Sulindac Side Effects

Brand Names: Clinoril

Please note - some side effects for Sulindac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Sulindac - for the Consumer

Sulindac

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sulindac:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; flushing; lower back or side pain; mental or mood changes; muscle or unusual joint aches or pain; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Sulindac Side Effects - for the Professional

Sulindac

The following adverse reactions were reported in clinical trials or have been reported since the drug was marketed. The probability exists of a causal relationship between Sulindac tablets and these adverse reactions. The adverse reactions which have been observed in clinical trials encompass observations in 1,865 patients, including 232 observed for at least 48 weeks.

Incidence Greater Than 1%

Gastrointestinal

The most frequent types of adverse reactions occurring with Sulindac tablets are gastrointestinal; these include gastrointestinal pain (10%), dyspepsia2, nausea2 with or without vomiting, diarrhea2, constipation2, flatulence, anorexia and gastrointestinal cramps.

Dermatologic

Rash2, pruritus.

Central Nervous System

Dizziness2, headache2, nervousness.

Special Senses

Tinnitus.

Miscellaneous

Edema.

2

Incidence between 3% and 9%. Those reactions occurring in 1% to 3% of patients are not marked with an asterisk.

Incidence Less Than 1 in 100

Gastrointestinal

Gastritis, gastroenteritis or colitis. Peptic ulcer and gastrointestinal bleeding have been reported. GI perforation and intestinal strictures (diaphragms) have been reported rarely.

Liver function abnormalities; jaundice, sometimes with fever; cholestasis; hepatitis; hepatic failure.

There have been rare reports of Sulindac metabolites in common bile duct "sludge" and in biliary calculi in patients with symptoms of cholecystitis who underwent a cholecystectomy.

Pancreatitis.

Ageusia; glossitis.

Dermatologic

Stomatitis, sore or dry mucous membranes, alopecia, photosensitivity.

Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, and exfoliative dermatitis have been reported.

Cardiovascular

Congestive heart failure, especially in patients with marginal cardiac function; palpitation; hypertension.

Hematologic

Thrombocytopenia; ecchymosis; purpura; leukopenia; agranulocytosis; neutropenia; bone marrow depression, including aplastic anemia; hemolytic anemia; increased prothrombin time in patients on oral anticoagulants.

Genitourinary

Urine discoloration; dysuria; vaginal bleeding; hematuria; proteinuria; crystalluria; renal impairment, including renal failure; interstitial nephritis; nephrotic syndrome.

Renal calculi containing Sulindac metabolites have been observed rarely.

Metabolic

Hyperkalemia.

Musculoskeletal

Muscle weakness.

Psychiatric

Depression; psychic disturbances including acute psychosis.

Nervous System

Vertigo; insomnia; somnolence; paresthesia; convulsions; syncope; aseptic meningitis (especially in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease, see PRECAUTIONS).

Special Senses

Blurred vision; visual disturbances; decreased hearing; metallic or bitter taste.

Respiratory

Epistaxis.

Hypersensitivity Reactions

Anaphylaxis; angioneurotic edema; urticaria; bronchial spasm; dyspnea.

Hypersensitivity vasculitis.

A potentially fatal apparent hypersensitivity syndrome has been reported. This syndrome may include constitutional symptoms (fever, chills, diaphoresis, flushing), cutaneous findings (rash or other dermatologic reactions – see above), conjunctivitis, involvement of major organs (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 (adenitis, arthralgia, arthritis, myalgia, fatigue, malaise, hypotension, chest pain, tachycardia).

Causal Relationship Unknown

A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group A β-hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, sometimes with fatal outcome .

Other reactions have been reported in clinical trials or since the drug was marketed, but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.

Cardiovascular

Arrhythmia.

Metabolic

Hyperglycemia.

Nervous System

Neuritis.

Special Senses

Disturbances of the retina and its vasculature.

Miscellaneous

Gynecomastia.

Side Effects by Body System

Gastrointestinal

Pancreatitis is a rare, but potentially severe, dose-independent side effect of sulindac. The majority of cases present within the first six months of therapy, although onset after five years of sulindac therapy is reported in at least one case.

Severe odynophagia secondary to sulindac-induced esophageal ulceration has been reported.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Sulindac should be used with caution in these patients.

