Domperidone

Domperidone is a stomach-emptying medicine sold by prescription outside the United States, including in Canada, but it is not FDA-approved for any use in humans. In the U.S. it has been available only through FDA expanded access, and the FDA said that program's supplier would stop distributing it after September 2025.

Domperidone blocks dopamine receptors, which helps the stomach contract and empty, and the FDA describes it as a dopamine antagonist with prokinetic properties that does not readily cross the blood-brain barrier^[2]. Metoclopramide, the FDA-approved alternative, carries a boxed warning for tardive dyskinesia, a movement disorder^[11].

The FDA warned in 2004 that domperidone carries a risk of irregular heart rhythms, cardiac arrest and sudden death, and says those risks are higher when it is taken with moderate or strong CYP3A4 inhibitors, a group that, in the FDA's list, includes some antidepressants, anti-nausea medicines, antibiotics, antifungals and heart medicines^[2]. Health Canada's 2015 safety review set the maximum recommended dose at 30 mg a day because of heart rhythm risks^[3]. The topics the FDA requires in the expanded access consent form also include raised prolactin levels, movement side effects and breast changes. In 2023 the FDA identified 6 cases of psychiatric symptoms, including agitation, anxiety, insomnia, suicidal thoughts and attempted suicide, in people who stopped or tapered domperidone taken to increase breast milk^[1].

Under the FDA's expanded access protocol, domperidone is taken by mouth at 10 mg to 30 mg 4 times a day, starting at the lowest dose and staying at the lowest dose that works^[2]. That protocol allows up to 120 mg a day, while Health Canada's 2015 review set a maximum recommended dose of 30 mg a day because of heart rhythm risks^[3], so the 2 references differ by a factor of 4 and the treating doctor decides the dose.

No. Domperidone is not FDA-approved for any use in the United States, though it is a prescription medicine in other countries. In the U.S. it has been available only through FDA expanded access, which a doctor requests for an individual patient.

The only lawful U.S. route is FDA expanded access, which a doctor requests for a patient, and the FDA said that program's supplier would stop distributing it after September 2025; a doctor who finds a new supplier can file a new application. Many patients have instead had it mailed from Canadian pharmacies, a personal import that depends on FDA discretion and was never part of the FDA program, and those deliveries are what the October 22, 2026 customs change is expected to stop.

Probably not reliably. From October 22, 2026, mailed packages holding FDA-regulated products need formal customs entry or CBP's new Entry Type 13, the Canadian International Pharmacy Association expects most mailed prescription orders to stop arriving, and domperidone has been under an FDA import alert since 2004.

Health Canada's 2015 safety review set the maximum recommended dose at 30 mg a day because of heart rhythm risks. The FDA's expanded access protocol allows 10 mg to 30 mg 4 times a day, starting low, so the treating doctor sets the dose.

Deudomperidone (CIN-102), a modified form of domperidone from CinDome Pharma, finished 2 Phase 2 gastroparesis trials, and the company expects topline results from one of them in late 2026. Neither trial is enrolling.