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Nolvadex (Tamoxifen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nolvadex (Tamoxifen) 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 (32)
Death (1)
Life Threatening Events (1)

Reports by Reaction Type

Retinal Detachment (3)Urticaria (3)Fall (3)Joint Stiffness (3)Chronic Lymphocytic Leukaemia (3)Musculoskeletal Stiffness (3)Tendonitis (3)Stress (3)Alopecia (3)Wrong Technique in Drug Usage Process (2)Intentional Drug Misuse (2)Genital Haemorrhage (2)

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

Possible Nolvadex side effects in 34 year old female

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: 34 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Off Label Use, Ovulation Disorder, Breast Cancer Recurrent

Adverse event resulted in: hospitalization

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

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2007-01-01
    End date: 2010-01-01



Possible Nolvadex side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: female

Reactions: Night Sweats, Stomatitis, Chapped Lips, Conjunctivitis, Rheumatoid Arthritis, Weight Increased, Hot Flush, Fibromyalgia, Systemic Lupus Erythematosus, DRY Eye

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

Arimidex
    Administration route: Oral
    Indication: Breast Cancer

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer



Possible Nolvadex side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 58 year old female

Reactions: Dysphonia, Neoplasm Malignant, Breast Cancer Female, Intentional Drug Misuse, Stress, Tendonitis, Fall

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

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 1998-01-01

Seroquel
    Administration route: Oral

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2009-01-01

Seroquel
    Administration route: Oral
    Start date: 2000-01-01

Seroquel
    Administration route: Oral
    Start date: 2005-12-02

Other drugs received by patient: Wellbutrin; Lamictal; Klonopin; Clonazepam



Possible Nolvadex side effects in female

Reported by a physician from Japan on 2012-07-02

Patient: female, weighing 47.0 kg (103.4 pounds)

Reactions: Retinal Detachment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2012-05-14

Zoladex
    Indication: Breast Cancer
    Start date: 2012-05-14



Possible Nolvadex side effects in 50 year old female

Reported by a physician from Japan on 2012-06-29

Patient: 50 year old female

Reactions: Organising Pneumonia

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

Zoladex
    Indication: Breast Cancer

Other drugs received by patient: LH-RH



Possible Nolvadex side effects in 61 year old female

Reported by a physician from Japan on 2012-06-29

Patient: 61 year old female

Reactions: Interstitial Lung Disease

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

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-01-01
    End date: 2011-01-01



Possible Nolvadex side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: 58 year old female

Reactions: Breast Cancer, Wrong Technique in Drug Usage Process, Dysphonia, Incorrect Dose Administered, Fall, Stress, Tendonitis

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Start date: 2000-01-01

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 1998-01-01

Seroquel
    Administration route: Oral
    Start date: 2005-12-02

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2009-01-01

Nolvadex
    Administration route: Oral

Other drugs received by patient: Klonopin; Clonazepam; Lamictal; Wellbutrin



Possible Nolvadex side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-21

Patient: female, weighing 72.6 kg (159.7 pounds)

Reactions: Skin Disorder, Intentional Drug Misuse, Off Label Use, Joint Swelling, Arthralgia, Heart Rate Increased, Oedema Peripheral, Alopecia, Adverse Event

Drug(s) suspected as cause:
Metoprolol Succinate
    Indication: Prophylaxis

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2009-09-01

Nolvadex
    Administration route: Oral

Other drugs received by patient: Toprol-XL; Femara



Possible Nolvadex side effects in 30 year old female

Reported by a physician from Japan on 2012-05-31

Patient: 30 year old female

Reactions: Retinal Detachment

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

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer



Possible Nolvadex side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-29

Patient: 64 year old female

Reactions: Cardiomyopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 6 cycles
    Indication: Breast Cancer Female
    Start date: 1988-01-28
    End date: 1988-08-08

Nolvadex
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Female
    Start date: 1989-03-15

