PMID- 36737400 OWN - NLM STAT- MEDLINE DCOM- 20231028 LR - 20231028 IS - 2472-1727 (Electronic) VI - 115 IP - 6 DP - 2023 Apr 1 TI - Embryo-fetal safety evaluation of ondansetron in rats. PG - 605-613 LID - 10.1002/bdr2.2154 [doi] AB - BACKGROUND: Ondansetron is a 5HT3 receptor antagonist, used to mitigate the effects of nausea and vomiting after chemotherapy or surgery. Since nausea and vomiting are common experiences during the first trimester of pregnancy, this antiemetic has been the main drug used during this period. METHODS: To evaluate the effects of ondansetron on the embryo-fetal development, which are still very contradictory, pregnant rats were exposed to therapeutic doses of ondansetron (1.7 or 2.5 mg/kg) daily, from gestational day (GD) 6 to 15. RESULTS: No clinical signs of toxicity were observed in dams during the treatment. Although the hemato-biochemical parameters were similar among the groups, histological changes, as well as a reduction in the weight of kidney were found in the treated dams. After fetal examination, no visceral and skeletal abnormalities were observed in treated fetuses. CONCLUSION: In conclusion, therapeutic doses of ondansetron have low teratogenic potential in rats. These data provide important information about the drug safety during pregnancy. CI - (c) 2023 Wiley Periodicals LLC. FAU - Reis, Ana Carolina Casali AU - Reis ACC AD - Department of Structural and Functional Biology, Institute of Biosciences of Botucatu, Universidade Estadual Paulista - UNESP, Botucatu, Sao Paulo, Brazil. FAU - Jorge, Barbara Campos AU - Jorge BC AD - Department of Structural and Functional Biology, Institute of Biosciences of Botucatu, Universidade Estadual Paulista - UNESP, Botucatu, Sao Paulo, Brazil. FAU - da Silva Moreira, Suyane AU - da Silva Moreira S AD - Department of Structural and Functional Biology, Institute of Biosciences of Botucatu, Universidade Estadual Paulista - UNESP, Botucatu, Sao Paulo, Brazil. FAU - Stein, Julia AU - Stein J AD - Department of Structural and Functional Biology, Institute of Biosciences of Botucatu, Universidade Estadual Paulista - UNESP, Botucatu, Sao Paulo, Brazil. FAU - Perdao, Carolina Barizan AU - Perdao CB AD - Department of Structural and Functional Biology, Institute of Biosciences of Botucatu, Universidade Estadual Paulista - UNESP, Botucatu, Sao Paulo, Brazil. FAU - de Matos Manoel, Beatriz AU - de Matos Manoel B AD - College of Health Science, Federal University of Grande Dourados, Dourados, Mato Grosso do Sul, Brazil. FAU - Arena, Arielle Cristina AU - Arena AC AUID- ORCID: 0000-0002-2373-9399 AD - Department of Structural and Functional Biology, Institute of Biosciences of Botucatu, Universidade Estadual Paulista - UNESP, Botucatu, Sao Paulo, Brazil. AD - Center of Toxicological Assistance (CEATOX), Institute of Biosciences of Botucatu, Universidade Estadual Paulista - Botucatu (UNESP), Botucatu, Sao Paulo, Brazil. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230203 PL - United States TA - Birth Defects Res JT - Birth defects research JID - 101701004 RN - 0 (Antiemetics) RN - 4AF302ESOS (Ondansetron) SB - IM MH - Animals MH - Female MH - Pregnancy MH - Rats MH - *Antiemetics/toxicity MH - *Embryo, Mammalian/drug effects MH - Nausea/drug therapy MH - *Ondansetron/toxicity MH - Vomiting/drug therapy OTO - NOTNLM OT - kidney OT - nausea and vomiting OT - organogenesis OT - rats OT - safety OT - teratogenicity EDAT- 2023/02/04 06:00 MHDA- 2023/03/21 06:00 CRDT- 2023/02/03 22:06 PHST- 2023/01/16 00:00 [revised] PHST- 2022/09/22 00:00 [received] PHST- 2023/01/23 00:00 [accepted] PHST- 2023/02/04 06:00 [pubmed] PHST- 2023/03/21 06:00 [medline] PHST- 2023/02/03 22:06 [entrez] AID - 10.1002/bdr2.2154 [doi] PST - ppublish SO - Birth Defects Res. 2023 Apr 1;115(6):605-613. doi: 10.1002/bdr2.2154. Epub 2023 Feb 3.