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Provera (Medroxyprogesterone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Provera (Medroxyprogesterone) 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 (219)
Death (4)
Life Threatening Events (4)
Disability (20)

Reports by Reaction Type

Breast Cancer Female (84)Depression (31)Breast Cancer (31)Breast Cancer Metastatic (23)Anxiety (21)Drug Ineffective (14)Pain in Extremity (12)Breast Mass (9)Insomnia (9)Abdominal Pain (8)Thrombosis (8)Hypertension (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Provera (Medroxyprogesterone). For a complete list or a specific selection of reports, please use the links above.

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 29 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 29 year old female, weighing 58.5 kg (128.7 pounds)

Reactions: Mood Swings, Emotional Disorder

Drug(s) suspected as cause:
Provera



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 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 65 year old female, weighing 79.4 kg (174.6 pounds)

Reactions: Menstrual Disorder, Drug Ineffective, Abnormal Withdrawal Bleeding

Drug(s) suspected as cause:
Medroxyprogesterone Acetate
    Dosage: unk
    Indication: Hormone Therapy

Provera
    Dosage: 10 mg a day for 12 days in a month
    Indication: Hormone Therapy

Other drugs received by patient: Coumadin; Calcium Lactate; Prilosec



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 consumer/non-health professional from United States on 2012-07-11

Patient: female

Reactions: Metrorrhagia

Drug(s) suspected as cause:
Provera



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 2012-07-10

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 2012-07-05

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 2012-07-05

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

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