Editing Sertraline (section)

==Side effects==
Nausea, ejaculation failure, insomnia, diarrhea, dry mouth, somnolence, dizziness, tremor, headache, excessive sweating, fatigue, [[restless legs syndrome]] and decreased [[libido]] are the common adverse effects associated with sertraline with the greatest difference from [[placebo]]. Those that most often result in interruption of the treatment are nausea, diarrhea, and insomnia.<ref name="DailyMed"/> The incidence of diarrhea is higher with sertraline – especially when prescribed at higher doses – in comparison with other [[SSRIs]].<ref name=ICP2014>{{cite journal | vauthors = Sanchez C, Reines EH, Montgomery SA | title = A comparative review of escitalopram, paroxetine, and sertraline: Are they all alike? | journal = International Clinical Psychopharmacology | volume = 29 | issue = 4 | pages = 185–96 | date = July 2014 | pmid = 24424469 | pmc = 4047306 | doi = 10.1097/YIC.0000000000000023 }}</ref>

Over more than six months of sertraline therapy for depression, people showed no significant weight increase.<ref name="pmid11105740">{{cite journal | vauthors = Fava M, Judge R, Hoog SL, Nilsson ME, Koke SC | title = Fluoxetine versus sertraline and paroxetine in major depressive disorder: changes in weight with long-term treatment | journal = The Journal of Clinical Psychiatry | volume = 61 | issue = 11 | pages = 863–7 | date = November 2000 | pmid = 11105740 | doi = 10.4088/JCP.v61n1109 }}</ref> A 30-month-long treatment with sertraline for OCD also resulted in no significant weight gain.<ref name="pmid15491240">{{cite journal | vauthors = Maina G, Albert U, Salvi V, Bogetto F | title = Weight gain during long-term treatment of obsessive-compulsive disorder: a prospective comparison between serotonin reuptake inhibitors | journal = The Journal of Clinical Psychiatry | volume = 65 | issue = 10 | pages = 1365–71 | date = October 2004 | pmid = 15491240 | doi = 10.4088/JCP.v65n1011 }}</ref> Although the difference did not reach [[statistical significance]], the average weight gain was lower for [[fluoxetine]] (1%) but higher for [[citalopram]], [[fluvoxamine]] and [[paroxetine]] (2.5%). Of the sertraline group, 4.5% gained a large amount of weight (defined as more than 7% gain). This result compares favorably with placebo, where, according to the literature, 3–6% of patients gained more than 7% of their initial weight. The large weight gain was observed only among female members of the sertraline group; the significance of this finding is unclear because of the small size of the group.<ref name="pmid15491240" />

Over a two-week treatment of healthy volunteers, sertraline slightly improved verbal [[fluency]] but did not affect word learning, [[short-term memory]], [[alertness|vigilance]], [[flicker fusion threshold|flicker fusion time]], choice [[reaction time]], [[memory span]], or [[motor coordination|psychomotor coordination]].<ref name="pmid11565624">{{cite journal | vauthors = Schmitt JA, Kruizinga MJ, Riedel WJ | s2cid = 26017110 | title = Non-serotonergic pharmacological profiles and associated cognitive effects of serotonin reuptake inhibitors | journal = Journal of Psychopharmacology | volume = 15 | issue = 3 | pages = 173–9 | date = September 2001 | pmid = 11565624 | doi = 10.1177/026988110101500304 }}</ref><ref name="pmid12692706">{{cite journal | vauthors = Siepmann M, Grossmann J, Mück-Weymann M, Kirch W | s2cid = 19178740 | title = Effects of sertraline on autonomic and cognitive functions in healthy volunteers | journal = Psychopharmacology | volume = 168 | issue = 3 | pages = 293–8 | date = July 2003 | pmid = 12692706 | doi = 10.1007/s00213-003-1448-4 }}</ref> In spite of lower subjective rating, that is, feeling that they performed worse, no clinically relevant differences were observed in the objective cognitive performance in a group of people treated for depression with sertraline for 1.5&nbsp;years as compared to healthy controls.<ref name="pmid16485140">{{cite journal | vauthors = Gorenstein C, de Carvalho SC, Artes R, Moreno RA, Marcourakis T | s2cid = 594353 | title = Cognitive performance in depressed patients after chronic use of antidepressants | journal = Psychopharmacology | volume = 185 | issue = 1 | pages = 84–92 | date = March 2006 | pmid = 16485140 | doi = 10.1007/s00213-005-0274-2 }}</ref> In children and adolescents taking sertraline for six weeks for anxiety disorders, 18 out of 20&nbsp;measures of memory, attention, and alertness stayed unchanged. [[Attention#Clinical model|Divided attention]] was improved and verbal memory under [[Interference theory#Proactive interference|interference conditions]] decreased marginally. Because of the large number of measures taken, it is possible that these changes were still due to chance.<ref name="pmid16190792">{{cite journal | vauthors = Günther T, Holtkamp K, Jolles J, Herpertz-Dahlmann B, Konrad K | title = The influence of sertraline on attention and verbal memory in children and adolescents with anxiety disorders | journal = Journal of Child and Adolescent Psychopharmacology | volume = 15 | issue = 4 | pages = 608–18 | date = August 2005 | pmid = 16190792 | doi = 10.1089/cap.2005.15.608 | citeseerx = 10.1.1.536.6334 }}</ref> The unique effect of sertraline on [[dopaminergic]] [[neurotransmission]] may be related to these effects on cognition and vigilance.<ref>{{cite journal | vauthors = Borkowska A, Pilaczyńska E, Araszkiewicz A, Rybakowski J | title = [The effect of sertraline on cognitive functions in patients with obsessive-compulsive disorder] | journal = Psychiatria Polska | volume = 36 | issue = 6 Suppl | pages = 289–95 | year = 2002 | pmid = 12647451 }}</ref><ref>{{cite journal | vauthors = Schmitt JA, Ramaekers JG, Kruizinga MJ, van Boxtel MP, Vuurman EF, Riedel WJ | s2cid = 25351919 | title = Additional dopamine reuptake inhibition attenuates vigilance impairment induced by serotonin reuptake inhibition in man | journal = Journal of Psychopharmacology | volume = 16 | issue = 3 | pages = 207–14 | date = September 2002 | pmid = 12236626 | doi = 10.1177/026988110201600303 | url = https://cris.maastrichtuniversity.nl/en/publications/3ff8af50-7c4a-4dc0-84a1-35e697e6ef8e }}</ref>

