Sulindac is an active pharmaceutical ingredient in the Acetic Acid Derivatives and Related Substances group (M01AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 10, 2026[1]
Sulindac is a non-steroidal, analgesic/anti-inflammatory agent with antipyretic properties. Indicated in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis, peri-articular disorders such as bursitis, tendinitis, and tenosynovitis.
How to take
GB
CACanada· Health Canada
2 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
TEVA-SULINDAC (sulindac tablets) is indicated for: The relief of signs and symptoms related to osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis.
Throughout this document, the term NSAIDs refers to both non-selective NSAIDs and selective COX-2 inhibitor NSAIDs, unless otherwise indicated. For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first.
See
How to take
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised December 11, 2025[3]
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).
Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis** 3. Ankylosing spondylitis 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) 5.
Acute gouty arthritis **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care).
Drug interactions
Known interactions involving Sulindac. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 378. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL177360121 · revised April 10, 2026
[2]Health Canada (DPD) · 00745588 · revised March 22, 2025
[3]FDA DailyMed · 0feabf47-8d0d-48… · revised December 11, 2025 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
4 ‘Special warnings and special precautions for use’). For oral use to be taken preferably with or after food. The dosage should be taken twice a day and adjusted to the severity of the disease. The usual dosage is 200 mg twice daily.
However, the dosage may be lowered depending on the response. Doses above 400 mg per day are not recommended. In the treatment of acute gouty arthritis, therapy for seven days is usually adequate. In peri-articular disorders, treatment should be limited to seven to ten days.
Sulindac should be administered preferably with fluids or food.
Children:
The use of sulindac in children is contra-indicated.
Use in the elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 10, 2026[1]
Sulindac is generally well tolerated. Those side effects experienced are usually mild and may often respond to a reduction in dosage. Side effects reported frequently Gastro intestinal: the most frequent types of side effects occurring with sulindac are gastro intestinal; these include gastro intestinal pain, dyspepsia, nausea with or without vomiting, diarrhoea, constipation, flatulence, anorexia, and gastro intestinal cramps.
Dermatological: rash, pruritus. Central nervous system: dizziness, headache, nervousness. Special senses: tinnitus. Miscellaneous: oedema. Side effects reported less frequently The following side effects were reported less frequently. The probability exists of a causal relationship between sulindac and these side effects: Gastro intestinal: stomatitis, gastritis or gastro enteritis.
4‘Special warnings and precautions for use’) have been reported, as well as gastro intestinal bleeding and gastro-intestinal perforations, sometimes fatal, particularly in the elderly. Pancreatitis, ageusia, glossitis, intestinal strictures (diaphragms), haematemisis, melaena, nausea.
It has also been reported that a probable sulindac metabolite has been found in biliary sludge in patients with symptoms of cholecystitis who underwent a cholecystectomy.
Hepatic:
Liver-function-test abnormalities, jaundice sometimes with fever, cholestasis, hepatitis, hepatic failure. Dermatological: purpura, sore or dry mucous membranes, alopecia, photosensitivity, erythema multiforme, toxic epidermal necrolysis, Stevens Johnson syndrome, exfoliative dermatitis.
Cardiovascular: congestive heart failure, especially in patients with marginal cardiac function; palpitation, hypertension. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4 ‘Special warnings and precautions for use’).
Haematological: thrombocytopenia; ecchymosis; purpura; leucopenia; agranulocytosis; neutropenia; bone-marrow depression, including aplastic anaemia; haemolytic anaemia, increased prothrombin time in patients on oral anticoagulants.
Renal/Genito urinary: urine discoloration, dysuria, vaginal bleeding, haematuria, proteinuria, crystalluria, renal impairment including renal failure, interstitial nephritis, nephrotic syndrome. 4 ‘Special warnings and precautions for use’).
Metabolic:
Hyperkalaemia.
Musculoskeletal:
Muscle weakness. Special senses: visual disturbances including blurred vision, optic neuritis, decreased hearing, metallic or bitter taste. Respiratory: epistaxis.
Hypersensitivity:
Hypersensitivity reactions have been reported following treatment with NSAIDs. 4 ‘Special warnings and precautions for use’). Causal relationship unknown: 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: hyperglycaemia. Nervous system: neuritis.
Special senses: disturbances of the retina and its vasculature. Miscellaneous: gynaecomastia. 4 ‘Special warnings and precautions for use’). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
GBOfficial regulatory label· Warnings and precautions· revised April 10, 2026[1]
2 ‘Posology and method of administration’ and GI and cardiovascular risks below). 5 ‘Interaction with other medicinal products and other forms of interaction’ ). 5 ‘Interaction with other medicinal products and other forms of interaction’).
