In patients taking etodolac or other NSAIDs, the most frequently
reported adverse experiences occurring in approximately 1 to 10% of patients
Gastrointestinal experiences including: abdominal
pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation,
heartburn, nausea, GI ulcers (gastric/duodenal), vomiting.
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 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 1000 mg/day).
Incidence Greater That or Equal to 1% - Probably Causally
Body as a whole - Chills and fever.
Digestive system - Dyspepsia (10%), abdominal pain* 5, diarrhea* 5,
flatulence* 5, nausea* 5, constipation, gastritis, melena, vomiting.
Nervous system - Asthenia/malaise* 5,
dizziness* 5, depression, nervousness.
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%,
5 *Drug-related patient complaints occurring in 3 to 9% of patients treated
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
Body as a whole - Allergic reaction,
anaphylactic/anaphylactoid reactions (including shock).
Cardiovascular system - Hypertension, congestive heart failure, flushing,
palpitations, syncope, vasculitis (including necrotizing and
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
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
Skin and appendages - Angioedema, sweating, urticaria, vesiculobullous rash,
purpura, Stevens-Johnson Syndrome,
toxic epidermal necrolysis, 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
Digestive system - Esophagitis with or without stricture or cardiospasm,
Metabolic and nutritional - Change in weight.
Nervous system - Paresthesia, confusion.
Respiratory system - Bronchitis, dyspnea, pharyngitis, rhinitis,
Skin and appendages - Alopecia, maculopapular rash, photosensitivity, skin
Special senses - Conjunctivitis, deafness, taste perversion.
Urogenital system - Cystitis, hematuria, leukorrhea, renal calculus,
interstitial nephritis, uterine bleeding irregularities.
Additional Adverse Reactions Reported with NSAIDs
Body as a whole – Sepsis, death.
Cardiovascular system – Tachycardia.
Digestive system – Gastric ulcers, gastritis, gastrointestinal bleeding,
Hemic and lymphatic system – Lymphadenopathy.
Nervous system – Anxiety, dream abnormalities, convulsions, coma,
hallucinations, meningitis, tremors, vertigo.
Respiratory system – Respiratory depression, pneumonia.
Urogenital system – Oliguria/polyuria, proteinuria.