Prescription medication · Nonsteroidal Anti-Inflammatory Drug (NSAID)
sulindac
Also sold as Clinoril. Sulindac can help with the pain and swelling from different types of arthritis.
Data updated 2026-05-15
- 2,380
- FDA reportsLightly reported
- 11
- InteractionsSeveral interactions
- $0.14
- Generic price (NADAC)
What the data shows
sulindac (Clinoril) is a prescription Nonsteroidal Anti-Inflammatory Drug (NSAID), among the least-reported drugs the FDA tracks (2,380 FDA reports), with 11 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.
sulindac (Clinoril) is a prescription Nonsteroidal Anti-Inflammatory Drug (NSAID). Sulindac can help with the pain and swelling from different types of arthritis.
Sulindac is a nonsteroidal anti-inflammatory drug (NSAID). It helps to reduce pain and swelling.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from sulindac's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of sulindac's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of sulindac'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 almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of sulindac's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store sulindac tablets in a tightly closed container at room temperature (68° to 77°F).
Side Effects (from patient reports)
Based on 2,380 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for sulindac, by number of reports
- Pain
Pain
182 reports
- Tiredness
Tiredness
151 reports
- Joint pain
Joint pain
138 reports
- Feeling sick to your stomach
Feeling sick to your stomach
123 reports
- Pain in your arm or leg
Pain in your arm or leg
114 reports
- Weakness
Weakness
106 reports
- Diarrhea
Diarrhea
102 reports
- Headache
Headache
98 reports
- Back pain
Back pain
95 reports
- Difficulty breathing
Difficulty breathing
95 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 sulindac 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 sulindac sits
sulindac has more FDA adverse-event reports than 15% 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 sulindac; the line is the median (50th percentile).
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
Reports Mentioning Death
132
5.5% of reports — not proof of cause
Hospitalization Reports
620
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 16 | CHRONIC KIDNEY DISEASE | 78 |
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,...
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.
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 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?
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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
Why some drugs demand precise dosing and monitoring
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 2,380 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.
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