FDA label 922837bf-5377-4b1b-94e5-9fa010f62afe

WARNINGS Risk of Gastrointestinal (GI) Ulceration, Bleeding, and Perforation with Nonsteroidal Anti-Inflammatory Drug (NSAID) Therapy Serious GI toxicity, such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms, in patients treated chronically with NSAIDs. Although minor upper GI problems, such as dyspepsia, are common, usually developing early in therapy, physicians should remain alert for ulceration and bleeding in patients treated chronically with NSAIDs, even in the absence of previous GI-tract symptoms. In patients observed in clinical trials of such agents for several months’ to 2 years’ duration, symptomatic upper GI ulcers, gross bleeding, or perforation appears to occur in approximately 1% of patients treated for 3 to 6 months and in about 2% to 4% of patients treated for 1 year. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur. Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Except for a prior history of serious GI events and other risk factors known to be associated with peptic ulcer disease, such as alcoholism, smoking, etc., no risk factors (e.g., age, sex) have been associated with increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less well than other individuals, and most spontaneous reports of fatal GI events are in this population. Studies to date are inconclusive concerning the relative risk of various NSAIDs in causing such reactions. High doses of any NSAID probably carry a greater risk of these reactions, although controlled clinical trials showing this do not exist in most cases. In considering the use of relatively large doses (within the recommended dosage range), sufficient benefit should be anticipated to offset the potential increased risk of GI toxicity. Anaphylactoid Reactions Anaphylactoid reactions may occur in patients without prior exposure to etodolac. Etodolac should not be given to patients with aspirin triad. The triad 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 nonsteroidal anti-inflammatory drugs. Fatal reactions have been reported in such patients (see CONTRAINDICATIONS and PRECAUTIONS – Pre-existing Asthma ). Emergency help should be sought in cases where an anaphylactoid reaction occurs. Advanced Renal Disease In cases with advanced kidney disease, as with other NSAIDs, treatment with etodolac should only be initiated with close monitoring of the patient’s kidney function (see PRECAUTIONS – Renal Effects ). Pregnancy In late pregnancy, as with other NSAIDs, etodolac should be avoided because it may cause premature closure of the ductus arteriosus (see PRECAUTIONS – Teratogenic Effects – Pregnancy Category C ).

ADVERSE REACTIONS Adverse-reaction information for etodolac was derived from 2,629 arthritic patients treated with etodolac in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with etodolac. New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of etodolac b.i.d. (i.e., 600 to 100 mg/day). Incidence Greater than or Equal to 1% - Probably Causally Related Body as a whole – Chills and fever. Digestive system – Dyspepsia (10%), abdominal pain*, diarrhea*, flatulence*, nausea*, constipation, gastritis, melena, vomiting. Nervous system – Asthenia/malaise*, dizziness*, depression, nervousness. Skin and appendages – Pruritus, rash. Special senses – Blurred vision, tinnitus. Urogenital system – Dysuria, urinary frequency. * Drug-related patient complaints occurring in 3 to 9% of patients treated with etodolac. Drug-related patient complaints occurring in fewer than 3%, but more than 1%, are unmarked. Incidence Less than 1% - Probably Causally Related (Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized) Body as a whole – Allergic reactions, anaphylactoid reaction . Cardiovascular system – Hypertension, congestive heart failure, flushing, palpitations, syncope, vasculitis (including necrotizing and allergic) . Digestive system – Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, cholestatic hepatitis , hepatitis, cholestatic jaundice , duodenitis, jaundice, hepatic failure, liver necrosis , peptic ulcer with or without bleeding and/or perforation, intestinal ulceration, pancreatitis . Hemic and lymphatic system – Ecchymosis, anemia, thrombocytopenia, bleeding time increased, agranulocytosis, hemolytic anemia, leukopenia, neutropenia, pancytopenia. Metabolic and nutritional – Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients. Nervous system – Insomnia, somnolence. Respiratory system – Asthma. Skin and appendages – Angioedema, sweating, urticaria, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, hyperpigmentation, erythema multiforme. Special senses – Photophobia, transient visual disturbances. Urogenital system – Elevated BUN, renal failure, renal insufficiency, renal papillary necrosis. Incidence Less than 1% - Causal Relationship Unknown (Medical events occurring under circumstances where causal relationship to etodolac is uncertain. These reactions are listed as alerting information for physicians) Body as a whole – Infection, headache. Cardiovascular system – Arrhythmias, myocardial infarction, cerebrovascular accident. Digestive system – Esophagitis with or without stricture or cardiospasm, colitis. Metabolic and nutritional – Change in weight. Nervous system – Paresthesia, confusion. Respiratory system – Bronchitis, dyspnea, pharyngitis, rhinitis, sinusitis. Skin and appendages – Alopecia, maculopapular rash, photosensitivity, skin peeling. Special senses – Conjunctivitis, deafness, taste perversion. Urogenital system – Cystitis, hematuria, leukorrhea, renal calculus, interstitial nephritis, uterine bleeding irregularities.