Two medicines, side by side
Misoprostol vs omeprazole
Misoprostol and omeprazole are both labeled for acid reflux and ulcers. Drugs@FDA records approvals of misoprostol since 1988 and of omeprazole since 1989. Pharmacies paid $0.719 per misoprostol 200 mcg tablet and $0.0295 per omeprazole DR 20 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Omeprazole's other strengths are brand-only: $14.75 per pen (Prilosec DR 2.5 mg suspension). In FDA's classes, misoprostol is a prostaglandin e1 analog and omeprazole a proton pump inhibitor.
Check it at the source: the misoprostol FDA label on DailyMed (effective June 4, 2026); the omeprazole FDA label on DailyMed (effective April 22, 2024).
Highlights of the misoprostol record
Misoprostol (Cytotec) · label of June 4, 2026
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: indicationsCytotec (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 omeprazole record
Omeprazole (Prilosec) · label of April 22, 2024
Used for
From the label: indicationsOmeprazole is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older ( 1.4 ) Treatment of erosive esophagitis […]
On the market
- Earliest approval on file
- September 14, 1989
- Generic labelers
- 118 labelers
- Pharmacy cost
- $0.0295 per capsule
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 7
Source: FDA drug labels via openFDA (Misoprostol label of June 4, 2026, Omeprazole label of April 22, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do misoprostol and omeprazole differ on the record?
In FDA's classes, misoprostol is a prostaglandin e1 analog and omeprazole a proton pump inhibitor.
Half-life, in each label's words: Misoprostol, “In normal volunteers, Cytotec (misoprostol) is rapidly absorbed after oral administration with a T max of misoprostol …”; Omeprazole, “disease classified as Child-Pugh Class A (n=3), B (n=4) and C (n=1), the bioavailability increased to approximately …”
Only the misoprostol label carries a boxed warning.
Generics: misoprostol since 2002; omeprazole since 2002 (Drugs@FDA).
| Misoprostol | Omeprazole | |
|---|---|---|
| Labeled for | Acid reflux and ulcers | Acid reflux and ulcers |
| Pharmacologic class | Prostaglandin E1 Analog | Proton Pump Inhibitor |
| How it works (label) | n/a | Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H + /K + ATPase enzyme system at the secretory surface of the gastric parietal … |
| 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. | disease classified as Child-Pugh Class A (n=3), B (n=4) and C (n=1), the bioavailability increased to approximately 100% compared to healthy subjects, reflecting decreased first-pass effect, and the plasma half-life of … |
| Earliest approval on file (Drugs@FDA) | December 27, 1988 | September 14, 1989 |
| First generic approved | July 10, 2002 | November 1, 2002 |
| Generic labelers (NDC) | 13 labelers | 118 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.719 per tablet (Misoprostol 200 mcg tablet) | $0.0295 per capsule (Omeprazole DR 20 mg capsule) |
| 12-month price change | +14% | -7% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 1 | 7 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 9,682 | 446,179 |
| DEA schedule | none | none |
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?
- Alternatives to misoprostol
- every medicine labeled for the same conditions