Misoprostol
Misoprostol is a prostaglandin-type medicine taken by mouth as a tablet to lower the risk of stomach ulcers caused by NSAID pain relievers, and it carries a serious pregnancy warning.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 25 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Misoprostol (Cytotec) is a prostaglandin-like medicine that lowers the risk of stomach ulcers from NSAID pain relievers by cutting acid and possibly protecting the stomach lining; around since the 1980s and available as a generic, it is now usually a second choice after acid reducers like omeprazole. Diarrhea and cramping are what most people notice, usually early, and they often ease with time. The boxed warning covers pregnancy, since misoprostol can cause abortion, birth defects, premature birth or a tear in the uterus (uterine rupture). Women who could become pregnant need a negative pregnancy test, reliable birth control and a start on day two or three of their next period.
Clinical pearls
- Take each dose with food and make the last one at bedtime, which also helps tame the diarrhea.
- Avoid magnesium-containing antacids such as milk of magnesia, since they make misoprostol's diarrhea more likely.
- Take it for as long as you take the NSAID; it lowers ulcer risk but does not ease NSAID stomach pain.
- Never share your tablets, especially with anyone who could be pregnant, and report any vaginal bleeding after menopause.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Misoprostol must not be taken during pregnancy. It can cause birth defects, abortion, premature birth, or a tear in the uterus (uterine rupture). The tear risk goes up later in pregnancy and in women who have had uterine surgery such as a cesarean delivery.
It should not be used to lower NSAID ulcer risk in women who can become pregnant unless they are at high risk of ulcer complications or of developing an ulcer. In that case, all of these must be true:
- A negative pregnancy test within 2 weeks before starting.
- Able to use effective birth control.
- Given both oral and written warnings about the risks, including birth control failure and danger to others if the drug is taken by mistake.
- Starting on the second or third day of the next normal period.
Never share this medicine with anyone else.
Patient information guide A plain-language walkthrough of Misoprostol, written from its FDA label.
What Misoprostol is used for
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Misoprostol tablets are used for one approved purpose.
- Cytotec (oral tablet) lowers the risk of NSAID-induced gastric ulcers in people at high risk of complications or of developing an ulcer.
- Misoprostol (oral tablet) is used for the same purpose.
- It has not been shown to reduce the risk of duodenal ulcers in people taking NSAIDs.
- In studies of 3 months, it reduced gastric ulcer risk, but it did not improve stomach pain or discomfort from NSAIDs compared with placebo.
How Misoprostol works
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Misoprostol is a prostaglandin-type medicine. NSAIDs reduce prostaglandins in the stomach lining, which can lower protective mucus and bicarbonate. Misoprostol lowers acid secretion and can raise mucus and bicarbonate. It binds to specific prostaglandin receptors, which may let it work directly on the stomach lining even when taken with food.
Misoprostol dosage
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Misoprostol tablets are taken by mouth, generally four times a day with food. The last dose is at bedtime. Taking it after meals and at bedtime helps limit diarrhea.
- Take it for as long as you take your NSAID, as prescribed.
- If the usual dose is not tolerated, your prescriber can lower it.
- Kidney problems usually do not require a change in schedule.
Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Misoprostol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Reducing the risk of NSAID-induced gastric ulcers (adults)
- 200 mcg four times daily with food
- If this dose cannot be tolerated, a dose of 100 mcg can be used
- Taken for the duration of NSAID therapy as prescribed by the physician
- The last dose of the day should be at bedtime
- Take with a meal
- Renal impairment
- Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated
- Dose reduction only if the 200-mcg dose is not tolerated
Read the label’s full dosing text
DOSAGE & ADMINISTRATION The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies . ) Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime. Renal impairment Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology . )
Read the full Dosage and Administration section on DailyMed →
Misoprostol side effects
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Most side effects involve the digestive system.
Common side effects
- Diarrhea (the most common, often early in treatment)
- Abdominal pain
- Nausea
- Gas (flatulence)
- Headache
- Indigestion (dyspepsia)
- Vomiting
- Constipation
- Diarrhea, often early and usually self-limiting
When to get medical help
- Call your doctor if you are or could be pregnant. Misoprostol can cause birth defects, abortion, premature birth or uterine rupture.
- Get help for severe or lasting diarrhea, especially with signs of dehydration.
- Tell your doctor about any vaginal bleeding after menopause.
- Seek urgent help for signs of an allergic reaction.
- Report chest pain, fainting, or signs of a blood clot or stroke right away.
Rare severe diarrhea can cause dehydration. Women may also have spotting or cramps. Contact your doctor for severe diarrhea, or any bleeding after menopause.
Misoprostol warnings and precautions
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Pregnancy is the biggest risk. Misoprostol can cause birth defects, abortion, premature birth and uterine rupture. It should not be taken by pregnant women to reduce NSAID ulcer risk.
- Women who can become pregnant need a negative pregnancy test and effective birth control.
- Severe diarrhea can lead to dehydration.
- Postmenopausal vaginal bleeding should be checked.
- Do not give the drug to others.
Misoprostol interactions
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A few interactions matter most.
- Oxytocin and similar drugs: misoprostol may increase their activity, so combined use is not recommended.
- Magnesium-containing antacids: they can worsen diarrhea.
- Aspirin, diclofenac and ibuprofen: no clinically significant effect found.
Interactions listed in the FDA-approved label
From the Misoprostol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Aspirin: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis and does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin.
- Diclofenac: Misoprostol has no clinically significant effect on the kinetics of diclofenac.
- Ibuprofen: Misoprostol has no clinically significant effect on the kinetics of ibuprofen.
- Oxytocic agents (oxytocin): Prostaglandins such as misoprostol may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended.
