ADVERSE REACTIONS
The adverse reactions which have been observed in clinical trials encompass observations in about 4370 patients treated with tolmetin sodium, over 800 of whom have undergone at least one year of therapy. These adverse reactions, reported below by body system, are among those typical of non-steroidal anti-inflammatory drugs and, as expected, gastrointestinal complaints were most frequent. In clinical trials with tolmetin sodium, about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature.
Incidence Greater Than 1%
The following adverse reactions which occurred more frequently than 1 in 100 were reported in controlled clinical trials.
Gastrointestinal: Nausea (11%), dyspepsia,* gastrointestinal distress,* abdominal pain,* diarrhea,* flatulence,* vomiting,* constipation, gastritis, and peptic ulcer. Forty percent of the ulcer patients had a prior history of peptic ulcer disease and/or were receiving concomitant anti-inflammatory drugs including corticosteroids, which are known to produce peptic ulceration.
Body as a Whole: Headache,* asthenia,* chest pain
Cardiovascular: Elevated blood pressure,* edema*
Central Nervous System: Dizziness,* drowsiness, depression
Metabolic/Nutritional: Weight gain,* weight loss*
Dermatologic: Skin irritation
Special Senses: Tinnitus, visual disturbance
Hematologic: Small and transient decreases in hemoglobin and hematocrit not associated with gastrointestinal bleeding have occurred. These are similar to changes reported with other non-steroidal anti-inflammatory drugs
Urogenital: Elevated BUN, urinary tract infection
* Reactions occurring in 3% to 9% of patients treated with tolmetin sodium. Reactions occurring in fewer than 3% of the patients are unmarked.
Incidence Less Than 1% - (Causal Relationship Probable)
The following adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing. The probability exists that there is a causal relationship between tolmetin sodium and these adverse reactions.
Gastrointestinal: Gastrointestinal bleeding with or without evidence of peptic ulcer, perforation, glossitis, stomatitis, hepatitis, liver function abnormalities
Body as a Whole: Anaphylactoid reactions, fever, lymphadenopathy, serum sickness
Hematologic: Hemolytic anemia, thrombocytopenia, granulocytosis, agranulocytosis
Cardiovascular: Congestive heart failure in patients with marginal cardiac function
Dermatologic: Urticaria, purpura, erythema multiforme, toxic epidermal necrolysis
Urogenital: Hematuria, proteinuria, dysuria, renal failure
Incidence Less Than 1% - (Causal Relationship Unknown)
Other adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing, but a causal relationship between tolmetin sodium and the reaction could not be determined. These rarely reported reactions are being listed as alerting information for the physician since the possibility of a causal relationship cannot be excluded.
Body as a Whole: Epistaxis
Special Senses: Optic neuropathy, retinal and macular changes
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