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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