Read the label’s full interactions text
Drug Interactions See Clinical Pharmacology . Misoprostol Tablets has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol Tablets does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Misoprostol Tablets has no clinically significant effect on the kinetics of diclofenac or ibuprofen. Prostaglandins such as Misoprostol Tablets may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Misoprostol
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- Do not use if pregnant for NSAID ulcer prevention.
- Do not use with a history of allergy to prostaglandins.
- Women who can become pregnant need a pregnancy test and contraception plan.
- Tell your doctor about inflammatory bowel disease or dehydration risk.
- Older adults had a similar safety profile in trials.
Misoprostol overdose
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The toxic dose in humans is not known. Total daily doses of 1600 mcg were tolerated with only stomach discomfort. Signs of overdose may include sedation, tremor, convulsions, shortness of breath, abdominal pain, diarrhea, fever, palpitations, low blood pressure or slow heart rate. Treatment is supportive, so seek emergency help.
What Misoprostol does in the body
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Misoprostol reduces stomach acid secretion and, in animals, protects the stomach lining. It can raise bicarbonate and mucus at doses that also reduce acid. It modestly lowers pepsin under basal conditions. It has no significant effect on gastrin or intrinsic factor output.
How your body processes Misoprostol
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Misoprostol is well absorbed and rapidly converted to misoprostol acid, the active form. Levels peak in about 12 minutes, and the half-life is 20–40 minutes. It does not build up with repeated dosing, and steady state is reached within two days. Food lowers the peak level, and antacids lower total exposure, though this does not appear clinically important.
How to store Misoprostol
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Store at or below 25°C (77°F), in a dry area.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Misoprostol
17 supplements and herbal products have documented interactions with Misoprostol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Misoprostol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Misoprostol — the kind of thing our pharmacy team would talk through with you at the counter.
What is misoprostol for?
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How should I take it?
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What side effects should I expect?
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Can I take it if I'm pregnant or might become pregnant?
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Can I take antacids with it?
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Can I share it with someone else?
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Is Misoprostol available over the counter?
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When was Misoprostol first available?
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Who makes Misoprostol?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Misoprostol on HelloPharmacist
Misoprostol forms and strengths (how it comes)
Misoprostol is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Misoprostol inactive ingredients by manufacturer.
Tablet
How this form is used
- Cytotec tablets reduce the risk of NSAID-induced gastric ulcers in people at high risk of ulcer complications or of developing an ulcer.
- Misoprostol tablets reduce the risk of NSAID-induced gastric ulcers in the same high-risk groups.
- Cytotec is taken by mouth with a meal, with the last dose of the day at bedtime.
- Misoprostol tablets are taken by mouth with a meal, with the last dose at bedtime.
- Cytotec and misoprostol tablets are taken for as long as NSAID therapy lasts, as prescribed.
Oral solution
Misoprostol on the U.S. market: products, makers and brands
How Misoprostol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
15 companies list 25 Misoprostol product records with the FDA, mostly as tablet, oral solution; the earliest marketing or approval year on record is 1986. Brand names on the directory include Cytotec; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Misoprostol is used (Medicaid data)
A general measure of how commonly Misoprostol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Misoprostol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Misoprostol prescribed? Of the 1,601 medications we measure, Misoprostol ranks #476 by Medicaid prescriptions — more than 70% of them.
Utilization by Misoprostol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
misoprostol 0.2 MG Oral Tablet Most dispensed
Summed across the 13 of 84 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 317128
misoprostol 0.1 MG Oral Tablet
Summed across the 5 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311727
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Misoprostol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 18 of 122 listed Misoprostol NDCs with Medicaid activity.
Compare Misoprostol products
A representative set of FDA-listed product records for Misoprostol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mcg | Oral | American Health Packaging | ANDA | View NDC → |
| 200 mcg | Oral | American Health Packaging | ANDA | View NDC → |
| 100 mcg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mcg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mcg | Oral | AvPAK | ANDA | View NDC → |
| 100 mcg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 100 mcg | Oral | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | View NDC → |
| 200 mcg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 200 mcg | Oral | GenBioPro, Inc. × 3 listings | ANDA | View NDC → |
| 100 mcg | Oral | Lupin Pharmaceuticals,Inc. | ANDA | View NDC → |
| 200 mcg | Oral | Lupin Pharmaceuticals,Inc. | ANDA | View NDC → |
| 100 mcg | Oral | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 200 mcg | Oral | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 100 mcg | Oral | Novel Laboratories, Inc. | ANDA | View NDC → |
| 200 mcg | Oral | Novel Laboratories, Inc. | ANDA | View NDC → |
| 100 mcg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mcg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 200 mcg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mcg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 200 mcg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 200 mcg | Oral | PharmPak, Inc. | ANDA | View NDC → |
| 200 mcg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 200 mcg | Oral | Redpharm Drug | NDA AUTHORIZED GENERIC | View NDC → |
Showing 25 of 25 products — FDA National Drug Code Directory. See every product, package size and price: browse all 25 Misoprostol NDCs →
Misoprostol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Misoprostol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Misoprostol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Misoprostol FDA approval history
How Misoprostol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Misoprostol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Misoprostol recalls since July 2021.
✅No Misoprostol recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 42331 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 372941In current FDA listings
Look up RxCUI 42331 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Misoprostol supply and shortage status
Whether Misoprostol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Misoprostol brand names
Misoprostol is sold under one brand name in the FDA directory — Cytotec. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Misoprostol: manufacturers and labelers
15 companies list Misoprostol products with the FDA. By number of product records, the largest are GenBioPro, Inc., ANI Pharmaceuticals, Inc., American Health Packaging. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Misoprostol drug class (RxNorm)
Misoprostol belongs to the Prostaglandin E1 Analog class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Misoprostol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →