FDA label
What is lubiprostone used for?
The FDA-approved uses of lubiprostone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for lubiprostone lists 3 uses: Chronic Idiopathic Constipation in Adults; Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain; Irritable Bowel Syndrome with Constipation.
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Lubiprostone, capsule
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA218640). Cross-references to other label sections are left out.
Chronic Idiopathic Constipation in Adults
Lubiprostone capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
Lubiprostone capsules are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Limitations of Use: Effectiveness of lubiprostone capsules in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
Irritable Bowel Syndrome with Constipation
Lubiprostone capsules are indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
Source: DailyMed label, set id 6d973d7d-a43e-4495-b618-a8ad3142683d, version 1, effective January 22, 2025. NDC 31722-403, one of 12 listings for this product.
Questions
What is lubiprostone used for?
The FDA label for lubiprostone lists 3 uses: Chronic Idiopathic Constipation in Adults; Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain; Irritable Bowel Syndrome with Constipation.
What drug class is lubiprostone?
FDA lists lubiprostone in the Chloride Channel Activator established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.