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 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 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 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 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
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 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 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 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 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 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 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 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 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 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
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
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