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Ogen (Estropipate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ogen (Estropipate) 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 (11)

Reports by Reaction Type

Breast Cancer Female (6)Depression (5)Abdominal Pain (3)Fibrocystic Breast Disease (3)Dyspepsia (3)Chest Pain (3)Breast Hyperplasia (3)Breast Mass (3)Ovarian Cyst (3)Aortic Stenosis (2)Chronic Obstructive Pulmonary Disease (2)Fatigue (2)

Possible Ogen side effects in female

Reported by a lawyer from United States on 2012-07-11

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Ogen
    Dosage: 0.625 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1986-03-20
    End date: 1993-02-01

Provera
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1986-03-20
    End date: 1993-02-01



Possible Ogen side effects in female

Reported by a lawyer from United States on 2012-06-26

Patient: female

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Provera
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1986-03-20
    End date: 1993-02-01

Ogen
    Dosage: 0.625 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1986-03-20
    End date: 1993-02-01



Possible Ogen side effects in female

Reported by a lawyer from United States on 2012-05-21

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Breast Cancer Female, Depression

Drug(s) suspected as cause:
Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-05-01
    End date: 1999-03-01

Cycrin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-05-01
    End date: 1996-10-01

Provera
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-02-01
    End date: 1998-02-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1998-02-01
    End date: 2000-06-01

Ogen
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1997-02-01
    End date: 1997-04-01

Other drugs received by patient: Wellbutrin SR; Wellbutrin SR



Possible Ogen side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: female, weighing 44.9 kg (98.8 pounds)

Reactions: Malaise

Drug(s) suspected as cause:
Ogen

Other drugs received by patient: Spiriva; Thyroid TAB



Possible Ogen side effects in female

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

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Ogen



Possible Ogen side effects in female

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

Patient: female

Reactions: Breast Cancer Female, Depression

Drug(s) suspected as cause:
Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-02-02
    End date: 1998-08-05

Cycrin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy

Ogen
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 2004-01-01

Medroxyprogesterone
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-01-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1998-08-05
    End date: 2004-01-01

Provera
    Dosage: unknonw
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-02-02
    End date: 1998-08-05



Possible Ogen side effects in female

Reported by a lawyer from United States on 2012-04-25

Patient: female

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Cycrin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy

Provera
    Dosage: unknonw
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-02-02
    End date: 1998-08-05

Premarin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-02-02
    End date: 1998-08-05

Ogen
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 2004-01-01

Prempro
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1998-08-05
    End date: 2004-01-01

Medroxyprogesterone Acetate
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-01-01



Possible Ogen side effects in female

Reported by a lawyer from United States on 2012-04-16

Patient: female

Reactions: Breast Cancer Female

Drug(s) suspected as cause:
Premarin
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-01-01

Prempro
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1996-01-01
    End date: 2004-01-01

Provera
    Dosage: unknonw
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-01-01

Cycrin
    Dosage: unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy

Medroxyprogesterone Acetate
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 1996-01-01

Ogen
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1987-01-01
    End date: 2004-01-01



Possible Ogen side effects in female

Reported by a physician from United States on 2011-12-01

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Foot Deformity, Abdominal Pain, Endometrial Hyperplasia, Aortic Stenosis, Chronic Obstructive Pulmonary Disease, Vitamin B12 Deficiency, Dyspepsia, Uterine Leiomyoma, Breast Hyperplasia, Metabolic Disorder, Arteriosclerosis, Breast Cancer, Cardiac Murmur, Hiatus Hernia, Ovarian Cyst, Coronary Artery Disease, Breast Mass, Cervical Dysplasia, Insomnia, Pelvic Pain, Fibrocystic Breast Disease, Fatigue, Chest Pain, Liver Function Test Abnormal, Dizziness, Depression, Gastrooesophageal Reflux Disease, Dyspnoea, Nausea, Amnesia, Rectocele, Dysuria, Visual Impairment

Drug(s) suspected as cause:
Premarin
    Dosage: 0.625 mg, unk
    Indication: Menopause
    Start date: 1990-11-26
    End date: 2000-11-01

Provera
    Dosage: 10 mg, unk
    Start date: 1990-11-26

Medroxyprogesterone
    Indication: Menopause
    Start date: 1991-01-01

Provera
    Dosage: 2.5 mg, unk
    End date: 2000-11-01

Ogen

Provera
    Indication: Menopause
    Start date: 1988-01-01
    End date: 1991-01-01

Premarin
    Start date: 1988-01-01
    End date: 1991-01-01

Prempro

Provera
    Start date: 1991-01-01

Premarin
    Administration route: Topical
    Indication: Menopause
    Start date: 1992-03-11
    End date: 1997-11-23

Hormones
    Administration route: Topical
    Indication: Menopause
    Start date: 1991-01-01

Climara

Estraderm
    Indication: Menopause
    Start date: 1991-01-01
    End date: 1993-03-11

