Metoclopramide
1. Pregnancy Evidence & Regulatory Labeling
FDA Pregnancy and Lactation Labeling Rule (PLLR 8.1) & EMA SmPC Section 4.6
Clinical Risk Summary
Regulatory Warnings & Contraindications
FDA Boxed Warning: This medication carries an official Boxed Warning regarding embryo-fetal toxicity or pregnancy-related adverse outcomes.
CONTRAINDICATIONS Metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. Metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phentolamine. Metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug. Metoclopramide should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.
2. Lactation & Breastfeeding Safety
NIH / NLM LactMed® Database & FDA Labeling Section 8.2
Summary of Use during Lactation
Nursing Mothers Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.
Drug Levels in Breast Milk & Relative Infant Dose
Evaluated in human/animal pharmacokinetic models.
3. Females & Males of Reproductive Potential
FDA Labeling Section 8.3 — Pregnancy Testing, Contraception & Infertility
Standard pre-treatment clinical assessment as indicated.
Review contraception duration based on drug elimination half-life.
No significant drug-induced impairment reported in standard models.
4. Regulatory Source Provenance & Comparison
Direct attribution to official regulatory documents without synthesized consensus
| Regulatory Organization | Jurisdiction | Document / Framework | Effective Date | Official Source Link |
|---|---|---|---|---|
|
U.S. Food and Drug Administration (FDA)
FDA Prescribing Information (PLLR)
|
United States | regulatory_label | 2026-07-24 | Official Record |
|
European Medicines Agency (EMA)
EMA Summary of Product Characteristics (SmPC 4.6)
|
European Union | regulatory_label | Recent | Official Record |