A Scoping Review of 5-HT<sub>3</sub> Antagonist Antiemetic Medication Safety in the Management of Nausea and Vomiting of Pregnancy.
Ondansetron appears to have a low risk of harm for pregnant women experiencing nausea and vomiting, but further investigation is needed for certain congenital anomalies.
Where it sits
this study against the rest of the navepegritide corpusSummary and findings
This review examined the safety of 5-HT3 antagonist medications, particularly ondansetron, for nausea and vomiting in pregnancy (NVP). It included 39 unique studies, focusing on maternal, neonatal, and child health outcomes. Results indicated minimal complications associated with ondansetron use and no elevated risk of congenital anomalies overall.
Abstract
<h4>Purpose</h4>The prescribing of 5-hydroxytryptamine 3 receptor and type 3 serotonin receptor (5-HT<sub>3</sub>) antagonists, particularly ondansetron, for nausea and vomiting in pregnancy (NVP) has increased globally. However, evidence on the safety of these medications in pregnancy remains unclear. This review aims to examine the available literature surrounding the safety of 5-HT<sub>3</sub> antagonist medication use for NVP.<h4>Methods</h4>Embase, Ovid Medline, Global Health, and CINAHL were searched from inception to 20 March 2024, updated on 7 May 2025. Full-text, original articles available in English, examining the use of 5-HT<sub>3</sub> antagonist medications (ondansetron, granisetron, tropisetron, dolasetron, palonosetron, ramosetron) for NVP were included. Any maternal, neonatal, or child health outcomes were of interest.<h4>Results</h4>Results were screened and extracted using Covidence and synthesized in Excel. The search strategy returned 1942 articles of which 39 unique, full-text studies were included. Most papers examined ondansetron (34/39 papers, 87%) with limited evidence for granisetron (5/39 papers, 13%). Ondansetron use for NVP yielded minimal complications for maternal health and late pregnancy outcomes. No elevated risk of any congenital anomalies overall was observed. Although the risks of cardiac and orofacial anomalies were conflicting, the absolute changes in risk are minimal for either anomaly, especially considering potential confounding from study methodology and limited sample sizes.<h4>Conclusion</h4>Ondansetron likely poses low risk of harm to maternal and neonatal health, especially considering the excess risks of untreated NVP; however additional research is required for certain congenital anomalies. Further investigation is also warranted into granisetron safety before its widespread use during pregnancy.
Background
The review addresses the safety of 5-HT3 antagonists, particularly ondansetron, in managing nausea and vomiting during pregnancy, a common condition that can significantly impact maternal and fetal health. Previous studies have yielded mixed results regarding the safety of these medications, creating uncertainty for clinicians. This scoping review is important as it aims to clarify the existing evidence and inform clinical practice regarding the use of these medications in pregnant patients.
Methods
The review involved a systematic search of databases including Embase, Ovid Medline, Global Health, and CINAHL from inception to March 20, 2024, updated on May 7, 2025. It included full-text, original articles in English that examined 5-HT3 antagonist medications for NVP, focusing on maternal, neonatal, or child health outcomes. The review synthesized findings from 39 studies after screening 1942 articles.
Results
The review found that ondansetron use for NVP yielded minimal complications for maternal health and late pregnancy outcomes. No elevated risk of congenital anomalies overall was observed. However, the risks of cardiac and orofacial anomalies were conflicting, with the review noting that absolute changes in risk were minimal, particularly when considering potential confounding factors.
Interpretation
The findings suggest that ondansetron likely poses a low risk of harm to maternal and neonatal health, which is significant given the risks associated with untreated NVP. However, the conflicting evidence regarding specific anomalies and the limitations of the studies included, such as small sample sizes and methodological confounds, suggest caution in interpreting these results. Further research is needed to better understand the safety of granisetron and the specific congenital anomalies mentioned.
Key findings
- 39 unique, full-text studies included.
- 34/39 papers (87%) examined ondansetron.
- No elevated risk of any congenital anomalies overall.
- Conflicting risks of cardiac and orofacial anomalies reported.
- Absolute changes in risk for anomalies were minimal.
Limitations
- Small sample sizes in many included studies.
- Potential confounding from study methodologies.
- Limited evidence for granisetron safety.