Norelgestromin/ethinylestradiol explained

Type:combo
Component1:Norelgestromin
Class1:Progestogen
Component2:Ethinylestradiol
Class2:Estrogen
Tradename:Ortho Evra, Xulane, Evra, others
Dailymedid:Norelgestromin and ethinyl estradiol
Pregnancy Category:Contraindicated
Routes Of Administration:Transdermal (patch)
Atc Prefix:G03
Atc Suffix:AA13
Legal Ca:Rx-only
Legal Ca Comment:[1]
Legal Uk:POM
Legal Uk Comment:[2]
Legal Us:Rx-only
Legal Us Comment:[3] [4] [5]
Legal Status:Rx-only
Pubchem:91758695
Chemspiderid:None
Kegg:D10839
Iupac Name:(3Z,8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-3-hydroxyimino-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol;(8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-3,17-diol
C:41
H:53
N:1
O:4
Smiles:CCC12CCC3C(C1CCC2(C#C)O)CCC4=CC(=NO)CCC34.CC12CCC3C(C1CCC2(C#C)O)CCC4=C3C=CC(=C4)O
Stdinchi:1S/C21H29NO2.C20H24O2/c1-3-20-11-9-17-16-8-6-15(22-24)13-14(16)5-7-18(17)19(20)10-12-21(20,23)4-2;1-3-20(22)11-9-18-17-6-4-13-12-14(21)5-7-15(13)16(17)8-10-19(18,20)2/h2,13,16-19,23-24H,3,5-12H2,1H3;1,5,7,12,16-18,21-22H,4,6,8-11H2,2H3/b22-15-;/t16-,17+,18+,19-,20-,21-;16-,17-,18+,19+,20+/m01/s1
Stdinchikey:KBFRRZPPJPKFHQ-WKXKRCMPSA-N

Norelgestromin/ethinylestradiol, sold under the brand name Ortho Evra among others, is a contraceptive patch containing the progestin norelgestromin and the estrogen ethinylestradiol.[6] [7]

The most common side effects include headache, nausea (feeling sick), breast tenderness, and irregular uterine bleeding.

Norelgestromin/ethinylestradiol is a transdermal patch (a patch that delivers a medicine across the skin). For the first three weeks of the menstrual cycle a new patch should be applied every week, followed by a fourth week, which is patch-free. The patch-free interval must not be longer than seven days; otherwise, additional non-hormonal contraceptive methods must be used, such as condoms. Transdermal patches must always be applied on the same day of the week to the buttock, abdomen (belly), upper arm or upper back. The same area of skin should not be used for two consecutive patches. Norelgestromin/ethinylestradiol may work less well in women weighing 198lb or more.

Norelgestromin/ethinylestradiol was approved for medical use in the United States in November 2001, and in the European Union in August 2002.[8] It is available as a generic medication.[9] In 2023, the combination was the 285th most commonly prescribed medication in the United States, with more than 600,000 prescriptions.[10] [11]

Medical uses

In the United States, norelgestromin/ethinylestradiol is indicated for the prevention of pregnancy in women with a BMI < 30 kg/m2 for whom a transdermal delivery system is an appropriate method of contraception.

In the European Union, norelgestromin/ethinylestradiol is indicated for use as female contraception.

See also

Notes and References

  1. Web site: Evra Product information . Health Canada . 21 June 2018 . 17 February 2020.
  2. Web site: Evra transdermal patch - Summary of Product Characteristics (SmPC) . (emc) . 26 June 2020 . 4 July 2020 . 24 October 2020 . https://web.archive.org/web/20201024122318/https://www.medicines.org.uk/emc/product/6794/smpc . dead .
  3. Web site: Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) Initial U.S. Approval: 2001 . DailyMed . 12 July 2018 . 4 July 2020.
  4. Web site: Xulane- norelgestromin and ethinyl estradiol patch . DailyMed . 7 April 2020 . 4 July 2020.
  5. Web site: Ortho Evra: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . https://web.archive.org/web/20170430101738/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021180 . dead . 30 April 2017 . 4 July 2020.
  6. Web site: Evra EPAR . European Medicines Agency (EMA) . 5 August 2008 . 4 July 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. Graziottin A . A review of transdermal hormonal contraception : focus on the ethinylestradiol/norelgestromin contraceptive patch . Treatments in Endocrinology . 5 . 6 . 359–65 . 2006 . 17107221 . 10.2165/00024677-200605060-00004 . 21033630 .
  8. Web site: Drug Approval Package: Ortho EVRA (Norelgestromin/Ethinyl Estradiol Transdermal System NDA #21-180 . U.S. Food and Drug Administration (FDA) . https://web.archive.org/web/20170119030738/http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021-180_ORTHO.cfm . dead . 19 January 2017 . 4 July 2020.
  9. Web site: Xulane (Norelgestromin and Ethinyl Estradiol Transdermal System), 150 mcg/35 mcg per day . 16 April 2014 . Abbreviated New Drug Application . U.S. Food and Drug Administration .
  10. Web site: The Top 300 of 2023 . ClinCalc . 17 August 2025 . 17 August 2025 . https://web.archive.org/web/20250817043812/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  11. Web site: Ethinyl Estradiol; Norelgestromin Drug Usage Statistics, United States, 2014 - 2023 . ClinCalc . 17 August 2025 .