Metoclopramide
MedicationReglan, Metozolv ODT
Dopamine antagonist prokinetic and antiemetic
Research strength: 4 / 5
MotherToBaby reports that metoclopramide has not been shown to increase the chance of birth defects, preterm delivery, or low birth weight, and that a small number of studies did not find an increased chance of miscarriage. Pasternak et al. (2013) and Sun et al. (2021) found no overall increase in birth defects, while Bérard et al. (2019) reported higher estimates for overall malformations and genital defects. NICE lists metoclopramide as a second-line treatment for pregnancy nausea and vomiting and limits that use to five days; EMA says it can be used during pregnancy if clinically needed. The FDA boxed warning says the risk of tardive dyskinesia, a potentially irreversible serious movement disorder, rises with longer treatment and the total cumulative dose; it calls for the shortest treatment and periodic reassessment. The FDA label says not to use Reglan in anyone with a history of tardive dyskinesia; it limits symptomatic reflux treatment to 12 weeks and advises against longer than 12 weeks for diabetic gastroparesis, with routine monitoring if longer treatment is unavoidable. Ask your provider about your situation.
Last reviewed: 2026-10-16
Research strength: 4 / 5
MotherToBaby reports that metoclopramide has not been shown to increase the chance of birth defects, preterm delivery, or low birth weight, and that a small number of studies did not find an increased chance of miscarriage. Pasternak et al. (2013), Bérard et al. (2019), and Sun et al. (2021) studied first-trimester exposure, so they do not give a separate second-trimester estimate. NICE lists metoclopramide as a second-line treatment for pregnancy nausea and vomiting and limits that use to five days; EMA says it can be used during pregnancy if clinically needed. The FDA boxed warning says the risk of tardive dyskinesia, a potentially irreversible serious movement disorder, rises with longer treatment and the total cumulative dose; it calls for the shortest treatment and periodic reassessment. The FDA label says not to use Reglan in anyone with a history of tardive dyskinesia; it limits symptomatic reflux treatment to 12 weeks and advises against longer than 12 weeks for diabetic gastroparesis, with routine monitoring if longer treatment is unavoidable. Ask your provider about your situation.
Last reviewed: 2026-10-16
Research strength: 4 / 5
MotherToBaby reports that metoclopramide has not been shown to increase birth defects, preterm delivery, or low birth weight; FDA labeling warns that use during delivery may cause movement signs in a newborn and calls for monitoring, while EMA advises avoiding use at the end of pregnancy and monitoring the newborn if it is used. Bylsma-Howell et al. (1983) found no marked differences in newborn scores in a small randomized delivery study, while Sánchez (2015) described movement symptoms in a mother and newborn after a maternal intravenous dose; neither report estimates how often such effects occur. Cho et al. (2025) found no substantial overall association with child neurodevelopmental disorders or delays, but reported a small ADHD signal with use in the second half of pregnancy and a delay signal with use for seven or more days. The FDA boxed warning says the risk of tardive dyskinesia, a potentially irreversible serious movement disorder, rises with longer treatment and the total cumulative dose; it calls for the shortest treatment and periodic reassessment. The FDA label says not to use Reglan in anyone with a history of tardive dyskinesia; it limits symptomatic reflux treatment to 12 weeks and advises against longer than 12 weeks for diabetic gastroparesis, with routine monitoring if longer treatment is unavoidable. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby - MetoclopramideTeratology service
- DailyMed - REGLANDrug company label
- EMA metoclopramide product informationEU agencyEuropean guidance
- Bylsma-Howell et al. 1983
- Sánchez 2015
- Cho et al. 2025US government
Metoclopramide — Breastfeeding
Research strength: 2 / 5
