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Activella (Estradiol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Activella (Estradiol) 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 (13)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Breast Cancer Female (4)Product Substitution Issue (2)Night Sweats (1)Drug Ineffective (1)Haemorrhage (1)Wrong Drug Administered (1)Vaginal Haemorrhage (1)Hypertrichosis (1)Hot Flush (1)Depression (1)Drug Dispensing Error (1)Breast Cancer (1)

Possible Activella side effects in female

Reported by a lawyer from United States on 2012-07-10

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Activella
    Dosage: 1mg/0.5mg
    Indication: Hormone Replacement Therapy
    Start date: 2003-01-01
    End date: 2003-08-01

Cycrin
    Dosage: 2.5 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Estrace
    Dosage: 0.1mg/gm
    Indication: Hormone Replacement Therapy

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2003-09-01

Premarin
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-02-01
    End date: 2003-10-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-04-01
    End date: 1996-06-01

Other drugs received by patient: Fosamax



Possible Activella side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Blood Glucose Decreased

Drug(s) suspected as cause:
Activella



Possible Activella side effects in female

Reported by a lawyer from United States on 2012-07-05

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Activella
    Dosage: 1mg/0.5mg
    Indication: Hormone Replacement Therapy
    Start date: 2003-01-01
    End date: 2003-08-01

Cycrin
    Dosage: 2.5 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Estrace
    Dosage: 0.1mg/gm
    Indication: Hormone Replacement Therapy

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2003-09-01

Premarin
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-02-01
    End date: 2003-10-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-04-01
    End date: 1996-06-01

Other drugs received by patient: Fosamax



Possible Activella side effects in female

Reported by a lawyer from United States on 2012-07-05

Patient: female, weighing 52.0 kg (114.4 pounds)

Reactions: Breast Cancer Metastatic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Activella
    Dosage: 1mg/0.5mg
    Indication: Hormone Replacement Therapy
    Start date: 2003-01-01
    End date: 2003-08-01

Cycrin
    Dosage: 2.5 mg unk
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Estrace
    Dosage: 0.1mg/gm
    Indication: Hormone Replacement Therapy
    Start date: 2002-03-01

Medroxyprogesterone
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 2003-09-01

Premarin
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-02-01
    End date: 1997-02-01

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-02-01
    End date: 2003-01-01

Prempro
    Dosage: 0.45mg/1.5mg
    Start date: 2003-08-01
    End date: 2003-10-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-04-01
    End date: 1996-06-01

Other drugs received by patient: Fosamax



Possible Activella side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: 69 year old female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Activella
    Dosage: unk
    Indication: Menopausal Symptoms

Estradiol
    Dosage: unk
    Indication: Menopausal Symptoms



Possible Activella side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 55 year old female, weighing 68.5 kg (150.7 pounds)

Reactions: Product Formulation Issue

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Activella
    Dosage: see above' nightly po
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-08-01
    End date: 2010-11-01

Estradiol and Norethindrone Acetate
    Dosage: see above nightly po
    Administration route: Oral
    Start date: 2010-11-30
    End date: 2012-03-31



Possible Activella side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-24

Patient: female, weighing 78.9 kg (173.6 pounds)

Reactions: Product Substitution Issue, Haemorrhage, Wrong Drug Administered, Drug Dispensing Error

Drug(s) suspected as cause:
Activella
    Dosage: 1.0/0.5mg one po q.d. oral
    Administration route: Oral
    Indication: Dysmenorrhoea
    Start date: 2008-01-21

Activella
    Dosage: 1.0/0.5mg one po q.d. oral
    Administration route: Oral
    Indication: Menorrhagia
    Start date: 2008-01-21



Possible Activella side effects in female

Reported by a lawyer from United States on 2012-03-30

Patient: female

Reactions: Breast Cancer, Anxiety, Depression

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Activella
    Dosage: 1/0.5mg
    Indication: Hormone Replacement Therapy
    Start date: 2002-01-01

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2002-01-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1995-01-01
    End date: 1996-01-01



Possible Activella side effects in female

Reported by a physician from United States on 2012-03-15

Patient: female, weighing 78.0 kg (171.6 pounds)

Reactions: Product Substitution Issue, Night Sweats, Hypertrichosis, Hot Flush, Vaginal Haemorrhage

Drug(s) suspected as cause:
Activella



Possible Activella side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-02-16

Patient: 63 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Nausea, Breast Mass

Drug(s) suspected as cause:
Activella

Other drugs received by patient: Avonex



Possible Activella side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-01-10

Patient: 60 year old female, weighing 70.3 kg (154.7 pounds)

Reactions: Breast Cancer Stage II

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Activella



Possible Activella side effects in female

Reported by a lawyer from United States on 2012-01-03

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Activella
    Indication: Menopausal Symptoms

Activella
    Dosage: 1mg/0.5mg
    Indication: Hormone Replacement Therapy
    Start date: 2001-03-21
    End date: 2001-10-04

Estrace
    Indication: Menopausal Symptoms

Estrace
    Dosage: 1 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1992-08-12
    End date: 1998-10-22

Estradiol
    Dosage: 1 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1998-01-19
    End date: 1998-10-22

Estradiol
    Indication: Menopausal Symptoms

Prefest
    Indication: Menopausal Symptoms

Prefest
    Dosage: 0.625 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 2000-02-03
    End date: 2000-03-02

Prempro
    Dosage: 0.625/2.5mg
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1998-10-22
    End date: 2000-02-08

Prempro
    Dosage: 0.625/5mg
    Administration route: Oral
    Start date: 2000-03-02
    End date: 2001-03-21

Provera
    Indication: Menopausal Symptoms

Provera
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1992-08-12
    End date: 1998-10-22

Other drugs received by patient: Flonase



Possible Activella side effects in female

Reported by a lawyer from United States on 2011-10-05

Patient: female, weighing 79.0 kg (173.8 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Activella
    Dosage: 1 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 2000-10-01
    End date: 2002-06-01

Medroxyprogesterone Acetate
    Dosage: 10 mg, unk
    Start date: 2002-06-01
    End date: 2002-07-01

Medroxyprogesterone Acetate
    Dosage: 10 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 2001-03-01
    End date: 2001-04-01

Prempro
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 2002-06-01
    End date: 2008-05-01

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