Drug Safety Information for PROVERA (Medroxyprogesterone acetate)

Safety-related Labeling Changes for DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for DEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) Rx Drug: FDA Link

Adverse Drug Reactions for PROVERA* (Medroxyprogesterone acetate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with PROVERA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Breast cancer female10146
2Breast cancer9629
3Breast cancer metastatic1530
4Oestrogen receptor assay positive963
5Progesterone receptor assay positive834
8Drug ineffective703
9Weight increased*657
11Unintended pregnancy621
12Breast cancer in situ606
14Ovarian cancer582
19Pulmonary embolism457

* This side effect also appears in "Top 10 Side Effects of PROVERA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking PROVERA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hormone replacement therapy19378
3Product used for unknown indication2728
5Menopausal symptoms2482
7Menstrual discomfort658
8Ill-defined disorder532
10Hot flush368

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for PROVERA

Total Reports Filed with FDA: 83919

Loading Chart
Male Patients
Female Patients
Unknown Patients

Number of FDA Adverse Event Reports by Patient Age for PROVERA

Total Reports Filed with FDA: 83919*

Loading Chart

Note: * Reports include 22,393 reports of unknown age.

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Medroxyprogesterone acetate (Cycrin, Curretab, Gestapuran, Depo-subq provera, Farlutal, Clinovir, Amen, Provera, Depo-provera)

Charts are based on 83919 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and PROVERA Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on PROVERA's side effects.