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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.

For the Consumer

Applies to fulvestrant: intramuscular solution

Along with its needed effects, fulvestrant (the active ingredient contained in Faslodex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking fulvestrant:

More Common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss

Less Common

  • Difficult or labored breathing
  • tightness in the chest

Incidence Not Known

  • Black, tarry stools
  • chest pain
  • chills
  • cough
  • fever
  • flushing or redness of the skin
  • hives or welts, itching, or rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pain in the chest, groin, or legs, especially the calves
  • painful or difficult urination
  • severe and sudden headache
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden and severe weakness or numbness in the arm or leg
  • sudden loss of coordination
  • swollen glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vaginal bleeding
  • vision changes

Some side effects of fulvestrant may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Back pain
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • depression
  • diarrhea
  • difficulty having a bowel movement
  • difficulty with moving
  • dizziness
  • dryness or soreness of the throat
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • feeling sad or empty
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • headache
  • hoarseness
  • irritability
  • joint pain
  • lack or loss of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • lower back or side pain
  • muscle aches and pains
  • muscle stiffness
  • nausea
  • pain at the injection site
  • pain in the arms or legs
  • pelvic pain
  • shivering
  • stomach pain
  • sudden sweating
  • tender, swollen glands in the neck
  • trouble concentrating
  • trouble with swallowing
  • unable to sleep
  • voice changes
  • vomiting
  • weight loss

Less Common

  • Nervousness
  • pain, swelling, or redness in the joints
  • pale skin

Incidence Not Known

  • Feeling of constant movement of self or surroundings
  • sensation of spinning

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Faslodex (fulvestrant)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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