FDA-filed SPL labeling · retrieved through openFDA

Diclofenac and Misoprostol

Diclofenac and misoprostol is a combination of an NSAID pain reliever and a stomach-protecting medicine, used to treat the signs and symptoms of osteoarthritis or rheumatoid arthritis in adults at high risk of NSAID-related stomach and duodenal ulcers.

Brand name Arthrotec
Drug class ⓘ Prostaglandin E1 Analog
Rx Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 16 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 →

At a glance
Linked label effectiveAug 31, 2026
Clinical labels in scope ⓘ16
AvailabilityRx
Earliest approval/marketing year ⓘ1997
FDA-listed product records ⓘ70
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Oct 1, 2026
⭐ Diclofenac and Misoprostol at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Diclofenac and misoprostol treats osteoarthritis and rheumatoid arthritis in adults who are at high risk of NSAID-related ulcers. It carries serious warnings, especially about pregnancy, heart attack, stroke and stomach bleeding. Use it exactly as prescribed, and talk with your prescriber or pharmacist about any concerns.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Do not take this medicine if you are pregnant. The misoprostol in it can cause miscarriage, premature birth, birth defects or uterine rupture (a tear in the uterus). The rupture risk is higher later in pregnancy and with prior uterine surgery, including cesarean delivery.

It should not be used in women who can become pregnant unless they truly need an NSAID and are at high risk of ulcers. In that case, a negative pregnancy test, reliable birth control, and starting at a set point in the menstrual cycle are required. Never share it with others.

Like all NSAIDs, it also raises the risk of heart attack and stroke, which can be fatal. It is not for use around CABG surgery. NSAIDs can also cause serious stomach or intestinal bleeding, ulcers and perforation, which can be fatal and may occur without warning. Older adults and people with past ulcers or GI bleeding are at higher risk.

Read the full warning on DailyMed →

📖 Diclofenac and Misoprostol: Patient Information Guide

A plain-language walkthrough of Diclofenac and Misoprostol — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

What Diclofenac and Misoprostol is used for

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Diclofenac and misoprostol is used for arthritis in adults who are at high risk of ulcers from NSAIDs.

  • Signs and symptoms of osteoarthritis
  • Signs and symptoms of rheumatoid arthritis
  • These uses apply to the oral delayed-release and film-coated tablets, including Arthrotec, in adults at high risk of NSAID-induced stomach and duodenal ulcers and their complications.

How Diclofenac and Misoprostol works

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Diclofenac is an NSAID that blocks COX enzymes and lowers prostaglandins, which drive pain and inflammation. Misoprostol is a synthetic prostaglandin E1 analog. It helps protect the stomach and duodenal lining by increasing mucus and bicarbonate, and it also reduces acid. NSAIDs lower the prostaglandins that normally protect the lining, and misoprostol helps make up for that.

How Diclofenac and Misoprostol is taken (dosage)

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These tablets are taken by mouth, usually three or four times a day depending on the type of arthritis. The dose may be adjusted if you have trouble tolerating it.

  • Take with food to help limit diarrhea.
  • Your prescriber will aim for the lowest effective dose for the shortest time.
  • Follow your prescriber and the label for exact directions.

Diclofenac and Misoprostol side effects in detail

▾

The most common side effects are stomach and digestive ones, which often ease within a few days.

  • Abdominal pain
  • Diarrhea
  • Indigestion
  • Nausea
  • Gas
  • Gastritis
  • Vomiting
  • Constipation
  • Headache
  • Dizziness
  • Raised liver enzyme tests and lower hematocrit (red blood cell level)

Seek help for signs of bleeding, heart attack or stroke, liver problems, serious allergic or skin reactions, or severe diarrhea and dehydration.

Diclofenac and Misoprostol warnings and precautions

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  • Pregnancy: Misoprostol can cause miscarriage, premature birth, birth defects and uterine rupture. NSAIDs late in pregnancy can harm fetal kidneys and the fetal heart vessel (ductus arteriosus).
  • Heart attack and stroke: The risk can start early and may rise with longer use. Avoid it after a recent heart attack unless the benefits outweigh the risks.
  • Stomach bleeding and ulcers: These can happen without warning. Risk is higher in older adults and with past ulcers, smoking, alcohol, or certain interacting drugs.
  • Liver: Liver injury can occur, so blood tests may be done.
  • Other: Blood pressure, heart failure and fluid retention, kidney problems, serious skin reactions, DRESS, and anemia.

Diclofenac and Misoprostol interactions: what it interacts with

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Several medicines can raise bleeding, kidney or toxicity risks when taken with this one.

