In patients taking etodolac or other NSAIDs, the most
frequently reported adverse experiences occurring in approximately 1 to 10% of
Gastrointestinal experiences including: abdominal
pain, constipation, diarrhea, dyspepsia, flatulence, gross
bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal),
Other events including: abnormal renal function,
anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding
time, pruritis, rashes, tinnitus.
Adverse-reaction information for etodolac was derived
from 2,629 arthritic patients treated with etodolac capsules and tablets 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
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 1000 mg/day). Incidence Greater
That or Equal to 1% - Probably Causally Related
Body as a whole - Chills and fever.
Digestive system - Dyspepsia (10%), abdominal
pain*5, diarrhea*5, flatulence*5, nausea*5, constipation, gastritis, melena,
Nervous system - Asthenia/malaise*5, dizziness*5,
Skin and appendages - Pruritus, rash.
Special senses - Blurred vision, tinnitus.
Urogenital system - Dysuria, urinary frequency.
Drug-related patient complaints occurring in fewer than
3%, but more than 1%, are unmarked. 5*Drug-related patient complaints occurring
in 3 to 9% of patients treated with etodolac. Incidence Less Than 1% - Probably
(Adverse reactions reported only in worldwide
postmarketing experience, not seen in clinical trials, are considered rarer and
Body as a whole - Allergic reaction,
anaphylactic/anaphylactoid reactions (including shock).
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
Nervous system - Insomnia, somnolence.
Respiratory system - Asthma, pulmonary
infiltration with eosinophilia.
Skin and appendages - Angioedema, sweating,
urticaria, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson
Syndrome, toxic epidermal necrolysis, hyperpigmentation, erythema multiforme.
Special senses - Photophobia, transient visual
Urogenital system - Elevated BUN, renal
failure, renal insufficiency, renal papillary necrosis.
Incidence Less Than 1% - Causal Relationship
(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
Urogenital system - Cystitis, hematuria,
leukorrhea, renal calculus, interstitial nephritis, uterine bleeding
Additional Adverse Reactions Reported with NSAIDs
Body as a whole - Sepsis, death.
Cardiovascular system - Tachycardia.
Digestive system - Gastric ulcers, gastritis,
gastrointestinal bleeding, glossitis, hematemesis.
Hemic and lymphatic system - Lymphadenopathy.
Nervous system - Anxiety, dream abnormalities,
convulsions, coma, hallucinations, meningitis, tremors, vertigo.
Respiratory system - Respiratory depression,
Urogenital system - Oliguria/polyuria,