopathy, serum creatinine increase

Postmarketing reports: Serum sickness

Postmarketing reports: Gynecomastia

Common (1% to 10%): Puncture site bleeding