  • Warfarin, aspirin, SSRIs, SNRIs, corticosteroids: higher bleeding or ulcer risk.
  • Other NSAIDs and salicylates: more GI toxicity without added benefit.
  • ACE inhibitors, ARBs, beta-blockers, diuretics: weaker blood pressure effect and possible kidney effects.
  • Digoxin, lithium, methotrexate, cyclosporine, pemetrexed: levels or toxicity can rise.
  • Magnesium-containing antacids: worsen diarrhea.
  • CYP2C9 inhibitors or inducers: change diclofenac exposure and effect.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

Before taking Diclofenac and Misoprostol

▾
  • Not for use in pregnancy, and not recommended in women who can become pregnant except under strict conditions.
  • Not for use around CABG surgery or with active GI bleeding.
  • Not for people with aspirin or NSAID-triggered asthma, hives or allergic reactions, or known allergy to its components.
  • Use caution with heart disease, high blood pressure, heart failure, and kidney or liver disease; avoid in advanced kidney disease.
  • Older adults with heart or kidney risk factors should avoid it.
  • Women having trouble conceiving may be advised to stop it, as infertility can be reversible.

Diclofenac and Misoprostol overdose: if you take too much

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Overdose symptoms can include drowsiness, lethargy, nausea, vomiting and stomach pain, and sometimes GI bleeding. Rarely, high blood pressure, kidney failure, slowed breathing or coma can occur. There is no specific antidote, so call poison control at 1-800-222-1222 or seek emergency care.

Pharmacodynamics: what Diclofenac and Misoprostol does in the body

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Diclofenac lowers prostaglandin production, which reduces pain and inflammation. Misoprostol reduces stomach acid and increases protective mucus and bicarbonate. Its acid-lowering effect begins about 30 minutes after a dose and lasts at least 3 hours.

Pharmacokinetics: how your body processes Diclofenac and Misoprostol

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Diclofenac is absorbed fully from the gut, with peak levels in about 2 hours. About half reaches the bloodstream because of first-pass metabolism. Misoprostol is absorbed rapidly, and its active form peaks in about 20 minutes. Food lowers peak misoprostol levels, and antacids reduce its total availability. The two drugs do not appear to interact with each other or build up with repeated dosing.

How to store Diclofenac and Misoprostol

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Store at 20°C to 25°C (68°F to 77°F).

📄 Written from Diclofenac and Misoprostol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Diclofenac and Misoprostol: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Diclofenac and Misoprostol — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

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It treats the signs and symptoms of osteoarthritis or rheumatoid arthritis in adults. It is for people at high risk of stomach or duodenal ulcers from NSAIDs. The misoprostol part helps protect your stomach lining while the diclofenac eases arthritis symptoms.

How should I take it?

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Take it by mouth as prescribed, usually three or four times a day. Taking it with food can help cut down on diarrhea. Avoid magnesium-containing antacids, since they can make diarrhea worse.

What side effects should I expect?

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Stomach upset is the most common, including belly pain, diarrhea, indigestion, nausea and gas. Diarrhea and pain often start early and usually pass in a few days. Call your doctor if they are severe or don't settle, or if you see black stools or vomit blood.

Can I take it if I might be pregnant?

▾
No. Misoprostol can cause miscarriage, premature birth, birth defects and uterine rupture. If you can become pregnant, your doctor will require a negative pregnancy test and reliable birth control first. Never share this medicine with anyone else.

Can I take aspirin or other pain relievers with it?

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Check with me first. Taking other NSAIDs or aspirin-type medicines with it raises your risk of stomach bleeding without adding much benefit. It also isn't a substitute for low-dose aspirin taken for heart protection.

When should I call my doctor right away?

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Get help right away for chest pain, trouble breathing, weakness on one side, or slurred speech. Also call for black or bloody stools, vomiting blood, yellow skin or eyes, a skin rash, swelling of the face or throat, or severe diarrhea. These can be signs of serious problems.

Is Diclofenac and Misoprostol available over the counter?

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Diclofenac and Misoprostol is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Diclofenac and Misoprostol first available?

▾
Diclofenac and Misoprostol has been available in the United States since at least 1997, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Diclofenac and Misoprostol?

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Diclofenac and Misoprostol is supplied by 18 manufacturers listed in the FDA NDC Directory, including Actavis Pharma, Inc., Bryant Ranch Prepack, BluePoint Laboratories.

💬 Answers drafted from Diclofenac and Misoprostol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 More about Diclofenac and Misoprostol on HelloPharmacist

🌿Drug & Supplement CheckerDiclofenac and Misoprostol vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Diclofenac and Misoprostol NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 Diclofenac and Misoprostol forms and strengths (how it comes)

Diclofenac and 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.

