Applies to fulvestrant: parenteral injection.

Side effects include:

Adverse GI effects (e.g., nausea, vomiting, constipation, diarrhea, abdominal pain ), headache, pain (e.g., back pain, bone pain, musculoskeletal pain, extremity pain, pelvic pain ), asthenia, vasodilation (hot flushes), pharyngitis, dyspnea, injection site reactions (e.g., pain ), increased cough, anorexia, peripheral edema, rash, chest pain, flu syndrome, dizziness, insomnia, fever, paresthesia, urinary tract infection, depression, anxiety, sweating, fatigue, arthralgia, joint disorder.

For Healthcare Professionals

Applies to fulvestrant: intramuscular solution.

Gastrointestinal

Very common (10% or more): Nausea (up to 34%), stomatitis (up to 28%), diarrhea (up to 24%), vomiting (up to 19%), abdominal pain (up to 12%)

Common (1% to 10%): Constipation^[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 83%), leukopenia (up to 53%), anemia (up to 30%), thrombocytopenia (up to 23%)

Common (1% to 10%): Reduced platelet count

Uncommon (0.1% to 1%): Leukorrhea, febrile neutropenia^[Ref]

Cardiovascular

Very common (10% or more): Vasodilation(up to 18%), hot flushes

Common (1% to 10%): Venous thromboembolism^[Ref]

Musculoskeletal

Very common (10% or more): Bone pain (up to 16%), muscle pain, joint pain

Common (1% to 10%): Back pain, pain in extremity^[Ref]

Nervous system

Very common (10% or more): Headache (up to 15%)

Common (1% to 10%): Sciatica, peripheral neuropathy, dysgeusia, dizziness, paresthesia

Uncommon (0.1% to 1%): Neuralgia^[Ref]

Respiratory

Very common (10% or more): Pharyngitis (up to 16%), dyspnea (up to 15%)

Common (1% to 10%): Epistaxis, cough, chest pain^[Ref]

Genitourinary

Very common (10% or more): Pelvic Pain (up to 10%)

Common (1% to 10%): Urinary tract infection, vaginal hemorrhage

Uncommon (0.1% to 1%): Vaginal moniliasis^[Ref]

Dermatologic

Very common (10% or more): Alopecia (up to 18%), rash (up to 17%)

Common (1% to 10%): Dry skin, sweating, pruritus^[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity reactions

Uncommon (0.1% to 1%): Anaphylaxis^[Ref]

Hepatic

Very common (10% or more): Elevated hepatic enzymes (ALT, AST, ALP)

Common (1% to 10%): Elevated bilirubin

Uncommon (0.1% to 1%): Hepatic failure, hepatitis, elevated gamma-GT^[Ref]

Immunologic

Very common (10% or more): Infections (up to 47%)

Common (1% to 10%): Influenza syndrome^[Ref]

Local

Very common (10% or more): Injection site pain (up to 12%), injection site reaction

Common (1% to 10%):

Uncommon (0.1% to 1%): Injection site hemorrhage, injection site hematoma^[Ref]

Ocular

Common (1% to 10%): Increased lacrimation, blurred vision, dry eye^[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 16%)

Common (1% to 10%): Peripheral edema^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression, anxiety^[Ref]

Other

Very common (10% or more): Fatigue (up to 41%), pain (up to 19%), pyrexia (up to 13%)

Common (1% to 10%): Asthenia^[Ref]