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Provera (Medroxyprogesterone) - Breast Mass - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Breast Mass (9)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Provera (Medroxyprogesterone) where reactions include breast mass. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Provera side effects in female

Reported by a consumer/non-health professional from Japan on 2012-03-26

Patient: female

Reactions: Breast Mass

Drug(s) suspected as cause:
Provera



Possible Provera side effects in female

Reported by a physician from United States on 2012-02-10

Patient: female

Reactions: Thrombosis, Asthma, Lymphadenopathy, Hypoglycaemia, Osteomyelitis, Lipids Increased, Cerebrovascular Disorder, Peripheral Sensory Neuropathy, Oedema Peripheral, Uterine Leiomyoma, Irritable Bowel Syndrome, Postmenopausal Haemorrhage, Hypoxia, Breast Cancer, Pneumonia, Pain in Extremity, Mastitis, Breast Mass, Hypoaesthesia, Diverticulum Intestinal, Adenomyosis, Diabetic Neuropathy, Staphylococcal Infection, Nervous System Disorder, Gastric Polyps, non-Hodgkin's Lymphoma, Sleep Apnoea Syndrome, Uterine Haemorrhage, Aphasia, Viith Nerve Paralysis, Fibrocystic Breast Disease, Neuropathy Peripheral, Fibromyalgia, Obesity, Depression, Lymphoedema, Transient Ischaemic Attack, Migraine, Abdominal Pain Lower, Type 2 Diabetes Mellitus, Motor Dysfunction, Urinary Tract Infection, Cognitive Disorder, Cystitis, Amnesia, Cerebrovascular Accident, Anxiety, Osteoarthritis, Dysarthria, Diarrhoea, Arthralgia, Dysuria, Flank Pain, Alopecia, Gait Disturbance, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Estraderm
    Dosage: 0.5 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1994-04-01
    End date: 1997-06-01

Vivelle
    Dosage: 0.1 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1997-10-01
    End date: 1997-12-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1994-03-01
    End date: 1994-08-01

Premarin
    Indication: Hormone Replacement Therapy

Medroxyprogesterone Acetate
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1994-09-01
    End date: 2000-02-16

Estraderm
    Dosage: 0.1 mg, unk
    Start date: 1997-08-01
    End date: 2000-02-01



Possible Provera side effects in female

Reported by a lawyer from United States on 2012-01-12

Patient: female

Reactions: Asthma, Thrombosis, Lymphadenopathy, Hypoglycaemia, Cerebrovascular Disorder, Lipids Increased, Peripheral Sensory Neuropathy, Uterine Leiomyoma, Irritable Bowel Syndrome, Hypoxia, Postmenopausal Haemorrhage, Breast Cancer, Pneumonia, Pain in Extremity, Breast Mass, Hypoaesthesia, Diverticulum Intestinal, Adenomyosis, Staphylococcal Infection, Diabetic Neuropathy, Nervous System Disorder, Gastric Polyps, non-Hodgkin's Lymphoma, Sleep Apnoea Syndrome, Uterine Haemorrhage, Aphasia, Viith Nerve Paralysis, Neuropathy Peripheral, Fibrocystic Breast Disease, Fibromyalgia, Obesity, Depression, Lymphoedema, Transient Ischaemic Attack, Migraine, Abdominal Pain Lower, Type 2 Diabetes Mellitus, Motor Dysfunction, Cognitive Disorder, Amnesia, Cerebrovascular Accident, Osteoarthritis, Dysarthria, Anxiety, Arthralgia, Diarrhoea, Gait Disturbance, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Estraderm
    Dosage: 0.5 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1994-04-01
    End date: 1997-06-01

Vivelle
    Dosage: 0.1 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1997-10-01
    End date: 1997-12-01

Premarin
    Indication: Hormone Replacement Therapy

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1994-03-01
    End date: 1994-08-01

Estraderm
    Dosage: 0.1 mg, unk
    Start date: 1997-08-01
    End date: 2000-02-01

Medroxyprogesterone Acetate
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Hormone Replacement Therapy
    Start date: 1994-09-01
    End date: 2000-02-16



Possible Provera side effects in female

Reported by a individual with unspecified qualification from United States on 2012-01-10

Patient: female, weighing 67.1 kg (147.7 pounds)

Reactions: Abdominal Pain, Metaplasia, Breast Cancer in Situ, Mammogram Abnormal, Breast Cyst, Uterine Leiomyoma, Biliary Dilatation, Emotional Disorder, Breast Hyperplasia, Melanocytic Naevus, Proctalgia, Muscle Spasms, Back Pain, Breast Cancer, Postoperative Adhesion, Intervertebral Disc Protrusion, Pain in Extremity, Anaemia, Breast Mass, General Physical Health Deterioration, Osteopenia, Breast Calcifications, Micturition Urgency, Paraesthesia, Uterine Prolapse, Cerebral Small Vessel Ischaemic Disease, Dilatation Intrahepatic Duct Acquired, Insomnia, Osteoporosis, Pain, Rectal Haemorrhage, Breast Induration, Oral Herpes, Fall, Fibrocystic Breast Disease, Fibroadenoma of Breast, Aortic Arteriosclerosis, Intervertebral Disc Degeneration, Injury, Sinusitis, RIB Fracture, Breast Disorder, Biopsy Breast, Avulsion Fracture, Deformity, Anxiety, Atrophic Vulvovaginitis, Oral Pain, Presyncope, Spinal Disorder, Lymph Nodes Scan Abnormal, Arthritis