Sertraline has a low level of exposure of an infant through the breast milk and is recommended as the preferred option for the antidepressant therapy of breast-feeding mothers.<ref>{{cite journal | vauthors = Lattimore KA, Donn SM, Kaciroti N, Kemper AR, Neal CR, Vazquez DM | title = Selective serotonin reuptake inhibitor (SSRI) use during pregnancy and effects on the fetus and newborn: a meta-analysis | journal = Journal of Perinatology | volume = 25 | issue = 9 | pages = 595–604 | date = September 2005 | pmid = 16015372 | doi = 10.1038/sj.jp.7211352 | doi-access = free }}</ref><ref name="pmid28440103">{{cite journal |vauthors=McAllister-Williams RH, Baldwin DS, Cantwell R, Easter A, Gilvarry E, Glover V, Green L, Gregoire A, Howard LM, Jones I, Khalifeh H, Lingford-Hughes A, McDonald E, Micali N, Pariante CM, Peters L, Roberts A, Smith NC, Taylor D, Wieck A, Yates LM, Young AH |title=British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017 |journal=J Psychopharmacol |volume=31 |issue=5 |pages=519–552 |date=May 2017 |pmid=28440103 |doi=10.1177/0269881117699361 |s2cid=3335470 |url=http://orca.cf.ac.uk/102601/1/British%20Association%20for%20Psychopharmacology%20consensus%20guidance%20on%20the%20use%20of%20psychotropic%20medication%20preconception.pdf }}</ref>  There is 29–42% increase in [[congenital heart defect]]s among children whose mothers were prescribed sertraline during pregnancy,<ref name="pmid30415641"/><ref name="pmid33354752">{{cite journal |vauthors=De Vries C, Gadzhanova S, Sykes MJ, Ward M, Roughead E |title=A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart Defects of Antidepressant Classes and Individual Antidepressants |journal=Drug Saf |volume=44 |issue=3 |pages=291–312 |date=March 2021 |pmid=33354752 |doi=10.1007/s40264-020-01027-x |issn=0114-5916 |s2cid=229357583 |url=https://unisa.alma.exlibrisgroup.com/view/delivery/61USOUTHAUS_INST/12212569530001831}}</ref> with sertraline use in the first trimester associated with 2.7-fold increase in [[Heart septal defect|septal heart defect]]s.<ref name="pmid30415641">{{cite journal |vauthors=Gao SY, Wu QJ, Sun C, Zhang TN, Shen ZQ, Liu CX, Gong TT, Xu X, Ji C, Huang DH, Chang Q, Zhao YH |title=Selective serotonin reuptake inhibitor use during early pregnancy and congenital malformations: a systematic review and meta-analysis of cohort studies of more than 9 million births |journal=BMC Med |volume=16 |issue=1 |pages=205 |date=November 2018 |pmid=30415641 |pmc=6231277 |doi=10.1186/s12916-018-1193-5 |url= |doi-access=free }}</ref>

