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Etodolac XR

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Etodolac XR

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
(Adverse Reactions)

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:
abdominal pain
dyspepsia
gross bleeding/perforation*
constipation
flatulence
nausea
diarrhea
GI ulcers (gastric/duodenal)*
vomiting
other events including:
abnormal renal function*
dizziness
headaches
infection
rashes
anemia*
edema*
hypertension
pharyngitis
rhinitis
asthenia
elevated liver enzymes*
increased bleeding time*
pruritus
tinnitus*
* 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:

Body as a whole - allergic reaction, anaphylactic/anaphylactoid reactions (including shock), chills, fever, sepsis

Cardiovascular system - congestive heart failure, flushing, palpitations, tachycardia, syncope, vasculitis (including necrotizing and allergic)

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

Hemic and lymphatic system - agranulocytosis, ecchymosis, eosinophilia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, purpura, thrombocytopenia

Metabolic and nutritional - hyperglycemia in previously controlled diabetic patients

Nervous system - anxiety, confusion, depression, dream abnormalities, insomnia, nervousness, paresthesia, somnolence, tremors, vertigo

Respiratory system - asthma, dyspnea, pulmonary infiltration with eosinophilia

Skin and appendages - angioedema, cutaneous vasculitis with purpura, erythema multiforme, hyperpigmentation, sweating, urticaria, vesiculobullous rash

Special senses - blurred vision, photophobia, transient visual disturbances

Urogenital system - dysuria, elevated BUN, oliguria/polyuria, proteinuria, renal failure, renal insufficiency, renal papillary necrosis, serum creatinine increase, urinary frequency

Other NSAID adverse reactions, which occur rarely are:

Body as a whole - anaphylactic reactions, appetite changes, death

Cardiovascular system - arrhythmia, cerebrovascular accident, hypotension, myocardial infarction

Digestive system - colitis, esophagitis with or without stricture or cardiospasm, thirst, ulcerative stomatitis

Hemic and lymphatic system - aplastic anemia, lymphadenopathy

Metabolic and nutritional - change in weight

Nervous system - coma, convulsions, hallucinations, meningitis

Respiratory - bronchitis, pneumonia, respiratory depression, sinusitis

Skin and appendages - alopecia, exfoliative dermatitis, maculopapular rash, photosensitivity, skin peeling, Stevens-Johnson syndrome, toxic epidermal necrosis

Special senses - conjunctivitis, deafness, hearing impairment, taste perversion

Urogenital System - cystitis, hematuria, interstitial nephritis, leukorrhea, renal calculus, uterine bleeding irregularities

Read the entire FDA prescribing information for Etodolac XR (Etodolac Extended Release) »

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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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