Dicyclomine Prescription Status
No, dicyclomine is not available over the counter—it requires a prescription (Rx only) in the United States. 1
Regulatory Classification
The FDA drug label explicitly designates dicyclomine hydrochloride tablets as "Rx Only," meaning it is a prescription-only medication that cannot be purchased without a valid prescription from a licensed healthcare provider. 1
This prescription requirement exists despite dicyclomine being a relatively older anticholinergic antispasmodic medication that has been used for decades in the treatment of irritable bowel syndrome (IBS). 2
Clinical Context for Prescription Requirement
Anticholinergic side effects necessitate medical supervision: Dicyclomine's mechanism of action involves blocking muscarinic receptors, which can cause dry mouth, blurred vision, dizziness, and other anticholinergic effects that require monitoring. 2
Serious safety concerns with improper administration: Intravenous administration of dicyclomine (which should never occur) can cause thrombotic complications, highlighting the need for proper medical oversight of administration routes. 3
Contraindications require medical assessment: Dicyclomine should be avoided in patients with constipation-predominant symptoms, as it can worsen this condition through its anticholinergic effects. 2, 4
Efficacy Evidence Supporting Prescription Status
The British Society of Gastroenterology guidelines note that dicyclomine bromide showed the most significant improvement in pain among anticholinergic antispasmodics in meta-analysis of 26 double-blind trials, though common anticholinergic side effects may limit use. 2
The American Gastroenterological Association acknowledges that only hyoscine, dicyclomine, and peppermint oil are available antispasmodics in the United States, with dicyclomine requiring prescription oversight. 2
Important caveat: While dicyclomine has Grade A recommendation evidence for reducing IBS pain, research from 2006 indicates that dicyclomine and hyoscyamine have not been definitively proven effective in reducing abdominal pain in IBS patients, suggesting the prescription requirement allows for appropriate patient selection and monitoring. 5