Answer
Apr 30, 2025 - 12:09 PM
Buscopan is not routinely available for people in the United States because its active ingredient, hyoscine butylbromide—also called scopolamine butylbromide—has never received FDA approval for human use. This does not mean the FDA banned or recalled it.
For a medicine to be marketed in the U.S., a manufacturer must submit a New Drug Application containing adequate safety, effectiveness and manufacturing data. There is no publicly documented human Buscopan application that resulted in approval, and the manufacturer has not clearly stated why it did not pursue or complete that process. It was likely a regulatory and commercial decision rather than a specific safety-related withdrawal.
Interestingly, Buscopan injection is FDA-approved in the U.S. for treating colic in horses, and its label specifically restricts it to veterinary use. It must never be substituted for a human product.
Also, Buscopan is different from the FDA-approved scopolamine skin patch used for motion sickness. Although the names are related, they have different formulations, absorption and uses.
For human intestinal cramping or IBS, U.S. clinicians may instead prescribe antispasmodics such as dicyclomine or hyoscyamine, depending on the cause and the patient’s medical history.