LactMed reports that metoclopramide passes into milk in variable amounts; most infants receive less than 10% of the mother's weight-adjusted dose, but some may reach active blood levels, and many studies did not adequately observe infants; FDA labeling calls for monitoring breastfed newborns for movement symptoms. MotherToBaby reports that most reports did not find infant side effects, with rare stomach discomfort or gas; Bellouard et al. (2023) described movement symptoms in a breastfed 21-week-old after maternal use, with metoclopramide found in the infant's blood and hair. NHS SPS describes short-term cautious use for nausea with infant monitoring, while EMA does not recommend metoclopramide during breastfeeding; LactMed and a 2024 review of 17 randomized trials found no added milk-supply benefit in the studied contexts. The FDA boxed warning says the risk of tardive dyskinesia, a potentially irreversible serious movement disorder, rises with longer treatment and the total cumulative dose; it calls for the shortest treatment and periodic reassessment. The FDA label says not to use Reglan in anyone with a history of tardive dyskinesia; it limits symptomatic reflux treatment to 12 weeks and advises against longer than 12 weeks for diabetic gastroparesis, with routine monitoring if longer treatment is unavoidable. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- LactMed - MetoclopramideUS government
- MotherToBaby - MetoclopramideTeratology service
- NHS Specialist Pharmacy ServiceUK government
- EMA metoclopramide product informationEU agencyEuropean guidance
- DailyMed - REGLANDrug company label
- Kauppila et al. 1983US government
- Bellouard et al. 2023
- Si et al. 2024US government
Pregnancy
MotherToBaby (page dated March 1, 2026) reports that metoclopramide has not been shown to increase the chance of birth defects, preterm delivery, or low birth weight; it says a small number of studies did not find an increased chance of miscarriage. In a Danish register-based cohort, Pasternak et al. (2013) studied 28,486 first-trimester-exposed pregnancies and 113,698 matched unexposed pregnancies: major malformations were reported in 25.3 per 1,000 exposed births and 26.6 per 1,000 unexposed births (prevalence OR 0.93, 95% CI 0.86-1.02); the cohort also found no increased spontaneous-abortion or stillbirth association. The Quebec Pregnancy Cohort study by Bérard et al. (2019) included 958 exposed pregnancies and reported an association with overall major malformations (adjusted OR 1.27, 95% CI 1.03-1.57) and genital-organ defects (adjusted OR 2.26, 95% CI 1.14-4.48; 10 exposed cases). Sun et al.'s 2021 meta-analysis of six studies (33,374 exposed infants and 373,498 controls) found no significant increase in major malformations (OR 1.14, 95% CI 0.93-1.38). Sørensen et al. (2000) studied 309 exposed pregnancies and 13,327 comparison pregnancies; it did not document significant increases in malformations, low birth weight, or preterm delivery, but its confidence intervals were wide. The largest malformation studies and the meta-analysis focus on first-trimester exposure; separate trimester-specific estimates for later pregnancy are limited. The FDA label says published cohort, registry, and meta-analysis studies do not report increased adverse pregnancy-related outcomes. For exposure near delivery, FDA labeling warns of newborn extrapyramidal signs; EMA says to avoid use at the end of pregnancy and monitor the newborn if it is used. Bylsma-Howell et al. (1983) randomized 23 cesarean patients, of whom 8 received intravenous metoclopramide, 12 saline, and 3 were lost to clinical follow-up; it found no marked differences in newborn Apgar, cardiovascular, or neurobehavioral scores. Sánchez (2015) reported a 38-week pregnancy in which the mother received 10 mg intravenous metoclopramide before cesarean delivery and both she and the newborn developed extrapyramidal symptoms; a case report cannot estimate frequency or prove general causality. A 2025 nationwide South Korean cohort included 630,904 children, 281,476 exposed to metoclopramide during pregnancy; it found no substantial overall association with neurodevelopmental disorders or delays, but reported a slightly elevated ADHD estimate for exposure in the second half of pregnancy (HR 1.12, 95% CI 1.06-1.18) and a delay signal for exposure lasting seven or more days. A 2026 case report described akathisia in a pregnant person at 33 weeks after intravenous bolus treatment. A 2026 Netherlands spontaneous-report analysis found depressive symptoms were reported more often in pregnancy-associated reports than non-pregnancy reports, but it could not establish causation or incidence.
