Prescription medication · Prostaglandin E1 Analog
misoprostol
Also sold as Cytotec. This medicine treats the symptoms of osteoarthritis or rheumatoid arthritis in adults.
Data updated 2026-05-15
- 9,536
- FDA reportsLightly reported
- 12
- InteractionsSeveral interactions
- $0.45
- Generic price (NADAC)
What the data shows
misoprostol (Cytotec) is a prescription Prostaglandin E1 Analog, reported less often than most tracked drugs (9,536 FDA reports), with 12 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
misoprostol (Cytotec) is a prescription Prostaglandin E1 Analog. This medicine treats the symptoms of osteoarthritis or rheumatoid arthritis in adults.
Diclofenac sodium/misoprostol is a combination drug used to treat arthritis symptoms while protecting your stomach from ulcers. It contains an anti-inflammatory (diclofenac) and a stomach protector (misoprostol).
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.45/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats the symptoms of osteoarthritis or rheumatoid arthritis in adults.
Common side effects
Abdominal pain, Diarrhea, Upset stomach
Key warnings
This medicine can cause serious problems: * **Risk of Uterine Rupture, Abortion, Premature Birth, and Birth Defects:** Do not take this medicine if you are pregnant.
The sections below are summarized in plain English from misoprostol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Diclofenac reduces pain and inflammation. Misoprostol helps protect your stomach lining from ulcers that can be caused by diclofenac. It does this by acting like a natural substance (prostaglandin) that protects the stomach.
How to Take It
Take this medicine exactly as your doctor tells you. For osteoarthritis, the usual dose is one tablet (50 mg diclofenac/200 mcg misoprostol) three times a day. For rheumatoid arthritis, the usual dose is one tablet three or four times a day. Do not take more than 150 mg of diclofenac per day for osteoarthritis or 200 mg per day for rheumatoid arthritis.
This is a plain-language summary of misoprostol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Do not take this medicine if you are pregnant. It can cause serious harm to your unborn baby, including miscarriage, premature birth, or birth defects. Talk to your doctor about using effective birth control while taking this medicine.
This is a plain-language summary of misoprostol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of misoprostol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store this medicine at room temperature (68°F to 77°F).
Side Effects (from patient reports)
Based on 9,536 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for misoprostol, by number of reports
- Bleeding
Bleeding
1,258 reports
- Incomplete miscarriage
Incomplete miscarriage
1,160 reports
- Baby exposed to the medicine during pregnancy
Baby exposed to the medicine during pregnancy
625 reports
- Pain
Pain
537 reports
- Low red blood cell count
Low red blood cell count
511 reports
- Pregnancy 448
Pregnancy
448 reports
- Feeling sick to your stomach 434
Feeling sick to your stomach
434 reports
- Throwing up 416
Throwing up
416 reports
- Fever 402
Fever
402 reports
- Mother exposed to the medicine during pregnancy 397
Mother exposed to the medicine during pregnancy
397 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for misoprostol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where misoprostol sits
misoprostol has more FDA adverse-event reports than 38% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is misoprostol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 9,536 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
9,536
Reports Mentioning Death
729
7.6% of reports — not proof of cause
Hospitalization Reports
2,942
Top Indication
Abortion Induced
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | HAEMORRHAGE | 1,258 |
| 2 | ABORTION INCOMPLETE | 1,160 |
| 4 | FOETAL EXPOSURE DURING PREGNANCY | 625 |
| 5 | PAIN | 537 |
| 6 | ANAEMIA | 511 |
| 7 | PREGNANCY | 448 |
| 8 | NAUSEA | 434 |
| 10 | VOMITING | 416 |
| 11 | PYREXIA | 403 |
| 12 | MATERNAL EXPOSURE DURING PREGNANCY | 397 |
| 13 | DIZZINESS | 390 |
| 14 | MUSCLE SPASMS | 352 |
| 15 | ABDOMINAL PAIN | 335 |
| 16 | EXPOSURE DURING PREGNANCY | 318 |
| 18 | FATIGUE | 280 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine can cause serious problems: * **Risk of Uterine Rupture, Abortion, Premature Birth, and Birth Defects:** Do not take this medicine if you are pregnant. It can cause your uterus to rupture, cause a miscarriage, premature birth, or birth defects. * **Heart Problems:** NSAIDs like diclofenac increase the risk of heart attack and stroke, which can be deadly. This risk can happen early in treatment and increases with longer use. Do not take this medicine if you are having heart bypass surgery. * **Stomach Problems:** NSAIDs increase the risk of stomach bleeding, ulcers, and holes in the stomach or intestines, which can be deadly. These problems can happen without warning. The risk is higher in older adults and people with a history of ulcers or stomach bleeding.
