Neurontin - Side Effects & Drug Interactions

(Page 3)

The overall incidence of adverse events and the types of adverse events seen were similar among men and women treated with Neurontin ® . The incidence of adverse events increased slightly with increasing age in patients treated with either Neurontin ® or placebo. Because only 3% of patients (28/ 921) in placebo-controlled studies were identified as nonwhite (black or other), there are insufficient data to support a statement regarding the distribution of adverse events by race.

Table 4 lists treatment-emergent signs and symptoms that occurred in at least 2% of Neurontin ® -treated patients age 3 to 12 years of age with epilepsy participating in placebo-controlled trials and were numerically more common in the Neurontin ® group. Adverse events were usually mild to moderate in intensity.

Other events in more than 2% of pediatric patients 3 to 12 years of age but equally or more frequent in the placebo group included: pharyngitis, upper respiratory infection, headache, rhinitis, convulsions, diarrhea, anorexia, coughing, and otitis media. Other Adverse Events Observed During All Clinical Trials

Clinical Trials in Adults and Adolescents (Except Clinical Trials in Neuropathic Pain)

Neurontin ® has been administered to 2074 patients >12 years of age during all adjunctive therapy clinical trials (except clinical trials in patients with neuropathic pain), only some of which were placebo-controlled. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified COSTART dictionary terminology. These categories are used in the listing below.

The frequencies presented represent the proportion of the 2074 patients >12 years of age exposed to Neurontin ® who experienced an event of the type cited on at least one occasion while receiving Neurontin ® . All reported events are included except those already listed in Table 3, those too general to be informative, and those not reasonably associated with the use of the drug.