Sulindac Side Effects

Some side effects of sulindac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sulindac: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking sulindac: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sulindac and call your doctor at once if you have a serious side effect such as:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• urinating less than usual or not at all;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects of sulindac may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• dry mouth;

• increased sweating, runny nose;

• blurred vision; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to sulindac: compounding powder, oral tablet

Gastrointestinal

Pancreatitis is a rare, but potentially severe, dose-independent side effect of sulindac. The majority of cases present within the first six months of therapy, although onset after five years of sulindac therapy is reported in at least one case.

Severe odynophagia secondary to sulindac-induced esophageal ulceration has been reported.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Sulindac should be used with caution in these patients.

Gastrointestinal (GI) side effects have included dyspepsia, nausea, diarrhea, constipation, flatulence, and occult GI blood loss. More serious GI side effects have included gastritis, gastroenteritis, colitis, esophageal ulcer, peptic ulcer with or without perforation, GI hemorrhage, colonic diaphragms, and pancreatitis. Severe odynophagia secondary to sulindac-induced esophageal ulceration has also been reported. GI events have been fatal in some cases.

Hepatic

Hepatic side effects have included elevations in liver function tests in up to 15% of patients. Jaundice, hepatitis (hepatocellular, cholestatic, and mixed-type), cholangitis, and hepatic failure have been reported. One case of drug-associated cholelithiasis has also been reported.

Elevations in liver function tests three times normal values occur in less than 1% of patients.

Significant hepatotoxicity has been reported in association with sulindac therapy and is sometimes fatal. While one review found a possible increased incidence in hepatotoxicity in females, in the elderly, and in patients with autoimmune connective tissue disorders, more severe hepatic reactions should be ruled out in any patient with significant or prolonged elevations in liver function tests or other signs and symptoms suggestive of liver injury.

Hypersensitivity

Hypersensitivity side effects have rarely included fever, rash, bronchial asthma, dyspnea, and anaphylaxis. In addition, hypersensitivity has been implicated in cases of hepatotoxicity, renal toxicity, pneumonitis, vasculitis, and generalized multiorgan reactions. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Hypersensitivity syndrome has also been reported.

One manufacturer described a potentially fatal hypersensitivity syndrome associated with sulindac. Symptoms included fever, chills, diaphoresis, flushing, rash, conjunctivitis, elevations in liver function tests, hepatic failure, jaundice, pancreatitis, pneumonitis, blood dyscrasias, disseminated intravascular coagulation, and renal failure. Other findings included malaise, arthralgia, myalgia, fatigue, hypotension, tachycardia, and chest pain.

Sulindac should be promptly discontinued if fever, pruritus, rash, elevations in liver function tests accompanied by fever, or other hypersensitivity response occurs.

Hematologic

The development of anemia may indicate occult gastrointestinal blood loss secondary to gastric irritation or gastrointestinal ulceration.

Thrombocytopenia appears to be secondary to peripheral destruction due to the development of an antiplatelet antibody. Hemolytic anemia also appears to be due to peripheral destruction secondary to the development of an autoantibody.

Hematologic side effects have included platelet dysfunction, resulting in increased bleeding times as well as thrombocytopenia, anemia, neutropenia, leukopenia, agranulocytosis, aplastic anemia, and immune hemolytic anemia.

Renal

Other nonsteroidal anti-inflammatory agents (NSAIDs) may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Sulindac may have the same effect. Hence, renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for NSAID-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Renal side effects have included acute renal failure secondary to membranous glomerulonephritis and interstitial nephritis, as well as nephrotic syndrome (despite a proposed "renal sparing effect" of sulindac). Hypersensitivity has been implicated in some forms of sulindac-induced renal toxicity.

Dermatologic

Dermatologic side effects have included rash (3% to 9%), pruritus (1% to 3%), alopecia, photosensitivity, fixed-drug eruption, stomatitis, sore or dry mucous membranes, Stevens-Johnson syndrome, toxic epidermal necrolysis, and rare cases of fulminant necrotizing fasciitis.

Nervous system

Underlying connective tissue disease, such as systemic lupus erythematosus, may be a predisposing factor for the development of sulindac-induced aseptic meningitis.

Nervous system side effects including aseptic meningitis, paresthesia, encephalopathy, vertigo, insomnia, somnolence, convulsions, and syncope have been reported in greater than 1% of patients. Peripheral neuropathy has been reported rarely. Dizziness and headache have also been reported.

Psychiatric

Psychiatric side effects have included rare cases of reversible psychotic behavior, irritability, obsessiveness, depression, and visual and auditory hallucinations.

Cardiovascular

Cardiovascular side effects have included palpitations and congestive heart failure, especially in patients with marginal cardiac function. Elevated blood pressure has also been reported.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Endocrine

Endocrine side effects have been reported rarely. These have included a case report of reversible gynecomastia.

Metabolic

Metabolic side effects have included hyperkalemia, probably secondary to sulindac-induced hyporeninemic hypoaldosteronism.

Musculoskeletal

Musculoskeletal side effects have included muscle weakness.

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