Drug Safety Information for PREFEST (Estradiol; norgestimate)

FDA Safety-related Labeling Changes for PREFEST (ESTRADIOL; NORGESTIMATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for PREFEST* (Estradiol; norgestimate)

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 PREFEST
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Breast cancer female	102
2	Breast cancer	72
3	Breast cancer metastatic	14
4	Pain	6
5	Breast cancer in situ	5
6	Fatigue	4
7	Nausea	4
8	Ovarian cancer	4
9	Anxiety	4
10	Myocardial infarction	4
11	Abdominal pain	4
12	Breast cancer stage ii	3
13	Emotional distress	3
14	Drug ineffective	3
15	Oestrogen receptor assay positive	3
16	Gallbladder disorder	3
17	Fibrocystic breast disease	3
18	Vomiting	3
19	Cardiac disorder	3
20	Gastrooesophageal reflux disease	3

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

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

	Reason	# of FDA Reports
1	Hormone replacement therapy	164
2	Menopausal symptoms	48
3	Menopause	45
4	Oestrogen replacement therapy	17
5	Amenorrhoea	8
6	Hot flush	5
7	Contraception*	4
8	Product used for unknown indication	2

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

Types of Adverse Events for PREFEST

Total Reports Filed with FDA: 500

Number of FDA Adverse Event Reports by Patient Age for PREFEST

Total Reports Filed with FDA: 500*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Estradiol; norgestimate (Prefest)

Charts are based on 500 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.

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.