2 ‘Posology and method of administration’) Platelet aggregation Sulindac has less effect on platelet function and bleeding time than aspirin; however, since sulindac is an inhibitor of platelet function, patients who may be adversely affected should be carefully observed when sulindac is administered.
Gastro-intestinal effects Sulindac should be used with caution in patients having a history of gastro-intestinal haemorrhage, ulcers, ulcerative colitis or Crohn’s disease. Gastro-intestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
Patients should report experiencing any of these effects, particularly the elderly and the treatment should be withdrawn. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding).
In patients with a history of peptic ulcer disease and in the elderly, NSAIDs should be given only after other forms of treatment have been considered. 3 ‘Contraindications’), and in the elderly. These patients should commence treatment on the lowest dose available.
g. 5 ‘Interaction with other medicinal products and other forms of interaction’). Respiratory effects Caution is required if administered to patients suffering from, or with a previous history of bronchial asthma, since NSAIDs have been reported to precipitate bronchospasm in some patients.
Hypersensitivity syndrome A potentially life-threatening, apparent hypersensitivity syndrome has been reported. In cases where the syndrome is suspected, therapy should be discontinued immediately, and not recontinued. 8 ‘Undesirable Effects’), conjunctivitis, involvement of major organs (changes in liver- function tests, hepatic failure, jaundice, pancreatitis, pneumonitis with or without pleural effusion, leucopenia, leucocytosis, eosinophilia, disseminated intravascular coagulation, anaemia, renal impairment, including renal failure), and other less specific findings (adenitis, arthralgia, arthritis, myalgia, fatigue, malaise, hypotension, chest pain, tachycardia).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 10, 2026[1]
Hypersensitivity to any component of this product. Severe heart failure. The use of sulindac is contra-indicated in severe renal failure and in patients with hepatic insufficiency. Poor liver function may alter the blood levels of circulating metabolites of sulindac.
Sulindac should not be used in patients in whom acute asthmatic attacks, urticaria, rhinitis, or angioedema have been precipitated by ibuprofen, aspirin or other non-steroidal anti-inflammatory agents. The drug should not be administered to patients with active gastro-intestinal bleeding or a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy.
The use of sulindac should be avoided in patients with active or previous peptic ulcer or haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Since paediatric indications and dosage have not yet been established, sulindac should not be given to children.
6 ‘Pregnancy and lactation’).
This is not medical advice. Consult a qualified healthcare professional.
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations Use of TEVA-SULINDAC should be limited to the lowest effective dose for the shortest possible duration of treatment. 2 Recommended Dose and Dosage Adjustment In osteoarthritis, rheumatoid arthritis and ankylosing spondylitis the recommended starting dosage is 150 mg twice a day.
The dosage may be lowered or raised dependi ng on the response. In acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis, the recommended dosage is 200 mg twice a day. After a satisfactory response has been achieved, the dosage may be reduced according to the response.
In acute painful shoulder, therapy for 7 to 14 days is usually adequate. In acute gouty arthritis, therapy for 7 days is usually adequate. The maximum recommended dose is 400 mg per day.
Pediatrics (< 12 years of age):
Health Canada has not authorized an indication for pediatric use.
See 2 CONTRAINDICATIONS Geriatrics (>65 years of age):
In the elderly, frail and debilitated, the dosage should be reduced to the lowest level providing control of symptoms, and adjusted when necessary. 4 Geriatrics Renal impairment: TEVA-SULINDAC and its metabolites are eliminated primarily by the kidneys.
A lower dose should be considered in patients with mild and moderate renal imp airment. 5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored).
See 2 CONTRAINDICATIONS Hepatic impairment:
Circulating levels of the sulfide and sulfone metabolites may be delayed, elevated and prolonged in patients with poor liver function. A lower dose should be considered in patients with mild and moderate hepatic impairment. TEVA-SULINDAC is contraindicated in severe liver impairment or active liver disease.
4 Administration TEVA-SULINDAC should be administered orally twice a day with food. 5 Missed Dose If a dose is missed, the patient should take it as soon as it is recognized. If it is almost time for the next dose, skip the missed dose and continue with the next schedul ed dose.
The patient should be instructed not take 2 doses at the same time. TEVA- SULINDAC (sulindac) Page 8 of 40
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
). Immune In common with other anti-inflammatory drugs, TEVA-SULINDAC may mask the usual signs of infection.
