From the Guidelines
Domperidone is safe to use during pregnancy, according to the most recent and highest quality study available. The 2023 study published in the Journal of Hepatology, which provides evidence-based guidelines for the management of liver diseases in pregnancy, lists domperidone as a compatible medication for use during pregnancy, including the first, second, and third trimesters 1. The study suggests that domperidone can be used as a second-line recommended treatment for managing Hyperemesis Gravidarum, a condition characterized by severe nausea and vomiting during pregnancy.
Some key points to consider when using domperidone during pregnancy include:
- The medication is listed as compatible with use during pregnancy, including all trimesters 1.
- Domperidone is recommended as a second-line treatment for Hyperemesis Gravidarum, after first-line options have been considered 1.
- The decision to use domperidone should be made under the guidance of a healthcare provider, taking into account the potential benefits and risks 1.
- It is essential to use the lowest effective dose for the shortest duration possible to minimize potential risks 1.
Overall, the current evidence suggests that domperidone can be safely used during pregnancy, when medically necessary and under close supervision 1.
From the FDA Drug Label
HUMAN WARNINGS Not for use in humans. For oral use in animals only. ... Pregnant and lactating women should use caution when handling EQUIDONE Gel, as systemic exposure to domperidone may affect reproductive hormones. The FDA drug label does not answer the question.
From the Research
Domperidone Safety in Pregnancy
- The safety of domperidone during pregnancy has been evaluated in several studies 2, 3, 4.
- A systematic review published in 2009 found that domperidone is one of the interventions used to treat nausea and vomiting in early pregnancy, but the quality of evidence for its effectiveness and safety was not fully established 2.
- A prospective cohort study published in 2013 found that domperidone does not appear to be a major human teratogen, but the study required further confirmation in larger studies 3.
- A retrospective cohort study published in 2021 found that the rate of natural pregnancy termination in pregnant women exposed to domperidone was lower than that in unexposed pregnant women, and the malformation rate in fetuses/newborns exposed to domperidone was comparable to that of unexposed fetuses/newborns 4.
Comparison with Other Medications
- Studies have also compared the safety and effectiveness of domperidone with other medications used to treat nausea and vomiting in pregnancy, such as metoclopramide 5, 6.
- A prospective multicenter international study published in 2002 found that metoclopramide use during the first trimester of pregnancy was not associated with an increased risk of malformations, spontaneous abortions, or decreased birth weight, but was associated with a higher rate of premature births 5.
- A study published in 2011 found that treatment with either metoclopramide or ondansetron resulted in significant improvement of nausea and vomiting symptoms in pregnant women, but alteration in treatment was more frequent in patients initially prescribed metoclopramide 6.
Key Findings
- The available evidence suggests that domperidone may be safe to use during pregnancy, but further studies are needed to confirm its safety and effectiveness 3, 4.
- Domperidone may be associated with a lower risk of natural pregnancy termination and a comparable risk of malformations compared to unexposed pregnant women 4.
- The safety and effectiveness of domperidone should be compared with other medications used to treat nausea and vomiting in pregnancy, such as metoclopramide and ondansetron 5, 6.