Sulindac

Sulindac is a prescription medication used to treat pain and inflammation caused by a variety of conditions including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, gouty arthritis, bursitis, and tendinitis.

This medication belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking substances called prostaglandins that cause pain and inflammation.

Sulindac comes in tablet form. It is usually taken twice daily with food and a full glass of water.

Common side effects include stomach pain, indigestion, and nausea. Sulindac can cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Sulindac is a prescription medication used to treat pain, inflammation, tenderness, and stiffness caused by:

• osteoarthritis (a breakdown of the lining of the joints)
• rheumatoid arthritis (swelling of the lining of the joints)
• ankylosing spondylitis (arthritis that mainly affects the spine)
• bursitis (inflammation of a fluid-filled sac in the shoulder joint)
• tendinitis (inflammation of the tissue that connects muscle to bone)
• gouty arthritis (attacks of severe joint pain and swelling caused by a build-up of certain substances in the joints)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Sulindac may be found in some form under the following brand names:

• Clinoril

Serious side effects have been reported. See "Precautions" section.

Common side effects include:

• stomach pain
• indigestion
• nausea
• vomiting
• diarrhea
• constipation
• gas
• rash
• dizziness

This is not a complete list of sulindac side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ACE inhibitors such as lisinopril (Prinivil), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec) and others
• angiotensin II receptor antagonists such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), valsartan (Diovan)
• aspirin (Ecotrin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• diuretics, or water pills, such as thiazides (hydrochlorothiazide) and furosemide (Lasix)
• lithium (Eskalith, Lithobid, others)
• medications (oral) for diabetes
• methotrexate (Rheumatrex, Trexall)
• probenecid (Benemid)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• warfarin (Coumadin)
• cimetidine (Tagamet)
• digoxin (Digitek, Lanoxin)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)

This is not a complete list of sulindac drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sulindac including:

• Cardiovascular thrombotic events. Sulindac can increase your risk of cardiovascular and heart diseases such as strokes and myocardial infarctions, which can lead to death. Tell your doctor if you have a history of heart disease.
• Gastrointestinal effects. Sulindac can cause digestive tract problems such as ulcers, bleeding, inflammation, and perforations (small holes). Tell your doctor if you have a history of digestive problems, or if you smoke or frequently drink alcohol. Alert your doctor if you take anticoagulants (blood-thinners) or corticosteroids such as prednisone.
• Hepatic events. Sulindac c­­an cause damage to the liver and increase liver tests. Tell your doctor if you have a history of liver disease.
• Hypertension. Sulindac may raise your blood pressure. Tell your doctor if you have a history of high blood pressure or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Congestive heart failure and edema. Sulindac can increase the chance of congestive heart failure, fluid retention, and weight gain.
• Renal effects. Kidney damage can result from the use of sulindac. Tell your doctor if you have a history of kidney disease or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Hypersensitivity reaction. An allergic reaction to sulindac can occur. Symptoms of a hypersensitivity reaction include:
  • hives
  • rash
  • difficulty breathing or swallowing
  • itching
  • swelling
• Adverse skin reactions. Sulindac can lead to dangerous skin reactions. Symptoms of a skin reaction include:
  • rash
  • red, itchy, or scaly skin
  • blisters
  • fever
• Pregnancy. Sulindac should not be taken past the 30th week of pregnancy.

Sulindac can cause dizziness. Do not drive or operate heavy machinery until you know how sulindac affects you.

Do not take sulindac if you:

• are allergic to sulindac 
• will have or have recently had coronary (heart) surgery

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of sulindac, there are no specific foods that you must exclude from your diet when receiving sulindac.

Before taking sulindac tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of heart, liver, or kidney disease
• have a history of gastrointestinal (digestive) problems
• have hypertension, or high blood pressure
• have a history of asthma
• have diabetes
• take ACE inhibitors such as lisinopril (Prinivil) and enalapril (Vasotec)
• take aspirin (Ecotrin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• take diuretics, or water pills, such as thiazides (hydrochlorothiazide) and furosemide (Lasix)
• are allergic to sulindac
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sulindac falls into category C before the 30th week of pregnancy, and category D after the 30th week.

For Pregnancy Category C before the 30th week of pregnancy: Studies in animals have shown a harmful and undesired effect on the unborn baby, yet there are no adequate and well-controlled studies in pregnant women. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

For Pregnancy Category D after the thirtieth week of pregnancy: Sulindac should be avoided during the third trimester of pregnancy. There is evidence of risk to the unborn baby based on studies in humans or adverse reaction data. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if sulindac is excreted in human breast milk or if it will harm your nursing baby.

• Sulindac comes as a tablet to take by mouth.
• It is usually taken with food twice daily.
• Take sulindac at around the same times each day. 
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of sulindac at the same time.

Take sulindac exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• Sulindac should be administered orally twice a day with food.
• The maximum dosage is 400 mg per day.

If you take too much sulindac, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store sulindac at room temperature.
• Keep this medication in a dry place.
• Keep this and all medicines out of the reach of children.

• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.  
• Sulindac is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. 

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.