Fulvestrant Side Effects
Applies to fulvestrant: intramuscular solution.
Serious side effects of fulvestrant
Along with its needed effects, fulvestrant 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 side effects
- black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or tightness
- chills
- cloudy urine
- cough
- difficulty breathing
- fainting
- fever
- hoarseness
- irregular heartbeat, recurrent
- lower back or side pain
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- tender, swollen glands in the neck
- tingling of the hands or feet
- trouble with swallowing
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Less common side effects
- anxiety
- confusion
- dizziness or lightheadedness
- fast heartbeat
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- pain in the chest, groin, or legs, especially the calves
- pain, redness, or swelling in the arm or leg
- seizures
- severe, sudden headache
- slurred speech
- stomach cramps
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- tremor
- vision changes
Incidence not known
- dark urine
- flushing or redness of the skin
- general feeling of tiredness or weakness
- headache
- hives or welts, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- light-colored stools
- nausea
- stomach pain, continuing
- upper right abdominal pain
- vaginal bleeding
- vomiting
- yellow eyes or skin
Other side effects of fulvestrant
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 side effects
- back pain
- bladder pain
- body aches or pain
- bone pain
- change in or loss of taste
- constipation
- decreased appetite
- depression
- diarrhea
- difficulty having a bowel movement
- difficulty with moving
- dry skin
- dryness or soreness of the throat
- feeling of warmth or heat
- feeling sad or empty
- frequent urge to urinate
- general feeling of discomfort or illness
- hair loss or thinning of hair
- irritability
- joint pain
- lack or loss of appetite
- lack or loss of strength
- loss of interest or pleasure
- muscle aches and pains
- muscle stiffness
- pain at the injection site
- pain in the arms or legs
- pelvic pain
- shivering
- stomach pain
- sudden sweating
- trouble concentrating
- voice changes
- weight loss
Less common side effects
- dry eye
- dry mouth
- increased tearing
- nervousness
- swelling or redness in the joints
Incidence not known
- feeling of constant movement of self or surroundings
- sensation of spinning
For healthcare professionals
Applies to fulvestrant: intramuscular solution.
Gastrointestinal adverse events
- 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
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. (2002) "Product Information. Faslodex (fulvestrant)." Astra-Zeneca Pharmaceuticals
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
Frequently asked questions
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Further information
Fulvestrant side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.