Gastrointestinal (GI) side effects have included dyspepsia, nausea, diarrhea, constipation, flatulence, and occult GI blood loss. More serious GI side effects have included gastritis, gastroenteritis, colitis, esophageal ulcer, peptic ulcer with or without perforation, GI hemorrhage, colonic diaphragms, and pancreatitis. Severe odynophagia secondary to sulindac-induced esophageal ulceration has also been reported. GI events have been fatal in some cases.

Hepatic

Hepatic side effects have included elevations in liver function tests in up to 15% of patients. Jaundice, hepatitis (hepatocellular, cholestatic, and mixed-type), cholangitis, and hepatic failure have been reported. One case of drug-associated cholelithiasis has also been reported.

Elevations in liver function tests three times normal values occur in less than 1% of patients.

Significant hepatotoxicity has been reported in association with sulindac therapy and is sometimes fatal. While one review found a possible increased incidence in hepatotoxicity in females, in the elderly, and in patients with autoimmune connective tissue disorders, more severe hepatic reactions should be ruled out in any patient with significant or prolonged elevations in liver function tests or other signs and symptoms suggestive of liver injury.

Hypersensitivity

Hypersensitivity side effects have rarely included fever, rash, bronchial asthma, dyspnea, and anaphylaxis. In addition, hypersensitivity has been implicated in cases of hepatotoxicity, renal toxicity, pneumonitis, vasculitis, and generalized multiorgan reactions. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Hypersensitivity syndrome has also been reported.

One manufacturer described a potentially fatal hypersensitivity syndrome associated with sulindac. Symptoms included fever, chills, diaphoresis, flushing, rash, conjunctivitis, elevations in liver function tests, hepatic failure, jaundice, pancreatitis, pneumonitis, blood dyscrasias, disseminated intravascular coagulation, and renal failure. Other findings included malaise, arthralgia, myalgia, fatigue, hypotension, tachycardia, and chest pain.

Sulindac should be promptly discontinued if fever, pruritus, rash, elevations in liver function tests accompanied by fever, or other hypersensitivity response occurs.

Hematologic

The development of anemia may indicate occult gastrointestinal blood loss secondary to gastric irritation or gastrointestinal ulceration.

Thrombocytopenia appears to be secondary to peripheral destruction due to the development of an antiplatelet antibody. Hemolytic anemia also appears to be due to peripheral destruction secondary to the development of an autoantibody.

Hematologic side effects have included platelet dysfunction, resulting in increased bleeding times as well as thrombocytopenia, anemia, neutropenia, leukopenia, agranulocytosis, aplastic anemia, and immune hemolytic anemia.

Renal

Other nonsteroidal anti-inflammatory agents (NSAIDs) may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Sulindac may have the same effect. Hence, renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for NSAID-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Renal side effects have included acute renal failure secondary to membranous glomerulonephritis and interstitial nephritis, as well as nephrotic syndrome (despite a proposed "renal sparing effect" of sulindac). Hypersensitivity has been implicated in some forms of sulindac-induced renal toxicity.

Dermatologic

Dermatologic side effects have included rash (3% to 9%), pruritus (1% to 3%), alopecia, photosensitivity, fixed-drug eruption, stomatitis, sore or dry mucous membranes, Stevens-Johnson syndrome, toxic epidermal necrolysis, and rare cases of fulminant necrotizing fasciitis.

Nervous system

Underlying connective tissue disease, such as systemic lupus erythematosus, may be a predisposing factor for the development of sulindac-induced aseptic meningitis.

Nervous system side effects including aseptic meningitis, paresthesia, encephalopathy, vertigo, insomnia, somnolence, convulsions, and syncope have been reported in greater than 1% of patients. Peripheral neuropathy has been reported rarely. Dizziness and headache have also been reported.

Psychiatric

Psychiatric side effects have included rare cases of reversible psychotic behavior, irritability, obsessiveness, depression, and visual and auditory hallucinations.

Cardiovascular

Cardiovascular side effects have included palpitations and congestive heart failure, especially in patients with marginal cardiac function. Elevated blood pressure has also been reported.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Endocrine

Endocrine side effects have been reported rarely. These have included a case report of reversible gynecomastia.

Metabolic

Metabolic side effects have included hyperkalemia, probably secondary to sulindac-induced hyporeninemic hypoaldosteronism.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.