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Exemestane Side Effects

For the Consumer

Applies to exemestane: oral tablet

Along with its needed effects, exemestane 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 exemestane:

More Common

  • Cough or hoarseness
  • difficult or labored breathing
  • fever or chills
  • lower back or side pain
  • mental depression
  • swelling of the hands, ankles, feet, or lower legs
  • tightness in the chest

Less Common

  • Chest pain
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • headache
  • sore throat
  • unexplained broken bones

Incidence Not Known

  • Abdominal or stomach pain
  • clay-colored stools
  • confusion
  • dark urine
  • decreased urine output
  • diarrhea
  • difficulty with speaking
  • dilated neck veins
  • dizziness
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • irregular breathing
  • irregular heartbeat
  • itching or rash
  • loss of appetite
  • nausea
  • slow speech
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • weight gain
  • yellow eyes or skin

Some side effects of exemestane 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:

More Common

  • Anxiety
  • constipation
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • hot flashes
  • increased sweating
  • pain
  • trouble sleeping

Less Common

  • Back pain
  • bone pain
  • burning, tingling, or prickly sensations
  • decreased sense of touch
  • increased appetite
  • joint pain
  • loss of hair
  • runny nose
  • stomach upset
  • weakness, generalized

For Healthcare Professionals

Applies to exemestane: oral tablet

Musculoskeletal

Very common (10% or more): Arthralgia (28.8%)

Common (1% to 10%): Pain in limb, back pain, osteoarthritis, myalgia, pathological fracture, hypoesthesia, skeletal pain, osteoporosis, muscle cramp

Uncommon (0.1% to 1%): Osteoporotic fracture[Ref]

General

The most commonly reported side effects were hot flushes, arthralgia, and fatigue.[Ref]

Immunologic

Common (1% to 10%): Infection[Ref]

Gastrointestinal

Very Common (10% or more): Nausea (up to 18%), abdominal pain (up to 11%)

Common (1% to 10%): Diarrhea, vomiting, constipation, dyspepsia

Uncommon (0.1% to 1%): Gastric ulcers[Ref]

Dermatologic

Very common (10% or more): Increased sweating (17.8%), alopecia (15.1%)

Common (1% to 10%): Dermatitis

Postmarketing reports: Urticaria, pruritus, acute generalized exanthemos pustulosis[Ref]

Cardiovascular

Very common (10% or more): Hot flushes (up to 32.9%), Hypertension (15.1%)

Common (1% to 10%): Lymphedema, chest pain

Uncommon (0.1% to 1%): Thromboembolism, myocardial infarction[Ref]

Hepatic

Very common (10% or more): Elevation of liver function tests (including enzymes, bilirubin, and alkaline phosphatase)

Postmarketing reports: Hepatitis including cholestatic hepatitis[Ref]

Psychiatric

Very common (10% or more): Insomnia (13.7%)

Common (1% to 10%): Depression, anxiety, confusion[Ref]

Nervous system

Very common (10% or more): Headache (13.6%), dizziness (10%)

Common (1% to 10%): Paresthesia, carpal tunnel syndrome

Uncommon (0.1% to 1%): Somnolence, neuropathy[Ref]

Respiratory

Very common (10% or more): Dyspnea

Common (1% to 10%): Coughing, bronchitis, sinusitis, upper respiratory tract infection, pharyngitis, rhinitis[Ref]

Ocular

Common (1% to 101%): Visual disturbances[Ref]

Oncologic

Common (1% to 10%): Other primary cancer[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity[Ref]

Other

Very common (10% or more): Fatigue (up to 22.2%), pain (13%)

Common (1% to 10%): Edema, influenza-like symptoms, fever, generalized weakness, pain at tumor sites, asthenia, peripheral edema[Ref]

Metabolic

Common (1% to 10%): Increased appetite, anorexia, hypercholesterolemia[Ref]

Genitourinary

Very common (10% or more): Gynecological (10.5%)

Common (1% to 10%): Urinary tract infection, vaginal hemorrhage

Uncommon (0.1% to 1%): Uterine polyp, uterine polydectomy

Rare (less than 0.1%): Endometrial hyperplasia[Ref]

Hematologic

Very common (10% or more): Decrease in lymphocytes (20%)

Uncommon (0.1%to 1%): Thrombocytopenia, leucopenia[Ref]

References

1. "Product Information. Aromasin (exemestane)" Pharmacia & Upjohn, Kalamazoo, MI.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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