Nervagest Plus Adverse Reactions

The most common side effects events seen with pregabalin treatment are dizziness, somnolence, headache, ataxia, asthenia, dry mouth, constipation, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention). Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all controlled and uncontrolled trials across various patient populations during the premarketing development of pregabalin, more than 10,000 patients have received pregabalin. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.
Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy: Undesirable Effects Leading to Discontinuation: In clinical trials in patients with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with pregabalin and 4% of patients treated with placebo discontinued prematurely due to undesirable effects. In the pregabalin treatment group, the most common reasons for discontinuation due to undesirable effects were dizziness (3%) and somnolence (2%). In comparison, <1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.
Most Common Undesirable Effects: Table lists all undesirable effects, regardless of causality, occurring in ≥1% of patients with neuropathic pain associated with diabetic neuropathy in the combined pregabalin group for which the incidence was greater in this combined pregabalin group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had undesirable effects with a maximum intensity of "mild" or "moderate".
Table: Treatment-emergent adverse reaction incidence in controlled trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (Events in at least 1% of all pregabalin-treated patients and at least numerically more in all pregabalin than in the placebo group) (see table).

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