Epirubicin Hydrochloride
    Dosage: 6 cycles
    Indication: Breast Cancer Female
    Start date: 1988-01-28
    End date: 1988-08-08

Fluorouracil
    Dosage: 6 cycles
    Indication: Breast Cancer Female
    Start date: 1988-01-28
    End date: 1988-08-08



Possible Nolvadex side effects in female

Reported by a individual with unspecified qualification from United States on 2012-05-17

Patient: female

Reactions: Embolism

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2000-12-05

Taxol
    Indication: Breast Cancer

Herceptin
    Dosage: maintenance dose over 30 mins, for 51 weeks

Adriamycin PFS
    Indication: Breast Cancer
    Start date: 2000-12-05

Herceptin
    Dosage: loading dose
    Indication: Breast Cancer

Cytoxan
    Indication: Breast Cancer
    Start date: 2000-12-05



Possible Nolvadex side effects in female

Reported by a consumer/non-health professional from Italy on 2012-05-11

Patient: female

Reactions: Dysphagia, Lymphadenopathy, Nausea, Medication Error, Drug Prescribing Error

Drug(s) suspected as cause:
Nolvadex
    Administration route: Oral
    Start date: 2012-01-11

Arimidex
    Administration route: Oral



Possible Nolvadex side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-05-08

Patient: 57 year old female

Reactions: Breast Cancer, Wrong Technique in Drug Usage Process, Incorrect Dose Administered, Fall, Stress, Tendonitis

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2009-01-01

Seroquel
    Administration route: Oral
    Start date: 2000-01-01

Seroquel
    Administration route: Oral
    Start date: 2005-12-02

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 1998-01-01

Nolvadex
    Administration route: Oral

Other drugs received by patient: Wellbutrin; Lamictal; Clonazepam; Klonopin



Possible Nolvadex side effects in 57 year old female

Reported by a physician from Austria on 2012-05-04

Patient: 57 year old female

Reactions: Retinal Detachment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Start date: 2007-01-01

Faslodex
    Dosage: monthly
    Indication: Breast Cancer
    Start date: 2007-10-01
    End date: 2010-04-01

Nolvadex
    Administration route: Oral
    Start date: 2005-05-01
    End date: 2006-06-01

Femara
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2006-06-01
    End date: 2007-10-01

Other drugs received by patient: Methotrexate



Possible Nolvadex side effects in female

Reported by a pharmacist from France on 2012-05-01

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Myalgia, Fatigue, Alopecia

Drug(s) suspected as cause:
Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-11-15

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-07-01
    End date: 2011-11-01



Possible Nolvadex side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-19

Patient: female

Reactions: Chronic Lymphocytic Leukaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Femara
    Indication: Breast Cancer
    Start date: 2004-01-01
    End date: 2009-01-01

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 1991-01-01
    End date: 2004-01-01

Cyclophosphamide
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Epirubicin Hydrochloride
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Fluorouracil
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Aromasin
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-03-05

Other drugs received by patient: Lexomil; Exforge; Previscan / 00789001 /; Fenofibrate; Anafranil



Possible Nolvadex side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-12

Patient: 76 year old female

Reactions: Chronic Lymphocytic Leukaemia, Neoplasm Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fluorouracil
    Dosage: unk, 6 cycles
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Nolvadex
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 1991-01-01
    End date: 2004-01-01

Femara
    Dosage: 1 df, 1x/day
    Indication: Breast Cancer
    Start date: 2004-01-01
    End date: 2009-01-01

Cyclophosphamide
    Dosage: unk, 6 cycles
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Aromasin
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-03-05

Epirubicin Hydrochloride
    Dosage: unk, 6 cycles
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Other drugs received by patient: Anafranil; Exforge; Lexomil; Fenofibrate; Previscan



Possible Nolvadex side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-11

Patient: female

Reactions: Chronic Lymphocytic Leukaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Femara
    Indication: Breast Cancer
    Start date: 2004-01-01
    End date: 2009-01-01

