From the Guidelines
Pyridoxine (vitamin B6) is beneficial during pregnancy, particularly for managing nausea and vomiting, with a recommended dose of 10-25 mg taken orally three to four times daily, as suggested by the American College of Obstetricians and Gynecologists (ACOG) 1. The use of pyridoxine in pregnancy has been supported by recent studies, including the 2024 AGA clinical practice update on pregnancy-related gastrointestinal and liver disease, which recommends pyridoxine as a first-line treatment for mild cases of nausea and vomiting 1. Key points to consider when using pyridoxine during pregnancy include:
- The maximum daily dose should not exceed 100 mg 1
- Pyridoxine is important for fetal brain development, red blood cell formation, and protein metabolism 1
- Most prenatal vitamins contain adequate pyridoxine (about 2 mg), but women with severe morning sickness may need additional supplementation 1
- Side effects are rare at recommended doses, but excessive amounts can cause nerve damage (peripheral neuropathy) 1 It is essential to consult with a healthcare provider before starting any supplement during pregnancy, as individual needs may vary based on diet and health conditions 1. In cases of severe nausea and vomiting, such as hyperemesis gravidarum, higher doses of pyridoxine may be used under medical supervision, and other treatment options, such as metoclopramide and ondansetron, may be considered 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Pyridoxine in Pregnancy: Benefits and Dosage
- Pyridoxine, also known as vitamin B6, is commonly used to treat nausea and vomiting during pregnancy (NVP) 2, 3, 4, 5, 6.
- The recommended dosage of pyridoxine for NVP is not explicitly stated in the provided studies, but it is often prescribed in combination with doxylamine, with a typical dosage of 10 mg of pyridoxine and 10 mg of doxylamine, taken 2-4 times a day 2, 4, 5.
- Studies have shown that pyridoxine supplementation, alone or in combination with other active substances, can significantly improve symptoms of nausea and vomiting during pregnancy 3, 5.
- A systematic review and meta-analysis found that pyridoxine supplementation alone, as well as combined treatment with an active ingredient, significantly improved symptoms of nausea according to the Rhode's score and PUQE score 3.
- However, some studies suggest that the combination of doxylamine and pyridoxine may not be more effective than pyridoxine alone, and there is limited evidence to support the use of doxylamine-pyridoxine as the first-line treatment for NVP 6.
Efficacy of Pyridoxine in Pregnancy
- A randomized controlled trial found that doxylamine-pyridoxine was more effective than placebo in improving symptoms of nausea and vomiting during pregnancy, but the difference was not statistically significant using all approaches to handling missing data 2.
- A matched, controlled cohort study found that doxylamine succinate-pyridoxine HCl was more effective than pyridoxine alone in reducing NVP symptoms, especially in women with more severe symptoms 5.
- A systematic review and meta-analysis found that pyridoxine supplementation alone, as well as combined treatment with an active ingredient, significantly improved symptoms of nausea and vomiting during pregnancy 3.
Safety and Recommendations
- Pyridoxine is generally considered safe during pregnancy, and there is stronger support for the safety of pyridoxine monotherapy than for the combination of doxylamine-pyridoxine 6.
- The US Food and Drug Administration (FDA) has approved doxylamine succinate and pyridoxine hydrochloride as a delayed-release combination pill called Diclegis for the treatment of NVP 4.
- However, some studies suggest that the role of doxylamine-pyridoxine as the first-line pharmacological treatment for NVP should be reconsidered due to limited evidence of its efficacy and potential safety concerns 6.