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Index of reports
> Cases resulting in a serious event (70)
> Cases with Malignant Breast Lump Removal (7)
Below is the selection of adverse event reports related to Estrace (Estradiol Vaginal) that includes cases resulting in a serious event where reactions include malignant breast lump removal.
Adverse event in 57 year old female receiving Estrace (Estradiol Vaginal)
Reported by a individual with unspecified qualification from United States on 2007-07-05
Patient: 57 year old female, weighing 68.0 kg (149.7 pounds)
Adverse reactions / side effects: Tooth Extraction, Neck Injury, Skin Burning Sensation, Breast Cancer in Situ, Malignant Breast Lump Removal, Rash, Biopsy, Biopsy Site Unspecified Abnormal, Erythema, Skin Reaction, Hot Flush, Road Traffic Accident, Depression, Bone Density Decreased, Ligament Sprain
Suspect drug(s):
Combipatch
Indication: Menopause
Start date: 2002-11-14
End date: 2002-12-31
Oral Contraceptive NOS
Dosage: unk, unk
Administration route: Oral
Start date: 1965-01-01
End date: 1972-01-01
Prempro
Indication: Menopause
Start date: 1996-01-01
End date: 1999-01-01
Estratest
Provera
Indication: Menopause
Start date: 1999-06-01
End date: 2005-03-01
Estrace
Other drugs received by patient: Tamoxifen Citrate; Arimidex
Adverse event in 62 year old female receiving Estrace (Estradiol Vaginal)
Reported by a individual with unspecified qualification from United States on 2007-07-02
Patient: 62 year old female, weighing 99.8 kg (219.5 pounds)
Adverse reactions / side effects: Polyp Colorectal, Mammogram Abnormal, Fibrocystic Breast Disease, Intervertebral Disc Disorder, Postmenopausal Haemorrhage, Breast Microcalcification, Blood Cholesterol Increased, Benign Breast Neoplasm, Breast Hyperplasia, Breast Cancer, Tonsillectomy, Abscess Drainage, Mastitis, Radiotherapy, Malignant Breast Lump Removal, Appendicitis, Anal Fissure, Haematochezia, Hysterectomy, Uterine Dilation and Curettage, Colonoscopy Abnormal
Adverse event resulted in: hospitalization
Suspect drug(s):
Estraderm
Start date: 1989-01-01
Premarin
Dosage: 0.625 unk, unk
Administration route: Oral
Start date: 1989-01-01
Prempro
Indication: Menopause
Start date: 1999-04-01
End date: 2002-04-01
Provera
Dosage: 10 mg, unk
Start date: 1989-01-01
Estratest
Start date: 1990-01-01
End date: 1999-01-01
Cycrin
Start date: 1999-01-01
Estrace
Dosage: unk, qhs
Start date: 1999-01-01
Other drugs received by patient: Steroids NOS; Oxygen Therapy; Lotrel; Cardizem
Adverse event in 53 year old female receiving Estrace (Estradiol Vaginal)
Reported by a individual with unspecified qualification from United States on 2007-06-26
Patient: 53 year old female, weighing 47.6 kg (104.8 pounds)
Adverse reactions / side effects: Breast Cancer, Chondropathy, Joint Manipulation, Neuropathy, Rectal Polyp, Radiotherapy, Malignant Breast Lump Removal, Periarthritis, Paraesthesia, Rectal Polypectomy, Anxiety, Breast Microcalcification, Depression, Neuralgia
Suspect drug(s):
Estraderm
Indication: Menopause
Start date: 1995-05-31
End date: 1995-01-01
Provera
Dosage: 10 mg, unk
Administration route: Oral
Indication: Menopause
Start date: 1994-05-27
End date: 1996-02-26
Ortho-EST
Indication: Menopause
Start date: 1994-05-27
Estrace
Indication: Menopause
Start date: 1994-06-24
End date: 1996-02-26
Prempro
Indication: Menopause
Start date: 1996-04-05
End date: 1996-10-11
Climara
Indication: Menopause
Start date: 1995-06-22
End date: 1995-01-01
Adverse event in 56 year old female receiving Estrace (Estradiol Vaginal)
Reported by a physician from United States on 2007-06-05
Patient: 56 year old female, weighing 63.5 kg (139.7 pounds)
Adverse reactions / side effects: Hysteroscopy, Liver Disorder, Fibrocystic Breast Disease, Uterine Leiomyoma, Liver Function Test Abnormal, Oedema Peripheral, Breast Microcalcification, Depression, Breast Hyperplasia, Pain in Extremity, Radiotherapy, Malignant Breast Lump Removal, Osteopenia, Hepatic Steatosis, Breast Cancer Metastatic, Uterine Dilation and Curettage, Menometrorrhagia
Suspect drug(s):
Estraderm
Dosage: 0.05mg
Indication: Hormone Replacement Therapy
Start date: 1990-12-01
End date: 1992-01-01
Premphase 14 / 14
Dosage: 0.625mg
Indication: Hormone Replacement Therapy
Start date: 1990-01-01
