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Faslodex

Last reviewed on RxList: 10/14/2020
Faslodex Side Effects Center

What Is Faslodex?

Faslodex (fulvestrant) Injection is an estrogen receptor antagonist used to treat some hormone-related breast cancer. Faslodex is also used in postmenopausal women whose breast cancer has progressed after treatment with other anti-estrogen medication.

What Are Side Effects of Faslodex?

Common side effects of Faslodex include:

  • injection site reactions (pain, swelling, redness),
  • nausea,
  • vomiting,
  • loss of appetite,
  • constipation,
  • diarrhea,
  • upset stomach,
  • dizziness,
  • headache,
  • tiredness,
  • weakness,
  • headache,
  • back pain,
  • joint pain,
  • muscle pain,
  • pain in your arms or legs,
  • other body aches/pains,
  • flushing and sweating (hot flushes/hot flashes),
  • tiredness,
  • cough,
  • trouble sleeping, or
  • trouble breathing.

Tell your doctor if you have serious side effects of Faslodex including:

Dosage for Faslodex

The recommended dose of Faslodex is 500 mg to be administered intramuscularly into the buttocks slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter.

What Drugs, Substances, or Supplements Interact with Faslodex?

Faslodex may interact with a blood thinner such as warfarin. Other drugs may interact with Faslodex. Tell your doctor all prescription and over-the-counter medications and supplements you use. Faslodex is used mainly in women after menopause.

Faslodex During Pregnancy and Breastfeeding

This medication should not be used during pregnancy. It may cause miscarriage, or harm to a fetus. Women of childbearing age should use non-hormonal birth control during treatment. Consult your doctor. It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, breastfeeding while using this drug is not recommended.

Additional Information

Our Faslodex (fulvestrant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Faslodex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • signs of nerve damage--numbness, tingling, weakness, or burning pain in your buttocks, back, or leg.

Common side effects may include:

  • pain where the medicine was injected;
  • headache;
  • pain in your arms, legs, feet, or back;
  • bone pain, joint pain, muscle pain;
  • nausea, vomiting, loss of appetite;
  • diarrhea, constipation;
  • weakness, feeling tired;
  • cough, feeling short of breath;
  • hot flashes; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Faslodex (Fulvestrant)

QUESTION

A lump in the breast is almost always cancer. See Answer
Faslodex Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Risk of Bleeding [see WARNINGS AND PRECAUTIONS]
  • Increased Exposure in Patients with Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
  • Injection Site Reaction [see WARNINGS AND PRECAUTIONS]
  • Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

Monotherapy

Comparison Of FASLODEX 500 mg And FASLODEX 250 mg (CONFIRM)

The following adverse reactions (ARs) were calculated based on the safety analysis of CONFIRM comparing the administration of FASLODEX 500 mg intramuscularly once a month with FASLODEX 250 mg intramuscularly once a month. The most frequently reported adverse reactions in the FASLODEX 500 mg group were injection site pain (11.6% of patients), nausea (9.7% of patients), and bone pain (9.4% of patients); the most frequently reported adverse reactions in the FASLODEX 250 mg group were nausea (13.6% of patients), back pain (10.7% of patients), and injection site pain (9.1% of patients).

Table 1 lists adverse reactions reported with an incidence of 5% or greater, regardless of assessed causality, from CONFIRM.

Table 1: Adverse Reactions in CONFIRM (≥5% in Either Treatment Group)

Adverse ReactionsFASLODEX 500 mg
N=361 %
FASLODEX 250 mg
N=374 %
Body as a Whole
Injection Site Pain1129
Headache87
Back Pain811
Fatigue86
Pain in Extremity77
Asthenia66
Vascular System
Hot Flash76
Digestive System
Nausea1014
Vomiting66
Anorexia64
Constipation54
Musculoskeletal System
Bone Pain98
Arthralgia88
Musculoskeletal Pain63
Respiratory System
Cough55
Dyspnea45
1 Including more severe injection site related sciatica, neuralgia, neuropathic pain, and peripheral neuropathy.

