Faslodex Side Effects

Generic name: fulvestrant

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

Some side effects of Faslodex 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 fulvestrant: intramuscular solution

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

Less serious side effects of fulvestrant may include:

• headache, back pain;

• bone pain, joint pain, muscle pain;

• vomiting, loss of appetite, constipation;

• weakness, feeling tired;

• cough, trouble breathing;

• pain in your arms or legs;

• hot flashes; or

• pain where the medicine was injected.

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 fulvestrant: intramuscular solution

Gastrointestinal

Gastrointestinal side effects have included nausea (26%), vomiting (13%), constipation (12.5%), diarrhea (12.3%), abdominal pain (11.8%), and anorexia (9%).

Hematologic

Hematologic side effects have included anemia (4.5%) and postmarketing reports of leukopenia.

Cardiovascular

Cardiovascular side effects have included vasodilation (17.7%), and peripheral edema (9%). Postmarketing reports have included thromboembolic phenomena.

Musculoskeletal

Musculoskeletal side effects have included bone pain (15.8%), and arthritis (2.8%). Postmarketing reports have included myalgia.

Nervous system

Nervous system side effects have included dizziness (6.9%), insomnia (6.9%), paresthesia (6.4%), depression (5.7%), and anxiety (5%). Postmarketing reports have included vertigo.

Respiratory

Respiratory side effects have included pharyngitis (16.1%), dyspnea (14.9%), and cough increased (10.4%).

Genitourinary

Genitourinary side effects have included urinary tract infection (6.1%). Postmarketing reports have included vaginal bleeding.

Dermatologic

Dermatologic side effects have included rash (7.3%).

Endocrine

Endocrine side effects have included sweating (5%).

General

General side effects have included asthenia (22.7%), pain (18.9%), headache (15.4%), back pain (14.4%), pain at injection site (10.9%), pelvic pain (9.9%), chest pain (7.1%), flu syndrome (7.1%), fever (6.4%), and accidental injury (4.5%).

Hypersensitivity

Hypersensitivity side effects including angioedema and urticaria have been reported.

Hepatic

Hepatic side effects have included postmarketing reports of elevated bilirubin, elevated gamma GT, hepatitis, and liver failure.

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