Motilium

Indicated For

nausea, vomiting, gastroparesis

About This Medication

# Domperidone Patient Assistance: Understanding Your Options ## Important Notice About Domperidone Availability Domperidone (brand name Motilium) is **not approved by the FDA for use in the United States** and is not marketed here. However, U.S. patients with severe gastrointestinal conditions may access domperidone through limited pathways. This guide explains your options. ## About Domperidone Domperidone is a medication prescribed to treat nausea, vomiting, and certain gastrointestinal motility disorders. It is available in 112 nations worldwide, including all European Union countries. In the U.S., the FDA has not approved domperidone due to concerns about potentially fatal side effects, particularly in nursing women. ## Who May Qualify for Domperidone in the U.S. You may be eligible to receive domperidone through the **FDA Expanded Access Investigational New Drug (IND) Program** if you meet these criteria: - You are 12 years of age or older - You have been diagnosed with one of these severe gastrointestinal conditions: - Gastroesophageal reflux disease (GERD) with upper GI symptoms - Gastroparesis - Chronic constipation - You have **failed standard therapies** for your condition - You are being treated by a U.S. licensed healthcare provider - Your physician believes domperidone's potential benefits justify its potential risks in your case ## Critical Information: Program Status Change **As of August 2025, the FDA's domperidone expanded access program faces significant changes.** The current supplier of domperidone tablets will no longer supply the medication for expanded access use after September 2025, once the current supply is exhausted. The FDA states that the current supply may be exhausted as early as the first or second quarter of 2025. This means: - New patients may not be able to access domperidone through this program - Existing patients on domperidone should work with their physicians to explore alternative treatment strategies - The FDA remains available to assist if a new domperidone supplier is identified ## How to Apply for Expanded Access Domperidone ### Step 1: Consult Your Physician Your doctor must initiate the process. Contact your healthcare provider and discuss whether domperidone may be appropriate for your condition. Your physician will need to: - Confirm you have a qualifying gastrointestinal condition - Document that you have failed standard therapies - Determine that domperidone's potential benefits outweigh risks in your case ### Step 2: Physician Submits IND Application Your physician (not you directly) submits an expanded access IND application to the FDA. Your doctor can download the Domperidone Packet from the FDA website, which contains required forms and instructions. ### Step 3: FDA Review The FDA reviews your physician's application. Processing timelines are not specified in available information. ### Step 4: Receive Medication If approved, domperidone is distributed through the FDA's expanded access program supplier. ## Insurance and Cost Information **There is no traditional patient assistance program for domperidone** because it is not marketed in the U.S. Instead: - **Expanded Access Program**: Domperidone provided through the FDA program is supplied at no cost to eligible patients - **International Purchase**: If you are not in the U.S. or have access to other countries' pharmacies, domperidone is very affordable internationally—less than $0.25 per tablet at accredited international pharmacies - **Prescription Requirement**: You will need a valid prescription from your U.S. licensed healthcare provider to purchase domperidone internationally ## Required Documentation Your physician will need to provide: - Medical records documenting your gastrointestinal condition - Documentation of failed standard therapies - Clinical justification for domperidone use - Your complete medical history You may need to provide: - Proof of U.S. residency - Identification - Insurance information (if applicable) ## What If Your Application Is Denied or the Program Becomes Unavailable Given the program's uncertain status as of September 2025, consider these alternatives: - **Discuss Alternative Medications**: Work with your physician to explore other FDA-approved treatments for your gastrointestinal condition - **International Pharmacy**: If legally permissible in your situation, purchase domperidone from accredited international pharmacies with a valid prescription - **Clinical Trials**: Ask your physician about clinical trials for gastrointestinal motility disorders - **Specialist Referral**: Consult a gastroenterologist for additional treatment options ## Important Disclaimer This guide provides general information about domperidone access in the United States as of March 2026. The FDA expanded access program for domperidone is subject to change and may no longer be available. **Always consult with your licensed healthcare provider** before pursuing any treatment option. The information provided here is not medical advice and should not replace professional medical guidance. Domperidone carries potential risks and is not FDA-approved for use in the U.S. Your physician is the appropriate person to determine whether domperidone is suitable for your condition and to guide you through any application process.

Program information last verified: March 30, 2026