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Index of reports
> Serious Events (208)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Provera (Medroxyprogesterone) serious events. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 208 Next >>
Possible Provera side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: male
Reactions: Asthma, Premature Baby, Anaemia, Maternal Exposure Timing Unspecified, Cryptorchism, Obesity, Bone Development Abnormal, Bronchitis
Drug(s) suspected as cause:
Provera
Possible Provera side effects in 50 year old female
Reported by a physician from United Kingdom on 2012-08-24
Patient: 50 year old female, weighing 73.8 kg (162.5 pounds)
Reactions: Amenorrhoea, Lower Respiratory Tract Infection
Drug(s) suspected as cause:
Provera
Possible Provera side effects in 62 year old female
Reported by a lawyer from United States on 2012-08-21
Patient: 62 year old female
Reactions: Emotional Distress, Breast Cancer Female
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prempro
Dosage: 0.625/2.5mg
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-08-01
End date: 2001-03-30
Provera
Dosage: 10 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-05-01
End date: 1996-08-01
Other drugs received by patient: Aspirin
Possible Provera side effects in 53 year old female
Reported by a lawyer from United States on 2012-08-17
Patient: 53 year old female
Reactions: Anxiety, Breast Cancer Female, Depression
Drug(s) suspected as cause:
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Premarin
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1988-01-01
End date: 1996-01-01
Prempro
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-01-01
End date: 2002-01-01
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1988-01-01
End date: 1996-01-01
Possible Provera side effects in 67 year old female
Reported by a lawyer from United States on 2012-08-17
Patient: 67 year old female, weighing 74.0 kg (162.8 pounds)
Reactions: Emotional Distress, Breast Cancer Female
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Premarin
Dosage: 0.625 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1983-01-01
End date: 1998-01-01
Premphase 14 / 14
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Prempro
Dosage: 0.625/2.5mg
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1998-01-01
End date: 2001-01-01
Provera
Dosage: 10 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1983-01-01
End date: 1998-01-01
Other drugs received by patient: Atenolol; Potassium Chloride; Zantac; Lasix
Possible Provera side effects in female
Reported by a pharmacist from Japan on 2012-08-07
Patient: female
Reactions: Autoimmune Hepatitis
Drug(s) suspected as cause:
Premarin
Dosage: unk
Indication: Hormone Replacement Therapy
Provera
Indication: Hormone Replacement Therapy
Possible Provera side effects in 37 year old female
Reported by a physician from Japan on 2012-08-06
Patient: 37 year old female
Reactions: Off Label Use, Cerebral Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Premarin
Dosage: 2.5 mg, 1x/day
Administration route: Oral
Indication: Thrombosis
Provera
Dosage: 10 mg, 1x/day
Administration route: Oral
Indication: Thrombosis
Sophia A
Administration route: Oral
Indication: Thrombosis
Other drugs received by patient: Selbex; Methotrexate
Possible Provera side effects in female
Reported by a physician from Japan on 2012-08-06
Patient: female
Reactions: Autoimmune Hepatitis
Drug(s) suspected as cause:
Premarin
Dosage: unk
Indication: Hormone Replacement Therapy
Provera
Indication: Hormone Replacement Therapy
Possible Provera side effects in 46 year old female
Reported by a physician from Japan on 2012-08-03
Patient: 46 year old female
Reactions: Cushing's Syndrome
Drug(s) suspected as cause:
Provera
Other drugs received by patient: Julina; Valtrex
Possible Provera side effects in
Reported by a physician from Japan on 2012-07-27
Patient:
Reactions: Cushing's Syndrome
Drug(s) suspected as cause:
Provera
Possible Provera side effects in 22 year old female
Reported by a consumer/non-health professional from Brazil on 2012-07-25
Patient: 22 year old female, weighing 62.0 kg (136.4 pounds)
Reactions: Eye Irritation, Blindness Transient
Drug(s) suspected as cause:
Provera
Possible Provera side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient: female, weighing 102.0 kg (224.4 pounds)
Reactions: Diabetes Mellitus, Drug Ineffective, Pain, Endometrial Hypertrophy, Hunger, Malaise, Fatigue, Palpitations, Dyspepsia, Dizziness, Abdominal Distension, Musculoskeletal Stiffness, Eye Pruritus, Muscle Spasms, Vein Disorder, Chest Discomfort, Pain in Extremity, Drug Intolerance, Eye Pain, Hyperplasia, Arthralgia, Rhinalgia, Insomnia, Dehydration, Vertigo, DRY Eye, Asthenia
Drug(s) suspected as cause:
Hyoscyamine
Hyoscyamine
Indication: Irritable Bowel Syndrome
Hyoscyamine
Dosage: 0.125 mg, 1x/day
Indication: Gastrooesophageal Reflux Disease
Omeprazole
Omeprazole
