Editing Modafinil (section)

==Adverse effects==
Modafinil is generally well-tolerated but can have potential risks and side effects. Common adverse effects of modafinil, experienced by less than 10% of users, include [[headache]]s, [[nausea]], and [[Anorexia (symptom)|reduced appetite]].<ref name="pmid18729534" /><ref name="Bello-2015">{{cite book |title=A worldwide yearly survey of new data in adverse drug reactions |vauthors=Bello NT |publisher=Elsevier |year=2015 |isbn=978-0-444-63525-9 |veditors=Ray SD |series=Side Effects of Drugs Annual |volume=37 |pages=1–13 |chapter=Central Nervous System Stimulants and Drugs That Suppress Appetite |doi=10.1016/bs.seda.2015.08.004 |issn=0378-6080}}</ref><ref name="pmid30285371" /> [[Anxiety]], [[insomnia]], [[dizziness]], [[diarrhea]], and [[rhinitis]] are also reported in 5% to 10% of users.<ref name="pmid30285371" /> Psychiatric reactions have occurred in individuals with and without a preexisting psychiatric history.<ref name="Australian Adverse Drug Reactions Bulletin-2008">{{cite web |date=December 1, 2008 |title=Australian Adverse Drug Reactions Bulletin 2008 |url=https://www.tga.gov.au/publication-issue/australian-adverse-drug-reactions-bulletin-vol-27-no-6#a2 |url-status=live |archive-url=https://web.archive.org/web/20200703041749/https://www.tga.gov.au/publication-issue/australian-adverse-drug-reactions-bulletin-vol-27-no-6#a2 |archive-date=July 3, 2020 |publisher=Australian Adverse Drug Reactions Bulletin}}</ref> [[Urinary retention]] and [[paresthesia]] have also been reported.<ref name="Davis2013">{{Cite book |last=Ciccone |first=Charles D. |title=Davis's drug guide for rehabilitation professionals |date=2013 |publisher=F.A. Davis |isbn=978-0-8036-2589-1 |location=Philadelphia |language=en |chapter=Modafinil |chapter-url=https://fadavispt.mhmedical.com/content.aspx?bookid=1873&sectionid=139018549 |archive-url=https://web.archive.org/web/20240916100601/https://fadavispt.mhmedical.com/content.aspx?bookid=1873&sectionid=139018549 |archive-date=2024-09-16 |url-status=live}}</ref>

No significant changes in body weight have been observed in clinical trials, although decreased appetite and weight loss have been noted in children and adolescents.<ref name="Medication Guide-2010">{{cite web |date=November 1, 2010 |title=Provigil |url=http://provigil.com/media/PDFs/medication_guide.pdf |url-status=dead |archive-url=https://web.archive.org/web/20160304035819/http://provigil.com/media/PDFs/medication_guide.pdf |archive-date=March 4, 2016 |access-date=December 31, 2013 |work=Medication Guide |publisher=Cephalon, Inc.}}</ref> Modafinil can cause a slight increase in [[Transaminase|aminotransferase enzymes]], indicative of liver function, but there is no evidence of serious liver damage when levels are within reference ranges.<ref name="pmid31643597">{{cite book |title=LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. |date=2012 |publisher=National Institute of Diabetes and Digestive and Kidney Diseases |location=Bethesda (MD) |chapter=Modafinil |pmid=31643597 |id={{NCBIBook|NBK548274}}}}</ref>

Rare but serious adverse effects include severe skin rashes and allergy-related symptoms. Between December 1998 and January 2007, the FDA received reports of six cases of severe cutaneous adverse reactions, including [[erythema multiforme]], [[Stevens–Johnson syndrome]], [[toxic epidermal necrolysis]], and [[DRESS syndrome]]. The FDA has issued alerts regarding these risks and also noted reports of angioedema and multi-organ hypersensitivity reactions in [[Postmarketing surveillance#United States|postmarketing surveillance]].<ref name="FDA-2007-Serious-Skin-Reactions">{{cite web |year=2007 |title=Modafinil (marketed as Provigil): Serious Skin Reactions |url=http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#modafinil |url-status=dead |archive-url=https://web.archive.org/web/20090115021301/http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#modafinil |archive-date=January 15, 2009 |publisher=U.S. [[Food and Drug Administration]] (FDA)}}</ref><ref name="Li-2023">{{cite news |date=November 6, 2023 |title=Three men hospitalised after taking modafinil or armodafinil to stay awake; drugs were not prescribed |url=https://www.straitstimes.com/singapore/three-men-hospitalised-after-taking-modafinil-or-armodafinil-to-stay-awake-drugs-were-not-prescribed |url-status=live |archive-url=https://web.archive.org/web/20231203191528/https://www.straitstimes.com/singapore/three-men-hospitalised-after-taking-modafinil-or-armodafinil-to-stay-awake-drugs-were-not-prescribed |archive-date=December 3, 2023 |access-date=December 3, 2023 |newspaper=The Straits Times |vauthors=Li TW}}</ref> In 2007, the FDA required Cephalon to modify the Provigil leaflet to include warnings about these serious conditions. The long-term safety and effectiveness of modafinil have not been conclusively established.<ref name="pmid15336235" />

The FDA does not endorse modafinil for children's medical conditions due to an increased risk of rare but serious dermatological toxicity, manifested as [[Stevens–Johnson syndrome]] which is a type of severe skin reaction.<ref name="Fda.gov-2015">{{cite web |date=January 2015 |title=FDA Provigil Drug Safety Data |url=https://www.fda.gov/downloads/Drugs/DrugSafety/UCM231722.pdf |url-status=live |archive-url=https://web.archive.org/web/20170502094203/https://www.fda.gov/downloads/Drugs/DrugSafety/UCM231722.pdf |archive-date=May 2, 2017 |publisher=U.S. [[Food and Drug Administration]] (FDA)}}</ref><ref name="pmid31951804" /><ref name="pmid19300563">{{cite journal |vauthors=Rugino T |date=June 2007 |title=A review of modafinil film-coated tablets for attention-deficit/hyperactivity disorder in children and adolescents |journal=Neuropsychiatric Disease and Treatment |volume=3 |issue=3 |pages=293–301 |pmc=2654790 |pmid=19300563}}</ref> However, in Europe, modafinil may be prescribed for treating narcolepsy in children.<ref name="pmid34173288" />