Sulindac Side Effects

It is possible that some side effects of sulindac may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sulindac: oral tablet

As well as its needed effects, sulindac may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sulindac, check with your doctor immediately:

More common
  • Acid or sour stomach
  • belching
  • constipation
  • headache
  • heartburn
  • nausea or vomiting
  • skin rash
  • stomach pain
Less common
  • Excess air or gas in the stomach or intestines
  • itching skin
  • passing gas
  • stomach cramps
  • swelling
  • weight loss
Rare
  • Back or leg pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • blurred or loss of vision
  • burning feeling in the chest or stomach
  • burning while urinating
  • chest pain
  • chills
  • clay-colored stools
  • confusion
  • cough or hoarseness
  • cracks in the skin
  • dark urine
  • decreased urine output
  • diarrhea
  • difficult or labored breathing
  • difficult or painful urination
  • difficulty with swallowing
  • dilated neck veins
  • discoloration of urine
  • disturbed color perception
  • dizziness
  • double vision
  • extreme fatigue
  • eye pain
  • fainting
  • feeling of warmth
  • fever
  • flu-like symptoms
  • general body swelling
  • general feeling of discomfort or illness
  • groin pain
  • halos around lights
  • hives
  • increased sensitivity of the skin to sunlight
  • increased sweating
  • increased thirst
  • indigestion
  • irregular breathing
  • joint or muscle pain
  • large, flat, blue, or purplish patches in the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • loss of heat from the body
  • lower back or side pain
  • muscle aches, pains, or weakness
  • nervousness
  • night blindness
  • noisy breathing
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • overbright appearance of lights
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pinpoint red or purple spots on the skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the face, neck, arms and occasionally, upper chest
  • redness or other discoloration of the skin
  • redness, swelling, or soreness of the tongue
  • scaly skin
  • seizures
  • severe or continuing stomach pain
  • severe sunburn
  • shortness of breath
  • slow or fast, irregular, pounding, or racing heartbeat or pulse
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stiff neck or back
  • stomach upset
  • swelling of the face, fingers, feet, or lower legs
  • swelling or inflammation of the mouth
  • swollen or painful glands
  • tenderness in the stomach area
  • tightness in the chest
  • troubled breathing
  • tunnel vision
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • vomiting of blood or material that looks like coffee grounds
  • watery or bloody diarrhea
  • weakness or heaviness of the legs
  • weight gain
  • wheezing
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking sulindac, get emergency help immediately:

Symptoms of overdose
  • Change in consciousness
  • decreased awareness or responsiveness
  • loss of consciousness
  • severe sleepiness

Some sulindac side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • hearing loss
Rare
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • decreased hearing
  • difficulty with moving
  • discharge, excessive tearing
  • discouragement
  • false sense of well-being
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • hair loss or thinning of the hair
  • hallucinations
  • irritability
  • loss of interest or pleasure
  • metallic or bitter taste
  • mood swings
  • muscle cramping or stiffness
  • personality changes
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • sensation of spinning
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sore or dry mucous membranes
  • swelling or redness in the joints
  • trouble with concentrating
  • trouble with sleeping
  • unable to sleep
  • vaginal bleeding

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Nervous system

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

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.[Ref]

Psychiatric

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

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.[Ref]

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.[Ref]

Endocrine

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

Metabolic

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

Musculoskeletal

Musculoskeletal side effects have included muscle weakness.

References

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6. Detlefs RL "Drug-induced pancreatitis presenting as subcutaneous fat necrosis." J Am Acad Dermatol 13 (1985): 305-7

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9. Singh G, Ramey DR, Morfeld D, Fries JF "Comparative toxicity of non-steroidal anti-inflammatory agents." Pharmacol Ther 62 (1994): 175-91

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51. Levitt L, Pearson RW "Sulindac-induced Stevens-Johnson toxic epidermal necrolysis syndrome." JAMA 243 (1980): 1262-3

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56. Sandyk R, Gillman MA "Acute exacerbation of Parkinson's disease with sulindac." Ann Neurol 17 (1985): 104-5

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