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Clinoril

Last reviewed on RxList: 4/25/2017
Clinoril Side Effects Center

Last reviewed on RxList 10/12/2016

Clinoril (Sulindac) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis, ankylosing spondylitis, tendinitis, bursitis, or gout. Clinoril is available in generic form. Common side effects of Clinoril include:

  • upset stomach,
  • stomach pain,
  • heartburn,
  • nausea,
  • vomiting,
  • gas,
  • bloating,
  • diarrhea,
  • constipation,
  • dizziness,
  • fatigue,
  • headache,
  • nervousness,
  • skin itching or rash,
  • dry mouth,
  • increased sweating,
  • runny nose,
  • blurred vision, or
  • ringing in your ears.

Tell your doctor if you have unlikely but serious side effects of Clinoril including:

  • swelling of the hands or feet (edema),
  • sudden or unexplained weight gain,
  • mental/mood changes,
  • difficult or painful swallowing, or
  • unusual tiredness.

The dose of Clinoril is individualized depending on condition and response. The maximum dosage is 400 mg per day. In osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, the recommended starting dosage is 150 mg twice a day. In acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis, the recommended dosage is 200 mg twice a day. Duration of treatment varies with condition and response. Clinoril may interact with cyclosporine, diuretics (water pills), lithium, methotrexate, blood thinners, steroids, heart or blood pressure medications, oral diabetes medications, ACE inhibitors, aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs). Tell your doctor all medications you are taking. Clinoril should be used only when prescribed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to a fetus and interference with normal labor/delivery. It is unknown if this drug passes into breast milk. Breastfeeding while using this medication is not recommended.

Our Clinoril (Sulindac) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Clinoril Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sulindac and call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • urinating less than usual or not at all;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • dry mouth;
  • increased sweating, runny nose;
  • blurred vision; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Clinoril (Sulindac)

Clinoril Professional Information

SIDE EFFECTS

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 CLINORIL (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 CLINORIL (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, 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).

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 (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.

Read the entire FDA prescribing information for Clinoril (Sulindac)

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