sulindac
Brand names: Clinoril
Sulindac is a nonsteroidal anti-inflammatory drug (NSAID). It helps to reduce pain and swelling.
Drug Pricing (NADAC)
Generic Price
$0.14/unit
Generic Available
Yes (5 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Sulindac can help with the pain and swelling from different types of arthritis.
Common side effects
Stomach pain, Upset stomach, Nausea (with or without vomiting)
Key warnings
NSAIDs like sulindac can increase your risk of heart attack or stroke, which can be fatal.
How It Works
Sulindac works by reducing substances in the body that cause pain and inflammation. It gets converted into an active form in your body. This active form then blocks the production of these inflammatory substances.
How to Take It
Take sulindac tablets by mouth twice a day with food. Your doctor will adjust your dose to best suit your needs. The highest dose is 400 mg per day. Follow your doctor's instructions carefully.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Sulindac may harm your unborn baby. It is not known if sulindac passes into breast milk.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store sulindac tablets in a tightly closed container at room temperature (68° to 77°F).
Side Effects (from patient reports)
Based on 1,322 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 2,380 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
2,380
Death-Related Reports
132
Hospitalization Reports
620
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 213 |
| 2 | PAIN | 182 |
| 3 | FATIGUE | 151 |
| 4 | ARTHRALGIA | 138 |
| 5 | NAUSEA | 123 |
| 6 | PAIN IN EXTREMITY | 114 |
| 7 | ASTHENIA | 106 |
| 8 | DIARRHOEA | 102 |
| 9 | HEADACHE | 98 |
| 10 | BACK PAIN | 95 |
| 11 | DYSPNOEA | 95 |
| 12 | DRUG HYPERSENSITIVITY | 92 |
| 13 | DIZZINESS | 84 |
| 14 | PRURITUS | 82 |
| 15 | FALL | 80 |
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
NSAIDs like sulindac can increase your risk of heart attack or stroke, which can be fatal. This risk can happen early in treatment and gets worse the longer you use sulindac. You should not take sulindac if you are having heart bypass surgery (CABG). NSAIDs also raise the risk of serious stomach problems like bleeding, ulcers, and holes in your stomach or intestines, which can be fatal. These problems can happen without warning. Older adults are at higher risk.
Known Drug Interactions
Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Mechanism: Sulindac can prevent your kidneys from removing methotrexate from your body as quickly as they should. This can cause methotrexate to build up and become toxic.
What to do: Use caution when taking these two drugs at the same time. Your doctor may need to monitor you closely for side effects or change your dose.
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. NSAIDs should be used with caution in patients taking cyclosporine, and renal function should be carefully monitored.
Mechanism: Taking these drugs together can increase the risk of kidney damage from cyclosporine. This is because sulindac reduces the production of natural chemicals that protect your kidneys.
What to do: Your doctor should monitor your kidney function very closely if you take these together. Use this combination with caution and report any changes in urination to your provider.
Table 3: Drugs that Can Increase the Risk of Bleeding Drug Class Specific Drugs Anticoagulants argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin Antiplatelet Agents aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticlopidine Non-steroidal Anti-Inflammatory Agents celecoxib, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, naproxen, oxaprozin, piroxicam, sulindac Serotonin Reuptake Inhibitors citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, sertraline, venlafa...
Mechanism: Both of these medications prevent blood from clotting normally in different ways. Using them at the same time increases the overall risk of dangerous bleeding throughout the body.
What to do: Be very careful when taking these two drugs together and report any bleeding to your doctor immediately. Your doctor may need to monitor your blood levels more frequently.
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.
Mechanism: Sulindac can stop furosemide from working well, making it harder for your body to remove extra salt and water.
What to do: Your doctor may need to watch your symptoms closely and adjust your water pill dose.
Aspirin The concomitant administration of aspirin with sulindac significantly depressed the plasma levels of the active sulfide metabolite. A double-blind study compared the safety and efficacy of sulindac 300 or 400 mg daily given alone or with aspirin 2.4 g/day for the treatment of osteoarthritis. The addition of aspirin did not alter the types of clinical or laboratory adverse experiences for sulindac; however, the combination showed an increase in the incidence of gastrointestinal adverse experiences.
Mechanism: Aspirin lowers the amount of active sulindac in your blood and makes stomach side effects more likely.
What to do: Use caution when taking these together and watch for signs of stomach pain or irritation.
Common Questions
Can I take sulindac with aspirin?
What should I do if I experience severe stomach pain while taking sulindac?
Can sulindac affect my blood pressure?
Is it safe to take sulindac if I have kidney problems?
How long does it take for sulindac to start working?
Can sulindac cause allergic reactions?
Should I avoid any other medications while taking sulindac?
Can sulindac cause weight gain?
What are the inactive ingredients in sulindac tablets?
Where can I find the medication guide for sulindac?
What are the common side effects of sulindac?
Does sulindac interact with other medications?
What drug class is sulindac?
Is sulindac safe during pregnancy?
Related Medications in Nonsteroidal Anti-Inflammatory Drug (NSAID)
Other drugs grouped near sulindac — same-class peers and common alternatives.
abatacept
Orencia
Orencia is a medicine that helps to reduce inflammation.
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acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
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acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
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acetaminophen/oxycodone
Percocet
Percocet is a strong pain medicine.
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adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
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Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for sulindac
The FDA label for sulindac (sold under brand names such as Clinoril) classifies it as a prescription-only medication in the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. Sulindac can help with the pain and swelling from different types of arthritis. Official labeling lists 15 commonly reported side effects, including Stomach pain, Upset stomach, Nausea (with or without vomiting).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,322 voluntary reports. The database also lists 11 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 $0.14.
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: December 11, 2025
Read our methodology — how this data is sourced, computed, and verified.
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