Exemestane Side Effects

Not all side effects for exemestane may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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
  • increased blood pressure
  • lower back or side pain
  • mental depression
  • shortness of breath
  • 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
  • wheezing
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
  • loss of appetite
  • nausea
  • rash
  • 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 with 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

Musculoskeletal side effects including arthralgia (14.6% to 28.8%), pain in limb (9%), osteoarthritis (5.9%), myalgia (5.5%), back pain, pathological fracture, and skeletal pain have been reported. Reductions in bone mineral density over time have also been reported.

General

General side effects including fatigue (11% to 22%), hot flushes (13% to 32.9%), pain (13%), edema (5.5% to 7%), influenza like symptoms (6%), asthenia (6%), and fever (5%) have been reported.

Immunologic

Immunologic side effects including grade 3 or 4 lymphocytopenia (20% of patients in clinical trials for advanced breast cancer) and infection have been reported.

Of the advanced breast cancer patients with grade 3 or 4 lymphocytopenia, 89% had a preexisting lower grade lymphopenia. Forty percent of patients either recovered or improved to a lesser severity while on treatment.

Gastrointestinal

Gastrointestinal side effects including nausea (8.5% to 18%), dyspepsia (16%), abdominal pain (6% to 11%), diarrhea (4% to 9.6%), vomiting (7%), anorexia (6%), constipation (5%), and increased appetite (3%) have been reported.

Dermatologic

Dermatologic side effects including increased sweating (11.8% to 17.8%), alopecia (15.1%), dermatitis (8.2%), hypoesthesia, rash, and itching have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (5% to 15.1%) and chest pain have been reported.

Hepatic

Hepatic side effects including elevations of serum levels of AST, ALT, alkaline phosphatase, and gamma glutamyl transferase greater than five times the upper value of the normal range have rarely been reported in patients treated for advanced breast cancer (but appear mostly attributable to the underlying presence of liver and/or bone metastases).

In early breast cancer patients, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving exemestane than either tamoxifen or placebo. Alkaline phosphatase elevations of any CTC grade (13.7% to 15.0%), treatment emergent bilirubin elevations (any CTC grade) (5.3% to 6.9%), CTC grade 3 to 4 increases in bilirubin (0.9%), and creatinine elevations (5.5% to 5.8%) have been reported.

Cholestatic hepatitis has been reported during clinical trials and postmarketing surveillance.

In the comparative study in advanced breast cancer patients, CTC grade 3 or 4 elevation of gamma glutamyl transferase without documented evidence of liver metastasis was reported in 2.7% of patients treated with exemestane and in 1.8% of patients treated with megestrol acetate.

Psychiatric

Psychiatric side effects including insomnia (12.4% to 13.7%), depression (6.2% to 9.6%), and anxiety (4.1%) have been reported.

Nervous system

Nervous system side effects including headache (6.9% to 13.1%), depression (13%), insomnia (11%), anxiety (10%), dizziness (8% to 9.7%), confusion, and paresthesia have been reported.

Respiratory

Respiratory side effects including dyspnea (10%), coughing (6%), upper respiratory tract infection, pharyngitis, rhinitis, bronchitis, and sinusitis have been reported.

Local

Local side effects including pain at tumor sites (8%) have been reported.

Ocular

Ocular side effects including visual disturbances (5%) have been reported.

Oncologic

Oncologic side effects reported from animal studies have included an increased incidence of hepatocellular adenomas and/or carcinomas as well as an increased incidence of renal tubular adenomas. Exemestane has also been clastogenic in human lymphocytes in vitro without metabolic activation.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of hypersensitivity, urticaria, and pruritus.

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