Neurontin

[Gabapentin]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Postherpetic Neuralgia

The most commonly observed adverse events associated with the use of Neurontin ® in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema. In the 2 controlled studies in postherpetic neuralgia, 16% of the 336 patients who received Neurontin ® and 9% of the 227 patients who received placebo discontinued treatment because of an adverse event. The adverse events that most frequently led to withdrawal in Neurontin -treated patients were dizziness, somnolence, and nausea.

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Incidence in Controlled Clinical Trials

Table 2 lists treatment-emergent signs and symptoms that occurred in at least 1% of Neurontin ® -treated patients with postherpetic neuralgia participating in placebo-controlled trials and that were numerically more frequent in the Neurontin ® group than in the placebo group. Adverse events were usually mild to moderate in intensity.

Other events in more than 1% of patients but equally or more frequent in the placebo group included pain, tremor, neuralgia, back pain, dyspepsia, dyspnea, and flu syndrome. There were no clinically important differences between men and women in the types and incidence of adverse events. Because there were few patients whose race was reported as other than white, there are insufficient data to support a statement regarding the distribution of adverse events by race.

Epilepsy
The most commonly observed adverse events associated with the use of Neurontin ® in combination with other antiepileptic drugs in patients >12 years of age, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, and nystagmus. The most commonly observed adverse events reported with the use of Neurontin ® in combination with other antiepileptic drugs in pediatric patients 3 to 12 years of age, not seen at an equal frequency among placebo-treated patients, were viral infection, fever, nausea and/ or vomiting, somnolence, and hostility (see WARNINGS, Neuropsychiatric Adverse Events).

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