The dose of Clinoril is individualized depending on condition and response. The maximum dosage is 400 mg per day. In osteoarthritis, rheumatoid arthritis, and ankylosingspondylitis, 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.
What Drugs, Substances, or Supplements Interact with Clinoril?
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 During Pregnancy or Breastfeeding
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.
Additional Information
Our Clinoril (Sulindac) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Clinoril Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using sulindac and call your doctor at once if you have:
changes in your vision;
shortness of breath (even with mild exertion), swelling, rapid weight gain;
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
nausea, vomiting, stomach pain, indigestion, loss of appetite;
diarrhea, constipation, gas;
headache, dizziness, nervousness;
itching, rash; 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.
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.
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.
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.
&Copy; Clinoril Patient Information is supplied by Cerner Multum, Inc. and Clinoril Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
