Arimidex Side Effects

Generic name: anastrozole

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

Some side effects of Arimidex 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 anastrozole: oral tablet

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

Call your doctor at once if you have:

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• a bone fracture;

• swollen glands;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling in your hands or feet; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• weakness, hot flashes;

• joint pain or stiffness, problems with your fingers while gripping;

• sore throat, headache, back pain, bone pain;

• depression, mood changes, sleep problems (insomnia);

• mild nausea, vomiting; or

• mild rash.

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 anastrozole: compounding powder, oral tablet

Gastrointestinal

Gastrointestinal side effects (up to 33%) have included nausea (up to 20%), vomiting (up to 11%), diarrhea (up to 8%), constipation (up to 8%), and abdominal pain (up to 8%).

Other

Other side effects have included headache (up to 18%), hot flushes (up to 13%), pain (up to 15%), and chest pain (up to 7%).

General

General side effects have included asthenia (up to 16%).

Musculoskeletal

Musculoskeletal side effects have included arthritis (up to 17%), arthralgia (up to 15%), bone pain (up to 12%), osteoporosis (up to 11%), fracture (up to 10%), and back pain (up to 11%).

Respiratory

Respiratory side effects have included dyspnea (up to 11%), pharyngitis (up to 9%), increased cough (up to 8%), and dry mouth (up to 6%).

Cardiovascular

Cardiovascular side effects have included hypertension (up to 13%), edema (up to 11%), including peripheral edema (up to 9%). Ischemic cardiovascular disease (4%) has also been reported.

Genitourinary

Genitourinary side effects include pelvic pain (up to 7%).

Dermatologic

Dermatologic side effects have included rash (up to 11%) and alopecia. Very rare cases of mucocutaneous disorders such as erythema multiforme and Stevens-Johnson syndrome have also been associated with the use of anastrozole (the active ingredient contained in Arimidex) Henoch-Schonlein purpura has been reported. A case of subacute cutaneous lupus erythematosus has also been reported.

Nervous system

Nervous system side effects have included insomnia (up to 10%), dizziness (up to 6%), paresthesia (up to 6%), and carpal tunnel syndrome.

Psychiatric

Psychiatric side effects have included depression (up to 5%).

Hepatic

Hepatic side effects have been reported including a case of severe acute hepatitis in a patient treated with anastrozole (the active ingredient contained in Arimidex)

Hematologic

Hematologic side effects have included lymphedema (10%) and anemia (4%).

Metabolic

Metabolic side effects have included hypercholesterolemia (up to 9%).

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