Breastfeeding
LactMed (last revised February 15, 2026) says metoclopramide appears in milk in variable amounts. It estimates that most infants receive less than 10% of the maternal weight-adjusted dose, while some may reach active serum levels; it also notes that many infant studies did not adequately observe for effects. In Kauppila et al. (1983), five early-postpartum mother-infant pairs and 18 mothers at 8 to 12 weeks postpartum were studied; metoclopramide was detected in all milk samples, but in the plasma of only one of five early-postpartum infants. Estimated infant exposure was 6 to 24 micrograms/kg/day early postpartum and 1 to 13 micrograms/kg/day later postpartum. LactMed describes occasional possible infant gastrointestinal effects and one reported extrapyramidal syndrome. Bellouard et al. (2023) reported a 21-week-old breastfed boy with an acute extrapyramidal syndrome 48 hours after his mother used a 10 mg rectal suppository; metoclopramide was detected in infant plasma and hair, and the authors said the findings may suggest transfer through milk. This single case cannot estimate frequency. MotherToBaby reports that most reports have not described infant effects, with rare stomach discomfort or gas. NHS SPS recommends caution, short-term use for nausea, and monitoring for infant symptoms; EMA says metoclopramide is not recommended during breastfeeding because adverse effects cannot be excluded. The recommendations differ, and galactagogue use is outside NHS SPS's assessment. LactMed and a 2024 Bayesian network meta-analysis of 17 randomized trials report no milk-volume advantage for metoclopramide over placebo; LactMed also finds no additional benefit in well-designed studies after breastfeeding technique has been optimized.
MotherToBaby describes metoclopramide as a prescription medicine used for nausea and vomiting, gastroesophageal reflux, and slow stomach emptying, and notes that it is also sometimes used to try to increase milk supply. The live entry's category, dopamine antagonist prokinetic and antiemetic, is retained. MotherToBaby lists Reglan and Metozolv ODT among the brand names; the current DailyMed Reglan label was checked, while a current Metozolv ODT label was not located in the earlier DailyMed label search.
What was tested
The pregnancy evidence includes registry cohorts, a meta-analysis, a small delivery trial, and a recent population cohort. Pasternak et al. (2013) matched 28,486 first-trimester-exposed pregnancies with 113,698 unexposed pregnancies and assessed malformations, spontaneous abortion, and stillbirth. Bérard et al. (2019) assessed 958 metoclopramide-exposed pregnancies in the Quebec Pregnancy Cohort for major malformations. Sun et al. (2021) pooled six studies with 33,374 exposed infants and 373,498 controls. Sørensen et al. (2000) compared 309 exposed pregnancies with 13,327 comparison pregnancies for malformations, low birth weight, preterm delivery, and stillbirth. Bylsma-Howell et al. (1983) studied 23 term cesarean patients in a blinded placebo comparison, with eight receiving intravenous metoclopramide, 12 saline, and three lost to follow-up; newborn scores were not markedly different. The 2025 South Korean cohort included 630,904 children, 281,476 metoclopramide-exposed, and assessed seven neurodevelopmental disorders and developmental delays. For breastfeeding, Kauppila et al. (1983) measured transfer in five early-postpartum mother-infant pairs and 18 later-postpartum mothers; Bellouard et al. (2023) reported one infant case after maternal rectal use; and Si et al. (2024) synthesized 17 randomized trials of milk-production medicines.
