Aromasin Side Effects

Generic name: exemestane

Note: This document contains side effect information about exemestane. Some of the dosage forms listed on this page may not apply to the brand name Aromasin.

Some side effects of Aromasin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to exemestane: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking exemestane (the active ingredient contained in Aromasin) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• new or unusual bone pain;

• vision problems;

• swelling in your hands or feet;

• feeling short of breath, even with mild exertion; or

• chest pain, sudden numbness or weakness, sudden headache, confusion, problems with vision, speech, or balance.

Less serious side effects of exemestane may include:

• hot flashes;

• headache, tired feeling;

• anxiety;

• joint pain;

• upset stomach;

• depressed mood;

• sleep problems (insomnia); or

• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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 (the active ingredient contained in Aromasin) 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 (the active ingredient contained in Aromasin) 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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