About ARIMIDEXARIMIDEX side effects

ARIMIDEX may cause side effects. Fortunately, there may be things you can do to to help manage some of these side effects. Some of the most common side effects are listed below, along with tips to help you manage your symptoms. Be sure to talk with your doctor about any side effects you may be experiencing, and to determine what's right for you.

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Don't stop taking any treatment your doctor has prescribed without talking to him or her first. If side effects cause you discomfort, notify your doctor immediately.

In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include

Hot flashes

Joint symptoms

Weakness

Mood changes/depression

Pain

Insomnia

Rash

Sore throat

Nausea and vomiting

High blood pressure

Osteoporosis

Fractures*

Swelling of arms/legs

Headache

*Fractures (including fractures of the spine, hip, and wrist) occurred more frequently with ARIMIDEX than with tamoxifen (10% vs 7%).

Coping with hot flashes

Hot flashes are one of the most common side effects of hormonal treatment, and have a lot to do with the hormonal changes within your body.

  • Keep a record of when your hot flashes occur, and what you were eating, doing, and feeling at the time
  • Try adjusting the timing of your hormonal treatment
  • Take steps to reduce stress — one of the most common hot-flash triggers
  • Talk to your doctor about medical options that reduce hot-flash triggers
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Coping with joint symptoms

Some women may experience discomfort in the bones and joints during hormonal treatment.

  • Use an over-the-counter medication, such as aspirin, acteminophen, or ibuprofen, as recommended by your doctor
  • Try a heating pad or warm bath or shower
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Coping with nausea and vomiting

Some women may experience nausea or vomiting while on hormonal treatment.

  • Try to stay hydrated with steady, small amounts of clear liquids
  • Eat small amounts of bland food until you know you can tolerate more
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Coping with bone loss

Postmenopausal women in general may be at increased risk for bone loss (osteoporosis). Certain hormonal treatments for breast cancer can also increase this risk.

  • Eat a balanced diet rich in calcium and vitamin D
  • Engage in regular weight-bearing exercise, such as walking
  • Avoid smoking and excessive alcohol consumption
  • Talk to your doctor about your risks for osteoporosis. Your doctor may order a bone mineral density (BMD) test to help determine your risk
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Coping with weakness and fatigue

Treatment-related fatigue can leave you feeling "wiped out," even after getting plenty of rest. It may also make it hard to concentrate or think clearly.

  • Try to eat nutritious meals and stay hydrated by drinking plenty of fluids
  • Restore concentration and stay active with moderate activity such as walking or gardening
  • Make time for rest
  • Be aware of your energy levels and pace yourself accordingly; reschedule activities if you need to
  • Ask for help from family and friends
  • Consult with your doctor if fatigue isn't relieved by rest or moderate activity
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Coping with swelling (lymphedema)

Some women who have had breast cancer that affected the lymph nodes may develop lymphedema. This is a swelling of the arm that is caused by an accumulation of lymphatic fluid.

  • Avoid using your affected arm to lift or carry shopping bags, large purses, or other heavy objects
  • Wear gloves when gardening or washing dishes to guard against infection
  • Avoid wearing anything tight on the affected arm, including clothing, watchbands, or bracelets
  • Wear a compression sleeve to help pooling fluid drain as directed by your physician
  • Perform gentle exercises to maintain flexibility and range of motion
  • Call your doctor if your arm or hand becomes red, warm, or swollen. You may have an infection that requires immediate treatment
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Important Information About ARIMIDEX

ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

Important Safety Information About ARIMIDEX

  • Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child
  • Based on information from a study in patients with early breast cancer, women with a history of blockages in heart arteries (ischemic heart disease) who take ARIMIDEX may have a slight increase in this type of heart disease compared to similar patients who take tamoxifen
  • ARIMIDEX can cause bone softening/weakening (osteoporosis) increasing the chance of fractures. In a clinical study in early breast cancer, there were more fractures (including fractures of the spine, hip, and wrist) with ARIMIDEX (10%) than with tamoxifen (7%)
  • In a clinical study in early breast cancer, some patients taking ARIMIDEX had an increase in cholesterol. Skin reactions, allergic reactions, and changes in blood tests of liver function have also been reported
  • In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include hot flashes, joint symptoms (including arthritis and arthralgia), weakness, mood changes, pain, back pain, sore throat, nausea and vomiting, rash, depression, high blood pressure, osteoporosis, fractures, swelling of arms/legs, insomnia, and headache
  • In advanced breast cancer trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, headache, bone pain, increased cough, shortness of breath, sore throat, and swelling of arms and legs. Joint pain/stiffness has been reported in association with the use of ARIMIDEX
  • ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies

Please click here for full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).