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
In addition to its needed effects, some unwanted effects may be caused by exemestane. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when 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
- Chest pain
- difficult, burning, or painful urination
- frequent urge to urinate
- sore throat
- unexplained broken bones
- Abdominal or stomach pain
- clay-colored stools
- dark urine
- decreased urine output
- difficulty with speaking
- dilated neck veins
- double vision
- inability to move the arms, legs, or facial muscles
- inability to speak
- irregular breathing
- irregular heartbeat
- loss of appetite
- slow speech
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- weight gain
- yellow eyes or skin
Some of the side effects that can occur with exemestane may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- general feeling of discomfort or illness
- general feeling of tiredness or weakness
- hot flashes
- increased sweating
- trouble with sleeping
- 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 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 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 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 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 side effects including increased sweating (11.8% to 17.8%), alopecia (15.1%), dermatitis (8.2%), hypoesthesia, rash, and itching have been reported.
Cardiovascular side effects including hypertension (5% to 15.1%) and chest pain have been reported.
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 side effects including insomnia (12.4% to 13.7%), depression (6.2% to 9.6%), and anxiety (4.1%) have been reported.
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 side effects including dyspnea (10%), coughing (6%), upper respiratory tract infection, pharyngitis, rhinitis, bronchitis, and sinusitis have been reported.
Local side effects including pain at tumor sites (8%) have been reported.
Ocular side effects including visual disturbances (5%) have been reported.
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 side effects have included postmarketing reports of hypersensitivity, urticaria, and pruritus.
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