Can I get domperidone in the US? Understanding FDA Regulations and Access

October 11, 2025 •

4 min read

The US Food and Drug Administration (FDA) issued a warning in 2004 regarding the distribution of domperidone, a drug available in many other countries for gastrointestinal issues and lactation enhancement. This means that for general use, the answer to "Can I get domperidone in the US?" is effectively no, as it is not an FDA-approved or legally marketed human drug in the United States.

Quick Summary

Domperidone is not an FDA-approved medication for human use in the United States due to safety concerns, including serious cardiac risks. Access is possible only through the FDA's restrictive Expanded Access program for patients with severe, treatment-resistant gastrointestinal motility disorders. Illegal importation or use for non-approved purposes, like lactation, is advised against by the FDA.

Key Points

FDA Unapproved: Domperidone is not approved for any human use by the U.S. Food and Drug Administration due to significant safety concerns.
Cardiac Risk: The primary reason for FDA restriction is the drug's association with serious cardiac adverse events, including arrhythmia, cardiac arrest, and sudden death.
Expanded Access Only: The only legal way to obtain domperidone for human use in the U.S. is through the FDA's Expanded Access (Compassionate Use) program for severe gastrointestinal motility disorders when standard therapies fail.
No Compounding or Importation: It is illegal for pharmacies to compound domperidone and for individuals to import it for human use, with the FDA issuing an import alert.
Not for Lactation: The FDA explicitly warns against using domperidone to enhance breast milk production, citing both maternal and infant safety concerns.
Strict Oversight: Obtaining domperidone through the legal Expanded Access program requires rigorous physician oversight and patient cardiac monitoring.
Metoclopramide Alternative: Metoclopramide (Reglan) is an FDA-approved alternative for gastroparesis, although it has different side effects, including a risk of neurological issues.

The question of whether one can I get domperidone in the US is a complex one, with the simple answer being that it is not available for standard medical use. Unlike many other countries where the drug is widely prescribed or even available over-the-counter, the United States Food and Drug Administration (FDA) has never approved domperidone for marketing or sale to humans. The agency's position is based on significant safety concerns, most notably the risk of serious cardiac arrhythmias, cardiac arrest, and sudden death. These risks led the FDA to issue warnings and impose strict regulations on the drug's distribution, importation, and compounding within the U.S.

The Strict Regulatory Status of Domperidone in the US

Domperidone's journey in the U.S. has been marked by strong regulatory action. In 2004, the FDA issued a talk paper warning against the use of unapproved domperidone, particularly for enhancing milk production in lactating women. The warning highlighted the cardiac risks associated with the drug, including QT prolongation, which can lead to irregular heartbeats. The FDA also noted that domperidone is excreted in breast milk, potentially exposing infants to unknown risks. These warnings have been reinforced over the years with updates that also mention potential neuropsychiatric adverse events associated with discontinuing the drug, such as anxiety and suicidal ideation.

Furthermore, the FDA has made it clear that distributing domperidone-containing products for human use in the U.S. is illegal. It cannot be legally compounded for humans, and an import alert allows FDA personnel to detain shipments of the drug. These stringent measures are in place to protect public health from what the agency deems to be a high-risk medication in an unregulated setting.

The Expanded Access Program: A Legal Pathway

For a narrow group of patients, there is a legal, albeit highly restrictive, path to obtain domperidone. The FDA recognizes that some patients with severe gastrointestinal motility disorders, for whom other treatments have failed, may benefit from the drug's prokinetic effects. These patients, aged 12 and older, with conditions like gastroparesis, severe gastroesophageal reflux disease, or chronic constipation, may be able to access the drug through the FDA's Expanded Access (Compassionate Use) Investigational New Drug (IND) program.

To enroll in this program, a patient's physician must submit an IND application to the FDA and obtain approval. The process is highly regulated and requires thorough documentation demonstrating that the patient has exhausted all other comparable treatment options. Even within this program, the FDA enforces strict cardiac monitoring due to the known risks. The domperidone obtained via this program is considered an investigational drug, and its use is closely overseen by the physician and the FDA.

