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Faslodex (Fulvestrant) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Faslodex (Fulvestrant) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (364)
Death (25)
Life Threatening Events (12)
Disability (7)

Reports by Reaction Type

Injection Site Pain (21)Fatigue (17)Back Pain (17)Dyspnoea (17)Pain (15)Pain in Extremity (15)Nausea (15)Arthralgia (15)Disease Progression (14)Hot Flush (13)Gait Disturbance (12)Death (11)

Below are a few examples of reports where side effects / adverse reactions may be related to Faslodex (Fulvestrant). For a complete list or a specific selection of reports, please use the links above.

Possible Faslodex side effects in 48 year old female

Reported by a pharmacist from United States on 2012-08-27

Patient: 48 year old female

Reactions: Weight Increased, Respiratory Failure, Neoplasm Progression

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in female

Reported by a physician from United Kingdom on 2012-08-27

Patient: female

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Faslodex

Faslodex
    Dosage: loading dose
    Indication: Breast Cancer Metastatic
    Start date: 2010-02-12

Faslodex
    Dosage: 250 mg i.m. on days 15 and 29 (loading dose)

Other drugs received by patient: Arimidex



Possible Faslodex side effects in 896 month old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 896 month old female, weighing 90.7 kg (199.5 pounds)

Reactions: Pain in Extremity, Sensation of Heaviness, Drug Intolerance, Oedema Peripheral, Hypoaesthesia

Drug(s) suspected as cause:
Faslodex
    Indication: Breast Cancer

Faslodex
    Start date: 2012-05-01

Other drugs received by patient: Unspecified High Blood Pressure Pill; Unspecified High Cholesterol Pill



Possible Faslodex side effects in

Reported by a physician from United States on 2012-08-22

Patient:

Reactions: Pulmonary Embolism

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in

Reported by a physician from United States on 2012-08-21

Patient:

Reactions: Tumour Marker Increased

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in 84 year old female

Reported by a physician from Japan on 2012-08-21

Patient: 84 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Breast Swelling, Neoplasm Malignant, Musculoskeletal Pain, Metastases To Spine, Asthenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Faslodex

Other drugs received by patient: Maglax; Lorfenamin; Selbex



Possible Faslodex side effects in

Reported by a physician from United States on 2012-08-21

Patient:

Reactions: Alopecia

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in

Reported by a physician from United States on 2012-08-21

Patient:

Reactions: Cell Marker Increased

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 55 year old female

Reactions: Dyspareunia

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Bipolar Disorder, Breast Cancer Female

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 52 year old female

Reactions: Emotional Distress, Drug Dose Omission, Panic Attack, Neoplasm Malignant, Adverse Event

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in female

Reported by a physician from Italy on 2012-08-20

Patient: female

Reactions: Hypercalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Faslodex
    Dosage: strength of 250 mg/5ml, 500 mg with unknown frequency
    Start date: 2012-06-09
    End date: 2012-06-09

Faslodex
    Dosage: 500 mg with unknown frequency
    Indication: Breast Cancer
    Start date: 2011-10-05
    End date: 2011-10-05

Other drugs received by patient: Diazepam; Omeprazole; Prednisone TAB; Oxycontin; Oxycodone and Acetaminophen



Possible Faslodex side effects in 83 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 83 year old female

Reactions: Abdominal Pain, Aphagia, Drug Dose Omission, Nausea, Disease Progression, Breast Cancer Recurrent, Haematemesis, Breast Cancer Metastatic, Hypertension, Gallbladder Perforation

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Faslodex
    Indication: Breast Cancer Recurrent

Tamoxifen Citrate
    Administration route: Oral
    Indication: Breast Cancer
    End date: 2008-01-01

Other drugs received by patient: High Blood Pressure Medicines



Possible Faslodex side effects in 68 year old female

Reported by a physician from Japan on 2012-08-17

Patient: 68 year old female

Reactions: Lichen Planus

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 54 year old female, weighing 69.4 kg (152.7 pounds)

Reactions: Weight Decreased, Hot Flush, Musculoskeletal Pain, Vulvovaginal Dryness, Blood Cholesterol Increased

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2004-09-01
    End date: 2008-01-01