Known Drug Interactions
7 DRUG INTERACTIONS See Table 1 for clinically significant drug interactions with diclofenac and misoprostol. Table 1: Clinically Significant Drug Interactions with Diclofenac and Misoprostol Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
Mechanism: Diclofenac can increase the risk of serious bleeding in the stomach. Misoprostol is used with it to help protect the lining of the stomach and reduce this risk.
What to do: Take this combination exactly as your doctor tells you to help prevent stomach ulcers and bleeding.
Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention: During concomitant use of diclofenac sodium/misoprostol and methotrexate, monitor patients for methotrexate toxicity.
Mechanism: The diclofenac in this medicine can stop your body from getting rid of methotrexate properly. This can cause methotrexate to build up to harmful levels in your blood.
What to do: Your doctor should monitor your blood levels and kidney function closely for signs of toxicity.
NSAIDs and Salicylates Clinical Impact: Concomitant use of diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see Warnings and Precautions (5.3) ].
Mechanism: Taking these two drugs together increases the risk of stomach and intestinal damage without providing extra benefits. Both drugs belong to a class that can irritate the digestive tract.
What to do: Avoid taking these two medications together because they increase the risk of stomach problems. Your doctor may suggest using only one of them.
Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.
Mechanism: This combination can prevent your water pill from working correctly, making it harder for your body to get rid of extra salt and fluid.
What to do: Your doctor should monitor you to make sure your diuretic is still working to control fluid levels.
Intervention: Monitor patients with concomitant use of diclofenac sodium/misoprostol with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding [see Warnings and Precautions (5.12) ] . Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as...
Mechanism: Taking these two drugs together increases the chance of serious stomach bleeding and does not provide any extra pain relief.
What to do: Tell your doctor if you notice signs of bleeding, like dark stools, or if you have new stomach pain.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take this medicine if I am trying to get pregnant?
Can I drink alcohol while taking this medicine?
How long does it take for this medicine to work?
Can I take this medicine with other pain relievers?
What should I do if I have severe stomach pain while taking this medicine?
Can this medicine affect my blood pressure?
Can this medicine cause liver problems?
Is it okay to drive while taking this medicine?
Can I take this medicine if I have kidney problems?
What are the ingredients in this medicine?
What are the common side effects of misoprostol?
Does misoprostol interact with other medications?
What drug class is misoprostol?
Is misoprostol safe during pregnancy?
Related Medications in Prostaglandin E1 Analog
Other drugs grouped near misoprostol - same-class peers and common alternatives.
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aprepitant
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bisacodyl
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bismuth subsalicylate
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cimetidine
Tagamet
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Medication Guides
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Common Drug Interactions
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What the FDA Data Shows for misoprostol
The FDA label for misoprostol (sold under brand names such as Cytotec) classifies it as a prescription-only medication in the Prostaglandin E1 Analog class. This medicine treats the symptoms of osteoarthritis or rheumatoid arthritis in adults. Official labeling lists 12 commonly reported side effects, including Abdominal pain, Diarrhea, Upset stomach.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 9,536 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.45.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: February 23, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages