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Sulindac Side Effects

In Summary

Commonly reported side effects of sulindac include: increased liver enzymes. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sulindac: oral tablet

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

Major Side Effects

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
  • 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

Minor Side Effects

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
  • 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


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. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Clinoril (sulindac)." Merck & Co, Inc, West Point, PA.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.