Editing Mifepristone (section)

==Side effects==
Serious complications with mifepristone are rare with about 0.04%–0.09% requiring hospitalization and 0.05% requiring blood transfusion.<ref>{{cite journal | vauthors = Cleland K, Creinin MD, Nucatola D, Nshom M, Trussell J | title = Significant adverse events and outcomes after medical abortion | journal = Obstetrics and Gynecology | volume = 121 | issue = 1 | pages = 166–71 | date = January 2013 | pmid = 23262942 | pmc = 3711556 | doi = 10.1097/AOG.0b013e3182755763 }}</ref>

Nearly all women using the mifepristone/misoprostol regimen experienced abdominal pain, uterine cramping, and vaginal bleeding or spotting for an average of 9–16 days. For most women, the most severe cramps after use of misoprostol last for less than 6 hours and can generally be managed with ibuprofen.<ref>{{cite journal | vauthors = Friedlander EB, Soon R, Salcedo J, Davis J, Tschann M, Kaneshiro B | title = Prophylactic Pregabalin to Decrease Pain During Medication Abortion: A Randomized Controlled Trial | journal = Obstetrics and Gynecology | volume = 132 | issue = 3 | pages = 612–618 | date = September 2018 | pmid = 30095762 | pmc = 6105469 | doi = 10.1097/AOG.0000000000002787 }}</ref> Up to 8% of women experienced some type of bleeding for 30 days or more. Other less common side effects included [[nausea]], [[vomiting]], diarrhea, dizziness, fatigue, and [[fever]].<ref name="miflabel">{{cite web | title=Mifeprex label | publisher=FDA | url=https://www.fda.gov/cder/foi/label/2005/020687s013lbl.pdf | date=19 July 2005 | access-date=22 August 2006 |archive-url = https://web.archive.org/web/20060628212659/https://www.fda.gov/cder/foi/label/2005/020687s013lbl.pdf <!-- Bot retrieved archive --> |archive-date = 28 June 2006}}</ref> [[Pelvic inflammatory disease]] is a very rare but serious complication.<ref name="pmid16531180">{{cite journal | vauthors = Lawton BA, Rose SB, Shepherd J | title = Atypical presentation of serious pelvic inflammatory disease following mifepristone-induced medical abortion | journal = Contraception | volume = 73 | issue = 4 | pages = 431–2 | date = April 2006 | pmid = 16531180 | doi = 10.1016/j.contraception.2005.09.003 }}</ref> Excessive bleeding and incomplete termination of a pregnancy require further intervention by a doctor (such as a repeat dose of misoprostol or a [[Suction-aspiration abortion|vacuum aspiration]]). Mifepristone is [[Contraindication|contraindicated]] in the presence of [[Adrenal gland|adrenal]] failure, long-term oral [[corticosteroid]] therapy (although inhaled and topical steroids are not contraindications), [[Bleeding|hemorrhagic]] disorders, inherited [[porphyria]], and hemophilia or [[anticoagulant]] use.<ref name="miflabel" /> Women with an [[intrauterine device]] in their uterus should remove the IUD prior to medication abortion to avoid unnecessary cramping. Mifepristone is not effective in treating [[ectopic pregnancy]].

A postmarketing summary found, of about 1.52 million women who had received mifepristone until April 2011 in the United States, 14 were reported to have died after application. Eight of these cases were associated with [[sepsis]]; the other six had various causes such as drug abuse and suspected murder. Other incidents reported to the FDA included 612 nonlethal hospitalizations, 339 blood transfusions, 48 severe infections, and 2,207 (0.15%) adverse events altogether.<ref>{{cite web |url=http://downloads.frc.org/EF/EF11G29.pdf |title=Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011 |access-date=14 November 2011 |url-status=live |archive-url=https://web.archive.org/web/20120118020524/http://downloads.frc.org/EF/EF11G29.pdf |archive-date=18 January 2012 }}</ref>

No long-term studies to evaluate the [[carcinogenic]] potential of mifepristone have been performed. This is in accord with ICH guidelines, which do not require carcinogenicity testing in nongenotoxic drugs intended for administration for less than six months.<ref>{{cite conference | title = Guideline IH. Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals S1A. | conference = International Conference on Harmonization | date = 1996 |url=http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S1A/Step4/S1A_Guideline.pdf | url-status=live |archive-url= https://web.archive.org/web/20131228140714/http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S1A/Step4/S1A_Guideline.pdf|archive-date=28 December 2013}}</ref>