Drug(s) suspected as cause:
Hormones
    Indication: Menopause
    Start date: 1988-01-01
    End date: 1989-01-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Menopause
    Start date: 1991-08-18
    End date: 1995-08-29

Prempro
    Dosage: .625/2.5 mg
    Administration route: Oral
    Indication: Menopause
    Start date: 1995-05-01
    End date: 1999-01-12

Premarin
    Dosage: 0.9 mg, unk
    Administration route: Oral
    Indication: Menopause
    Start date: 1991-05-08
    End date: 1991-05-15

Premarin
    Dosage: 0.625 mg, unk
    Administration route: Oral
    Start date: 1991-05-16
    End date: 1995-08-29

Estraderm
    Dosage: 0.1 (units not spec.) 2x weekly
    Indication: Menopause
    Start date: 1991-08-18
    End date: 1991-10-01

Other drugs received by patient: Anusol HC; H2 Blocker ^ratiopharm^



Possible Provera 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 Provera 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 Provera 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



Possible Provera side effects in female

Reported by a lawyer from United States on 2011-11-28

Patient: female, weighing 59.0 kg (129.7 pounds)

Reactions: Abdominal Pain, Pulmonary Hypertension, Lymphocyte Count Increased, FAT Embolism, Myocardial Ischaemia, Endoscopy Upper Gastrointestinal Tract, Chronic Obstructive Pulmonary Disease, Lumbar Spinal Stenosis, Metastatic Lymphoma, Hypoxia, Back Pain, Pain in Extremity, Breast Cancer Stage I, Breast Mass, Renal Cyst, Osteopenia, Hepatic Steatosis, Breast Cancer Stage II, Bone Densitometry, Breast Necrosis, Ultrasound Abdomen Abnormal, Pleural Fibrosis, Dyslipidaemia, Osteoporosis, Aortic Aneurysm, Gastritis, Dyspnoea Exertional, Interstitial Lung Disease, Basal Cell Carcinoma, Blood Cholesterol Increased, Malignant Melanoma, Oestrogen Receptor Assay Positive, Myocardial Infarction, Emphysema, Scoliosis, Dyspnoea, Nausea, Squamous Cell Carcinoma, Spondylolisthesis, Peripheral Vascular Disorder, Progesterone Receptor Assay Positive, Pulmonary Fibrosis, Osteoarthritis, Cardiac Failure, Nuclear Magnetic Resonance Imaging Abnormal, Spinal Osteoarthritis, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Medroxyprogesterone
    Indication: Hormone Replacement Therapy
    Start date: 1997-01-01
    End date: 2002-01-01

Prempro
    Dosage: .625/2.5 mg
    Administration route: Oral
    Indication: Osteoporosis Prophylaxis
    Start date: 1998-12-01
    End date: 2002-10-01

Estraderm
    Dosage: 0.05 mg, unk
    Indication: Osteoporosis Prophylaxis
    Start date: 1992-01-01
    End date: 1998-12-01

Provera
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Indication: Osteoporosis Prophylaxis
    Start date: 1992-01-01
    End date: 1998-12-01

Other drugs received by patient: Letairis; Calcium; Coumadin; Zocor; Advair Diskus 100 / 50; Boniva; Hydrochlorothiazide; Cozaar; Vitamin D; Spiriva; Celebrex; Viagra; Fosamax



Possible Provera side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-20

Patient: female, weighing 95.2 kg (209.5 pounds)

Reactions: Osteoporosis, Perivascular Dermatitis, Radiation Skin Injury, Headache, Fall, Fibrocystic Breast Disease, Breast Cyst, Skin Lesion, Breast Cancer, Breast Pain, Breast Disorder, Post Herpetic Neuralgia, Breast Mass, Osteopenia, Rash, Breast Calcifications, Paraesthesia, Hyperlipidaemia, Burning Sensation, Breast Haemorrhage, Arthralgia, Nuclear Magnetic Resonance Imaging Abnormal, Breast Inflammation, Breast Fibrosis, Influenza Like Illness

Drug(s) suspected as cause:
Combipatch
    Dosage: 0.5 mg, unk
    Indication: Menopause
    Start date: 2001-01-24
    End date: 2005-01-03

Prempro
    Administration route: Oral
    Indication: Menopause
    Start date: 1998-01-01
    End date: 2000-12-01

Premarin
    Administration route: Oral
    Indication: Menopause
    Start date: 1995-01-01
    End date: 1997-12-01

Provera
    Administration route: Oral
    Indication: Menopause
    Start date: 1995-01-01
    End date: 1997-12-01

Other drugs received by patient: Lipitor; Atenolol

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