Information about Domperidone

Domperidone is not an FDA-approved drug for any indication, or use, in humans. Domperidone is approved in some countries, but not in the U.S., to treat certain gastrointestinal disorders. Domperidone is not approved in any country to stimulate lactation or enhance breast milk production.

What patients/consumers should know about domperidone use in humans

• Although not approved in the U.S. for human use, FDA is aware some people have used domperidone to stimulate lactation or enhance breast milk production.
  • The effectiveness of domperidone to stimulate lactation or increase milk supply has not been established.
• Domperidone has been associated with serious cardiac adverse events, including cardiac arrhythmias (irregular heartbeat), cardiac arrest, and sudden death.
  • FDA has identified cases of serious cardiac adverse events with domperidone use in lactating individuals.
  • In 2004 and again in 2012, FDA published a warning about cardiac-related risks with the use of domperidone to increase lactation.
• In 2023, FDA completed a review of cases to evaluate neuropsychiatric adverse events associated with the discontinuation or attempted discontinuation (slow dose-reduction) of domperidone when used for lactation.
  • FDA identified six cases reporting various adverse events, including agitation, anxiety, attempted suicide, confusion, insomnia, intrusive thoughts, homicidal ideation, obsessive thoughts and suicidal ideation.
  • FDA’s findings provide sufficient evidence to suggest a potential association between the development of neuropsychiatric adverse events upon the sudden discontinuation or tapering of domperidone when used for lactation.
• When taken by a lactating individual, domperidone is excreted in breast milk and could expose a breastfeeding infant to unknown risks.
• FDA cautions that use of domperidone to increase milk production or stimulate lactation could cause serious adverse effects.
• Some patients with certain gastrointestinal conditions may be able to receive treatment with domperidone through an expanded access investigational new drug application. Talk to your health care professional for more information.

What health care professionals should know about domperidone use in humans

For lactation

• Domperidone has been associated with serious cardiac adverse events, including QT prolongation, torsade de pointes, cardiac arrest, and sudden death.
  • FDA has identified cases of serious cardiac adverse events with domperidone use in lactating individuals.
  • In 2004 and in 2012, FDA published a warning about cardiac-related risks with the use of domperidone to increase lactation.

• When taken by a lactating individual, domperidone is excreted in breast milk and could expose a breastfeeding infant to unknown risks.
• FDA completed a review of cases to evaluate withdrawal-related neuropsychiatric adverse events associated with the sudden discontinuation or tapering of domperidone when used for lactation.
  • FDA identified six cases reporting various adverse events, including agitation, anxiety, attempted suicide, confusion, insomnia, intrusive thoughts, homicidal ideation, obsessive thoughts and suicidal ideation.
  • Five cases reported a domperidone dose of at least 90 mg per day; the remaining case did not report their domperidone dose.
  • FDA’s findings provide sufficient evidence to suggest a potential drug-event association between the development of withdrawal-related neuropsychiatric adverse events upon the sudden discontinuation or tapering of domperidone when used for lactation.
• FDA cautions that use of domperidone to increase milk production or stimulate lactation could cause serious adverse effects.

For gastrointestinal conditions

• Patients 12 years of age and older with certain gastrointestinal (GI) conditions who have failed standard therapies may be able to receive treatment with domperidone through an expanded access investigational new drug application. These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation.
• Visit FDA’s domperidone expanded access use webpage to learn more about submitting an IND for domperidone.

Legal status of domperidone

• Because compounded drugs containing domperidone do not meet the conditions under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act, products containing domperidone cannot be legally compounded for humans under those sections.
• In general, distributing any domperidone-containing products for human use in the U.S. is illegal.
  • There are limited exceptions, such as use under an investigational new drug application.

Related Information

• FDA Talk Paper: FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production
• How to Request Domperidone for Expanded Access Use