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Two medicines, side by side

Misoprostol vs sucralfate

Misoprostol and sucralfate are both labeled for acid reflux and ulcers. Drugs@FDA records approvals of misoprostol since 1988 and of sucralfate since 1981. Pharmacies paid $0.719 per misoprostol 200 mcg tablet and $0.173 per sucralfate 1 g tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, misoprostol is a prostaglandin e1 analog and sucralfate an aluminum complex.

Check it at the source: the misoprostol FDA label on DailyMed (effective June 4, 2026); the sucralfate FDA label on DailyMed (effective September 2, 2026).

Highlights of the misoprostol record

Misoprostol (Cytotec) · label of June 4, 2026

Boxed warning

CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY (see also PRECAUTIONS and LABOR AND DELIVERY ).

Used for

From the label: indications

Cytotec (misoprostol) is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. […]

On the market

Earliest approval on file
December 27, 1988
Generic labelers
13 labelers
Pharmacy cost
$0.719 per tablet

Supply and safety

Shortage
No current entry
Recalls
1

Highlights of the sucralfate record

Sucralfate (Carafate) · label of September 2, 2026

Used for

From the label: indications

Sucralfate is indicated in: • Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. • Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

On the market

Earliest approval on file
October 30, 1981
Generic labelers
43 labelers
Pharmacy cost
$0.173 per tablet

Supply and safety

Shortage
No current entry
Recalls
6

Source: FDA drug labels via openFDA (Misoprostol label of June 4, 2026, Sucralfate label of September 2, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do misoprostol and sucralfate differ on the record?

In FDA's classes, misoprostol is a prostaglandin e1 analog and sucralfate an aluminum complex.

Only the misoprostol label carries a boxed warning.

Generics: misoprostol since 2002; sucralfate since 1996 (Drugs@FDA).

MisoprostolSucralfate
Labeled forAcid reflux and ulcersAcid reflux and ulcers
Pharmacologic classProstaglandin E1 AnalogAluminum Complex
How it works (label)n/an/a
Half-life (label)In normal volunteers, Cytotec (misoprostol) is rapidly absorbed after oral administration with a T max of misoprostol acid of 12 ± 3 minutes and a terminal half-life of 20–40 minutes.n/a
Earliest approval on file (Drugs@FDA)December 27, 1988October 30, 1981
First generic approvedJuly 10, 2002March 29, 1996
Generic labelers (NDC)13 labelers43 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.719 per tablet (Misoprostol 200 mcg tablet)$0.173 per tablet (Sucralfate 1 g tablet)
12-month price change+14%-6%
Boxed warningYesNo
Shortage nowNo current entryNo current entry
Recalls recorded16
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)9,68223,820
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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