Drug Safety Information for FEMRING (Estradiol acetate)

Safety-related Labeling Changes for FEMRING (ESTRADIOL ACETATE) Rx Drug: FDA 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
1Drug ineffective22
2Headache14
3Breast cancer13
4Hot flush12
5Vulvovaginal mycotic infection9
6Nausea8
7Back pain6
8Ovarian cyst6
9Breast tenderness6
10Deep vein thrombosis6
11Pain6
12Medical device complication6
13Chest pain6
14Muscle spasms5
15Fatigue5
16Vulvovaginal discomfort5
17Abdominal pain upper5
18Fungal infection5
19Condition aggravated5
20Night sweats5

* 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
1Hormone replacement therapy*159
2Menopausal symptoms84
3Vulvovaginal dryness60
4Hot flush23
5Premature menopause20
6Product used for unknown indication19
7Oestrogen replacement therapy19
8Menopause19
9Chronic obstructive pulmonary disease11
10Bladder disorder8

*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.

Click to go back to search results and FEMRING 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 FEMRING's side effects.