Delayed-release tablet

By mouth
How this form is used
What it may be used for
  • Diclofenac Sodium and Misoprostol delayed-release tablets treat the signs and symptoms of osteoarthritis or rheumatoid arthritis in adults at high risk of NSAID-induced stomach and duodenal ulcers.
Important instructions
  • Diclofenac Sodium and Misoprostol delayed-release tablets are taken by mouth, and the label says to use the lowest effective dose for the shortest time.
  • Diclofenac Sodium Misoprostol delayed-release tablets are a fixed combination and are not recommended if you would not receive the right dose of both ingredients.
Available strengths 2 strengths
50 mg / 200 mcg 75 mg / 200 mcg
44 FDA-listed product records ⓘ

Tablet

By mouth
Brands Arthrotec
How this form is used
What it may be used for
  • Arthrotec treats the signs and symptoms of osteoarthritis or rheumatoid arthritis in adults at high risk of NSAID-induced stomach and duodenal ulcers.
Important instructions
  • Arthrotec is taken by mouth, and the label says to use the lowest effective dose for the shortest time.
  • Arthrotec is a fixed combination, and the dose and frequency may be adjusted after your response is observed.
Available strengths 2 strengths
50 mg / 200 mcg 75 mg / 200 mcg
26 FDA-listed product records ⓘ

📊 Diclofenac and Misoprostol on the U.S. market: products, makers and brands

How Diclofenac and 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.

2
Dose forms ⓘ
18
Manufacturers
6
Brand names
70
FDA-listed product records ⓘ
1997
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Actavis Pharma, Inc.11%
Bryant Ranch Prepack10%
BluePoint Laboratories9%
Nivagen Pharmaceuticals, Inc.9%
Pfizer Laboratories Div Pfizer Inc9%
Amneal Pharmaceuticals LLC9%
Other makers44%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Diclofenac and Misoprostol is used (Medicaid data)

A general measure of how commonly Diclofenac and 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 Diclofenac and 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.

956
Medicaid prescriptions filled (Q1–Q4 2025)
$68,210 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Diclofenac and Misoprostol prescribed? Of the 1,599 medications we measure, Diclofenac and Misoprostol ranks #1,287 by Medicaid prescriptions — more than 20% of them.

Where Diclofenac and Misoprostol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,287 of 1,599
#1,282 Nevirapine 1,003 Rx #1,283 Selegiline Transdermal... 984 Rx #1,284 Atazanavir 980 Rx #1,285 Berotralstat 980 Rx #1,286 Belumosudil 979 Rx #1,287 Diclofenac and Misopro... 956 Rx #1,288 Encorafenib 949 Rx #1,289 Butorphanol Injection 940 Rx #1,290 Pentamidine Injection 931 Rx #1,291 Neomycin, Polymyxin, B... 928 Rx #1,292 Elacestrant 927 Rx

Utilization by Diclofenac and 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.

The 75 mg / 0.2 mg delayed release oral tablet is the most-dispensed Diclofenac and Misoprostol product — about 74% of these Medicaid prescriptions.

diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet Most dispensed

709 Medicaid prescriptions (Q1–Q4 2025) 74% of Diclofenac and Misoprostol prescriptions shown $52,901 gross reimbursement (before rebates) ≈ $75 per prescription (gross)

Summed across the 4 of 64 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1359105

diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral Tablet

247 Medicaid prescriptions (Q1–Q4 2025) 26% of Diclofenac and Misoprostol prescriptions shown $15,309 gross reimbursement (before rebates) ≈ $62 per prescription (gross)

Summed across the 4 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857706

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 Diclofenac and 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 8 of 98 listed Diclofenac and Misoprostol NDCs with Medicaid activity.

🔍 Compare Diclofenac and Misoprostol products

A representative set of FDA-listed product records for Diclofenac and 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.)

Showing 70 of 70 products — FDA National Drug Code Directory. See every product, package size and price: browse all 70 Diclofenac and Misoprostol NDCs →

🏷️ Diclofenac and Misoprostol brand names

Arthrotec

🏭 Who makes Diclofenac and Misoprostol: manufacturers and labelers

Actavis Pharma, Inc. 8 Bryant Ranch Prepack 7 BluePoint Laboratories 6 Nivagen Pharmaceuticals, Inc. 6 Pfizer Laboratories Div Pfizer Inc 6 Amneal Pharmaceuticals LLC 6 Micro Labs Limited 6 Greenstone LLC 4 Preferred Pharmaceuticals Inc. 4 AvKARE 4 Mylan Pharmaceuticals Inc. 4 Preferred Pharmaceuticals, Inc. 2 Proficient Rx LP 2 Direct Rx 1 A-S Medication Solutions 1 Remedyrepack Inc. 1 Advanced Rx Pharmacy of Tennessee, LLC 1 Sportpharm LLC 1

Diclofenac and Misoprostol drug class (RxNorm)

Diclofenac and Misoprostol belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other dermatologicals, Acetic acid derivatives and related substances, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase Inhibitors

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 Diclofenac and 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 31, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Diclofenac and Misoprostol.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Diclofenac and Misoprostol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
16
NDC products indexed
70
Distinct labelers/manufacturers represented
18
Linked representative label ⓘ
Greenstone LLC
Linked label effective
Aug 31, 2026
Composite sections available
24
Linked SPL Set ID
a7701e8c-4e16-4165-8b83-de2c08d5ded3
Linked SPL Document ID
354b9b31-a5f4-4f05-b476-2759945ed43e
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 16 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Greenstone LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.