Registration Dossier
Registration Dossier
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EC number: 206-662-9 | CAS number: 364-62-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Hyperprolactinemia may be associated with menstrual disturbances and infertility in women. Although amenorrhea/galactorrhea in women and impotence in men on metoclopramide have been reported to the manufacturer (AH Robins, Richmond VA), we are not aware of data to suggest how often therapy might be associated with impairment of fertility.
Metoclopramide. REPROTOX® Database: Klasco RK: REPROTOX® Database. Truven Health Analytics, Greenwood Village, Colorado.
Effects on developmental toxicity
Description of key information
Based on experimental animal studies and human experiences, metoclopramide therapy during pregnancy is not anticipated to increase the risk of congenital anomalies.
Metoclopramide. REPROTOX® Database: Klasco RK: REPROTOX® Database. Truven Health Analytics, Greenwood Village, Colorado.
U.S. Food and Drug Administration's Pregnancy Category: Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
Metoclopramide. DRUGDEX® System: Klasco RK: DRUGDEX® System. Truven Health Analytics, Greenwood Village, Colorado.
Toxicity to reproduction: other studies
Description of key information
Metoclopramide is excreted in variable amounts in breastmilk. 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 is used as a galactogogue.Metoclopramide increases serum prolactin, but its clinical value in increasing milk supply is questionable. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production. 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.
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. Long-term uses of metoclopramide also increases the risk of tardive dyskinesia. Other reported side effects in nursing mothers include tiredness, nausea, headache, diarrhea, dry mouth, breast discomfort, vertigo, restless legs, intestinal gas, hair loss and anxiety.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.
Metoclopramide. Drugs and Lactation Database [Internet]. Bethesda (MD): National Library of Medicine (US). Available from: http://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm
Justification for classification or non-classification
Overall, available data indicate that the substance in experimental and human experiences does not increase the risk of congenital anomalies. There are not data to suggest how often therapy with metoclopramide might be associated with impairment of fertility. The substance is in Category B of U.S. FDA. Available data are conclusive but not sufficient for the classification of the substance for toxicity to reproduction.
Additional information
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