In the pooled safety population (N=1127) from clinical trials comparing FASLODEX 500 mg to FASLODEX 250 mg, post-baseline increases of ≥1 CTC grade in either AST, ALT, or alkaline phosphatase were observed in >15% of patients receiving FASLODEX. Grade 3-4 increases were observed in 1-2% of patients. The incidence and severity of increased hepatic enzymes (ALT, AST, ALP) did not differ between the 250 mg and the 500 mg FASLODEX arms.

Comparison Of FASLODEX 500 mg And Anastrozole 1 mg (FALCON)

The safety of FASLODEX 500 mg versus anastrozole 1 mg was evaluated in FALCON. The data described below reflect exposure to FASLODEX in 228 out of 460 patients with HR-positive advanced breast cancer in postmenopausal women not previously treated with endocrine therapy who received at least one (1) dose of treatment in FALCON.

Permanent discontinuation associated with an adverse reaction occurred in 4 of 228 (1.8%) patients receiving FASLODEX and in 3 of 232 (1.3%) patients receiving anastrozole. Adverse reactions leading to discontinuation for those patients receiving FASLODEX included drug hypersensitivity (0.9%), injection site hypersensitivity (0.4%), and elevated liver enzymes (0.4%).

The most common adverse reactions (≥10%) of any grade reported in patients in the FASLODEX arm were arthralgia, hot flash, fatigue, and nausea.

Adverse reactions reported in patients who received FASLODEX in FALCON at an incidence of ≥5% in either treatment arm are listed in Table 2, and laboratory abnormalities are listed in Table 3.

Table 2: Adverse Reactions in FALCON

Adverse ReactionsFASLODEX 500 mg
N=228
Anastrozole 1 mg
N=232
All Grades %Grade 3 or 4 %All Grades %Grade 3 or 4 %
Vascular Disorders
Hot flash110100
Gastrointestinal Disorders
Nausea11010<1
Diarrhea606<1
Musculoskeletal and Connective Tissue Disorders
Arthralgia170100
Myalgia7030
Pain in extremity6040
Back pain9<160
General Disorders and Administration Site Conditions
Fatigue11<17<1

Table 3: Laboratory Abnormalities in FALCON1

Laboratory ParametersFASLODEX 500 mg
N=228
Anastrozole 1 mg
N=232
All Grades %Grade 3 or 4 %All Grades %Grade 3 or 4 %
Alanine aminotransferase increased (ALT)7130
Aspartate aminotransferase increased (AST)513<1
1 In FALCON, post-baseline increases of ≥1 CTC grade in either AST, ALT, or alkaline phosphatase were observed in >10% of patients receiving FASLODEX. Grade 3-4 increases were observed in 1%-3% of patients.

Comparison Of FASLODEX 250 mg And Anastrozole 1 mg In Combined Trials (Studies 0020 And 0021)

The most commonly reported adverse reactions in the FASLODEX and anastrozole treatment groups were gastrointestinal symptoms (including nausea, vomiting, constipation, diarrhea, and abdominal pain), headache, back pain, vasodilatation (hot flashes), and pharyngitis.

Injection site reactions with mild transient pain and inflammation were seen with FASLODEX and occurred in 7% of patients given the single 5 mL injection (Study 0020) and in 27% of patients given the 2 x 2.5 mL injections (Study 0021) in the two clinical trials that compared FASLODEX 250 mg and anastrozole 1 mg.

Table 4 lists adverse reactions 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.

