Exemestane Side Effects

Brand Names: Aromasin

Please note - some side effects for Exemestane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Exemestane - for the Consumer

Exemestane

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Exemestane:

Anxiety; back, joint, muscle, or limb pain; constipation; coughing; diarrhea; dizziness; flu-like symptoms; hair loss; headache; hot flashes; increased or decreased appetite; increased sweating; nausea; stomach pain or upset; tiredness; trouble sleeping; weight gain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; depression; fainting; general feeling of being unwell; numbness, burning, or tingling in the skin, hands, or feet; numbness of an arm or leg; one-sided weakness; severe or sudden bone pain; severe stomach pain; shortness of breath; sudden, severe dizziness, headache, or vomiting; sudden, unusual weight gain; swelling of the hands, legs, or feet; vision or speech changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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

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.

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 postmarketing surveillance.

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.

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