Aseptic Meningitis:
Rarely, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. ) seem to be pre-disposed. Therefore, in such patients, the health care provider must be vigilant to the development of this complication.
Monitoring and Laboratory Tests Cardiovascular:
Patients on long-term treatment with TEVA-SULINDAC should have their blood pressure monitored regularly.
Hematology:
Hemoglobin, hematocrit, red blood cells (RBCs), white blood cells (WBCs), and platelets should be checked in patients on long-term treatment with TEVA-SULINDAC. Additionally, concurrent therapy with warfarin requires close monitoring of the international normalized ratio (INR).
Hepatic:
During long-term therapy, liver function tests should be monitored periodically. If this drug is to be used in the presence of impaired liver function, it must be done under strict observation.
TEVA- SULINDAC (sulindac) Page 13 of 40 Ophtalmologic:
Ophthalmic examination should be carried out at periodic intervals in any patient receiving this drug for an extended period of time.
Renal:
Serum creatinine, creatine clearance and serum urea should be checked in patient during TEVA-SULINDAC therapy. Electrolytes including serum potassium should be monitored periodically.
Pregnancy:
If TEVA-SULINDAC is administered in the middle (approximately 20 weeks) to the end of the second trimester, it is recommended that pregnant women on TEVA-SULINDAC be closely monitored for amniotic fluid volume since TEVA-SULINDAC may result in reduction of amniotic fluid volume and even oligohydramnios.
1 Pregnant Women TEVA-SULINDAC is contraindicated for use in the third trimester of pregnancy. Neurologic Some patients may experience drowsiness, dizziness, blurred vision, vertigo, tinnitus, hearing loss, insomnia or depression with the use of NSAIDs, such as TEVA-SULINDAC.
If patients experience such adverse reaction(s), they should exercise caution in carrying out activities that require alertness. Ophthalmologic Blurred and/or diminished vision has been reported with the use of sulindac and other nonsteroidal anti-inflammatory drugs.
If such symptoms develop this drug should be discontinued and an ophthalmologic examination performed: ophthalmic examination should be carried out at periodic intervals in any patient receiving this drug for an extended period of time.
Peri-Operative Considerations See 2 CONTRAINDICATIONS - Coronary Artery Bypass Graft Surgery. Psychiatric See 7 WARNINGS AND PRECAUTIONS – Neurologic. Renal Long term administration of NSAIDs to animals has resulted in renal papillary necrosis and other abnormal renal pathology.
In humans, there have been reports of acute interstitial nephritis, hematuria, low grade proteinuria and occasionally nephrotic syndrome. Renal insufficiency due to NSAID use is seen in patients with pre -renal conditions leading to reduction in renal blood flow or blood volume.
Under these circumstances, renal prostaglandins help maintain renal perfusion and glomerular filtration rate (GFR). In these patients, administration of a NSAID may cause a reduction in prostaglandin synthesis leading to impaired renal function.
Patients at greatest risk of this reaction are those with pre -existing renal insufficiency (GFR < 60 mL/min or 1 mL/s), dehydrated patients, patients on salt restricted diets, those with congestive heart failure, cirrhosis, liver dysfunction, taking angiotensin -converting enzyme inhibitors, angiotensin-II receptor blockers, cyclosporin, diuretics, and those who are TEVA- SULINDAC (sulindac) Page 14 of 40 elderly.
Serious or life-threatening renal failure has been reported in patients with normal or impaired renal function after short term therapy with NSAIDs. g. dehydration due to gastroenteritis). Discontinuation of NSAIDs is usually followed by recovery to the pre-treatment state.
Caution should be used when initiating treatment with NSAIDs, such as TEVA -SULINDAC, in patients with considerable dehydration. Such patients should be rehydrated prior to initiation of therapy. Caution is also recommended in patients with pre -existing kidney disease.
Advanced renal disease: (See 2 CONTRAINDICATIONS) Fluid and Electrolyte Balance:
Use of NSAIDs, such as TEVA-SULINDAC, can promote sodium retention in a dose-dependent manner, which can lead to fluid retention and edema, and consequences of increased blood pressure and exacerbation of congestive h eart failure.
Thus, caution should be exercised in prescribing TEVA-SULINDAC in patients with a history of congestive heart failure, compromised cardiac function, hypertension, increased age or other conditions predisposing to fluid retention (See 7 WARNINGS AND PRECAUTIONS - Cardiovascular).
