Prescription medicine
Sulindac First approved as Clinoril
Sulindac (Clinoril) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.189 per sulindac 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the sulindac FDA label on DailyMed (effective December 20, 2024, Epic Pharma, LLC); the NDA 17911 record on Drugs@FDA; every sulindac label on DailyMed.
Highlights of the record
FDA label of December 20, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ).
Sulindac tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS ).
Used for
From the label: indications and usageCarefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac.
Forms and strengths
- 150 mg
- 200 mg
Tablet.
On the market
- Earliest approval on file
- September 27, 1978 Clinoril, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first March 3, 1988; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 7 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.189 per tablet Sulindac 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 2,402 through July 30, 2026
What is sulindac used for?
From the label: indications and usageCarefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis** 3. Ankylosing spondylitis 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) 5. […]
Conditions named in the indications of sulindac's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (SULINDAC), Epic Pharma, LLC, effective December 20, 2024 (SPL set 96c73bd2-4577-487d-a642-bd8f91e94c3a), via openFDA; the full label on DailyMed
What does the patient leaflet for sulindac 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 medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: o with increasing doses of NSAIDs o with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed
Source: FDA drug label (SULINDAC), Epic Pharma, LLC, effective December 20, 2024 (SPL set 96c73bd2-4577-487d-a642-bd8f91e94c3a), via openFDA; the full label on DailyMed
Is there a generic for sulindac (Clinoril)?
The FDA approved the first generic sulindac on March 3, 1988. 12 generic applications are approved; 5 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 sulindac from 7 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1978 earliest approval on file
- 1988 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 sulindac (Clinoril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.189 per Sulindac 150 mg tablet, up 4% from $0.182 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.
- Sulindac 150 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sulindac 150 mg tablet | Generic | $0.189 per tablet | $5.67 | +4% |
| Sulindac 200 mg tablet | Generic | $0.221 per tablet | $6.63 | -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 sulindac been recalled?
The FDA's Enforcement Report lists 1 recall naming sulindac since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sulindac label say about other medicines?
The sulindac label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name sulindac. 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 |
|---|---|---|
| Acetaminophen | drug interactions | Acetaminophen Acetaminophen had no effect on the plasma levels of sulindac or its sulfide metabolite. |
| Aspirin | contraindications | Sulindac should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. |
| Cyclosporine | drug interactions | Cyclosporine Administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporine has been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin. |
| Diflunisal | drug interactions | Diflunisal The concomitant administration of sulindac and diflunisal in normal volunteers resulted in lowering of the plasma levels of the active sulindac sulfide metabolite by approximately one-third. |
| Furosemide | drug interactions | Diuretics Clinical studies, as well as post marketing observations, have shown that sulindac can reduce the natriuretic effect of furosemide and thiazides in some patients. |
| Lithium | drug interactions | Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. |
| Methotrexate | drug interactions | Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. |
| Probenecid | drug interactions | Probenecid Probenecid given concomitantly with sulindac had only a slight effect on plasma sulfide levels, while plasma levels of sulindac and sulfone were increased. |
| Warfarin | drug interactions | The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. |
Other labels that name sulindac
Source: FDA drug label (SULINDAC), Epic Pharma, LLC, effective December 20, 2024 (SPL set 96c73bd2-4577-487d-a642-bd8f91e94c3a), via openFDA; the full label on DailyMed
What do FAERS reports show for sulindac?
The FDA Adverse Event Reporting System holds 2,402 reports that list sulindac among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 132 are coded as a death and 625 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 sulindac?
21 other medicines are given the same way (oral) and in the same FDA class as sulindac 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 |
| Diclofenac | Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does sulindac compare with medicines for the same use?
3 side-by-side pages set sulindac beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to sulindac
- 21 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Sulindac side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other