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
Along with its needed effects, exemestane (the active ingredient contained in Aromasin) 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
- 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 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
- 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 (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 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 (the active ingredient contained in Aromasin) has also been clastogenic in human lymphocytes in vitro without metabolic activation.
Hypersensitivity side effects have included postmarketing reports of hypersensitivity, urticaria, and pruritus.
More about Aromasin (exemestane)
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