Use of NSAIDs, such as TEVA-SULINDAC, can increase the risk of hyperkalemia, especially in patients with diabetes mellitus, renal failure, increased age, or those receiving concom itant therapy with adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-II receptor antagonists, cyclosporin, or some diuretics.
Electrolytes should be monitored periodically (see 2 CONTRAINDICATIONS).
Reproductive Health:
Female and Male Potential Fertility The use of TEVA-SULINDAC, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of TEVA-SULINDAC should be considered.
Respiratory […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
1 Pregnant Women 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS………………………………………………………………………………………………………………2 RECENT MAJOR LABEL CHANGES ..............................................................................................
2 TABLE OF CONTENTS ................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION........................................................................
7 5 OVERDOSAGE .................................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING...................................... 8 7 WARNINGS AND PRECAUTIONS.......................................................................................
1 Special Populations ............................................................................................... 1 Pregnant Women..................................................................................................
This is not medical advice. Consult a qualified healthcare professional.
How to take
USOfficial regulatory label· revised December 11, 2025[3]
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).
After observing the response to initial therapy with Sulindac Tablets USP, the dose and frequency should be adjusted to suit an individual patient’s needs. Sulindac Tablets should be administered orally twice a day with food. The maximum dosage is 400 mg per day.
Dosages above 400 mg per day are not recommended. In osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, the recommended starting dosage is 150 mg twice a day. The dosage may be lowered or raised depending on the response.
A prompt response (within one week) can be expected in about one-half of patients with osteoarthritis, ankylosing spondylitis, and rheumatoid arthritis. Others may require longer to respond. In acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis, the recommended dosage is 200 mg twice a day.
After a satisfactory response has been achieved, the dosage may be reduced according to the response. In acute painful shoulder, therapy for 7-14 days is usually adequate. In acute gouty arthritis, therapy for 7 days is usually adequate.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 36 reports total. [4]
Pain 8
Diarrhoea 7
Fatigue 7
Headache 6
Nausea 6
Abdominal Discomfort 4
Death 4
Decreased Appetite 4
Haematochezia 4
Haemorrhage 4
Ileus Paralytic 4
Intestinal Perforation 4
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised December 11, 2025[3]
ADVERSE REACTIONS
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 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 are gastrointestinal; these include gastrointestinal pain (10%), dyspepsia***, nausea*** with or without vomiting, diarrhea***, constipation***, flatulence, anorexia and gastrointestinal cramps.
Dermatologic Rash***, pruritus Central Nervous System Dizziness***, headache***, nervousness. Special Senses Tinnitus. Miscellaneous Edema (see WARNINGS ). 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 (see PRECAUTIONS ). Ageusia; glossitis.
Dermatologic Stomatitis, sore or dry mucous membranes, alopecia, photosensitivity. Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, fixed drug eruption (FDE), 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 (see PRECAUTIONS ).
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 ).
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 (see also PRECAUTIONS, General ).
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.
***Incidence between 3% and 9%. Those reactions occurring in 1% to 3% of patients are not marked with an asterisk.
USOfficial regulatory label· Warnings and precautions· revised December 11, 2025[3]
WARNINGS CARDIOVASCULAR EFFECTS
Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.
Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as sulindac, increases the risk of serious gastrointestinal (GI) events (see WARNINGS ).
Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG (see CONTRAINDICATIONS ). Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised December 11, 2025[3]
CONTRAINDICATIONS
Sulindac is contraindicated in patients with known hypersensitivity to sulindac or the excipients (see DESCRIPTION ). Sulindac should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Severe, rarely fatal, anaphylactic/anaphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS – Anaphylactic/Anaphylactoid Reactions , and PRECAUTIONS – Preexisting Asthma ). Sulindac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
This is not medical advice. Consult a qualified healthcare professional.
Infections Non-steroidal anti-inflammatory drugs, including sulindac, may mask the usual signs and symptoms of infection; therefore, the physician must be continually on the alert for this and should use the drug with extra care in the presence of existing infection.
Ocular effects Because of reports of adverse eye findings with agents of this class it is recommended that patients who develop eye complaints during treatment with sulindac have ophthalmological evaluations. Cardiovascular and cerebrovascular effects Peripheral oedema has been observed in some patients taking sulindac; therefore, as with other drugs in this class, sulindac should be used with caution in patients with compromised cardiac function, hypertension, or other conditions predisposed to fluid retention.
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of some NSAIDS (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events ( for example myocardial infarction or stroke).
