Domperidone and Gastroparesis

Domperidone is a prokinetic medicine that helps the stomach empty and eases nausea, and some people with gastroparesis turn to it when approved drugs do not work. It is not approved by the United States Food and Drug Administration, and the only legal United States pathway, a special FDA access program, lost its supplier and ended its supply after September 2025.

What is domperidone and how does it help gastroparesis?

Domperidone belongs to a group of drugs called prokinetics, which encourage the stomach to contract and move food along. It also works as an antiemetic, meaning it can reduce nausea and vomiting. Those two effects are why it has long drawn interest in gastroparesis, the condition in which the stomach empties too slowly. Domperidone is sold in many other countries, but in the United States its story is different, and that difference is the reason this page exists.

Is domperidone available in the United States?

Domperidone is not approved by the Food and Drug Administration for any use in people in the United States. For years, the only legal way to use it was through an FDA expanded-access program, a route that lets a patient receive an unapproved drug when no approved option has worked. According to the FDA, patients aged twelve and older with certain digestive conditions, including gastroparesis, gastroesophageal reflux disease with upper digestive symptoms, and chronic constipation, could receive domperidone this way after standard therapies had failed. A doctor, not the patient, applied to the FDA to make this happen.

What changed for domperidone access in 2025?

The supply behind that program ended. The FDA was informed in late 2022 that the company supplying domperidone for the program was leaving the business, and the FDA has stated that domperidone will no longer be distributed for expanded-access use by that supplier after September 2025. In plain terms, the established route that patients and doctors relied on for years is no longer being supplied.

The FDA has said that if a new supplier is found, a doctor could submit a new expanded-access application for consideration, and that if the supplier is outside the United States, the doctor would also have to follow the FDA's drug-importation rules. The agency has said it remains available to help once a new supplier is identified.

How could someone get domperidone for gastroparesis now?

With the program's supply ended, there is no routine way to obtain domperidone in the United States. It is not a prescription you can simply fill at a pharmacy. The only lawful path remains an expanded-access application that a physician submits to the FDA, and that path now depends on a supplier being available. If you and your doctor believe domperidone may help, the conversation starts with your gastroenterologist, who can explain the current options and, where appropriate, work through the FDA process. The approved medicines for gastroparesis are covered on our gastroparesis medications page.

Why is domperidone not approved in the United States?

The central reason is heart safety. The FDA has linked domperidone to serious cardiac problems, including abnormal heart rhythms, cardiac arrest, and sudden death, and observational studies have tied its use to a higher risk of sudden cardiac death. Because of these risks, the drug has never been approved for general use, and distributing domperidone for human use in the United States is generally illegal, apart from limited exceptions such as use under an FDA expanded-access program. That heart risk is also why any use should be supervised by a doctor rather than self-managed.

How does domperidone compare with metoclopramide?

Metoclopramide is the only medicine the FDA has approved specifically for gastroparesis. It carries a boxed warning, the FDA's strongest, about a movement disorder called tardive dyskinesia, although recent research suggests this side effect occurs in fewer than one in a hundred patients. Domperidone avoids that particular risk but brings the heart-rhythm risk described above. Weighing those trade-offs, the American Gastroenterological Association's 2025 guideline issued a conditional recommendation against using domperidone as a routine first choice, noting that its symptom benefit did not reach the threshold for clinical importance and that observational studies linked it to sudden cardiac death. A full comparison of the approved drugs is on our gastroparesis medications page.

Sources

Reviewed by Owen Hastings.

• U.S. Food and Drug Administration, How to Request Domperidone for Expanded Access Use (fda.gov), for domperidone's unapproved status, the expanded-access program, the eligibility criteria (age twelve and older, gastroparesis and other digestive conditions, failure of standard therapy), the supplier's exit (the FDA was informed in late 2022), the statement that domperidone will no longer be distributed for expanded-access use by the current supplier after September 2025, and the path to a new application if another supplier is found.
• U.S. Food and Drug Administration, Information about Domperidone (fda.gov), for the cardiac safety concerns (abnormal heart rhythms, cardiac arrest, and sudden death) and the legal status of distributing domperidone for human use.
• American Gastroenterological Association, Clinical Practice Guideline on Gastroparesis (gastro.org), published September 2025, for the conditional recommendation against routine first-line domperidone and that domperidone remains unavailable in the United States outside investigational access.

This page is general health information, not medical advice. Talk to your doctor or gastroenterologist about your own care. Last reviewed June 2026.