Prescription and over-the-counter medicine
Misoprostol Brand names: Cytotec
Misoprostol (Cytotec) is a prescription and over-the-counter medicine with an FDA approval on record since 1988. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $0.719 per misoprostol 200 mcg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the misoprostol FDA label on DailyMed (effective June 4, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 19268 record on Drugs@FDA; every misoprostol label on DailyMed.
Highlights of the record
FDA label of June 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 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 ). CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (see CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. Cytotec should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, Cytotec may be prescribed if the patient
has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
is capable of complying with effective contraceptive measures. […]
Used for
From the label: indications and usageCytotec (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.
Forms and strengths
Tablet.
On the market
- Earliest approval on file
- December 27, 1988 Cytotec, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first July 10, 2002; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 13 under generic applications, 1 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.719 per tablet Misoprostol 200 mcg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest September 9, 2016; 2 more by firms not listed as its makers
- FAERS reports
- 9,682 through July 30, 2026
What is misoprostol used for?
From the label: indications and usageCytotec (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. Cytotec has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. […]
Conditions named in the indications of misoprostol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Prostaglandin E1 Analog.
Source: FDA drug label (Cytotec), Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026 (SPL set 4ab12da7-5731-4e06-bf1c-bc3f2e711f12), via openFDA; the full label on DailyMed
Is there a generic for misoprostol (Cytotec)?
The FDA approved the first generic misoprostol on July 10, 2002. 4 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists misoprostol from 13 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1988 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for misoprostol (Cytotec)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.719 per Misoprostol 200 mcg tablet, up 14% from $0.630 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Misoprostol 200 mcg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Misoprostol 100 mcg tablet | Generic | $0.465 per tablet | $13.94 | -4% |
| Misoprostol 200 mcg tablet | Generic | $0.719 per tablet | $21.57 | +14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has misoprostol been recalled?
The FDA's Enforcement Report lists 3 recalls naming misoprostol since 2013: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of misoprostol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 9, 2016 | Class III | Pfizer Inc. | Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL HCL, Tablet, 10 mg, NDC 59762502001, Pedigree: AD42611_4, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the misoprostol label say about other medicines?
The misoprostol label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Cytotec does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. |
| Diclofenac | drug interactions | Cytotec has no clinically significant effect on the kinetics of diclofenac or ibuprofen. |
| Ibuprofen | drug interactions | Cytotec has no clinically significant effect on the kinetics of diclofenac or ibuprofen. |
Source: FDA drug label (Cytotec), Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026 (SPL set 4ab12da7-5731-4e06-bf1c-bc3f2e711f12), via openFDA; the full label on DailyMed
What do FAERS reports show for misoprostol?
The FDA Adverse Event Reporting System holds 9,682 reports that list misoprostol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 741 are coded as a death and 2,992 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as misoprostol?
21 other medicines are given the same way (oral) and in the same FDA class as misoprostol or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
| Omeprazole | Acid reflux and ulcers | 121 labelers | $0.0295 per capsule 20 mg capsule | A presentation being discontinued |
| Famotidine | Acid reflux and ulcers | 144 labelers | $0.0289 per tablet 20 mg tablet | No current entry |
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| Pantoprazole | Acid reflux and ulcers | 52 labelers | $0.0358 per tablet 40 mg tablet | No current entry |
| Lansoprazole | Acid reflux and ulcers | 59 labelers | $0.106 per capsule 30 mg capsule | No current entry |
| Sucralfate | Acid reflux and ulcers | 43 labelers | $0.173 per tablet 1 g tablet | No current entry |
| Metoclopramide | Acid reflux and ulcers | 28 labelers | $0.0439 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as misoprostol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does misoprostol compare with medicines for the same use?
2 side-by-side pages set misoprostol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to misoprostol
- 21 medicines for the same use
- Other prostaglandin e1 analogs
- the pharmacologic class, with prices and generics
- Misoprostol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other