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Clinoril Side Effects

Generic name: sulindac

Medically reviewed by Last updated on Jun 27, 2023.

Note: This document contains side effect information about sulindac. Some dosage forms listed on this page may not apply to the brand name Clinoril.

Applies to sulindac: oral tablet.


Oral route (Tablet)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Sulindac is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs may also cause an increased risk of serious gastrointestinal (GI) adverse events, especially in the elderly. These events may include GI bleeding, ulceration, and perforation, which can be fatal.

Serious side effects of Clinoril

Along with its needed effects, sulindac (the active ingredient contained in Clinoril) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sulindac:

More common

Less common


Get emergency help immediately if any of the following symptoms of overdose occur while taking sulindac:

Symptoms of overdose

Other side effects of Clinoril

Some side effects of sulindac may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common


For Healthcare Professionals

Applies to sulindac: compounding powder, oral tablet.


The most frequently reported adverse effects were gastrointestinal (GI) in nature and included GI pain, dyspepsia, nausea with or without vomiting, diarrhea, constipation, flatulence, and GI cramps.[Ref]


Common (1% to 10%): Gastrointestinal (GI) pain, dyspepsia, nausea, vomiting, diarrhea, constipation, flatulence, anorexia, GI cramps

Frequency not reported: Gastritis, gastroenteritis, colitis, peptic ulcer, GI bleeding, GI perforation, intestinal strictures, pancreatitis, glossitis, stomatitis, hematemesis, melena[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Frequency not reported: Ageusia, paresthesia, somnolence, convulsions, syncope, neuritis, drowsiness[Ref]


Common (1% to 10%): Tinnitus, edema

Frequency not reported: Sore/dry mucous membranes, vertigo, insomnia, aseptic meningitis, hearing decreased, metallic/bitter taste, asthenia, malaise, fatigue[Ref]


Common (1% to 10%): Nervousness

Frequency not reported: Depression, psychic disturbances, acute psychosis, hallucinations, confusion[Ref]


Common (1% to 10%): Rash, pruritus

Frequency not reported: Alopecia, photosensitivity, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, ecchymosis, purpura, urticaria, angioneurotic edema, fulminant necrotizing fasciitis, sweating[Ref]


Frequency not reported: Thrombocytopenia, leukopenia, agranulocytosis, neutropenia, bone marrow depression, aplastic anemia, hemolytic anemia, prothrombin time increased[Ref]


Frequency not reported: Congestive heart failure, palpitation, hypertension, arrhythmia[Ref]


Frequency not reported: Anaphylaxis, hypersensitivity vasculitis[Ref]

A potentially fatal apparent hypersensitivity reaction has been reported. Signs and symptoms of such reaction include constitutional symptoms (e.g., fever, chills, diaphoresis, and flushing), cutaneous reactions (e.g., rash or other dermatologic reactions), conjunctivitis, involvement of major organs (e.g., changes in liver function including hepatic failure, jaundice, pancreatitis, pneumonitis with or without pleural effusion, leukopenia, leukocytosis, eosinophilia, disseminated intravascular coagulation, anemia, renal impairment, including renal failure), and other less specific findings (e.g., adenitis, arthralgia, arthritis, myalgia, fatigue, malaise, hypotension, chest pain, and tachycardia).[Ref]


Rare cases of metabolites of this drug being found in common bile duct "sludge" and biliary calculi have been reported in patients with symptoms of cholecystitis who underwent a cholecystectomy.[Ref]

Frequency not reported: Jaundice, cholestasis, hepatitis, hepatic failure, liver function abnormalities[Ref]


Frequency not reported: Renal impairment, renal failure, interstitial nephritis, nephrotic syndrome, renal calculi[Ref]


Frequency not reported: Hyperkalemia, hyperglycemia[Ref]


Frequency not reported: Muscle weakness[Ref]


Frequency not reported: Urine discoloration, dysuria, vaginal bleeding, hematuria, proteinuria, crystalluria[Ref]


Frequency not reported: Blurred vision, visual disturbances, disturbance of retina and its vasculature[Ref]


Frequency not reported: Epistaxis, bronchial spasm, dyspnea[Ref]


Frequency not reported: Gynecomastia[Ref]


1. Product Information. Clinoril (sulindac). Merck & Co., Inc. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.