Drug Safety Information for ESTROSTEP 21 (Ethinyl estradiol; norethindrone acetate)
FDA Safety-related Labeling Changes for LOESTRIN FE 1/20 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for LOESTRIN FE 1.5/30 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for LOESTRIN 21 1.5/30 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for LOESTRIN 21 1/20 (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ESTROSTEP 21 (ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for FEMHRT (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for LOESTRIN 24 FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for LO LOESTRIN FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for MINASTRIN 24 FE (ETHINYL ESTRADIOL; NORETHINDRONE ACETATE) Rx Drug: Safety Information Link
Adverse Drug Reactions for ESTROSTEP 21* (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 ESTROSTEP 21
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Breast cancer | 364 |
2 | Breast cancer female | 234 |
3 | Pain | 227 |
4 | Nausea* | 224 |
5 | Pulmonary embolism | 171 |
6 | Anxiety* | 165 |
7 | Headache* | 165 |
8 | Fatigue | 152 |
9 | Drug ineffective | 151 |
10 | Depression* | 141 |
11 | Vomiting | 123 |
12 | Abdominal pain | 122 |
13 | Dizziness | 115 |
14 | Injury | 115 |
15 | Deep vein thrombosis | 102 |
16 | Cholecystitis chronic | 101 |
17 | Diarrhoea | 94 |
18 | Metrorrhagia | 91 |
19 | Abdominal pain upper | 91 |
20 | Cholelithiasis | 90 |
* This side effect also appears in "Top 10 Side Effects of ESTROSTEP 21 " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking ESTROSTEP 21
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Contraception* | 2145 |
2 | Hormone replacement therapy | 973 |
3 | Product used for unknown indication | 556 |
4 | Menopausal symptoms* | 387 |
5 | Menopause* | 348 |
6 | Oral contraception | 248 |
7 | Menstruation irregular* | 186 |
8 | Ovarian cyst* | 154 |
9 | Menorrhagia* | 126 |
10 | Uterine leiomyoma | 120 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ESTROSTEP 21
Total Reports Filed with FDA: 12749
Number of FDA Adverse Event Reports by Patient Age for ESTROSTEP 21
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 ESTROSTEP 21 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.