{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T23:02:51Z","timestamp":1789772571001,"version":"4.0.1"},"reference-count":14,"publisher":"Georg Thieme Verlag KG","issue":"07","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Drug Res (Stuttg)"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>This study aimed to explore the spectrum of adverse events associated with\nhydroxyprogesterone and provide a comprehensive understanding of the drug\u2019s\nsafety profile based on the Food and Drug Administration\u02bcs Adverse Event\nReporting System database.<\/jats:p>\n                  <jats:p>Adverse events associated with hydroxyprogesterone were extracted from the\nFood and Drug Administration\u02bcs Adverse Event Reporting System database,\ncovering the period from the first quarter of 2004 to the second quarter of\n2025. Disproportionality analysis methods were used to detect potential\nsafety signals related to hydroxyprogesterone. We further analyzed the\ndemographic characteristics of the population and the onset time of adverse\nevents.<\/jats:p>\n                  <jats:p>A total of 40,450 adverse event reports related to hydroxyprogesterone were\nincluded, corresponding to 197 significant preferred terms categorized into\n21 system organ classes per Medical Dictionary for Regulatory Activities\ncriteria. In addition to commonly observed adverse events, several\nclinically relevant adverse events not previously documented were\nidentified, including fetal distress syndrome, abnormal fetal heart rate\ndeceleration, neonatal jaundice, neonatal respiratory distress, and low\nbirth weight infant. The median time to the onset of\nhydroxyprogesterone-induced adverse events was 20 days (interquartile range:\n0\u201372 d), with 57.8% of adverse events occurring within the initial 30 days\nfollowing hydroxyprogesterone administration.<\/jats:p>\n                  <jats:p>In this study, we identified both clinically observed adverse events and\npotential safety signals associated with hydroxyprogesterone. These results\nprovide valuable evidence to support clinical monitoring, safety risk\nidentification, and the development of subsequent safety investigations.<\/jats:p>","DOI":"10.1055\/a-2877-4087","type":"journal-article","created":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T23:26:21Z","timestamp":1785885981000},"page":"163-169","source":"Crossref","is-referenced-by-count":0,"title":["The Real-World Safety Profile of Hydroxyprogesterone: A\nPharmacovigilance Study Based on the Food and Drug Administration\u02bcs Adverse\nEvent Reporting System Database"],"prefix":"10.1055","volume":"76","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4798-1956","authenticated-orcid":false,"given":"Likun","family":"Ding","sequence":"first","affiliation":[{"name":"Xijing Hospital, the Fourth Military Medical University, China","place":["Xi`an"],"department":["Department of Pharmacy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danjun","family":"Ren","sequence":"first","affiliation":[{"name":"Xijing Hospital, the Fourth Military Medical University, China","place":["Xi`an"],"department":["Department of Pharmacy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meiyou","family":"Liu","sequence":"additional","affiliation":[{"name":"Xijing Hospital, the Fourth Military Medical University, China","place":["Xi`an"],"department":["Department of Pharmacy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juanli","family":"Zhang","sequence":"additional","affiliation":[{"name":"Xijing Hospital, the Fourth Military Medical University, China","place":["Xi`an"],"department":["Department of Pharmacy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Di","family":"Zhang","sequence":"additional","affiliation":[{"name":"Xijing Hospital, the Fourth Military Medical University, China","place":["Xi`an"],"department":["Department of Pharmacy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tingting","family":"Fan","sequence":"additional","affiliation":[{"name":"Xijing Hospital, the Fourth Military Medical University, China","place":["Xi`an"],"department":["Department of Pharmacy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Fang","sequence":"additional","affiliation":[{"name":"Xijing Hospital, the Fourth Military Medical University, China","place":["Xi`an"],"department":["Department of Respiratory Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2026,8,4]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"bvaf149.387","DOI":"10.1210\/jendso\/bvaf149.387","article-title":"SUN-417 crinecerfont maintains adrenocorticotropic hormone and\n17-hydroxyprogesterone levels with reduced glucocorticoid doses in adults with\nclassic congenital adrenal hyperplasia: 1-year results from the CAHtalyst\u2122 adult\nstudy","volume":"9","author":"R Auchus","year":"2025","journal-title":"J Endocr Soc"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1186\/s42826-025-00259-1","article-title":"11\u03b1-hydroxyprogesterone dampens lung metastasis via EMT modulation in\nPyMT-induced breast cancer murine model","author":"N Kim","year":"2025","journal-title":"Lab Anim Res"},{"issue":"02","key":"ref3","doi-asserted-by":"publisher","first-page":"144","DOI":"10.1016\/j.ajogmf.2019.04.004","article-title":"The association between 17-hydroxyprogesterone caproate use and postpartum\nhemorrhage","volume":"1","author":"E S Miller","year":"2019","journal-title":"Am J Obstet Gynecol MFM"},{"issue":"25","key":"ref4","doi-asserted-by":"publisher","first-page":"7438","DOI":"10.1080\/14767058.2021.1949451","article-title":"Comparison the efficacy of vaginal progesterone versus\n17-alpha-hydroxyprogesterone caproate to prevent preterm birth in high-risk\npregnant women undergo cerclage: A randomized clinical trial","volume":"35","author":"A Alavi","year":"2021","journal-title":"J Matern-Fetal Neonat Med"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"e071752","DOI":"10.1136\/bmj-2022-071752","article-title":"Characterization and corroboration of safety signals identified from the US Food\nand drug administration adverse event reporting system, 2008-19: Cross sectional\nstudy","volume":"379","author":"M M Dhodapkar","year":"2022","journal-title":"BMJ"},{"issue":"02","key":"ref6","doi-asserted-by":"publisher","first-page":"109","DOI":"10.2165\/00002018-199920020-00002","article-title":"The medical dictionary for regulatory activities (MedDRA)","volume":"20","author":"DE G Brown","year":"1999","journal-title":"Drug Saf"},{"issue":"08","key":"ref7","doi-asserted-by":"publisher","first-page":"910","DOI":"10.1002\/pds.5624","article-title":"Sensitivity and specificity in signal detection with the reporting 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Heo","year":"2020","journal-title":"Stat Med"},{"issue":"08","key":"ref11","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1002\/pds.1001","article-title":"The reporting odds ratio and its advantages over the proportional reporting\nratio","volume":"13","author":"K J Rothman","year":"2004","journal-title":"Pharmacoepidemiol Drug Saf"},{"issue":"08","key":"ref12","doi-asserted-by":"publisher","first-page":"678","DOI":"10.1159\/000546356","article-title":"Sensorimotor development in rat neonates exposed to 17-\u03b1-hydroxyprogesterone\ncaproate: A progestin used in obstetrics","volume":"115","author":"P L Graney","year":"2025","journal-title":"Neuroendocrinology"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwaf202","article-title":"Clarifying contradictions: Transportability in 17OHP-C trials and\npreterm birth outcomes using doubly debiased machine learning","author":"A V Virkud","year":"2025","journal-title":"Am J Epidemiol"},{"issue":"01","key":"ref14","doi-asserted-by":"publisher","first-page":"132.e1","DOI":"10.1016\/j.ajog.2021.10.035","article-title":"In utero exposure to 17\u03b1-hydroxyprogesterone caproate and risk of cancer in\noffspring","volume":"226","author":"C C Murphy","year":"2022","journal-title":"Am J Obstet Gynecol"}],"container-title":["Drug 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