omparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the LYRICA group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).
Most Common Adverse Reactions
Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined LYRICA group for which the incidence was greater in this combined LYRICA group than in the placebo group. In addition, an event is included, even if the incidence in the all LYRICA group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate". Overall, 12.4% of all pregabalin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.
Table 4. Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with postherpetic neuralgia (events in at least 1% of all LYRICA-treated patients and at least numerically more in all LYRICA than in the placebo group)
Body system
Preferred term 75 mg/d
[N=84]
% 150 mg/d
[N=302]
% 300 mg/d
[N=312]
% 600 mg/d
[N=154]
% All PGB*
[N=852]
% Placebo
[N=398]
%
* PGB: pregabalin † Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking. ‡ Investigator term; summary level term is amblyopia
Body as a whole
Infection 14 8 6 3 7 4
Headache 5 9 5 8 7 5
Pain 5 4 5 5 5 4
Accidental injury 4 3 3 5 3 2
Flu syndrome 1 2 2 1 2 1
Face edema 0 2 1 3 2 1
Digestive system
Dry mouth 7 7 6 15 8 3
Constipation 4 5 5 5 5 2
Flatulence 2 1 2 3 2 1
Vomiting 1 1 3 3 2 1
Metabolic and nutritional disorders
Peripheral edema 0 8 16 16 12 4
Weight gain 1 2 5 7 4 0
Edema 0 1 2 6 2 1
Musculoskeletal system
Myasthenia 1 1 1 1 1 0
Nervous system
Dizziness 11 18 31 37 26 9
Somnolence 8 12 18 25 16 5
Ataxia 1 2 5 9 5 1
Abnormal gait 0 2 4 8 4 1
Confusion 1 2 3 7