Table 4: Adverse Reactions in Studies 0020 and 0021 (≥5% from Combined Data)

Adverse ReactionsFASLODEX 250 mg
N=423 %
Anastrozole 1 mg
N=423 %
Body as a Whole6868
Asthenia2327
Pain1920
Headache1517
Back Pain1413
Abdominal Pain1212
Injection Site Pain1117
Pelvic Pain109
Chest Pain75
Flu Syndrome76
Fever66
Accidental Injury56
Cardiovascular System3028
Vasodilatation1817
Digestive System5248
Nausea2625
Vomiting1312
Constipation1311
Diarrhea1213
Anorexia911
Hemic and Lymphatic Systems1414
Anemia55
Metabolic and Nutritional Disorders1818
Peripheral Edema910
Musculoskeletal System2628
Bone Pain1614
Arthritis36
Nervous System3434
Dizziness77
Insomnia79
Paresthesia68
Depression67
Anxiety54
Respiratory System3934
Pharyngitis1612
Dyspnea1512
Cough Increased1010
Skin and Appendages2223
Rash78
Sweating55
Urogenital System1815
Urinary Tract Infection64
1 Including more severe injection site related sciatica, neuralgia, neuropathic pain, and peripheral neuropathy. All patients on FASLODEX received injections, but only those anastrozole patients who were in Study 0021 received placebo injections.

Combination Therapy

Combination Therapy With Palbociclib (PALOMA-3)

The safety of FASLODEX 500 mg plus palbociclib 125 mg/day versus FASLODEX plus placebo was evaluated in PALOMA-3. The data described below reflect exposure to FASLODEX plus palbociclib in 345 out of 517 patients with HR-positive, HER2-negative advanced or metastatic breast cancer who received at least 1 dose of treatment in PALOMA-3. The median duration of treatment for FASLODEX plus palbociclib was 10.8 months while the median duration of treatment for FASLODEX plus placebo arm was 4.8 months.

No dose reduction was allowed for FASLODEX in PALOMA-3. Dose reductions of palbociclib due to an adverse reaction of any grade occurred in 36% of patients receiving FASLODEX plus palbociclib.

Permanent discontinuation associated with an adverse reaction occurred in 19 of 345 (6%) patients receiving FASLODEX plus palbociclib, and in 6 of 172 (3%) patients receiving FASLODEX plus placebo. Adverse reactions leading to discontinuation for those patients receiving FASLODEX plus palbociclib included fatigue (0.6%), infections (0.6%), and thrombocytopenia (0.6%).

The most common adverse reactions (≥10%) of any grade reported in patients in the FASLODEX plus palbociclib arm by descending frequency were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, diarrhea, thrombocytopenia, vomiting, alopecia, rash, decreased appetite, and pyrexia.

The most frequently reported Grade ≥3 adverse reactions (≥5%) in patients receiving FASLODEX plus palbociclib in descending frequency were neutropenia and leukopenia.

Adverse reactions (≥10%) reported in patients who received FASLODEX plus palbociclib or FASLODEX plus placebo in PALOMA-3 are listed in Table 5, and laboratory abnormalities are listed in Table 6.

Table 5: Adverse Reactions (≥10%) in PALOMA-3

Adverse ReactionsFASLODEX plus Palbociclib
N=345
FASLODEX plus Placebo
N=172
All Grades %Grade 3 %Grade 4 %All Grades %Grade 3 %Grade 4 %
Infections and Infestations
Infections1472313130
Blood and Lymphatic System Disorders
Neutropenia835511410
Leukopenia53301511
Anemia30401320
Thrombocytopenia2321000
Metabolism and Nutrition Disorders
Decreased appetite1610810
Gastrointestinal Disorders
Nausea34002810
Stomatitis328101300
Diarrhea24001910
Vomiting19101510
Skin and Subcutaneous Tissue Disorders
Alopecia184N/AN/A65N/AN/A
Rash61710600
General Disorders and Administration Site Conditions
Fatigue41202910
Pyrexia13<10500
Grading according to CTCAE v.4.0.
CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable.
1Infections includes all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations.
2Most common infections (≥1%) include: nasopharyngitis, upper respiratory infection, urinary tract infection, influenza, bronchitis, rhinitis, conjunctivitis, pneumonia, sinusitis, cystitis, oral herpes, respiratory tract infection, gastroenteritis, tooth infection, pharyngitis, eye infection, herpes simplex, paronychia.
3Stomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, stomatitis.
4Grade 1 events - 17%; Grade 2 events - 1%.
5Grade 1 events - 6%.
6Rash includes: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, toxic skin eruption.