First-trimester birth-defect findings
- Source A says
- Pasternak et al. found no overall association in a large Danish registry cohort, and Sun et al.'s six-study meta-analysis found no statistically significant overall increase. MotherToBaby says metoclopramide has not been shown to increase the chance of birth defects. (Pasternak et al. - Metoclopramide in pregnancy and risk of major congenital malformations and fetal death, Sun et al. - First-trimester malformation systematic review and meta-analysis, MotherToBaby - Metoclopramide)
- Source B says
- Bérard et al.'s Quebec cohort reported an association with overall major malformations and genital-organ defects after first-trimester exposure. (Bérard et al. - New evidence for concern over the risk of birth defects from medications for nausea and vomiting of pregnancy)
- Why they differ
- The studies used different populations, designs, and outcome groupings. The Quebec study had 958 exposed pregnancies and only 10 exposed genital-defect cases, while the Danish cohort had 28,486 first-trimester exposures and the pooled review included 33,374 exposed infants. These differences and the low counts for specific defects can produce different estimates.
- What the evidence shows overall
- The live entry's unqualified wording should be softened: the larger cohort and pooled estimate did not show an overall increase, but one cohort reported a signal. The evidence does not establish zero risk or resolve every specific defect.
Newborn movement effects after maternal use near delivery
- Source A says
- FDA labeling warns that maternal administration during delivery may cause extrapyramidal signs in newborns and calls for monitoring; EMA advises avoiding use at the end of pregnancy and monitoring newborns if the medicine is used. A 2015 case report described symptoms in a mother and newborn after maternal intravenous use. (DailyMed - REGLAN pregnancy and delivery warning, EMA - Metoclopramide Article 31 Annex III product information, Sánchez - Extrapyramidal effects of metoclopramide in pregnancy and newborn)
- Source B says
- A small randomized cesarean study found no marked differences in newborn Apgar, cardiovascular, or neurobehavioral scores between metoclopramide and placebo groups. (Bylsma-Howell et al. - Placental transport of metoclopramide: Assessment of maternal and neonatal effects)
- Why they differ
- The randomized study was small, with eight exposed patients and three patients lost to follow-up, and measured short-term scores rather than rare movement events. The case report cannot estimate frequency. The evidence types answer different questions.
- What the evidence shows overall
- Keep the delivery-timing warning and monitoring language, but do not suggest that a rate is known. The small trial does not rule out uncommon newborn effects.
Metoclopramide during breastfeeding
- Source A says
- EMA product information says metoclopramide is not recommended during breastfeeding because adverse effects in the breastfed infant cannot be excluded. (EMA - Metoclopramide Article 31 Annex III product information)
- Source B says
- NHS SPS allows short-term use for nausea with caution and infant monitoring. LactMed reports variable milk transfer, mostly low infant exposure, and that most studies did not find infant effects, although many studies did not monitor infants adequately. (NHS Specialist Pharmacy Service - Treating nausea during breastfeeding, LactMed - Metoclopramide)
- Why they differ
- EMA takes a precautionary position because infant effects cannot be excluded. NHS SPS addresses short-term nausea treatment with monitoring, not use to increase milk supply. The evidence includes small studies and a case report, so it does not settle all uses or treatment durations.
- What the evidence shows overall
- Keep the guidance rating and show both positions. Do not turn limited reports of few effects into a claim that infant effects cannot occur.
- NICE lists metoclopramide as a second-line treatment for nausea and vomiting in pregnancy and says use for this indication is not recommended for more than five days because of maternal nervous-system effects. (NICE NG201 Table 1)
- NHS SPS describes short-term use for nausea during breastfeeding with caution and infant monitoring; it sets a maximum of 30 mg daily for up to five days and advises avoiding use in people with a history of depression. (NHS Specialist Pharmacy Service)
- EMA product information says metoclopramide is not recommended during breastfeeding and advises considering discontinuation while breastfeeding. (European Medicines Agency)
General research, not specific to pregnancy.