Abrupt interruption of sertraline treatment may result in [[antidepressant discontinuation syndrome|withdrawal or discontinuation syndrome]]. Dizziness, insomnia, anxiety, agitation, and irritability are common symptoms.<ref name="pmid23596418">{{cite journal |vauthors=Renoir T |title=Selective serotonin reuptake inhibitor antidepressant treatment discontinuation syndrome: a review of the clinical evidence and the possible mechanisms involved |journal=Front Pharmacol |volume=4 |pages=45 |date=2013 |pmid=23596418 |pmc=3627130 |doi=10.3389/fphar.2013.00045 |doi-access=free }}</ref> It typically occurs within a few days from drug discontinuation and lasts a few weeks.<ref name="pmid25721705"/>  The withdrawal symptoms for sertraline are less severe and frequent than for paroxetine, and more frequent than for [[fluoxetine]].<ref name="pmid23596418"/><ref name="pmid25721705">{{cite journal |vauthors=Fava GA, Gatti A, Belaise C, Guidi J, Offidani E |title=Withdrawal Symptoms after Selective Serotonin Reuptake Inhibitor Discontinuation: A Systematic Review |journal=Psychother Psychosom |volume=84 |issue=2 |pages=72–81 |date=2015 |pmid=25721705 |doi=10.1159/000370338 |doi-access=free }}</ref> In most cases symptoms are mild, short-lived, and resolve without treatment. More severe cases are often successfully treated by temporary reintroduction of the drug with a slower tapering-off rate.<ref name ="WarnerAFP">{{cite journal | vauthors = Warner CH, Bobo W, Warner C, Reid S, Rachal J | title = Antidepressant discontinuation syndrome | journal = American Family Physician | volume = 74 | issue = 3 | pages = 449–56 | date = August 2006 | pmid = 16913164 }}</ref>

Sertraline and SSRI antidepressants in general may be associated with [[bruxism]] and other [[movement disorders]].<ref name="pmid32546134">{{cite journal |vauthors=Revet A, Montastruc F, Roussin A, Raynaud JP, Lapeyre-Mestre M, Nguyen TT |title=Antidepressants and movement disorders: a postmarketing study in the world pharmacovigilance database |journal=BMC Psychiatry |volume=20 |issue=1 |pages=308 |date=June 2020 |pmid=32546134 |pmc=7298955 |doi=10.1186/s12888-020-02711-z |doi-access=free }}</ref><ref>{{cite journal | vauthors = Garrett AR, Hawley JS | title = SSRI-associated bruxism: A systematic review of published case reports | journal = Neurology. Clinical Practice | volume = 8 | issue = 2 | pages = 135–141 | date = April 2018 | pmid = 29708207 | pmc = 5914744 | doi = 10.1212/CPJ.0000000000000433 }}</ref> Sertraline appears to be associated with [[microscopic colitis]], a rare condition of unknown [[etiology]].<ref name="pmid30881078">{{cite journal |vauthors=Shor J, Churrango G, Hosseini N, Marshall C |title=Management of microscopic colitis: challenges and solutions |journal=Clin Exp Gastroenterol |volume=12 |pages=111–120 |date=2019 |pmid=30881078 |pmc=6398419 |doi=10.2147/CEG.S165047 |doi-access=free }}</ref>

===Sexual===
Like other SSRIs, sertraline is associated with sexual side effects, including [[sexual arousal disorder]], [[erectile dysfunction]] and difficulty achieving [[orgasm]]. While [[nefazodone]] and [[bupropion]] do not have negative effects on sexual functioning, 67% of men on sertraline experienced ejaculation difficulties versus 18% before the treatment.<ref name="pmid11229450">{{cite journal | vauthors = Ferguson JM | title = The effects of antidepressants on sexual functioning in depressed patients: a review | journal = The Journal of Clinical Psychiatry | volume = 62 | issue = Suppl 3 | pages = 22–34 | year = 2001 | pmid = 11229450 | series = 62 }}</ref> [[Sexual arousal]] disorder, defined as "inadequate lubrication and swelling for women and erectile difficulties for men", occurred in 12% of people on sertraline as compared with 1% of patients on placebo. The mood improvement resulting from the treatment with sertraline sometimes counteracted these side effects, so that [[sexual desire]] and overall satisfaction with sex stayed the same as before the sertraline treatment. However, under the action of placebo the desire and satisfaction slightly improved.<ref name="pmid10363731">{{cite journal | vauthors = Croft H, Settle E, Houser T, Batey SR, Donahue RM, Ascher JA | title = A placebo-controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained-release bupropion and sertraline | journal = Clinical Therapeutics | volume = 21 | issue = 4 | pages = 643–58 | date = April 1999 | pmid = 10363731 | doi = 10.1016/S0149-2918(00)88317-4 }}</ref> Some people continue experiencing sexual side effects after they stop taking SSRIs.<ref>{{cite journal | vauthors = Bala A, Nguyen HM, Hellstrom WJ | title = Post-SSRI Sexual Dysfunction: A Literature Review | journal = Sexual Medicine Reviews | volume = 6 | issue = 1 | pages = 29–34 | date = January 2018 | pmid = 28778697 | doi = 10.1016/j.sxmr.2017.07.002 }}</ref>

