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Tardive Dyskinesia

  • Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.
  • Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
  • Treatment with metoclopramide (all dosage forms and outes of administration) for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

FDA and Industry Communications

Index to FDA Drug Safety Information

Medication Guides

Patient Medication Guide - Metoclopramide Oral Solution
Patient Medication Guide - Metoclopramide Nasal Spray (GIMOTI)
Patient Medication Guide - METOZOLV ODT
Patient Medication Guide - REGLAN Injection
Patient Medication Guide - REGLAN Tablets
Patient Medication Guide - REGLAN ODT

Package Inserts


Additional Information

Updated July 2020