Sulindac Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 26, 2024.

Applies to sulindac: oral tablet.

Important warnings This medicine can cause some serious health issues

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 side effects

• acid or sour stomach
• belching
• constipation
• headache
• heartburn
• nausea or vomiting
• skin rash
• stomach pain

Less common side effects

• excess air or gas in the stomach or intestines
• itching skin
• passing gas
• stomach cramps
• swelling
• weight loss

Rare side effects

• 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

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

Symptoms of overdose

• change in consciousness
• decreased awareness or responsiveness
• loss of consciousness
• severe sleepiness

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 side effects

• continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss

Rare side effects

• 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.

General adverse events

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

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

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]

Further information

Sulindac side effects can vary depending on the individual. 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.

Medical Disclaimer