Additional adverse reactions occurring at an overall incidence of <10.0% of patients receiving FASLODEX plus palbociclib in PALOMA-3 included asthenia (7.5%), aspartate aminotransferase increased (7.5%), dysgeusia (6.7%), epistaxis (6.7%), lacrimation increased (6.4%), dry skin (6.1%), alanine aminotransferase increased (5.8%), vision blurred (5.8%), dry eye (3.8%), and febrile neutropenia (0.9%).

Table 6: Laboratory Abnormalities in PALOMA-3

Laboratory ParametersFASLODEX plus Palbociclib
N=345
FASLODEX plus Placebo
N=172
All Grades %Grade 3 %Grade 4 %All Grades %Grade 3 %Grade 4 %
WBC decreased994512601
Neutrophils decreased9656111401
Anemia78304020
Platelets decreased62211000
Aspartate aminotransferase increased43404840
Alanine aminotransferase increased36203400
N=number of patients; WBC=white blood cells.

Combination Therapy With Abemaciclib (MONARCH 2)

The safety of FASLODEX (500 mg) plus abemaciclib (150 mg twice daily) versus FASLODEX plus placebo was evaluated in MONARCH 2. The data described below reflect exposure to FASLODEX in 664 patients with HR-positive, HER2-negative advanced breast cancer who received at least one dose of FASLODEX plus abemaciclib or placebo in MONARCH 2.

Median duration of treatment was 12 months for patients receiving FASLODEX plus abemaciclib and 8 months for patients receiving FASLODEX plus placebo.

Dose reductions due to an adverse reaction occurred in 43% of patients receiving FASLODEX plus abemaciclib. Adverse reactions leading to dose reductions ≥5% of patients were diarrhea and neutropenia. Abemaciclib dose reduction due to diarrhea of any grade occurred in 19% of patients receiving FASLODEX plus abemaciclib compared to 0.4% of patients receiving FASLODEX plus placebo. Abemaciclib dose reductions due to neutropenia of any grade occurred in 10% of patients receiving FASLODEX plus abemaciclib compared to no patients receiving FASLODEX plus placebo.

Permanent study treatment discontinuation due to an adverse event was reported in 9% of patients receiving FASLODEX plus abemaciclib and in 3% of patients receiving FASLODEX plus placebo. Adverse reactions leading to permanent discontinuation for patients receiving FASLODEX plus abemaciclib were infection (2%), diarrhea (1%), hepatotoxicity (1%), fatigue (0.7%), nausea (0.2%), abdominal pain (0.2%), acute kidney injury (0.2%), and cerebral infarction (0.2%).

Deaths during treatment or during the 30-day follow up, regardless of causality, were reported in 18 cases (4%) of FASLODEX plus abemaciclib treated patients versus 10 cases (5%) of FASLODEX plus placebo treated patients. Causes of death for patients receiving FASLODEX plus abemaciclib included: 7 (2%) patient deaths due to underlying disease, 4 (0.9%) due to sepsis, 2 (0.5%) due to pneumonitis, 2 (0.5%) due to hepatotoxicity, and one (0.2%) due to cerebral infarction.

The most common adverse reactions reported (≥20%) in the FASLODEX plus abemaciclib arm were diarrhea, fatigue, neutropenia, nausea, infections, abdominal pain, anemia, leukopenia, decreased appetite, vomiting, and headache (Table 7). The most frequently reported (≥5%) Grade 3 or 4 adverse reactions were neutropenia, diarrhea, leukopenia, anemia, and infections.

