Drug Safety Information for GILDESS FE 1/20 (Ethinyl estradiol; norethindrone acetate)

Safety-related Labeling Changes for LOESTRIN FE 1/20 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for LOESTRIN FE 1.5/30 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for LOESTRIN 21 1.5/30 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for LOESTRIN 21 1/20 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for FEMHRT (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for LOESTRIN 24 FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for LO LOESTRIN FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for MINASTRIN 24 FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: FDA Link

Adverse Drug Reactions for GILDESS FE 1/20* (Ethinyl estradiol; 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 GILDESS FE 1/20
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Breast cancer364
2Breast cancer female234
3Pain227
4Nausea*224
5Pulmonary embolism171
6Anxiety*165
7Headache*165
8Fatigue152
9Drug ineffective151
10Depression*141
11Vomiting123
12Abdominal pain122
13Dizziness115
14Injury115
15Deep vein thrombosis102
16Cholecystitis chronic101
17Diarrhoea94
18Metrorrhagia91
19Abdominal pain upper91
20Cholelithiasis90

* This side effect also appears in "Top 10 Side Effects of GILDESS FE 1/20 " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking GILDESS FE 1/20
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Contraception*2145
2Hormone replacement therapy973
3Product used for unknown indication556
4Menopausal symptoms*387
5Menopause*348
6Oral contraception248
7Menstruation irregular*186
8Ovarian cyst*154
9Menorrhagia*126
10Uterine leiomyoma120

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


Types of Adverse Events for GILDESS FE 1/20

Total Reports Filed with FDA: 12749


Number of FDA Adverse Event Reports by Patient Age for GILDESS FE 1/20

Total Reports Filed with FDA: 12749*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethinyl estradiol; norethindrone acetate (Jevantique, Norlestrin 21 1/50, Norlestrin 21 2.5/50, Norlestrin 28 1/50, Tri-legest 21, Gildess 1.5/30, Microgestin fe 1/20, Gildess 1/20, Jinteli, Loestrin fe 1.5/30, Larin 24 fe, Gildess 24 fe, Tri-legest fe, Gildess fe 1/20, Loestrin 24 fe, Microgestin, Loestrin 21 1.5/30, Larin 1/20, Larin fe 1.5/30, Junel fe 1.5/30, Estrostep fe, Microgestin 1.5/30, Larin 1.5/30, Estrostep 21, Loestrin fe 1/20, Junel 1/20, Junel fe 1/20, Loestrin 1/20, Gildess fe 1.5/30, Larin fe 1/20, Minastrin 24 fe, Femhrt, Junel 1.5/30, Microgestin 1/20, Lo loestrin fe, Loestrin 21 1/20, Lo minastrin fe, Loestrin 1.5/30)

Charts are based on 12749 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 GILDESS FE 1/20 Reviews and Review Summary .

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.