What is High dose budesonide rectal foam used for?

High dose budesonide rectal foam is indicated for Ulcerative colitis (distal/left-sided disease), Proctitis, Proctosigmoiditis.

Who makes High dose budesonide rectal foam?

High dose budesonide rectal foam is developed by Bausch Health Americas, Inc..

What development phase is High dose budesonide rectal foam in?

High dose budesonide rectal foam is FDA-approved (marketed).

What are the side effects of High dose budesonide rectal foam?

Common side effects include Headache, Abdominal pain, Nausea, Rectal irritation, Flatulence.

Last reviewed 2026-05-14 · How we verify

High dose budesonide rectal foam

Bausch Health Americas, Inc. · FDA-approved active Small molecule

Budesonide is a corticosteroid that suppresses local inflammation in the colon and rectum by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production.

Budesonide is a corticosteroid that suppresses local inflammation in the colon and rectum by binding to glucocorticoid receptors and inhibiting pro-inflammatory cytokine production. Used for Ulcerative colitis (distal/left-sided disease), Proctitis, Proctosigmoiditis.

At a glance

Generic name	High dose budesonide rectal foam
Sponsor	Bausch Health Americas, Inc.
Drug class	Corticosteroid
Target	Glucocorticoid receptor
Modality	Small molecule
Therapeutic area	Gastroenterology / Immunology
Phase	FDA-approved

Mechanism of action

Budesonide is a synthetic glucocorticoid that exerts potent anti-inflammatory effects through activation of intracellular glucocorticoid receptors, leading to suppression of inflammatory mediators and immune cell activation in the rectal and colonic mucosa. The rectal foam formulation delivers high local concentrations directly to the distal colon and rectum while minimizing systemic absorption. This localized delivery reduces inflammation characteristic of ulcerative colitis and other inflammatory bowel conditions affecting the lower gastrointestinal tract.

Approved indications

Ulcerative colitis (distal/left-sided disease)
Proctitis
Proctosigmoiditis

Common side effects

Headache
Abdominal pain
Nausea
Rectal irritation
Flatulence

Key clinical trials

Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

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