This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fareston (Toremifene) 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 (16)
Death (4)
Reports by Reaction Type
Hepatic Function Abnormal (4),
White Blood Cell Count Decreased (4),
Interstitial Lung Disease (3),
Hepatitis Acute (2),
Condition Aggravated (2),
Bronchiectasis (2),
Diarrhoea (2),
Respiratory Failure (2),
Neoplasm Progression (1),
Osteomyelitis (1),
Bone Fistula (1),
Pleural Effusion (1)
Possible Fareston side effects in
Reported by a individual with unspecified qualification from Finland on 2012-08-22
Patient:
Reactions: Hepatitis Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fareston
Possible Fareston side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-10
Patient: female, weighing 76.0 kg (167.2 pounds)
Reactions: Primary Sequestrum, Gingivitis, Respiratory Disorder, Exposed Bone in JAW, Bone Pain, Neoplasm Progression, Osteomyelitis, Bone Fistula, Periodontal Infection, Pleural Effusion, Pneumonia Staphylococcal, Metastases To Chest Wall, Bone Lesion, General Physical Health Deterioration, Bone Swelling, Mediastinal Shift, Neoplasm Malignant, Osteonecrosis of JAW, Bone Neoplasm, Gingival Infection, Metastases To Bone
Adverse event resulted in: death
Drug(s) suspected as cause:
Aredia
Dosage: 90 mg, daily
Indication: Metastases To Bone
Start date: 2006-02-01
End date: 2006-05-01
Fareston
Dosage: 40 mg, daily
Administration route: Oral
Indication: Breast Cancer
Start date: 2009-07-27
End date: 2010-11-22
Femara
Dosage: 2.5 mg, daily
Administration route: Oral
Indication: Breast Cancer
Start date: 2010-11-22
End date: 2011-04-25
Medroxyprogesterone Acetate
Dosage: 1200 mg, daily
Administration route: Oral
Indication: Breast Cancer
Start date: 2008-06-02
End date: 2009-07-27
Tamoxifen Citrate
Dosage: 20 mg, daily
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-04-25
End date: 2011-09-13
Zometa
Dosage: 4 mg, daily
Indication: Metastases To Bone
Start date: 2006-05-01
End date: 2008-05-01
Other drugs received by patient: Capecitabine; Paclitaxel; Medroxyprogesterone Acetate
Possible Fareston side effects in
Reported by a individual with unspecified qualification from Finland on 2012-08-01
Patient:
Reactions: Interstitial Lung Disease, Bronchiectasis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fareston
Other drugs received by patient: Alfarol; Pravastatin; Norvasc; Pletal; Trichlormethiazide
Possible Fareston side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-01
Patient:
Reactions: Hepatic Function Abnormal
Drug(s) suspected as cause:
Fareston
Possible Fareston side effects in 84 year old female
Reported by a individual with unspecified qualification from Japan on 2012-08-01
Patient: 84 year old female
Reactions: Bronchiectasis, Interstitial Lung Disease, Condition Aggravated, Respiratory Tract Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fareston
Other drugs received by patient: Trichlormethiazide; Pletal; Pravastatin Sodium; Alfarol; Norvasc
Possible Fareston side effects in
Reported by a health professional (non-physician/pharmacist) from Finland on 2012-07-26
Patient:
Reactions: Hepatic Function Abnormal
Drug(s) suspected as cause:
Fareston
Possible Fareston side effects in
Reported by a consumer/non-health professional from Japan on 2012-07-25
Patient:
Reactions: Endometrial Sarcoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fareston
Possible Fareston side effects in female
Reported by a individual with unspecified qualification from Japan on 2012-07-20
Patient: female
Reactions: White Blood Cell Count Decreased, Haematotoxicity
Drug(s) suspected as cause:
Fareston
Other drugs received by patient: Acetaminophen; Morphine
Possible Fareston side effects in
Reported by a physician from Finland on 2012-07-20
Patient:
Reactions: Hepatic Function Abnormal, Respiratory Failure
Drug(s) suspected as cause:
Fareston
Possible Fareston side effects in 84 year old female
Reported by a individual with unspecified qualification from Japan on 2012-07-20
Patient: 84 year old female
Reactions: Interstitial Lung Disease, Condition Aggravated
Adverse event resulted in: death
Drug(s) suspected as cause:
Fareston
Possible Fareston side effects in 77 year old female
Reported by a individual with unspecified qualification from Japan on 2012-07-20
Patient: 77 year old female
Reactions: Hepatitis Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fareston
Possible Fareston side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-17
Patient: female
Reactions: Hepatic Function Abnormal, Respiratory Failure, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
Drug(s) suspected as cause:
Fareston
Possible Fareston side effects in 83 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-23
Patient: 83 year old female
Reactions: White Blood Cell Count Decreased, Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fareston
Dosage: 120 mg oral
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-28
End date: 2011-09-03
Fareston
Dosage: 120 mg oral
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-09-04
End date: 2011-10-26
TS-1 (Tegafur) 80 MG
Dosage: 80 mg oral
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-28
End date: 2011-09-03
Possible Fareston side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-21
Patient: 49 year old female
Reactions: Toxic Skin Eruption
Drug(s) suspected as cause:
Fareston
Other drugs received by patient: Etodolac; Isalon
Possible Fareston side effects in 83 year old female
Reported by a individual with unspecified qualification from Japan on 2011-11-14
Patient: 83 year old female
Reactions: White Blood Cell Count Decreased, Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fareston
Dosage: 120 mg, oral
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-28
End date: 2011-09-03
TS-1 (Tegafur)
Dosage: 80 mg oral
Administration route: Oral
Indication: Breast Cancer
Start date: 2011-08-28
End date: 2011-09-03
Possible Fareston side effects in 83 year old female
Reported by a individual with unspecified qualification from Japan on 2011-10-07
Patient: 83 year old female
Reactions: White Blood Cell Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fareston
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