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Fareston (Toremifene) - Side Effect Reports to FDA

 
 



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)Respiratory Failure (2)Diarrhoea (2)Bronchiectasis (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 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 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

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 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 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 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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