Indication: Irritable Bowel Syndrome
Omeprazole
Dosage: 20 mg, 1x/day
Indication: Gastrooesophageal Reflux Disease
Provera
Dosage: 5 mg, unk
Administration route: Oral
Indication: Neoplasm Malignant
Start date: 2012-07-01
Provera
Dosage: unk
Administration route: Oral
Indication: Endometrial Hypertrophy
Start date: 2010-08-01
End date: 2010-01-01
Provera
Dosage: 10 mg, 1x/day
Administration route: Oral
Indication: Endometrial Hyperplasia
Start date: 2012-07-12
End date: 2012-07-01
Provera
Dosage: unk
Administration route: Oral
Indication: Menorrhagia
Other drugs received by patient: Bactroban
Possible Provera side effects in 68 year old female
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient: 68 year old female, weighing 61.2 kg (134.7 pounds)
Reactions: Osteoarthritis, Shoulder Operation, Intervertebral Disc Degeneration
Drug(s) suspected as cause:
Premarin
Dosage: unk
Indication: Premature Menopause
Prempro
Dosage: 0.625/2.5 mg, daily
Indication: Premature Menopause
Prempro
Dosage: 0.625/2.5 mg, every other day
Provera
Dosage: unk
Indication: Premature Menopause
Possible Provera side effects in
Reported by a physician from United States on 2012-07-19
Patient:
Reactions: Abdominal Pain, Lymphadenopathy, Glossodynia, Osteomyelitis, Chronic Obstructive Pulmonary Disease, Colonic Polyp, Abdominal Discomfort, Oral Candidiasis, Pharyngeal Ulceration, Cellulitis, Peptic Ulcer, Oral Infection, Rectal Adenoma, Fungal Infection, Insomnia, Fistula Discharge, Tooth Abscess, Abdominal Pain Upper, Colitis Microscopic, Chest Pain, Blood Cholesterol Increased, Gastrooesophageal Reflux Disease, Drug Hypersensitivity, Haemorrhoids, Dental Caries, Musculoskeletal Pain, Appendix Disorder, Hyperlipidaemia, Anxiety, Osteonecrosis of JAW, Diarrhoea, Sepsis, Hypertension
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Actonel
Administration route: Oral
Indication: Osteoporosis Prophylaxis
Start date: 2008-04-20
End date: 2010-01-01
Fosamax
Dosage: 70 mg, qw
Administration route: Oral
Start date: 2008-02-12
End date: 2008-03-01
Fosamax
Dosage: 70 mg, qw
Administration route: Oral
Indication: Osteoporosis Prophylaxis
Start date: 2001-01-29
End date: 2008-03-20
Provera
Administration route: Oral
Start date: 2001-01-01
Possible Provera side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient: female, weighing 78.0 kg (171.6 pounds)
Reactions: Emotional Distress, Breast Cancer Stage I
Drug(s) suspected as cause:
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-01-01
End date: 1998-01-01
Premarin
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-01-26
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-01-26
Possible Provera side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: female, weighing 102.0 kg (224.4 pounds)
Reactions: Drug Ineffective, Endometrial Hypertrophy, Malaise, Fatigue, Palpitations, Dyspepsia, Dizziness, Abdominal Distension, Musculoskeletal Stiffness, Muscle Spasms, Chest Discomfort, Hyperplasia, Arthralgia, Vertigo, DRY Eye, Asthenia
Drug(s) suspected as cause:
Provera
Dosage: unk
Administration route: Oral
Indication: Endometrial Hypertrophy
Start date: 2010-08-01
End date: 2010-01-01
Provera
Dosage: 10 mg, 1x/day
Administration route: Oral
Indication: Endometrial Hyperplasia
Start date: 2012-07-12
Provera
Dosage: unk
Administration route: Oral
Indication: Menorrhagia
Other drugs received by patient: Omeprazole; Omeprazole; Hyoscyamine; Hyoscyamine; Bactroban; Omeprazole; Hyoscyamine
Possible Provera side effects in female
Reported by a physician from United States on 2012-07-13
Patient: female, weighing 99.8 kg (219.5 pounds)
Reactions: Breast Cancer Female, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cycrin
Dosage: 2.5 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1997-07-01
End date: 2001-03-01
Premarin
Dosage: 0.625 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-01-01
End date: 2002-07-01
Provera
Dosage: 2.5 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1994-06-01
End date: 2002-07-01
Other drugs received by patient: Levothroid; Tenormin; Pioglitazone; Mevacor; Aspirin; Allegra; Cozaar; Lisinopril and Hydrochlorothiazide
Possible Provera side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12
Patient: female, weighing 86.0 kg (189.2 pounds)
Reactions: Breast Cancer Female, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Medroxyprogesterone
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Prempro
Dosage: 2.5 mg, unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-08-01
End date: 2000-10-31
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Other drugs received by patient: Prednisone
Possible Provera 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 Provera side effects in female
Reported by a lawyer from United States on 2012-07-11
Patient: female, weighing 57.0 kg (125.4 pounds)
Reactions: Breast Cancer Female, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Premphase 14 / 14
