Drug Safety Information for FEMRING (Estradiol acetate)

FDA Safety-related Labeling Changes for FEMRING (ESTRADIOL ACETATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for FEMRING* (Estradiol 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 FEMRING
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	22
2	Headache	14
3	Breast cancer	13
4	Hot flush	12
5	Vulvovaginal mycotic infection	9
6	Nausea	8
7	Back pain	6
8	Ovarian cyst	6
9	Breast tenderness	6
10	Deep vein thrombosis	6
11	Pain	6
12	Medical device complication	6
13	Chest pain	6
14	Muscle spasms	5
15	Fatigue	5
16	Vulvovaginal discomfort	5
17	Abdominal pain upper	5
18	Fungal infection	5
19	Condition aggravated	5
20	Night sweats	5

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

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

	Reason	# of FDA Reports
1	Hormone replacement therapy*	159
2	Menopausal symptoms	84
3	Vulvovaginal dryness	60
4	Hot flush	23
5	Premature menopause	20
6	Product used for unknown indication	19
7	Oestrogen replacement therapy	19
8	Menopause	19
9	Chronic obstructive pulmonary disease	11
10	Bladder disorder	8

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

Types of Adverse Events for FEMRING

Total Reports Filed with FDA: 633

Number of FDA Adverse Event Reports by Patient Age for FEMRING

Total Reports Filed with FDA: 633*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Estradiol acetate (Femtrace, Femring)

Charts are based on 633 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.