Summary
Commonly reported side effects of sulindac include: increased liver enzymes. Continue reading for a comprehensive list of adverse effects.
Applies to sulindac: oral tablet.
Warning
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
- 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
Rare
- 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
- Continuing ringing or buzzing or other unexplained noise in the ears
- hearing loss
Rare
- 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
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
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]
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]