=== Suicide ===
The US [[Food and Drug Administration]] (FDA) requires all antidepressants, including sertraline, to carry a [[boxed warning]] stating that antidepressants increase the risk of suicide in persons younger than 25 years.<ref>{{cite journal | vauthors = Fornaro M, Anastasia A, Valchera A, Carano A, Orsolini L, Vellante F, Rapini G, Olivieri L, Di Natale S, Perna G, Martinotti G, Di Giannantonio M, De Berardis D | title = The FDA "Black Box" Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? | journal = Frontiers in Psychiatry | volume = 10 | issue = | pages = 294 | date = 2019 | pmid = 31130881 | pmc = 6510161 | doi = 10.3389/fpsyt.2019.00294 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Friedman RA | title = Antidepressants' black-box warning--10 years later | journal = The New England Journal of Medicine | volume = 371 | issue = 18 | pages = 1666–8 | date = October 2014 | pmid = 25354101 | doi = 10.1056/NEJMp1408480 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Stone MB | title = The FDA warning on antidepressants and suicidality--why the controversy? | journal = The New England Journal of Medicine | volume = 371 | issue = 18 | pages = 1668–71 | date = October 2014 | pmid = 25354102 | doi = 10.1056/NEJMp1411138 | doi-access = free }}</ref> This warning is based on statistical analyses conducted by two independent groups of FDA experts that found a 100% increase of suicidal thoughts and behavior in children and adolescents, and a 50% increase in the 18–24 age group.<ref name=FDA>{{cite web|vauthors=Levenson M, Holland C | title =Antidepressants and Suicidality in Adults: Statistical Evaluation. (Presentation at Psychopharmacologic Drugs Advisory Committee; December 13, 2006)|publisher = FDA|access-date = 11 July 2008|url = https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4272s1-04-FDA.ppt}}</ref><ref name="FDA2">{{cite Q|Q118139691}}</ref><ref name="FDA3">{{cite Q|Q118139771}}</ref>

[[Suicidal ideation]] and behavior in clinical trials are rare. For the above analysis, the FDA combined the results of 295&nbsp;trials of 11&nbsp;antidepressants for psychiatric indications to obtain [[statistically significant]] results. Considered separately, sertraline use in adults decreased the odds of suicidal behavior with a marginal statistical significance of 37%<ref name =FDA3 /> or 50%<ref name =FDA2 /> depending on the statistical technique used. The authors of the FDA analysis note that "given the large number of comparisons made in this review, chance is a very plausible explanation for this difference".<ref name =FDA2 /> The more complete data submitted later by the sertraline manufacturer Pfizer indicated increased suicidal behavior.<ref>{{cite web |url=https://www.fda.gov/ohrms/dockets/dockets/06n0414/06N-0414-EC32-Attach-1.pdf |title=Memorandum from Pfizer Global Pharmaceuticals Re: DOCKET: 2006N-0414&nbsp;–"Suicidality data from adult antidepressant trials" Background package for December 13 Advisory Committee|access-date=11 July 2008 |author=Pfizer Inc. |date= 30 November 2006|work=FDA DOCKET 2006N-0414 |publisher=FDA}}</ref> Similarly, the analysis conducted by the UK [[Medicines and Healthcare products Regulatory Agency|MHRA]] found a 50% increase of odds of suicide-related events, not reaching statistical significance, in the patients on sertraline as compared to the ones on placebo.<ref>{{cite web|url=http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con019472.pdf |title=Report of the CSM expert working group on the safety of selective serotonin reuptake inhibitor antidepressants|access-date=11 July 2008 |date=December 2004 |publisher=MHRA}}</ref><ref name="pmid15718537">{{cite journal | vauthors = Gunnell D, Saperia J, Ashby D | title = Selective serotonin reuptake inhibitors (SSRIs) and suicide in adults: meta-analysis of drug company data from placebo controlled, randomised controlled trials submitted to the MHRA's safety review | journal = BMJ | volume = 330 | issue = 7488 | pages = 385 | date = February 2005 | pmid = 15718537 | pmc = 549105 | doi = 10.1136/bmj.330.7488.385 }}</ref>