Prescription medicine
Diclofenac and misoprostol Brand names: Arthrotec
Diclofenac and misoprostol (Arthrotec) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.665 per diclofenac-misoprostol DR 50-0.2 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $8.55 per Arthrotec 50 mg-200 mcg tablet.
- Generic listed
- Boxed warning
Check it at the source: the diclofenac and misoprostol FDA label on DailyMed (effective August 31, 2026, Actavis Pharma, Inc.); the NDA 20607 record on Drugs@FDA; every diclofenac and misoprostol label on DailyMed.
Highlights of the record
FDA label of August 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS.
Uterine Rupture, Abortion, Premature Birth, and Birth Defects Administration of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets, to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects. Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or an abortion [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnancy [see Contraindications ( 4 )] and not recommended in women of childbearing potential. Patients must be advised of the abortifacient property and warned not to give the drug to others [see Warnings and Precautions (5.1) ]. If diclofenac sodium and misoprostol delayed-release tablets are prescribed, verify the pregnancy status of females of reproductive potential prior to initiation of treatment and advise them to use effective contraception during treatment [see Use in Specific Populations ( 8.3 )]. Cardiovascular Thrombotic Events NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. […]
Used for
From the label: indications and usageDiclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
Forms and strengths
- 50 mg
- 75 mg
Delayed-release tablet; tablet; film-coated tablet.
On the market
- Earliest approval on file
- December 24, 1997 Arthrotec, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first July 9, 2012; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.665 per tablet Diclofenac-misoprostol DR 50-0.2 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2013 0 Class I among all firms' recalls; latest April 20, 2018
- FAERS reports
- 6,975 through July 30, 2026
What is diclofenac and misoprostol used for?
From the label: indications and usageDiclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3) ]. […]
Conditions named in the indications of diclofenac and misoprostol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug and Prostaglandin E1 Analog.
Source: FDA drug label (Diclofenac Sodium and Misoprostol), Actavis Pharma, Inc., effective August 31, 2026 (SPL set df8b8660-0c24-4848-8bea-c1b935090c66), via openFDA; the full label on DailyMed
What does the patient leaflet for diclofenac and misoprostol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about diclofenac sodium and misoprostol delayed-release tablets?Diclofenac sodium and misoprostol delayed-release tablets contain diclofenac (a nonsteroidal anti-inflammatory drug (NSAID)) and misoprostol, and can cause uterus to tear (uterine rupture), abortion, premature birth, or birth defects. The risk of uterine rupture increases as your pregnancy advances, if you have given birth to 5 or more children, and if you have had surgery on the uterus, such as a cesarean delivery. Do not take diclofenac sodium and misoprostol delayed-release tablets if you are pregnant. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with diclofenac sodium and misoprostol delayed-release tablets. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with diclofenac sodium and misoprostol delayed-release tablets. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with diclofenac sodium and misoprostol delayed-release tablets.
Source: FDA drug label (Diclofenac Sodium and Misoprostol), Actavis Pharma, Inc., effective August 31, 2026 (SPL set df8b8660-0c24-4848-8bea-c1b935090c66), via openFDA; the full label on DailyMed
Is there a generic for diclofenac and misoprostol (Arthrotec)?
The FDA approved the first generic diclofenac and misoprostol on July 9, 2012. 7 generic applications are approved; 4 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 diclofenac and misoprostol from 10 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.
- 1997 earliest approval on file
- 2012 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 diclofenac and misoprostol (Arthrotec)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.665 per Diclofenac-misoprostol DR 50-0.2 mg tablet, down 30% from $0.954 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Diclofenac-misoprostol DR 50-0.2 mg tablet (generic)
- Arthrotec 50 mg-200 mcg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Diclofenac-misoprostol DR 50-0.2 mg tablet | Generic | $0.665 per tablet | $19.94 | -30% |
| Diclofenac-misoprostol DR 75-0.2 mg tablet | Generic | $0.966 per tablet | $28.99 | -5% |
| Arthrotec 50 mg-200 mcg tablet | Brand | $8.55 per tablet | $256.48 | n/a |
| Arthrotec 75 mg-200 mcg tablet | Brand | $8.47 per tablet | $254.24 | -0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has diclofenac and misoprostol been recalled?