Faslodex

Other drugs received by patient: Nolvadex



Possible Faslodex side effects in 58 year old female

Reported by a physician from Japan on 2012-08-16

Patient: 58 year old female

Reactions: Hot Flush, Vomiting, Asthenia, Ascites, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in 76 year old female

Reported by a physician from Japan on 2012-08-15

Patient: 76 year old female, weighing 39.0 kg (85.8 pounds)

Reactions: Injection Site Cellulitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Faslodex

Other drugs received by patient: Zometa; Medroxyprogesterone Acetate; Alfarol; Tramadol Hydrochloride; Estazolam; Mirtazapine; Depas



Possible Faslodex side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: female

Reactions: Drug Hypersensitivity, Injection Site Swelling

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: female

Reactions: Swelling, Urticaria, Erythema

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in 77 year old female

Reported by a pharmacist from Australia on 2012-08-14

Patient: 77 year old female

Reactions: Breast Cancer

Adverse event resulted in: death

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in 49 year old female

Reported by a physician from United States on 2012-08-11

Patient: 49 year old female, weighing 54.9 kg (120.8 pounds)

Reactions: Arthralgia, Joint Swelling

Drug(s) suspected as cause:
Faslodex



Possible Faslodex side effects in 78 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 78 year old female

Reactions: Thrombosis, Wrong Technique in Drug Usage Process, Injection Site Haemorrhage, Platelet Count Increased, Erythema, Metastases To Lymph Nodes, Breast Cancer Recurrent, Hot Flush, Dizziness, White Blood Cell Count Increased, Pain in Extremity, RED Blood Cell Count Increased, Injection Site Pain, Alopecia, Gait Disturbance, Feeling Abnormal, Haemoglobin Increased

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer

Faslodex
    Indication: Breast Cancer Metastatic
    Start date: 2011-01-01



Possible Faslodex side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female

Reactions: Blood Oestrogen Increased

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral

Faslodex
    Start date: 2012-04-01



Possible Faslodex side effects in 57 year old female

Reported by a physician from United States on 2012-08-10

Patient: 57 year old female

Reactions: Metastatic Neoplasm, Myalgia, Arthralgia, Pain, Disease Progression

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer

Faslodex

Zometa



Possible Faslodex side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-10

Patient: female, weighing 45.4 kg (99.9 pounds)

Reactions: Nausea, Heart Rate Increased, Insomnia, Alopecia

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2005-01-01

Faslodex
    Indication: Breast Cancer
    Start date: 2012-04-10

Other drugs received by patient: Vicodin; Atenolol; Cartia XT



Possible Faslodex side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 62 year old female

Reactions: Drug Ineffective, Recurrent Cancer, Nodule

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral

Faslodex



Possible Faslodex side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 51 year old female

Reactions: Back Pain, Respiratory Disorder, Drug Prescribing Error, Menopause, Abdominal Pain Upper, Mania, Hot Flush, Arthralgia, Alopecia, Anger, Depression, Mood Swings, Depressed Mood, Uterine Haemorrhage

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2010-01-01
    End date: 2010-01-01

Arimidex
    Administration route: Oral
    Start date: 2010-04-08

Crestor
    Administration route: Oral
    Indication: Blood Cholesterol Abnormal

Faslodex
    Dosage: 500 mg
    Indication: Breast Cancer
    Start date: 2011-12-01

Symbicort
    Dosage: 160 mcg, as needed
    Indication: Asthma
    Start date: 2012-01-01

Other drugs received by patient: Valium; Lexapro; Zometa; Zetia; Synthroid; Coumadin; Dilaudid



Possible Faslodex side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female

Reactions: Oestradiol Increased

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral

Faslodex

Other drugs received by patient: Herceptin; Tykerb



Possible Faslodex side effects in 75 year old female

Reported by a physician from Japan on 2012-08-09

Patient: 75 year old female

Reactions: Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Faslodex

Other drugs received by patient: Zometa



Possible Faslodex side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 59 year old female, weighing 51.7 kg (113.7 pounds)

Reactions: Hypertrichosis, Skin Odour Abnormal, Injection Site Pain

Drug(s) suspected as cause:
Faslodex

Other drugs received by patient: Zometa; Citalopram Hydrobromide; Gabapentin; Provigil

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