There are insufficient data to exclude such a risk for sulindac. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with sulindac after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Hepatic effects A patient with signs and/or symptoms suggesting liver dysfunction, or in whom an abnormal liver-function test has occurred, should be evaluated for evidence of a more severe hepatic reaction while on therapy.
Significant elevations of AST (SGOT) and ALT (SGPT) (three times higher than normal) were seen in less than 1% of patients in controlled clinical trials. Cases of hepatitis, jaundice, or both, with or without fever, may occur within the first three […]
32 TEVA- SULINDAC (sulindac) Page 4 of 40 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TEVA-SULINDAC (sulindac tablets) is indicated for: The relief of signs and symptoms related to osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis.
Throughout this document, the term NSAIDs refers to both non-selective NSAIDs and selective COX-2 inhibitor NSAIDs, unless otherwise indicated. For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first.
See 2 […]
In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of sulindac tablets, in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If sulindac tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Hypertension NSAIDs, including sulindac, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.
NSAIDs, including sulindac, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients.
In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
, diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)] (see Drug Interactions ). Avoid the use of sulindac tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
If sulindac tablets are used in patients with severe heart failure, monitor patients for signs of worsening heart failure. Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation NSAIDs, including sulindac, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year.
These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with prior history of ulcer disease or gastrointestinal bleeding.
Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.
Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration.
Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out.
For high risk patients, alternate therapies that do not involve NSAIDs should be considered. Hepatic Effects In addition to hypersensitivity reactions involving the liver, in some patients the findings are consistent with those of cholestatic hepatitis (see WARNINGS,Hypersensitivity ).
As with other non-steroidal anti-inflammatory drugs, borderline elevations of one or more liver tests without any other signs and symptoms may occur in up to 15% of patients taking NSAIDs including sulindac. These laboratory abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy.
The SGPT (ALT) test is probably the most sensitive indicator of liver dysfunction. Meaningful (3 times the upper limit of normal) elevations of SGPT or SGOT (AST) occurred in controlled clinical trials in less than 1% of patients. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs.
In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with sulindac.
), sulindac should be discontinued. In clinical trials with sulindac, the use of doses of 600 mg/day has been associated with an increased incidence of mild liver test abnormalities (see DOSAGE AND ADMINISTRATION for maximum dosage recommendation).
Renal Effects Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. In these patients, administration of a non-steroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.
Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, patients who are volume-depleted, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease No information is available from controlled clinical studies regarding the use of sulindac in patients with advanced renal disease. Therefore, treatment with sulindac is not recommended in these patients with advanced renal disease.
If sulindac therapy must be initiated, close monitoring of the patient’s renal function is advisable. Anaphylactic/Anaphylactoid Reactions As with other NSAIDs, anaphylactic/anaphylactoid reactions may occur in patients without known prior exposure to sulindac.
Sulindac should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS – Preexisting Asthma ).
Emergency help should be sought in cases where an anaphylactic/anaphylactoid reaction occurs. Serious Skin Reactions NSAIDs, including sulindac, can cause serious adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of sulindac at the first appearance of skin rash or any other sign of hypersensitivity.
Sulindac is contradicted in patients with previous serious skin reactions to NSAIDs ( see CONTRAINDICATIONS ). Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as sulindac.
Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis.
Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If such signs or symptoms are present, discontinue sulindac and evaluate the patient immediately. Hypersensitivity Rarely, fever and other evidence of hypersensitivity (see ADVERSE REACTIONS ) including abnormalities in one or more liver function tests and severe skin reactions have occurred during therapy with sulindac.
Fatalities have occurred in these patients. Hepatitis, jaundice, or both, with or without fever, may occur usually within the first one to three months of therapy. Determinations of liver function should be considered whenever a patient on therapy with sulindac develops unexplained fever, rash or other dermatologic reactions or constitutional symptoms.
If unexplained fever or other evidence of hypersensitivity occurs, therapy with sulindac should be discontinued. The elevated temperature and abnormalities in liver function caused by sulindac characteristically have reverted to normal after discontinuation of therapy.
Administration of sulindac should not be reinstituted in such patients.
Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus:
Avoid use of NSAIDs, including sulindac, in pregnant women at about 30 weeks gestation and later. NSAIDs including sulindac, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment:
Use of NSAIDs, including sulindac, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit sulindac use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if sulindac treatment extends beyond 48 hours.
Discontinue sulindac if oligohydramnios occurs and follow up according to clinical practice (see PRECAUTIONS; Pregnancy).