Drug Safety Information for OGEN .625 (Estropipate)

Adverse Drug Reactions for OGEN .625* (Estropipate)

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 OGEN .625
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Breast cancer female539
2Breast cancer500
3Breast cancer metastatic77
4Nausea75
5Oestrogen receptor assay positive72
6Pain69
7Progesterone receptor assay positive64
8Depression63
9Anxiety60
10Drug ineffective58
11Fatigue56
12Dizziness55
13Headache54
14Dyspnoea52
15Asthenia45
16Fall42
17Arthralgia42
18Breast cancer in situ40
19Weight increased*40
20Pain in extremity38

* This side effect also appears in "Top 10 Side Effects of OGEN .625 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking OGEN .625
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hormone replacement therapy*1240
2Menopause403
3Menopausal symptoms345
4Product used for unknown indication273
5Hot flush184
6Hormone therapy164
7Contraception109
8Hysterectomy83
9Postmenopause70
10Ill-defined disorder42

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


Types of Adverse Events for OGEN .625

Total Reports Filed with FDA: 7305


Number of FDA Adverse Event Reports by Patient Age for OGEN .625

Total Reports Filed with FDA: 7305*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Estropipate (Genoral, Ogen 5, Ogen .625, Ogen, Ogen 1.25, Harmonet, Ortho-est, Ogen 2.5, Harmogen, Estropipate)

Charts are based on 7305 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 OGEN .625 Reviews and Review Summary .

Historical 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.