Comparison of Domperidone and Metoclopramide

In the U.S., metoclopramide (brand name Reglan) is the only FDA-approved prokinetic medication for gastroparesis, despite its own risk profile, particularly for long-term use. Here is a comparison of these two drugs:


Feature	Domperidone (Not generally available in US)	Metoclopramide (Reglan) (FDA-approved in US)
FDA Status	Not approved for any human use; access only via Expanded Access IND for specific GI conditions.	FDA-approved for gastroparesis and other GI issues.
Availability	Prescription only via restricted access program or illegal import.	Widely available via prescription.
CNS Side Effects	Minimally crosses the blood-brain barrier, resulting in fewer neurological side effects (e.g., extrapyramidal symptoms).	Crosses the blood-brain barrier, carrying a risk of neurological side effects, including tardive dyskinesia, especially with prolonged use.
Cardiac Risks	Associated with cardiac arrhythmias, QT prolongation, and sudden death.	Also associated with QT prolongation and cardiac risks.
Primary Use (International)	Nausea, vomiting, gastroparesis, and off-label for lactation enhancement.	Gastroparesis, nausea, and vomiting.

The Risks of Sourcing Domperidone Illegally

For those considering ordering domperidone from online pharmacies or importing it from countries where it is available, the risks are substantial. The FDA warns that the quality of illegally imported drugs cannot be assured, and they may be mislabeled, contaminated, or contain incorrect dosages. Moreover, the serious cardiac and neuropsychiatric risks remain, and individuals who bypass the legal pathway do so without the crucial medical oversight and safety monitoring required under the FDA's strict protocol. In addition to health risks, importing unapproved drugs can have legal consequences.

Domperidone's Off-Label Use for Lactation

One of the most controversial uses of domperidone is as a galactagogue, a drug to increase milk production in breastfeeding mothers. While it is used for this purpose in some other countries, the FDA explicitly warns against this use, citing safety concerns for both the mother and the infant. The FDA's stance is that the benefits of using domperidone for lactation do not outweigh the serious risks, particularly since the drug's effectiveness for this purpose has not been definitively established.

Conclusion

In summary, the answer to Can I get domperidone in the US? is multifaceted. The drug is not and will not be available for general prescription use due to serious safety warnings from the FDA regarding cardiac risks and other side effects. The only legal path to access domperidone for human use is for a limited group of patients with severe, treatment-resistant gastrointestinal motility disorders, and it requires a physician to submit an Investigational New Drug (IND) application through the FDA's Expanded Access Program. For those considering other avenues, such as importation, it is crucial to understand the significant health and legal risks involved. Patients should always consult with their healthcare provider to discuss safe and effective treatment alternatives approved for use in the United States.

For more information on the Expanded Access program for domperidone, please visit the official FDA website.

Frequently Asked Questions

The FDA has not approved domperidone for human use in the US due to safety concerns, most notably the risk of serious cardiac arrhythmias, cardiac arrest, and sudden death. These risks were considered to outweigh the potential benefits for many of its intended uses.

No, importing domperidone into the U.S. is illegal. The FDA has an import alert allowing personnel to detain shipments of the drug. The agency warns against illegally imported drugs, as their safety and quality cannot be assured.

The Expanded Access Program allows patients aged 12 and older with severe, treatment-resistant gastrointestinal motility disorders (like gastroparesis) to receive domperidone under a specific Investigational New Drug (IND) application. A physician must file the application with the FDA after standard therapies have failed.

No, the FDA strongly advises against using domperidone for lactation enhancement due to potential serious cardiac adverse events for the mother and unknown risks for the infant. The effectiveness for this use is also not established to the FDA's satisfaction.

Common side effects can include dry mouth, headaches, abdominal cramps, and elevated prolactin levels, which can lead to breast enlargement or pain. More serious, albeit rare, side effects include cardiac arrhythmias, and neuropsychiatric effects upon withdrawal.

The main FDA-approved alternative is metoclopramide (Reglan), though it carries different side effect risks, particularly neurological ones, limiting its long-term use. Erythromycin and antiemetics like ondansetron may also be used.

Domperidone has fewer neurological side effects because it minimally crosses the blood-brain barrier at therapeutic doses, unlike metoclopramide. This limits its impact on the central nervous system, reducing the risk of issues like tardive dyskinesia.