Drug Safety Information for ESTRATAB (Estrogens, esterified)

Adverse Drug Reactions for ESTRATAB* (Estrogens, esterified)

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 ESTRATAB
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Breast cancer793
2Breast cancer female699
3Nausea135
4Anxiety133
5Depression133
6Pain127
7Breast cancer metastatic123
8Headache*118
9Dyspnoea100
10Fatigue100
11Drug ineffective98
12Cerebrovascular accident94
13Arthralgia85
14Dizziness83
15Oestrogen receptor assay positive74
16Insomnia72
17Hypertension72
18Vomiting70
19Asthenia68
20Chest pain68

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

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

Reason # of FDA Reports
1Hormone replacement therapy2549
2Menopause535
3Product used for unknown indication375
4Menopausal symptoms365
5Hysterectomy74
6Hormone therapy68
7Hot flush68
8Parkinson's disease65
9Premature menopause61
10Oestrogen replacement therapy46

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


Types of Adverse Events for ESTRATAB

Total Reports Filed with FDA: 12619


Number of FDA Adverse Event Reports by Patient Age for ESTRATAB

Total Reports Filed with FDA: 12619*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Estrogens, esterified (Estratest, Femogen, Amnestrogen, Estratest h.s., Essian, Syntest ds, Evex, Syntest hs, Estratab, Menest, Esterified estrogens)

Charts are based on 12619 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 ESTRATAB 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.