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- Clinician Information:
Etodolac XR Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Etodolac-XL Extended-Release is a nonsteroidal anti-inflammatory drug (NSAID) used to treat the symptoms of juvenile arthritis, rheumatoid arthritis, and osteoarthritis. This medication is available in generic form. Common side effects include abdominal pain, constipation, diarrhea, nausea or vomiting, dizziness, headaches, high blood pressure, rash, or ringing in the ears.
For relief of the signs and symptoms of osteoarthritis or rheumatoid arthritis, the recommended starting dose of etodolac extended-release is 400 to 1000 mg, given once daily. Dosage to treat juvenile arthritis is based on the child's body weight. Etodolac-XL may interact with ACE inhibitors, aspirin, furosemide and thiazides, lithium, methotrexate, and warfarin. Tell your doctor all medications and supplements you use. Use of etodolac-XL during pregnancy (particularly late pregnancy) should be avoided. It is unknown if etodolac-XL is excreted in breast milk. Consult your doctor before breastfeeding.
Our Etodolac-XL Extended-Release Tablets 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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Etodolac XR FDA Prescribing Information: Side Effects
A total of 1552 patients were exposed to etodolac extended-release tablets in controlled clinical studies of at least 4 weeks in length and using daily doses in the range of 400 to 1200 mg. In the tabulations below, adverse event rates are generally categorized based on the incidence of events in the first 30 days of treatment hwith etodolac extended-release tablets. As with other NSAIDs, the cumulative adverse event rates may increase significantly over time with extended therapy.
In patients taking NSAIDs, including etodolac extended-release tablets, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:
|gastrointestinal experiences including:|
GI ulcers (gastric/duodenal)*
|other events including:|
|abnormal renal function*
elevated liver enzymes*
increased bleeding time*
|* Adverse events that were observed in < 1% of patients in the first 30 days of treatment with etodolac extended-release tablets in clinical trials.|
Additional NSAID Adverse Experiences Reported Occasionally with NSAIDs or Etodolac Extended- Release Tablets Include:
Digestive system - anorexia, cholestatic hepatitis, cholestatic jaundice, dry mouth, duodenitis, eructation, esophagitis, gastritis, gastric/peptic ulcers, glossitis, hepatic failure, hepatitis, hematemesis, intestinal ulceration, jaundice, liver necrosis, melena, pancreatitis, rectal bleeding, stomatitis
Metabolic and nutritional - hyperglycemia in previously controlled diabetic patients
Other NSAID adverse reactions, which occur rarely are:
Body as a whole - anaphylactic reactions, appetite changes, death
Metabolic and nutritional - change in weight
Read the entire FDA prescribing information for Etodolac XR (Etodolac Extended Release) »
Additional Etodolac XR Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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