Can I take metoclopramide while pregnant or breastfeeding?

Pregnancy Category B Reproduction studies performed in rats, mice, and rabbits by the I.V., I.M., S.C. 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.

Prescribing label, section “Pregnancy”: Metoclopramide (oral), ATLANTIC BIOLOGICALS CORP. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Metoclopramide is excreted in variable amounts in breastmilk. After oral and intranasal administration, most infants would receive less than 10% of the maternal weight-adjusted dosage, but some receive doses that achieve pharmacologically active serum levels, elevated serum prolactin and possible gastrointestinal side effects. Although most studies have found no adverse effects in breastfed infants during maternal metoclopramide use, many did not adequately observe for side effects.

Metoclopramide increases serum prolactin and has been used as a galactogogue.[1,2] In well-designed studies that evaluated the effectiveness of metoclopramide as a galactogogue in women who continue to have difficulty producing milk after nursing techniques have been optimized, it was of no additional benefit. Prophylactic use in the mothers of preterm infants has also shown little or no benefit. A meta-analysis of 5 placebo-controlled studies concluded that 2 weeks of metoclopramide caused no increase of serum prolactin over placebo, but 3 weeks of treatment did.[3] A more recent meta-analysis concluded that metoclopramide was of no benefit as a galactogogue in the mothers of preterm infants.[4] A third meta-analysis of 8 trials involving 342 lactating women with a preterm or full-term infant found that metoclopramide increased serum prolactin, but did not increase milk supply.[5] The lack of efficacy of metoclopramide as a galactogogue was confirmed in the most recent and largest meta-analysis.[6] Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[7,8]

Metoclopramide has no officially established dosage for increasing milk supply. Most studies have used metoclopramide in a dosage of 10 mg 2 or 3 times daily for 7 to 14 days. Some studies used a tapering dosage for the last days few of the regimen to avoid an abrupt drop in milk supply after drug discontinuation. No published literature supports the efficacy or safety of higher dosages, longer treatment periods or repeated courses of therapy.

Postpartum mothers are at a relatively high risk for postpartum depression and metoclopramide can cause depression as a side effect. Therefore, metoclopramide should probably be avoided in women with a history of major depression and not used for prolonged periods in any mothers during this time of high susceptibility.[9,10] Long-term uses of metoclopramide also increases the risk of tardive dyskinesia.[11] Other reported side effects in nursing mothers include tiredness, nausea, headache, diarrhea, dry mouth, breast discomfort, vertigo, restless legs, intestinal gas, hair loss, irritability and anxiety.[10,12-14] In a survey of nursing mothers in the United States, 32 had used metoclopramide as a galactogogue and all reported having experienced an adverse reaction from the drug.[15] A larger survey of women taking metoclopramide for lactation enhancement found that 4.8% of women had either palpitations or racing heart rate, 12% reported depression, and 1 to 7% reported other central nervous system side effects ranging from dizziness and headache to involuntary grimacing and tremors. Diarrhea, irritability and fatigue were also relatively common.[16]

“Summary of Use during Lactation”, LactMed record “Metoclopramide” (LM477), quoted verbatim. Everything LactMed reports about Metoclopramide while breastfeeding.

Nursing Mothers Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.

Prescribing label, section “Nursing Mothers”: Metoclopramide (oral), ATLANTIC BIOLOGICALS CORP. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.