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Domperidone is a dopamine D2 receptor antagonist with gastrointestinal prokinetic and antiemetic activity. It is approved in some countries for selected gastrointestinal uses, but FDA has not approved domperidone for any human indication in the United States. Routine sale and human compounding of domperidone are not legally permitted under current U.S. rules.
read more about domperidone ...Domperidone blocks peripheral dopamine D2 receptors in the gastrointestinal tract and in the chemoreceptor trigger zone outside the blood-brain barrier. Dopamine receptor blockade increases upper gastrointestinal motility and contributes to antiemetic activity. Its limited penetration into the brain distinguishes it pharmacologically from centrally acting dopamine antagonists.
No. FDA states that domperidone is not approved for any human indication in the United States. It is also not approved in any country specifically to stimulate lactation or increase breast milk production. FDA states that effectiveness for increasing milk supply has not been established.
FDA describes limited investigational access for patients age 12 and older with certain gastrointestinal disorders who have not responded to standard therapies. Access requires an expanded access investigational new drug application and a suitable drug source. FDA reported that the prior expanded-access supplier stopped distribution after September 2025.
FDA has linked domperidone use with serious cardiac events, including abnormal heart rhythms, cardiac arrest, and sudden death. FDA has also identified withdrawal-related neuropsychiatric reactions after abrupt discontinuation or tapering when the drug was used for lactation. There is no FDA-approved U.S. dosing regimen for domperidone.
No. FDA has not approved domperidone for any human indication in the United States.
No. FDA states that domperidone does not meet the federal conditions for routine human drug compounding.
No. FDA states that domperidone is not approved for lactation and its effectiveness for increasing milk supply has not been established.
No. Since domperidone is not FDA approved, there is no FDA-approved U.S. dosing regimen.
Domperidone. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Domperidone. Date Accessed September 25, 2026.
Domperidone IND Packet. U.S. Food and Drug Administration. https://www.fda.gov/media/100064/download. Date Accessed September 25, 2026.
Gastroparesis. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK551528/. Date Accessed September 25, 2026.
How to Request Domperidone for Expanded Access Use. U.S. Food and Drug Administration. https://www.fda.gov/drugs/investigational-new-drug-application-ind/how-request-domperidone-expanded-access-use. Date Accessed September 25, 2026.
Information about Domperidone. U.S. Food and Drug Administration. https://www.fda.gov/drugs/investigational-new-drug-application-ind/information-about-domperidone. Date Accessed September 25, 2026.