From the Guidelines
Metoclopramide (Reglan) is considered safe for use during pregnancy when medically necessary, with a typical dosage of 5-10 mg taken every 6-8 hours. This recommendation is based on the most recent and highest quality study available, which found no significant increase in the risk of major congenital defects associated with metoclopramide use during pregnancy 1. The study, published in 2023, analyzed data from over 33,000 first-trimester women who used metoclopramide and found an odds ratio of 1.14 (99% CI 0.93-1.38) for major congenital defects.
Key Considerations
- Metoclopramide is commonly used to treat nausea and vomiting of pregnancy, and its use is supported by a consensus of 95.24% among experts 1.
- The medication should only be used when the potential benefits outweigh the risks, and treatment duration should be kept as short as possible to manage symptoms.
- Prolonged use (more than 12 weeks) or high doses should be avoided due to potential neurological side effects.
- Women may experience drowsiness, restlessness, or fatigue while taking metoclopramide, and should consult with their healthcare provider before starting or stopping the medication.
Comparison with Other Treatments
- Ondansetron, another medication used to treat nausea and vomiting during pregnancy, has been linked to a marginal relative increase in cleft palate and cardiovascular malformations, although the risk is considered small 1.
- A 2024 study published in Gastroenterology found that metoclopramide and ondansetron had similar efficacy in treating hyperemesis gravidarum, but metoclopramide was associated with fewer adverse events 1.
- The American College of Obstetricians and Gynecologists (ACOG) recommends a step-up approach for treating nausea and vomiting during pregnancy, with metoclopramide considered a second-line therapy after vitamin B6 (pyridoxine) and other first-line treatments 1.
From the FDA Drug Label
Reproduction studies performed in rats, mice, and rabbits by the IM, IV, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Metoclopramide safety during pregnancy: Metoclopramide should be used during pregnancy only if clearly needed, as there are no adequate and well-controlled studies in pregnant women, although animal reproduction studies have shown no significant harm to the fetus 2.
From the Research
Safety of Metoclopramide during Pregnancy
- Metoclopramide is considered safe for use during pregnancy, particularly for treating nausea and vomiting, according to several studies 3, 4, 5.
- A study published in the American Journal of Obstetrics and Gynecology in 2002 found that metoclopramide may be effective for treating nausea and vomiting in pregnancy, but safety data were insufficient to recommend it as a first-line agent 3.
- Another study published in Expert Opinion on Drug Safety in 2017 found that metoclopramide has been documented to be safe for fetal use, along with doxylamine/pyridoxine combination and H1 blockers 4.
- A systematic review published in JAMA in 2016 found that metoclopramide was associated with improved symptoms of nausea and vomiting in pregnancy, particularly for mild symptoms, and was also effective for moderate symptoms 5.
- However, the same review noted that the quality of evidence for metoclopramide and other interventions was generally low, and more research is needed to fully understand their safety and effectiveness during pregnancy 5.
Comparison with Other Treatments
- A study published in Clinical and Experimental Obstetrics & Gynecology in 2013 compared the effectiveness of metoclopramide with ondansetron in treating severe nausea and vomiting in pregnancy, and found that ondansetron had a more favorable effect in controlling vomiting 6.
- The JAMA review also compared metoclopramide with other treatments, including ondansetron, pyridoxine-doxylamine, and corticosteroids, and found that each had varying levels of effectiveness for different symptom severities 5.
Overall Safety Profile
- While metoclopramide is considered safe for use during pregnancy, it is essential to weigh the benefits and risks of treatment, particularly for severe nausea and vomiting, and to discuss treatment options with a healthcare provider 7, 4.
- The available evidence suggests that metoclopramide can be a safe and effective treatment option for nausea and vomiting in pregnancy, but more research is needed to fully understand its safety profile and to inform treatment decisions 3, 4, 5.