The FDA boxed warning concerns tardive dyskinesia, a potentially irreversible serious movement disorder, and the label contraindicates Reglan in patients with a history of tardive dyskinesia. The label says risk rises with treatment duration and total cumulative dose, calls for the shortest duration and periodic reassessment, limits symptomatic reflux treatment to 12 weeks, and advises against more than 12 weeks for diabetic gastroparesis, with routine monitoring if longer use is unavoidable. The label also warns about depression and suicidal thoughts or actions. LactMed advises avoiding prolonged use during the postpartum period and says use should probably be avoided in people with a history of major depression.
- The FDA label contraindicates Reglan in patients with a history of tardive dyskinesia. (DailyMed - REGLAN boxed warning and contraindications)
- The FDA label says metoclopramide can cause tardive dyskinesia, a potentially irreversible serious movement disorder; risk increases with treatment duration and total cumulative dose. (DailyMed - REGLAN (metoclopramide hydrochloride tablets))
- The FDA label limits treatment duration for symptomatic documented reflux to 12 weeks and advises against treatment longer than 12 weeks for diabetic gastroparesis; if longer use is unavoidable, it calls for routine monitoring for tardive dyskinesia. (DailyMed - REGLAN (metoclopramide hydrochloride tablets))
- The FDA label warns about depression and suicidal ideation or suicide; LactMed notes postpartum depression concern and advises against prolonged use and use in people with a history of major depression. (DailyMed - REGLAN depression warning, LactMed - Metoclopramide)
- LactMed says well-designed studies have not shown an additional milk-supply benefit after breastfeeding techniques were optimized; NHS SPS's short-term nausea guidance does not cover use to increase milk supply. (LactMed - Metoclopramide, NHS Specialist Pharmacy Service - Treating nausea during breastfeeding)
- MotherToBaby - MetoclopramideTeratology serviceSecondaryPage dated 2026-03-01
- LactMed - MetoclopramideUS governmentSecondaryPage dated 2026-02-15
- DailyMed - REGLAN (metoclopramide hydrochloride tablets)Drug company labelTertiaryPage dated 2026-02-09
- DailyMed - Metoclopramide tablet (live-entry label)Drug company labelTertiary
- EMA - Metoclopramide Article 31 Annex III product informationEU agencySecondaryIndependent checkEuropean guidance
- EMA - Metoclopramide PSUSA/00002036/202111EU agencySecondaryPage dated 2022-07-08European guidance
- NICE NG201 Table 1 - nausea and vomiting in pregnancySecondaryIndependent check
- NHS Specialist Pharmacy Service - Treating nausea during breastfeedingUK governmentSecondaryPage dated 2024-03-26Independent check
- Pasternak et al. - Metoclopramide in pregnancy and risk of major congenital malformations and fetal deathUS governmentPrimaryIndependent check
- Bérard et al. - New evidence for concern over the risk of birth defects from medications for nausea and vomiting of pregnancyUS governmentPrimaryIndependent check
- Sun et al. - First-trimester malformation systematic review and meta-analysisUS governmentPrimaryIndependent check
- Sørensen et al. - Birth outcome following maternal use of metoclopramideUS governmentPrimaryIndependent check
- Cho et al. - Antiemetic use during pregnancy and child neurodevelopmentUS governmentPrimaryIndependent check
- Bylsma-Howell et al. - Placental transport of metoclopramide: Assessment of maternal and neonatal effectsPrimaryIndependent check
- Sánchez - Extrapyramidal effects of metoclopramide in pregnancy and newbornPrimaryIndependent check
- Nakamura et al. - Akathisia induced by metoclopramide in a pregnant womanUS governmentPrimary
- Conijn et al. - Metoclopramide and depressive symptoms in pregnancy: Netherlands spontaneous-report analysisUS governmentPrimary
- Kauppila et al. - Metoclopramide and breast feeding: transfer into milk and the newbornUS governmentPrimaryIndependent check
- Bellouard et al. - Metoclopramide intoxication through breast milkPrimaryPage dated 2023-01-25Independent check
- Si et al. - Network meta-analysis of metoclopramide and domperidone for milk productionUS governmentPrimaryPage dated 2024-12-18Independent check
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.