{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T06:47:27Z","timestamp":1791010047049,"version":"4.1.0"},"reference-count":54,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2026,8,8]],"date-time":"2026-08-08T00:00:00Z","timestamp":1786147200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003197","name":"Italian Medicines Agency","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100003197","id-type":"DOI","asserted-by":"crossref"}]},{"id":[{"id":"https:\/\/ror.org\/01ttmqc18","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background\/Objectives: The increased incidence of obesity and type 2 diabetes, along with the growing use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), particularly semaglutide, among women of childbearing age makes it especially important to assess their safety profile during pregnancy. Methods: A post-marketing study was conducted using reports from the U.S. FDA Adverse Event Reporting System (FAERS) database (2017\u20132025). Descriptive analyses focused on pregnancy outcomes and fetal\/neonatal disorders. Disproportionality analyses assessed adverse event (AE) reporting by System Organ Class (SOC) and pregnancy-related AEs associated with semaglutide versus other medications. A Standardized MedDRA Query (SMQ)-based disproportionality analysis was also performed. Results: A total of 249 cases involving semaglutide use during pregnancy were identified, comprising 922 AEs. \u201cInjury, poisoning and procedural complications\u201d was the most frequently reported SOC, while abortion- and pregnancy loss-related events accounted for 27.3% of reported AEs. Compared with other medications, semaglutide showed higher reporting odds for \u201cPregnancy, puerperium and perinatal conditions\u201d (ROR 1.59; 95% CI 1.37\u20131.86), \u201cInjury, poisoning and procedural complications\u201d (ROR 1.93; 95% CI 1.70\u20132.20), and gastrointestinal disorders (ROR 1.72; 95% CI 1.38\u20132.15), with no significant association for \u201cCongenital, familial and genetic disorders\u201d or \u201cReproductive system and breast disorders\u201d. SMQ-based analysis showed increased reporting odds for \u201cTermination of pregnancy and risk of abortion\u201d (ROR 3.71; 95% CI 3.07\u20134.48). Conclusions: Disproportionate reporting was identified for pregnancy- and perinatal-related events, procedural\/exposure-related complications, and pregnancy termination, with no evidence of a disproportionate congenital-anomaly signal. These findings should be interpreted cautiously and do not necessarily indicate a causal association.<\/jats:p>","DOI":"10.3390\/ph19081249","type":"journal-article","created":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T01:20:03Z","timestamp":1786324803000},"page":"1249","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Semaglutide Exposure During Pregnancy: Results from the FAERS Database"],"prefix":"10.3390","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9425-9923","authenticated-orcid":false,"given":"Alessia","family":"Zinzi","sequence":"first","affiliation":[{"name":"Department of Life Sciences, Health, and Health Professions, Link Campus University, 00198 Rome, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Department of Experimental Medicine, Section of Pharmacology \u201cL. Donatelli\u201d, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4287-5510","authenticated-orcid":false,"given":"Mario","family":"Gaio","sequence":"additional","affiliation":[{"name":"Department of Life Sciences, Health, and Health Professions, Link Campus University, 00198 Rome, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Department of Experimental Medicine, Section of Pharmacology \u201cL. Donatelli\u201d, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annamaria","family":"Mascolo","sequence":"additional","affiliation":[{"name":"Department of Life Sciences, Health, and Health Professions, Link Campus University, 00198 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gorizio","family":"Pieretti","sequence":"additional","affiliation":[{"name":"Plastic Surgery Unit, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mattia","family":"Cipriani","sequence":"additional","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Department of Experimental Medicine, Section of Pharmacology \u201cL. Donatelli\u201d, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joao Marcos","family":"Della Ragione","sequence":"additional","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Department of Experimental Medicine, Section of Pharmacology \u201cL. Donatelli\u201d, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rossana","family":"D\u2019Amato","sequence":"additional","affiliation":[{"name":"Maternal and Child Care Unit, Local Health Authority (ASL), 84121 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Rossi","sequence":"additional","affiliation":[{"name":"Department of Life Sciences, Health, and Health Professions, Link Campus University, 00198 Rome, Italy"},{"name":"Department of Experimental Medicine, Section of Pharmacology \u201cL. Donatelli\u201d, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalisa","family":"Capuano","sequence":"additional","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Department of Experimental Medicine, Section of Pharmacology \u201cL. Donatelli\u201d, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosanna","family":"Ruggiero","sequence":"additional","affiliation":[{"name":"Department of Life Sciences, Health, and Health Professions, Link Campus University, 00198 Rome, Italy"},{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Department of Experimental Medicine, Section of Pharmacology \u201cL. Donatelli\u201d, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,8]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1038\/s41392-024-01931-z","article-title":"Glucagon-like Peptide-1 Receptor: Mechanisms and Advances in Therapy","volume":"9","author":"Zheng","year":"2024","journal-title":"Signal Transduct. Target. Ther."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2050","DOI":"10.7150\/ijbs.59965","article-title":"GLP-1 Receptor Agonists (GLP-1RAs): Cardiovascular Actions and Therapeutic Potential","volume":"17","author":"Ma","year":"2021","journal-title":"Int. J. Biol. 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