Estraderm
    Dosage: 0.05 mg, biw
    Start date: 1992-03-11
    End date: 1993-03-11

Cycrin
    Dosage: 2.5 mg, unk
    Indication: Menopause
    Start date: 1997-11-17
    End date: 1997-12-17

Other drugs received by patient: Calcium Carbonate; Fosamax; Plavix; Prednisone TAB; Tamoxifen Citrate; Zantac; Magnesium Sulfate; Tricor; Methotrexate; Fluconazole; Paxil; Naproxen (Aleve); Aspirin; Prevacid; Macrodantin; Folic Acid; Zoloft



Possible Ogen side effects in female

Reported by a individual with unspecified qualification from United States on 2011-12-01

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: Abdominal Pain, Muscle Atrophy, Breast Cancer in Situ, Loss of Consciousness, Breast Cancer Recurrent, Metastasis, Dyspepsia, Vulvovaginal Dryness, Mammogram, Breast Hyperplasia, Back Pain, Dyspareunia, Intervertebral Disc Protrusion, Dysphagia, Oestrogen Receptor Assay Negative, Breast Cancer Stage I, Ovarian Cyst, Breast Cancer Stage III, Breast Mass, Renal Cyst, Osteopenia, Colitis, Breast Necrosis, Excessive Granulation Tissue, Confusional State, Application Site Reaction, Head Injury, Osteoporosis, Pain, Fall, Weight Increased, Fibrocystic Breast Disease, Chest Pain, Intervertebral Disc Degeneration, Injury, Oestrogen Receptor Assay Positive, Depression, Hallucination, Gastrooesophageal Reflux Disease, Progesterone Receptor Assay Negative, Scoliosis, Bone Giant Cell Tumour, Radius Fracture, Anxiety, Atrophic Vulvovaginitis, Spinal Osteoarthritis, Arthritis, Physical Disability, Breast Fibrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Premarin
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Start date: 1992-10-01
    End date: 1997-07-01

Provera
    Dosage: 5/2.5 mg day 1-14
    Administration route: Oral
    Start date: 1992-10-01
    End date: 1997-07-01

Ogen
    Start date: 1992-06-01
    End date: 1993-04-01

Estraderm
    Dosage: 0.05 mg, 2x/wk
    Start date: 1995-09-01
    End date: 1995-11-01

Prempro
    Dosage: 625/2.5 mg
    Indication: Menopausal Symptoms
    Start date: 1996-06-01
    End date: 1996-06-01

Premarin

Other drugs received by patient: Multivitamins, Combinations; Xanax; Prozac; Evista



Possible Ogen side effects in female

Reported by a lawyer from United States on 2011-11-29

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Abdominal Pain, Aortic Stenosis, Pelvic Pain, Chronic Obstructive Pulmonary Disease, Fatigue, Fibrocystic Breast Disease, Dyspepsia, Uterine Leiomyoma, Chest Pain, Liver Function Test Abnormal, Dizziness, Breast Hyperplasia, Depression, Arteriosclerosis, Breast Cancer, Cardiac Murmur, Hiatus Hernia, Nausea, Breast Mass, Ovarian Cyst, Cervical Dysplasia, Amnesia, Rectocele, Visual Impairment

Drug(s) suspected as cause:
Provera
    Dosage: 10 mg, unk
    Start date: 1990-11-26

Cycrin
    Dosage: 2.5 mg, unk
    Indication: Menopause
    Start date: 1997-11-17
    End date: 1997-12-17

Prempro

Hormones
    Administration route: Topical
    Indication: Menopause
    Start date: 1991-01-01

Ogen

Provera
    Start date: 1991-01-01

Premarin
    Dosage: 0.625 mg, unk
    Indication: Menopause
    Start date: 1990-11-26
    End date: 2000-11-01

Premarin
    Administration route: Topical
    Indication: Menopause
    Start date: 1992-03-11
    End date: 1997-11-23

Estraderm
    Dosage: 0.05 mg, biw
    Start date: 1992-03-11
    End date: 1993-03-11

Premarin
    Start date: 1988-01-01
    End date: 1991-01-01

Medroxyprogesterone
    Indication: Menopause
    Start date: 1991-01-01

Provera
    Indication: Menopause
    Start date: 1988-01-01
    End date: 1991-01-01

Provera
    Dosage: 2.5 mg, unk
    End date: 2000-11-01

Climara

Estraderm
    Indication: Menopause
    Start date: 1991-01-01
    End date: 1993-03-11

Other drugs received by patient: Methotrexate; Aspirin; Naproxen (Aleve); Magnesium Sulfate; Plavix; Macrodantin; Tamoxifen Citrate; Zantac; Prevacid; Fluconazole; Paxil; Prednisone; Folic Acid; Zoloft; Calcium Carbonate; Fosamax; Tricor

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