FDA label

What is cimetidine used for?

The FDA-approved uses of cimetidine, 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 says: “Cimetidine tablets are indicated in:”

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Cimetidine, tablet, film coated

Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA074246). Cross-references to other label sections are left out.

Cimetidine tablets are indicated in:

1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine.

2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine tablets 400 mg at bedtime for periods of up to 5 years.

3. Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks.

4. Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine tablets beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD).

5. The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).

Source: DailyMed label, set id 06c0a509-026f-44e0-9975-a94a8de51d43, version 12, effective July 15, 2026. NDC 0378-0053, one of 25 listings for this product.

Cimetidine Hydrochloride, solution

Indications and Usage, quoted from the label by Chartwell Governmental & Specialty RX, LLC. (ANDA074251). Cross-references to other label sections are left out.

Cimetidine Hydrochloride Oral Solution is indicated in:

Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see Dosage and Administration-Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine.

Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to 5 years.

Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks.

Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established (see Dosage and Administration-GERD).

The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).

Source: DailyMed label, set id e40bb1f6-338a-42e7-9217-8c32d14ccfd3, version 1, effective November 4, 2025. NDC 68999-809, one of 3 listings for this product.

Questions

What is cimetidine used for?

The FDA label says: “Cimetidine tablets are indicated in:”

What drug class is cimetidine?

FDA lists cimetidine in the Histamine-2 Receptor Antagonist 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.

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