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),
Hot Flush (1),
Hypertrichosis (1),
Depression (1),
Drug Dispensing Error (1),
Product Formulation Issue (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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