Summary
More frequently reported side effects include: abdominal pain, asthenia, diarrhea, dyspepsia, nausea, flatulence, and malaise. Continue reading for a comprehensive list of adverse effects.
Applies to etodolac: oral conventional capsules and tablets, oral extended-release tablets.
Warning
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Cardiovascular Risk
- Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).1 500 502 508 Risk may occur early in treatment and may increase with duration of use.500 502 505 506 508 (See Cardiovascular Thrombotic Effects under Cautions.)
- Contraindicated in the setting of CABG surgery.508
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GI Risk
- Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).1 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.1 Geriatric individuals are at greater risk for serious GI events.1 (See GI Effects under Cautions.)
Side effects include:
Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, GI bleeding, GI perforation, nausea, peptic ulcer, vomiting, renal function abnormalities, anemia, dizziness, edema, liver function test abnormalities, headache, prolonged bleeding time, pruritus, rash, tinnitus.
For Healthcare Professionals
Applies to etodolac: oral capsule, oral tablet, oral tablet extended release.
General
The most frequently reported side effects were gastrointestinal in nature and included dyspepsia, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, gastric ulcers, duodenal ulcers, and vomiting.[Ref]
Gastrointestinal
Very common (10% or more): Dyspepsia (10%)
Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, gastric ulcer, duodenal ulcer, vomiting, abdominal distention, epigastric pain, stools abnormal, gastritis, melena
Very rare (less than 0.01%): Pancreatitis
Frequency not reported: Dry mouth, ulcerative stomatitis, eructation, peptic ulcer, gastrointestinal (GI) bleeding, perforation, esophagitis, esophageal stricture, cardiospasm, colitis, GI discomfort, burning sensation, gastralgia, upper abdominal discomfort, glossitis, hematemesis, rectal bleeding, heartburn, indigestion, ulcerative colitis exacerbated, Crohn's disease exacerbated
Postmarketing reports: Intestinal ulceration[Ref]
Cardiovascular
Frequency not reported: Hypertension, congestive heart failure, flushing, palpitations, arrhythmia, myocardial infarction, tachycardia, cardiac failure
Postmarketing reports: Necrotizing vasculitis[Ref]
Renal
Common (1% to 10%): Renal function abnormal
Frequency not reported: Renal calculus, interstitial nephritis, renal impairment, nephrotoxicity, nephrotic syndrome, renal failure
Postmarketing reports: Renal insufficiency, renal papillary necrosis[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache
Frequency not reported: Syncope, somnolence, cerebrovascular accident, paresthesia, taste perversion, loss of taste, convulsion, coma, tremor, drowsiness, optic neuritis, stroke[Ref]
Dermatologic
Common (1% to 10%): Pruritus, rash
Very rare (less than 0.01%): Stevens-Johnson Syndrome, toxic epidermal necrolysis
Frequency not reported: Ecchymosis, angioedema, sweating, urticaria, exfoliative dermatitis, vesiculobullous rash, hyperpigmentation, alopecia, maculopapular rash, photosensitivity, skin peeling, purpura, erythema multiforme
Postmarketing reports: Allergic vasculitis, cutaneous vasculitis, leukocytoclastic vasculitis[Ref]
Hepatic
Common (1% to 10%): Liver enzymes increased
Frequency not reported: Bilirubinuria, hepatitis, jaundice
Postmarketing reports: Cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, hepatic failure, liver necrosis, fatal fulminant hepatitis[Ref]
Hematologic
Common (1% to 10%): Anemia, bleeding time increased
Frequency not reported: Thrombocytopenia, lymphadenopathy, neutropenia, agranulocytosis, hemolytic anemia, aplastic anemia, pancytopenia, leukopenia[Ref]
Metabolic
Frequency not reported: Anorexia
Postmarketing reports: Hyperglycemia[Ref]
Psychiatric
Common (1% to 10%): Depression, nervousness
Frequency not reported: Insomnia, confusion, anxiety, dreams abnormal, hallucination, disorientation[Ref]
Genitourinary
Common (1% to 10%): Dysuria, urinary frequency
Frequency not reported: Cystitis, hematuria, leukorrhea, uterine bleeding irregular, oliguria, polyuria, proteinuria[Ref]
Ocular
Common (1% to 10%): Vision blurred
Frequency not reported: Photophobia, transient visual disturbance, conjunctivitis[Ref]
Respiratory
Frequency not reported: Asthma/aggravated asthma, bronchitis, bronchospasm, dyspnea, pharyngitis, rhinitis, sinusitis, respiratory depression, pneumonia
Postmarketing reports: Pulmonary infiltration eosinophilic[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia
Frequency not reported: Muscle pain[Ref]
Other
Common (1% to 10%): Edema, tinnitus, fever, chills, asthenia, malaise, fatigue
Frequency not reported: Serum creatinine increased, infection, weight abnormal, irritability, deafness, meningitis, vertigo, sepsis, death, weakness, aseptic meningitis
Postmarketing reports: Thirst, BUN increased[Ref]
Immunologic
Frequency not reported: Allergic/hypersensitivity reaction, anaphylactic/anaphylactoid reaction[Ref]
