Sulindac Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 10, 2025.

Applies to sulindac: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or if you are using certain other medicines (such as a steroid medicine or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow skin or eyes. . Also, signs of serious heart problems could occur such as chest pain, fast or irregular heartbeat, tightness in the chest, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking sulindac and check with your doctor right away if you notice any of these warning signs.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include a color change of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause problems with your pancreas. Check with your doctor right away if you have any of the following symptoms while taking this medicine: bloating; chills; constipation; darkened urine; fast heartbeat; fever; indigestion; loss of appetite; nausea; pains in the stomach, side, or abdomen, possibly radiating to the back; vomiting; or yellow eyes or skin.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Call your doctor right away if you have confusion, drowsiness, a fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of meningitis.

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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