Gesitram Adverse Reactions

Tramadol injection was administered to 550 patients during the double blind or open label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions are felt to be probably related to tramadol injection administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these were similar for tramadol injection with codeine #3 (acetaminophen 300 mg with codeine phosphate 30 mg), and aspirin 325 mg with codeine phosphate 30 mg.
Incidence 1% to less than 5% possibly causally related: the following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials and for which the possibility of a causal relationship with tramadol injection exists.