Fluorouracil
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Aromasin
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-03-05

Epirubicin Hydrochloride
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 1991-01-01
    End date: 2004-01-01

Cyclophosphamide
    Indication: Breast Cancer
    Start date: 1998-10-01
    End date: 1999-01-01

Other drugs received by patient: Anafranil; Exforge; Lexomil; Fenofibrate; Previscan / 00789001 /



Possible Nolvadex side effects in 765 month old female

Reported by a pharmacist from France on 2012-03-07

Patient: 765 month old female

Reactions: Fatigue, Alopecia, Paralysis

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-08-01
    End date: 2011-11-01

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-11-01



Possible Nolvadex side effects in 88 year old female

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: 88 year old female

Reactions: Thrombosis, Death, Endometrial Hypertrophy

Adverse event resulted in: death

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

Nexium
    Administration route: Oral



Possible Nolvadex side effects in female

Reported by a consumer/non-health professional from Belgium on 2012-01-27

Patient: female

Reactions: Anaemia, Pancreatitis

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg, unk
    Indication: Metastases To Bone

Nolvadex
    Indication: Breast Cancer



Possible Nolvadex side effects in female

Reported by a physician from United States on 2012-01-20

Patient: female, weighing 96.1 kg (211.4 pounds)

Reactions: Syncope, Pulse Absent

Drug(s) suspected as cause:
Nolvadex



Possible Nolvadex side effects in 54 year old female

Reported by a physician from Japan on 2012-01-10

Patient: 54 year old female

Reactions: Endometrial Cancer, Genital Haemorrhage

Adverse event resulted in: hospitalization

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

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-08-01



Possible Nolvadex side effects in 50 year old female

Reported by a physician from Japan on 2012-01-04

Patient: 50 year old female, weighing 44.0 kg (96.8 pounds)

Reactions: Ovarian Enlargement, Cervical Polyp

Drug(s) suspected as cause:
Nolvadex



Possible Nolvadex side effects in 54 year old female

Reported by a physician from Japan on 2012-01-03

Patient: 54 year old female

Reactions: Endometrial Cancer, Genital Haemorrhage

Adverse event resulted in: hospitalization

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

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-08-01



Possible Nolvadex side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-28

Patient:

Reactions: Appendicitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nolvadex



Possible Nolvadex side effects in 50 year old female

Reported by a physician from Japan on 2011-12-23

Patient: 50 year old female

Reactions: Ovarian Enlargement

Drug(s) suspected as cause:
Nolvadex



Possible Nolvadex side effects in 849 month old female

Reported by a consumer/non-health professional from Belgium on 2011-12-22

Patient: 849 month old female, weighing 87.0 kg (191.4 pounds)

Reactions: Urticaria, Musculoskeletal Stiffness, Joint Stiffness

Drug(s) suspected as cause:
Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-06-09
    End date: 2011-09-05

Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-09-01
    End date: 2011-11-01

Other drugs received by patient: Prophor; Analgesics; Antidepressives



Possible Nolvadex side effects in 849 month old female

Reported by a consumer/non-health professional from Belgium on 2011-12-22

Patient: 849 month old female, weighing 87.0 kg (191.4 pounds)

Reactions: Urticaria, Musculoskeletal Stiffness, Joint Stiffness

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-09-01
    End date: 2011-11-01

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-06-09
    End date: 2011-09-05

Other drugs received by patient: Antidepressives; Prophor; Analgesics



Possible Nolvadex side effects in 71 year old female

Reported by a consumer/non-health professional from Belgium on 2011-12-12

Patient: 71 year old female

Reactions: Urticaria, Musculoskeletal Stiffness, Joint Stiffness

Drug(s) suspected as cause:
Arimidex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-09-01
    End date: 2011-11-01

Nolvadex
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-06-09
    End date: 2011-09-05

Other drugs received by patient: Analgesics; Prophor; Antidepressives

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