ADVERSE REACTIONS
In patients taking Lodine or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:
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 Lodine was derived from 2,629 arthritic patients treated with Lodine (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 Lodine.
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 Lodine b.i.d. (i.e., 600 to 1000 mg/day).
Incidence Greater Than Or Equal To 1%—Probably Causally Related
Body as a whole—Chills and fever.
Digestive system—Dyspepsia (10%), abdominal painDrug-related patient complaints occurring in 3 to 9% of patients with Lodine.
Drug-related patient-complaints occurring in few than 3%, but more than 1%, are unmarked., 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.
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 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 patients.
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 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 Lodine 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.
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, pneumonia
Urogenital system—Oliguria/polyuria, proteinuria
|
