Drug Safety Information for CENESTIN (Estrogens, conjugated synthetic a)

Safety-related Labeling Changes for CENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A) Rx Drug: FDA Link

Adverse Drug Reactions for CENESTIN* (Estrogens, conjugated synthetic a)

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 CENESTIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Breast cancer female189
2Breast cancer114
8Drug ineffective34
11Abdominal pain25
14Feeling abnormal21
15Pain in extremity21
20Oedema peripheral18

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

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

Reason # of FDA Reports
1Hormone replacement therapy465
2Menopausal symptoms*173
3Product used for unknown indication121
6Hot flush*37
7Hormone therapy23
9Blood oestrogen11
10Oestradiol decreased7

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

Types of Adverse Events for CENESTIN

Total Reports Filed with FDA: 3125

Number of FDA Adverse Event Reports by Patient Age for CENESTIN

Total Reports Filed with FDA: 3125*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Estrogens, conjugated synthetic a (Cenestin)

Charts are based on 3125 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 CENESTIN 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 CENESTIN's side effects.