===Pregnancy===
Mifepristone alone results in abortion within 1–2 weeks in 54% to 92% of pregnancies.<ref name="Gross2015">{{cite journal |vauthors=[[Daniel Grossman (physician)|Grossman D]], White K, Harris L, Reeves M, [[Paul D. Blumenthal|Blumenthal PD]], Winikoff B, [[David Grimes (physician)|Grimes DA]] |date=September 2015 |title=Continuing pregnancy after mifepristone and "reversal" of first-trimester medical abortion: a systematic review |url=https://www.contraceptionjournal.org/article/S0010-7824(15)00226-7/fulltext |journal=[[Contraception (journal)|Contraception]] |type=Review article |volume=92 |issue=3 |pages=206–11 |doi=10.1016/j.contraception.2015.06.001 |pmid=26057457 |url-access=subscription |access-date=26 April 2023 |archive-date=8 April 2023 |archive-url=https://web.archive.org/web/20230408185711/https://www.contraceptionjournal.org/article/S0010-7824(15)00226-7/fulltext |url-status=live }}</ref><ref>{{Cite book|url=https://books.google.com/books?id=iK7xrRr2p9sC|title=Management of Unintended and Abnormal Pregnancy: Comprehensive Abortion Care| veditors = Paul M, Lichtenberg S, Borgatta L, Grimes DA, Stubblefield PG, Creinin MD |date=24 August 2011|publisher=John Wiley & Sons|isbn=978-1-4443-5847-6|url-status=live|archive-url=https://web.archive.org/web/20170908135429/https://books.google.com/books?id=iK7xrRr2p9sC|archive-date=8 September 2017}}</ref> The effectiveness increases to greater than 90% if [[misoprostol]] is given after the mifepristone.<ref>{{cite book | vauthors = | title = CADTH Canadian Drug Expert Committee Final Recommendation Mifepristone and Misoprostol | date = 18 April 2017 | pmid = 30512906 | url = https://www.ncbi.nlm.nih.gov/books/NBK534607/ | publisher = Canadian Agency for Drugs and Technologies in Health | series = CADTH Common Drug Reviews | access-date = 19 April 2019 | archive-date = 28 August 2021 | archive-url = https://web.archive.org/web/20210828172922/https://www.ncbi.nlm.nih.gov/books/NBK534607/ | url-status = live }}</ref> There is no evidence that the effects of mifepristone can be reversed,<ref name=Gross2015/><ref>{{cite journal | vauthors = Bhatti KZ, Nguyen AT, Stuart GS | title = Medical abortion reversal: science and politics meet | journal = American Journal of Obstetrics and Gynecology | volume = 218 | issue = 3 | pages = 315.e1–315.e6 | date = March 2018 | pmid = 29141197 | doi = 10.1016/j.ajog.2017.11.555 | s2cid = 205373684 }}</ref> although some [[anti-abortion]] groups claim that it can be reversed by giving progesterone.<ref>{{cite news|title=As controversial 'abortion reversal' laws increase, researcher says new data shows protocol can work |work=[[The Washington Post]] |url-access=subscription |url=https://www.washingtonpost.com/news/to-your-health/wp/2018/04/03/as-controversial-abortion-reversal-laws-multiply-researcher-says-new-data-shows-it-can-work-critics-are-still-skeptical/|access-date=23 April 2018|archive-date=4 May 2018|archive-url=https://web.archive.org/web/20180504011657/https://www.washingtonpost.com/news/to-your-health/wp/2018/04/03/as-controversial-abortion-reversal-laws-multiply-researcher-says-new-data-shows-it-can-work-critics-are-still-skeptical/|url-status=live}}</ref><ref>{{cite news|title=California Board of Nursing Sanctions Unproven Abortion 'Reversal' (Updated) - Rewire|url=https://rewire.news/article/2017/08/17/california-board-nursing-sanctions-unproven-abortion-reversal/|access-date=23 November 2017|work=Rewire|archive-date=1 December 2017|archive-url=https://web.archive.org/web/20171201034343/https://rewire.news/article/2017/08/17/california-board-nursing-sanctions-unproven-abortion-reversal/|url-status=live}}</ref> Researchers in the United States initiated a trial of the so-called "reversal" regimen in 2019, but stopped prematurely due to serious safety concerns about using mifepristone without follow-up misoprostol.<ref>{{cite news |title=Controversial 'Abortion Reversal' Regimen Is Put To The Test |url=https://www.npr.org/sections/health-shots/2019/03/22/688783130/controversial-abortion-reversal-regimen-is-put-to-the-test |newspaper=NPR |date=22 March 2019 |access-date=19 April 2019 |vauthors=Gordon M |archive-date=18 April 2019 |archive-url=https://web.archive.org/web/20190418231735/https://www.npr.org/sections/health-shots/2019/03/22/688783130/controversial-abortion-reversal-regimen-is-put-to-the-test |url-status=live }}</ref><ref name="Gordon_2019">{{Cite news|vauthors=Gordon M|date=5 December 2019|url=https://www.npr.org/sections/health-shots/2019/12/05/785262221/safety-problems-lead-to-early-end-for-study-of-abortion-pill-reversal|title=Safety Problems Lead To Early End For Study Of 'Abortion Pill Reversal'|newspaper=NPR|access-date=12 December 2019|archive-date=6 December 2019|archive-url=https://web.archive.org/web/20191206191742/https://www.npr.org/sections/health-shots/2019/12/05/785262221/safety-problems-lead-to-early-end-for-study-of-abortion-pill-reversal|url-status=live}}</ref> Giving progesterone has not been shown to halt medication abortion, and not completing the combination regimen of mifepristone and misoprostol may cause serious bleeding.<ref name="Gordon_2019" />

In those who continue pregnancy after use of mifepristone together with misoprostol for termination, birth defects may occur.<ref name=Preg2018/> Exposure to a single large dose of mifepristone in newborn rats was not associated with any reproductive problems, although chronic low-dose exposure of newborn rats to mifepristone was associated with structural and functional reproductive abnormalities.<ref name="miflabel"/> Studies in mice, rats, and rabbits revealed developmental abnormalities for rabbits, but not rats or mice.<ref name="miflabel"/>