Table 7: Adverse Reactions ≥10% of Patients Receiving FASLODEX Plus Abemaciclib and ≥2% Higher Than FASLODEX Plus Placebo in MONARCH 2

Adverse ReactionsFASLODEX plus Abemaciclib
N=441
FASLODEX plus Placebo
N=223
All Grades %Grade 3 %Grade 4 %All Grades %Grade 3 %Grade 4 %
Gastrointestinal Disorders
Diarrhea8613025<10
Nausea45302310
Abdominal pain135201610
Vomiting26<101020
Stomatitis15<101000
Infections and Infestations
Infections2435<1253<1
Blood and Lymphatic System Disorders
Neutropenia34624341<1
Anemia4297<1410
Leukopenia5289<1200
Thrombocytopenia6162130<1
General Disorders and Administration Site Conditions
Fatigue7463032<10
Edema peripheral1200700
Pyrexia11<1<16<10
Metabolism and Nutrition Disorders
Decreased appetite271012<10
Respiratory, Thoracic, and Mediastinal Disorders
Cough13001100
Skin and Subcutaneous Tissue Disorders
Alopecia1600200
Pruritus1300600
Rash1110400
Nervous System Disorders
Headache201015<10
Dysgeusia1800300
Dizziness1210600
Investigations
Alanine aminotransferase increased134<1520
Aspartate aminotransferase increased1220730
Creatinine increased12<10<100
Weight decreased10<102<10
1Includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort, abdominal tenderness.
2Includes upper respiratory tract infection, urinary tract infection, lung infection, pharyngitis, conjunctivitis, sinusitis, vaginal infection, sepsis.
3Includes neutropenia, neutrophil count decreased.
4Includes anemia, hematocrit decreased, hemoglobin decreased, red blood cell count decreased.
5Includes leukopenia, white blood cell count decreased.
6Includes platelet count decreased, thrombocytopenia.
7Includes asthenia, fatigue.

Additional adverse reactions in MONARCH 2 include venous thromboembolic events (deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, subclavian vein thrombosis, axillary vein thrombosis, and DVT inferior vena cava), which were reported in 5% of patients treated with FASLODEX plus abemaciclib as compared to 0.9% of patients treated with FASLODEX plus placebo.

Table 8: Laboratory Abnormalities ≥10% in Patients Receiving FASLODEX Plus Abemaciclib and ≥2% Higher Than FASLODEX Plus Placebo in MONARCH 2

Laboratory ParametersFulvestrant plus Abemaciclib
N=441
Fulvestrant plus Placebo
N=223
All Grades %Grade 3 %Grade 4 %All Grades %Grade 3 %Grade 4 %
Creatinine increased98107400
White blood cell decreased9023<133<10
Neutrophil count decreased87294304<1
Anemia843033<10
Lymphocyte count decreased6312<13220
Platelet count decreased53<111500
Alanine aminotransferase increased414<13210
Aspartate aminotransferase increased3740254<1

Combination Therapy With Ribociclib (MONALEESA-3)

The safety of FASLODEX 500 mg plus ribociclib 600 mg versus FASLODEX plus placebo was evaluated in MONALEESA-3. The data described below reflect exposure to FASLODEX plus ribociclib in 483 out of 724 postmenopausal patients with HR-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine based therapy or after disease progression on endocrine therapy who received at least one dose of FASLODEX plus ribociclib or placebo in MONALEESA-3. Median duration of treatment was 15.8 months for FASLODEX plus ribociclib and 12 months for FASLODEX plus placebo.

Dose reductions due to adverse reactions occurred in 32% of patients receiving FASLODEX plus ribociclib and in 3% of patients receiving FASLODEX plus placebo. Among patients receiving FASLODEX plus ribociclib, 8% were reported to have permanently discontinued both FASLODEX plus ribociclib, and 9% were reported to have discontinued ribociclib alone due to ARs. Among patients receiving FASLODEX plus placebo, 4% were reported to have permanently discontinued both FASLODEX and placebo and 2% were reported to have discontinued placebo alone due to ARs.

