Sulindac (Oral route)
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 .
Acetic Acid (class)
Uses of This Medicine:
Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (e.g., osteoarthritis and rheumatoid arthritis) or acute gout, such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it.
Sulindac is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. This medicine may also be used to treat painful shoulder (bursitis or tendinitis).
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of sulindac in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulindac in the elderly. However, elderly patients may be more sensitive to the effects of sulindac than younger adults, and are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving sulindac.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Beta Glucan
- Dabigatran Etexilate
- Pentosan Polysulfate Sodium
- Protein C
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azilsartan Medoxomil
- Candesartan Cilexetil
- Enalapril Maleate
- Ethacrynic Acid
- Olmesartan Medoxomil
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia or
- Bleeding problems or
- Blood clots or
- Edema (fluid retention or body swelling) or
- Heart attack, history of or
- Heart disease (e.g., congestive heart failure) or
- Hypertension (high blood pressure) or
- Kidney disease (e.g., kidney stones), history of or
- Liver disease (e.g., hepatitis) or
- Pancreatitis (inflammation of the pancreas) or
- Stomach ulcers or intestinal bleeding, history of or
- Stroke, history of—Use with caution. May make these conditions worse.
- Aspirin-sensitive asthma or
- Aspirin sensitivity, history of—Should not be used in patients with these conditions.
- Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.
- Systemic lupus erythematosus (SLE)—May cause side effects to become worse.
Proper Use of This Medicine:
For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.
This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.
It is best to take this medicine with food. Also drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis:
- Adults—At first, 150 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 mg per day.
- Children—Use and dose must be determined by your doctor.
- For acute gout, bursitis, or tendinitis:
- Adults—At first, 200 milligrams (mg) two times a day. After the pain is relieved, your doctor may direct you to take a lower dose for a while before treatment is stopped completely.
- Children—Use and dose must be determined by your doctor.
- For osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
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 this medicine 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.
Side Effects of This Medicine:
- More common
- Acid or sour stomach
- nausea or vomiting
- skin rash
- stomach pain
- Less common
- Excess air or gas in the stomach or intestines
- itching skin
- passing gas
- stomach cramps
- weight loss
- Back or leg pains
- bleeding gums
- blistering, peeling, or loosening of the skin
- 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
- clay-colored stools
- cough or hoarseness
- cracks in the skin
- dark urine
- decreased urine output
- difficult or labored breathing
- difficult or painful urination
- difficulty with swallowing
- dilated neck veins
- discoloration of urine
- disturbed color perception
- double vision
- extreme fatigue
- eye pain
- feeling of warmth
- flu-like symptoms
- general body swelling
- general feeling of discomfort or illness
- groin pain
- halos around lights
- increased sensitivity of the skin to sunlight
- increased sweating
- increased thirst
- 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
- night blindness
- noisy breathing
- 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
- 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
- yellow eyes or skin
- Symptoms of overdose
- Change in consciousness
- decreased awareness or responsiveness
- loss of consciousness
- severe sleepiness
- 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
- false sense of well-being
- feeling of constant movement of self or surroundings
- feeling sad or empty
- hair loss or thinning of the hair
- 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
- sensation of spinning
- sleepiness or unusual drowsiness
- sore or dry mucous membranes
- swelling or redness in the joints
- trouble with concentrating
- trouble with sleeping
- unable to sleep
- vaginal bleeding
Along with its needed effects, a medicine 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:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014