What Is Lactulose Used For? FDA-Approved Uses

The FDA label says: “For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.”

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Lactulose, solution

Indications and Usage, quoted from the label by Chartwell Governmental & Specialty RX, LLC. (ANDA209517). Cross-references to other label sections are left out.

For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Source: DailyMed label, set id 887157ba-3c91-4fbf-bb12-b49c6fa4252c, version 1, effective November 13, 2025. NDC 68999-002, one of 29 listings for this product.

Lactulose, powder, for solution

Indications and Usage, quoted from the label by PAI Holdings, LLC dba PAI Pharma (ANDA217914). Cross-references to other label sections are left out.

Lactulose for Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Source: DailyMed label, set id 5ae4b6da-44df-419a-9f2b-8c4d79f635c8, version 4, effective July 7, 2026. NDC 0121-0965, one of 8 listings for this product.

Questions

What is lactulose used for?

The FDA label says: “For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.”

What drug class is lactulose?

FDA lists lactulose in the Osmotic Laxative 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.