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Title: Black Box Warning for Metoclopramide

Category: Toxicology

Keywords: metoclopramide, black box warning, tardive dyskinesia (PubMed Search)

Posted: 3/12/2009 by Bryan Hayes, PharmD (Updated: 7/21/2026)

Add metoclopramide (Reglan) to the laundry list of medications with black box warnings from the FDA. Why was a black box warning added?

  • Long-term metoclopramide use has been linked to tardive dyskinesia (involuntary and repetitive body movements) even after the drug is no longer being taken.
  • Risk factors: Long-term or high-dose use, elderly, female gender.
  • Recommended that metoclopramide treatment not exceed 3 months.
What implications does this have for our practice in the ED?
  • None really.
  • Just be aware of the dopamine antagonist effects (EPS - dystonic reactions) that are possible whenever you order metoclopramide in the acute setting.
  • These effects can be treated effectively with an anticholinergic agent, such as diphenhydramine or benztropine.

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