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sulindac

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Brand names: Clinoril

Nonsteroidal Anti-Inflammatory Drug (NSAID) Rx

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.

The medicine is not working
213
Pain
182
Tiredness
151
Joint pain
138
Feeling sick to your stomach
123
Pain in your arm or leg
114
Weakness
106
Diarrhea
102
Headache
98
Back pain
95

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

Female 1,581 (70%)
Male 684 (30%)

Age Distribution

0–17 29
18–44 224
45–64 746
65–74 357
75+ 194

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

DEATH 39
CARDIAC ARREST 12
TOXICITY TO VARIOUS AGENTS 11
SEPSIS 9
PULMONARY EMBOLISM 8
RENAL FAILURE 8
ACUTE KIDNEY INJURY 7
CARDIO-RESPIRATORY ARREST 7
CHRONIC KIDNEY DISEASE 7
DRUG INTERACTION 6

Reactions in Hospitalization Reports

FALL 47
PAIN 47
FATIGUE 45
ASTHENIA 42
NAUSEA 38
DIARRHOEA 37
DYSPNOEA 37
ARTHRALGIA 36
PNEUMONIA 36
DIZZINESS 34

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.

moderate warfarin

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.

minor aspirin

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.

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Common Questions

Can I take sulindac with aspirin?
No, taking sulindac with aspirin is not recommended.
What should I do if I experience severe stomach pain while taking sulindac?
Stop taking sulindac and contact your doctor immediately.
Can sulindac affect my blood pressure?
Yes, sulindac can increase your blood pressure.
Is it safe to take sulindac if I have kidney problems?
Talk to your doctor before taking sulindac if you have kidney problems.
How long does it take for sulindac to start working?
Some people feel better within a week, but others may need longer.
Can sulindac cause allergic reactions?
Yes, sulindac can cause allergic reactions, especially if you are allergic to aspirin or other NSAIDs.
Should I avoid any other medications while taking sulindac?
Talk to your doctor about all the medications you take, including over-the-counter drugs.
Can sulindac cause weight gain?
Sulindac can cause swelling, which might seem like weight gain.
What are the inactive ingredients in sulindac tablets?
The inactive ingredients are magnesium stearate, microcrystalline cellulose, plasdone, and sodium starch glycolate.
Where can I find the medication guide for sulindac?
You can find the medication guide at www.puracaplabs.com/medguide/Sulindac-Tablet.pdf
What are the common side effects of sulindac?
The most commonly reported side effects of sulindac include Stomach pain, Upset stomach, Nausea (with or without vomiting), Diarrhea, Constipation. Based on 1,322 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does sulindac interact with other medications?
Yes, sulindac has 11 known drug interactions. Notable interactions include methotrexate, cyclosporine, warfarin. Always inform your doctor about all medications you are taking.
What drug class is sulindac?
sulindac belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) drug class. It requires a prescription (Rx). Sulindac can help with the pain and swelling from different types of arthritis.
Is sulindac safe during pregnancy?
Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Sulindac may harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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Medication Guides

Related Health & Safety Data

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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

All federal data sources used on this page