Adverse reactions leading to treatment discontinuation of FASLODEX plus ribociclib (as compared to FASLODEX plus placebo) were ALT increased (5% vs. 0%), AST increased (3% vs. 0.6%), and vomiting (1% vs. 0%).

The most common adverse reactions (reported at a frequency ≥20% on the FASLODEX plus ribociclib arm and ≥2% higher than FASLODEX plus placebo) were neutropenia, infections, leukopenia, cough, nausea, diarrhea, vomiting, constipation, pruritus, and rash. The most frequently reported Grade 3/4 adverse reactions (reported at a frequency ≥5%) in patients receiving FASLODEX plus ribociclib in descending frequency were neutropenia, leukopenia, infections, and abnormal liver function tests.

Adverse reactions and laboratory abnormalities occurring in patients in MONALEESA-3 are listed in Table 9 and Table 10, respectively.

Table 9: Adverse Reactions Occurring in ≥10% and ≥2% higher than FASLODEX plus Placebo Arm in MONALEESA-3 (All Grades)

Adverse ReactionsFASLODEX plus Ribociclib
N=483
FASLODEX plus Placebo
N=241
All Grades %Grade 3 %Grade 4 %All Grades %Grade 3 %Grade 4 %
Infections and Infestations
Infections142503020
Blood and Lymphatic System Disorders
Neutropenia69467200
Leukopenia2712<1<100
Anemia1730520
Metabolism and Nutrition Disorders
Decreased appetite16<101300
Nervous System Disorders
Dizziness13<10800
Respiratory, Thoracic, and Mediastinal Disorders
Cough22001500
Dyspnea151<11220
Gastrointestinal Disorders
Nausea451028<10
Diarrhea29<1020<10
Vomiting27101300
Constipation25<101200
Abdominal pain171013<10
Skin and Subcutaneous Tissue Disorders
Alopecia1900500
Pruritus20<10700
Rash23<10700
General Disorders and Administration Site Conditions
Edema peripheral1500700
Pyrexia11<10700
Investigations
Alanine aminotransferase increased15725<10
Aspartate aminotransferase increased13515<10
Grading according to CTCAE 4.03.
CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients
1 Infections; urinary tract infections; respiratory tract infections; gastroenteritis; sepsis (<1%).

Additional adverse reactions in MONALEESA-3 for patients receiving FASLODEX plus ribociclib included asthenia (14%), dyspepsia (10%), thrombocytopenia (9%), dry skin (8%), dysgeusia (7%), electrocardiogram QT prolonged (6%), dry mouth (5%), vertigo (5%), dry eye (5%), lacrimation increased (4%), erythema (4%), hypocalcemia (4%), blood bilirubin increased (1%), and syncope (1%).

Table 10: Laboratory Abnormalities Occurring in ≥10% of Patients in MONALEESA-3

Laboratory parametersFASLODEX plus Ribociclib
N=483
FASLODEX plus Placebo
N=241
All Grades %Grade 3 %Grade 4 %All Grades %Grade 3 %Grade 4 %
Hematology
Leukocyte count decreased9525<126<10
Neutrophil count decreased9246721<10
Hemoglobin decreased60403530
Lymphocyte count decreased69141354<1
Platelet count decreased33<111100
Chemistry
Creatinine increased65<1<133<10
Gamma-glutamyl transferase increased52614982
Aspartate aminotransferase increased49524330
Alanine aminotransferase increased44833720
Glucose serum decreased23001800
Phosphorous decreased18508<10
Albumin decreased1200800

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of FASLODEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

For FASLODEX 250 mg, other adverse reactions 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.

Elevation of bilirubin, elevation of gamma GT, hepatitis, and liver failure have been reported infrequently (<1%).

Read the entire FDA prescribing information for Faslodex (Fulvestrant)

Related Resources for Faslodex

Related Health

Read the Faslodex User Reviews »

© Faslodex Patient Information is supplied by Cerner Multum, Inc. and Faslodex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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