Faslodex Side Effects

Generic Name: fulvestrant

Please note - some side effects for Faslodex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Faslodex - for the Consumer

Faslodex

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Faslodex:

Abnormal skin sensations; anxiety; back, bone, joint, or pelvic pain; constipation; diarrhea; dizziness; headache; hot flushes; increased cough; loss of appetite; nausea; pain, swelling, or redness at the injection site; sleeplessness; sore throat; stomach pain; sweating; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; fever or chills; frequent or painful urination; mental or mood changes; pain, redness, or tenderness in the legs; persistent sore throat; persistent vaginal bleeding; severe tiredness or weakness; shortness of breath; swelling of the hands or feet.

Faslodex Side Effects - for the Professional

Faslodex

The most commonly reported adverse experiences in the Faslodex and anastrozole treatment groups, regardless of the investigator’s assessment of causality, were gastrointestinal symptoms (including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back pain, vasodilatation (hot flushes), and pharyngitis.

Injection site reactions with mild transient pain and inflammation were seen with Faslodex and occurred in 7% of patients (1% of treatments) given the single 5 mL injection (predominately European Trial) and in 27% of patients (4.6% of treatments) given the 2 x 2.5 mL injections (North American Trial).

Table 4 lists adverse experiences reported with an incidence of 5% or greater, regardless of assessed causality, from the two controlled clinical trials comparing the administration of Faslodex 250 mg intramuscularly once a month with anastrozole 1 mg orally once a day.

Other adverse events reported as drug-related and seen infrequently (<1%) include thromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions including angioedema and urticaria.

Vaginal bleeding has been reported infrequently (<1%), mainly in patients during the first 6 weeks after changing from existing hormonal therapy to treatment with Faslodex. If bleeding persists, further evaluation should be considered.

Side Effects by Body System

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%).

Cardiovascular

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

Musculoskeletal

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

Nervous system

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

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%).

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.

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