Drug Safety Information for AYGESTIN (Norethindrone acetate)

Adverse Drug Reactions for AYGESTIN* (Norethindrone 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 AYGESTIN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Breast cancer female	200
2	Breast cancer	162
3	Hot flush	81
4	Pain*	67
5	Nausea	67
6	Headache*	59
7	Anxiety	50
8	Abdominal pain	48
9	Metrorrhagia	43
10	Vaginal haemorrhage	43
11	Fatigue	41
12	Depression*	38
13	Menorrhagia	38
14	Endometriosis	36
15	Drug ineffective	35
16	Dizziness	33
17	Oestrogen receptor assay positive	31
18	Vomiting	31
19	Muscle spasms*	30
20	Mood swings*	28

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	1148
2	Hormone replacement therapy	438
3	Menopausal symptoms	208
4	Endometriosis*	136
5	Menorrhagia*	48
6	Prophylaxis	44
7	Menopause	39
8	Contraception	33
9	Hot flush	32
10	Hormone therapy	32

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

Types of Adverse Events for AYGESTIN

Total Reports Filed with FDA: 3844

Number of FDA Adverse Event Reports by Patient Age for AYGESTIN

Total Reports Filed with FDA: 3844*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Norethindrone acetate (Norlutate, Aygestin)

Charts are based on 3844 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.