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-08-01
End date: 1997-01-01
Prempro
Dosage: 5mg to 0.625
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1997-01-01
End date: 2002-02-01
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1983-11-01
End date: 1984-09-01
Possible Provera side effects in female
Reported by a lawyer from United States on 2012-07-10
Patient: female, weighing 67.0 kg (147.4 pounds)
Reactions: Breast Cancer Female
Drug(s) suspected as cause:
Aygestin
Dosage: unk
Indication: Hormone Replacement Therapy
Start date: 1987-01-01
End date: 1996-04-01
Medroxyprogesterone Acetate
Dosage: unk
Start date: 2000-07-01
End date: 2003-02-01
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 2000-07-01
End date: 2003-02-01
Premarin
Dosage: unk
Administration route: Oral
Start date: 2000-07-01
End date: 2003-02-01
Premarin
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1987-01-01
End date: 1996-04-01
Prempro
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-04-01
End date: 2000-07-01
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 2000-07-01
End date: 2003-02-01
Other drugs received by patient: Prinivil; Acetylsalicylic Acid; Albuterol; Combivent; Flonase; Lisinopril
Possible Provera 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 Provera side effects in female
Reported by a lawyer from United States on 2012-07-05
Patient: female, weighing 67.0 kg (147.4 pounds)
Reactions: Breast Cancer Metastatic
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aygestin
Dosage: unk
Indication: Hormone Replacement Therapy
Start date: 1987-01-01
End date: 1996-04-01
Cycrin
Indication: Hormone Replacement Therapy
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 2000-07-01
End date: 2003-02-01
Medroxyprogesterone Acetate
Dosage: unk
Start date: 2000-07-01
End date: 2003-02-01
Premarin
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1987-01-01
End date: 1996-04-01
Premarin
Dosage: unk
Administration route: Oral
Start date: 2000-07-01
End date: 2003-02-01
Prempro
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-04-01
End date: 2000-07-01
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 2000-07-01
End date: 2003-02-01
Other drugs received by patient: Acetylsalicylic Acid; Prinivil; Flonase; Lisinopril; Combivent; Albuterol; Singulair
Possible Provera side effects in female
Reported by a lawyer from United States on 2012-07-05
Patient: female, weighing 67.0 kg (147.4 pounds)
Reactions: Breast Cancer Female
Drug(s) suspected as cause:
Aygestin
Dosage: unk
Indication: Hormone Replacement Therapy
Start date: 1987-01-01
End date: 1996-04-01
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 2000-07-01
End date: 2003-02-01
Medroxyprogesterone Acetate
Dosage: unk
Start date: 2000-07-01
End date: 2003-02-01
Premarin
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1987-01-01
End date: 1996-04-01
Premarin
Dosage: unk
Administration route: Oral
Start date: 2000-07-01
End date: 2003-02-01
Prempro
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-04-01
End date: 2000-07-01
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 2000-07-01
End date: 2003-02-01
Other drugs received by patient: Flonase; Prinivil; Lisinopril; Acetylsalicylic Acid; Albuterol; Combivent
Possible Provera 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 Provera side effects in female
Reported by a lawyer from United States on 2012-07-05
Patient: female
Reactions: Breast Cancer
Drug(s) suspected as cause:
Medroxyprogesterone Acetate
Dosage: unk
Premarin
Dosage: unk
Prempro
Dosage: unk
Provera
Dosage: unk
Possible Provera 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 Provera 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:
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 Provera side effects in female
Reported by a lawyer from United States on 2012-06-20
Patient: female, weighing 104.0 kg (228.8 pounds)
Reactions: Anxiety, Breast Cancer Metastatic, Depression
Drug(s) suspected as cause:
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Start date: 1992-11-01
End date: 1996-06-01
Medroxyprogesterone Acetate
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1992-11-01
End date: 1996-06-01
Premarin
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1992-11-01
End date: 1996-06-01
Prempro
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1996-06-01
End date: 2002-09-01
Provera
Dosage: unk
Administration route: Oral
Indication: Hormone Replacement Therapy
Start date: 1992-11-01
End date: 1996-06-01
Other drugs received by patient: Vioxx
Possible Provera side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: female, weighing 79.4 kg (174.6 pounds)
Reactions: Impaired Driving Ability, Pain in Extremity
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Premarin
Dosage: 0.3 mg, daily
Indication: Menopause
Provera
Dosage: 2.5 mg, daily
Indication: Menopause
Other drugs received by patient: Teveten
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