The FDA's Enforcement Report lists 7 recalls naming diclofenac and misoprostol since 2013: 0 Class I (the most serious), 7 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 20, 2018 | Class II | Exela Pharma Sciences LLC | Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets. |
| September 26, 2014 | Class II | Actavis Laboratories, FL, Inc. | Failed Tablet/Capsule Specifications: Presence of split or broken tablets. |
| April 24, 2014 | Class II | Actavis Laboratories, FL, Inc. | Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. |
| December 20, 2013 | Class II | Watson Laboratories, Inc.-(Actavis) - Florida | Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. |
| March 22, 2013 | Class II | Actavis Inc | Failed Tablet/Capsule Specifications: Broken tablets |
| March 22, 2013 | Class II | Watson Laboratories, Inc.-(Actavis) - Florida | Failed Tablet/Capsule Specifications: Broken tablets |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the diclofenac and misoprostol label say about other medicines?
The diclofenac and misoprostol label names 12 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 | contraindications | … Warnings and Precautions (5.3 )] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of diclofenac and cyclosporine may increase cyclosporine’s nephrotoxicity. Intervention: During concomitant use of diclofenac sodium and misoprostol delayed-release tablets and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of diclofenac with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy. Intervention: The concomitant use of diclofenac sodium and misoprostol delayed-release tablets with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of diclofenac sodium and misoprostol delayed-release tablets and digoxin, monitor serum digoxin levels. |
| Furosemide | drug interactions | 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. … Intervention: During concomitant use of diclofenac sodium and misoprostol delayed-release tablets with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy … |
| Lithium | drug interactions | Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. … Intervention: During concomitant use of diclofenac sodium and misoprostol delayed-release tablets and lithium, monitor patients for signs of lithium toxicity. |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). Intervention: During concomitant use of diclofenac sodium and misoprostol delayed-release tablets and methotrexate, monitor patients for methotrexate toxicity. |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of diclofenac and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of diclofenac sodium and misoprostol delayed-release tablets and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for … |
| Propranolol | drug interactions | Clinical Impact: NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (…), or have renal impairment, co-administration of an NSAID with ACE inhibitors … Intervention: The concomitant administration of these drugs should be done with caution. Patients should be adequately hydrated and the clinical need to monitor the renal function should be assessed at the beginning of … |
| Rifampin | drug interactions | CYP2C9 Inhibitors or Inducers Clinical Impact: Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g., voriconazole) may enhance the exposure and toxicity of diclofenac whereas co-administration with … Intervention: CYP2C9 inhibitors: When concomitant use of CYP2C9 inhibitors is necessary, the total daily dose of diclofenac should not exceed the lowest recommended dose of diclofenac sodium and misoprostol … |
| Voriconazole | drug interactions | CYP2C9 Inhibitors or Inducers Clinical Impact: Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g., voriconazole) may enhance the exposure and toxicity of diclofenac whereas co-administration with … Intervention: CYP2C9 inhibitors: When concomitant use of CYP2C9 inhibitors is necessary, the total daily dose of diclofenac should not exceed the lowest recommended dose of diclofenac sodium and misoprostol … |
| Warfarin | drug interactions | 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. … Intervention: Monitor patients with concomitant use of diclofenac sodium and misoprostol delayed-release tablets with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of … |
Source: FDA drug label (Diclofenac Sodium and Misoprostol), Actavis Pharma, Inc., effective August 31, 2026 (SPL set df8b8660-0c24-4848-8bea-c1b935090c66), via openFDA; the full label on DailyMed
What do FAERS reports show for diclofenac and misoprostol?
The FDA Adverse Event Reporting System holds 6,975 reports that list diclofenac and misoprostol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 320 are coded as a death and 1,794 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 diclofenac and misoprostol?
20 other medicines are given the same way (oral) and in the same FDA class as diclofenac and misoprostol or labeled mainly for the same use (osteoarthritis), the same class first. Osteoarthritis 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 |
|---|---|---|---|---|
| Ibuprofen | Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Meloxicam | Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Nabumetone | Osteoarthritis, Rheumatoid arthritis | 28 labelers | $0.128 per tablet 500 mg tablet | No current entry |
| Piroxicam | Osteoarthritis, Rheumatoid arthritis | 10 labelers | $0.215 per capsule 20 mg capsule | No current entry |
Every medicine labeled for the same conditions as diclofenac and misoprostol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to diclofenac and misoprostol
- 20 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Diclofenac and misoprostol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other