Editing Contraceptive patch (section)

==Side effects==
In three large clinical trials involving a total of 3,330 women using the Ortho Evra / Evra patch for up to one year, 12% of users discontinued the patch because of adverse events. The most frequent adverse events leading to patch discontinuation were: nausea and/or vomiting (2.4%), application site reaction (1.9%), breast discomfort, engorgement or pain (1.9%), headache (1.1%), and emotional lability (1.0%).<ref name="sibai 2002">{{cite journal | vauthors = Sibai BM, Odlind V, Meador ML, Shangold GA, Fisher AC, Creasy GW | title = A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra) | journal = Fertility and Sterility | volume = 77 | issue = 2 Suppl 2 | pages = S19–S26 | date = February 2002 | pmid = 11849632 | doi = 10.1016/S0015-0282(01)03264-2 | doi-access = free }}</ref>

The most frequent adverse events reported while using the Ortho Evra / Evra patch were: breast discomfort, engorgement or pain (22%), headache (21%), application site reaction (17%), nausea (17%), upper respiratory tract infection (10%), menstrual cramps (10%), and abdominal pain (9%).<ref name="sibai 2002"/>

[[Breakthrough bleeding]] and/or spotting while using the Ortho Evra / Evra patch was reported by: 18% in cycle 1, 12% in cycle 3, 8% in cycle 6 and cycle 13. Breakthrough bleeding (requiring more than one pad or tampon per day) was reported by: 4% in cycle 1, 3% in cycle 3 and cycle 6, and 1% in cycle 13.<ref name="zieman 2002">{{cite journal | vauthors = Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW | title = Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data | journal = Fertility and Sterility | volume = 77 | issue = 2 Suppl 2 | pages = S13–S18 | date = February 2002 | pmid = 11849631 | doi = 10.1016/S0015-0282(01)03275-7 | doi-access = free }}</ref>

Overall, side effects that tend to go away after two or three months include bleeding between periods, breast tenderness, and nausea and vomiting.{{medical citation needed|date=July 2020}} Symptoms that may last longer include skin irritation around the area where the patch is placed and a change in the woman's sexual desires.{{medical citation needed|date=July 2020}}

Additional side effect information is provided in the Ortho Evra label information and the Evra [[Summary of Product Characteristics]] (SPC) and [[Patient information leaflet|PIL]].<ref name="Xulane label"/><ref name="Evra SmPC"/><ref name="Evra PIL">{{cite web |author=Janssen-Cilag |author-link=Janssen-Cilag |date=January 26, 2007 |title=Evra Patient Information Leaflet (PIL) |url=http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=12125 |access-date=2007-07-20 |archive-url=https://web.archive.org/web/20070928060133/http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=12125 |archive-date=September 28, 2007 |url-status=dead }}</ref>

===Interactions and contraindications===
Contraceptive effectiveness of the patch or any other hormonal contraceptive may be reduced significantly if administered alongside various [[antibiotics]], [[antifungals]], [[anticonvulsants]], or other drugs that increase metabolism of contraceptive steroids.{{medical citation needed|date=February 2020}}

However, despite the interactions with many other antibiotics, a clinical pharmacokinetic drug interaction study showed that oral administration of [[tetracycline]] HCl 500&nbsp;mg for three days prior to and seven days during use of Ortho Evra "did not reduce effectiveness of Ortho Evra."  This is a significant factor in the common decision to administer tetracycline-derived antibiotics following an [[abortion]] (preventatively to fight potential infection) when synthetic hormone contraceptives are to be used afterwards.{{medical citation needed|date=July 2007}}

Drugs containing [[St. John's Wort|St. John's wort]] are also known to affect the effectiveness of hormonal contraceptives.{{medical citation needed|date=February 2020}}

It has also been found that the patch is less effective in women who weigh more than 198 pounds (90&nbsp;kg).

The contraceptive patch and other combination hormonal contraceptives are contraindicated in women older than 35 years who smoke cigarettes.<ref name="Xulane label" />

The contraceptive patch is contraindicated for use in women with a BMI ≥ 30{{nbsp}}kg/m<sup>2</sup>.<ref name="Xulane label" />

===Thromboembolism===
All combined [[hormonal birth control]] products have a very small increased risk of serious or fatal [[thrombosis|thromboembolic]] events. There is ongoing research into the thromboembolic risks of Ortho Evra as compared to combined oral contraceptive pills. A recent study found that users of the contraceptive patch may have a twofold increased risk for non-fatal venous thromboembolic events compared with women who took a norgestimate-containing oral contraceptive with 35&nbsp;μg of estrogen.<ref name="Alert">Medpage Today. [http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/2697 Evidence on Ortho Evra Patch Thrombosis Risk Is Contradictory] {{Webarchive|url=https://web.archive.org/web/20060301110459/http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/2697 |date=2006-03-01 }}. Published February 17, 2006.</ref><ref name="Cole2007">{{cite journal | vauthors = Cole JA, Norman H, Doherty M, Walker AM | title = Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users | journal = Obstetrics and Gynecology | volume = 109 | issue = 2 Pt 1 | pages = 339–346 | date = February 2007 | pmid = 17267834 | doi = 10.1097/01.AOG.0000250968.82370.04 | s2cid = 1572286 }}</ref> However, a different study concluded that the risk of nonfatal venous thromboembolism for the contraceptive patch is similar to the risk for oral contraceptives containing 35&nbsp;μg of ethinylestradiol and [[norgestimate]].<ref name="Contraception">{{cite journal | vauthors = Jick S, Kaye JA, Li L, Jick H | title = Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol | journal = Contraception | volume = 76 | issue = 1 | pages = 4–7 | date = July 2007 | pmid = 17586129 | doi = 10.1016/j.contraception.2007.03.003 }}</ref> The contradiction in findings between the two studies is not easily resolved, because the [[confidence interval]]s for the studies are overlapping.

In studies with oral contraceptives, the risk for cardiovascular disease (such as thromboembolism) is significantly increased in women over the age of 35 years who also [[Tobacco smoking|smoke tobacco]].<ref name="smoking">{{cite journal | vauthors = Pitsavos C, Stefanadis C, Toutouzas P | title = Contraception in women at high risk or with established cardiovascular disease | journal = Annals of the New York Academy of Sciences | volume = 900 | issue = 1 | pages = 215–227 | year = 2000 | pmid = 10818409 | doi = 10.1111/j.1749-6632.2000.tb06233.x | s2cid = 45035196 | bibcode = 2000NYASA.900..215P }}</ref>  Hence, Ortho Evra's package insert states: "Women who use hormonal contraceptives, including Ortho Evra, should be strongly advised not to smoke."

According to the manufacturer, the patches introduce a 60% higher level of estrogen into the bloodstream as compared to oral contraceptives; however, the clinical significance of this difference is unknown.{{medical citation needed|date=February 2020}}

On November 10, 2005, Ortho McNeil, in conjunction with the [[U.S. Food and Drug Administration|FDA]], revised the label for Ortho Evra, including a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35&nbsp;μg of estrogen, noting that higher levels of estrogen may put some women at increased risk for getting blood clots. The label was again revised in September 2006, and on January 18, 2008, the FDA again updated the label to reflect study results: "The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options."<ref name="FDA2008">[https://web.archive.org/web/20080120221214/http://www.fda.gov/bbs/topics/NEWS/2008/NEW01781.html FDA Approves Update to Label on Birth Control Patch]. FDA. January 18, 2008 </ref>