Skip to main content

Sulindac Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 28, 2023.

Applies to sulindac: oral tablet.

Warning

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 Sulindac

Along with its needed effects, sulindac 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

Rare

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

Symptoms of overdose

Other side effects of Sulindac

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

Rare

For Healthcare Professionals

Applies to sulindac: compounding powder, oral tablet.

General

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]

Gastrointestinal

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]

Other

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]

Psychiatric

Common (1% to 10%): Nervousness

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

Dermatologic

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]

Hematologic

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

Cardiovascular

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

Hypersensitivity

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]

Hepatic

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]

Renal

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

Metabolic

Frequency not reported: Hyperkalemia, hyperglycemia[Ref]

Musculoskeletal

Frequency not reported: Muscle weakness[Ref]

Genitourinary

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

Ocular

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

Respiratory

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

Endocrine

Frequency not reported: Gynecomastia[Ref]

References

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.