End date: 1999-10-01
Cycrin
Dosage: 10mg unk
Indication: Hormone Replacement Therapy
Start date: 1990-01-01
End date: 1992-01-01
Estratest
Indication: Hormone Replacement Therapy
Start date: 1990-01-01
End date: 2002-01-01
Premarin
Dosage: unk, unk
Indication: Hormone Replacement Therapy
Start date: 1993-07-01
End date: 1993-01-01
Provera
Dosage: unk, unk
Indication: Hormone Replacement Therapy
Start date: 1991-12-01
End date: 1996-01-01
Ogen
Indication: Hormone Replacement Therapy
Start date: 1999-01-01
End date: 2002-01-01
Estrace
Dosage: unk, unk
Indication: Hormone Replacement Therapy
Start date: 1993-01-01
End date: 1996-01-01
Prempro
Indication: Menopause
Start date: 2001-12-01
End date: 2002-01-01
Other drugs received by patient: Paxil; Xanax; Pamelor
Adverse event in 56 year old female receiving Estrace (Estradiol Vaginal)
Reported by a individual with unspecified qualification from United States on 2007-04-16
Patient: 56 year old female, weighing 59.0 kg (129.7 pounds)
Adverse reactions / side effects: Tinnitus, Seroma, Hyperhidrosis, Depression Postoperative, Mammogram Abnormal, Hot Flush, Malaise, Breast Cyst, Uterine Leiomyoma, Bacterial Test Positive, Nervousness, Breast Cancer, Back Pain, Pain in Extremity, Breast Haematoma, Radiotherapy, Libido Decreased, Osteopenia, Bursitis, Dolichocolon, Pain, Breast Oedema, Radiation Skin Injury, Constipation, Gastritis, Abdominal Pain Upper, Weight Increased, Blepharoplasty, Fatigue, Body Dysmorphic Disorder, Nerve Root Lesion, Abdominal Distension, Depression, Oestrogen Receptor Assay Positive, Gastrooesophageal Reflux Disease, Intestinal Polyp, Scoliosis, Haemorrhoids, Deafness Neurosensory, Malignant Breast Lump Removal, Progesterone Receptor Assay Positive, Anxiety, Spinal Osteoarthritis, Asthenia, Hypertension
Suspect drug(s):
Premarin
Indication: Hormone Replacement Therapy
Start date: 1985-01-01
End date: 1999-01-01
Provera
Indication: Hormone Replacement Therapy
Start date: 1985-01-01
End date: 1999-01-01
Estraderm
Indication: Hormone Replacement Therapy
Start date: 1985-01-01
End date: 1999-01-01
Medroxyprogesterone
Dosage: 5 mg, unk
Indication: Hormone Replacement Therapy
Start date: 1998-07-29
End date: 1999-10-01
Estrace
Indication: Hormone Replacement Therapy
Other drugs received by patient: Inderal; Nexium
Adverse event in 65 year old female receiving Estrace (Estradiol Vaginal)
Reported by a physician from United States on 2007-04-03
Patient: 65 year old female, weighing 64.9 kg (142.7 pounds)
Adverse reactions / side effects: Diverticulitis, Breast Cellulitis, Exomphalos, Irritable Bowel Syndrome, Depression, Lymphadenectomy, Breast Cancer, Radiotherapy, Malignant Breast Lump Removal, Hernia Repair, Facet Joint Syndrome, Spondylitis, Anxiety, Cholelithiasis, Cholecystectomy, Spinal Osteoarthritis
Suspect drug(s):
Estraderm
Indication: Hormone Replacement Therapy
Start date: 1988-08-08
End date: 1991-01-01
Estrace
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1991-01-01
End date: 1996-01-01
Prempro
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-01-01
End date: 2001-01-01
Premarin
Indication: Hormone Replacement Therapy
Start date: 1996-01-01
End date: 2001-01-01
Adverse event in 61 year old female receiving Estrace (Estradiol Vaginal)
Reported by a individual with unspecified qualification from United States on 2007-03-28
Patient: 61 year old female, weighing 89.8 kg (197.5 pounds)
Adverse reactions / side effects: Breast Cancer, Biopsy Breast Abnormal, Breast Mass, Malignant Breast Lump Removal, Progesterone Receptor Assay Positive, Haemangioma of Liver, Limb Discomfort, Oedema Peripheral, Depression, Lymphadenectomy, Knee Arthroplasty, Oestrogen Receptor Assay Positive, Lung Infiltration
Adverse event resulted in: hospitalization
Suspect drug(s):
Vivelle
Indication: Hormone Replacement Therapy
Vivelle-DOT
Indication: Hormone Replacement Therapy
Estrace
Indication: Night Sweats
Estratab
Dosage: 0.625 mg, qd
Indication: Night Sweats
Estropipate
Dosage: 1 mg, unk
Indication: Amnesia
Prempro
Indication: Amnesia
Premarin
Dosage: 0.625 mg, unk
Indication: Affective Disorder
Provera
Dosage: 2.5 mg, qd
Indication: Hormone Replacement Therapy
Other drugs received by patient: Fish OIL; Alprazolam; Celebrex
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