Most Common Adverse Reactions

Table 7 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".

Table 7. Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with spinal cord injury (events in at least 2% of all LYRICA-treated patients and occurring more frequently in the all pregabalin-group than in the placebo treatment group)
System Organ Class
Preferred term PGB* (N=182) Placebo (N=174)
% %
* PGB: Pregabalin
Ear and labryrinth disorders 
Vertigo 2.7 1.1
Eye disorders 
Vision blurred 6.6 1.1
Gastrointestinal disorders  
Dry mouth 11.0 2.9
Constipation 8.2 5.7
Nausea 4.9 4.0
Vomiting 2.7 1.1
General disorders and administration site conditions 
Fatigue 11.0 4.0
Edema peripheral 10.4 5.2
Edema 8.2 1.1
Pain 3.3 1.1
Infections and infestations 
Nasopharyngitis 8.2 4.6
Investigations 
Weight increased 3.3 1.1
Blood creatine phosphokinase increased 2.7 0
Musculoskeletal and connective tissue disorders 
Muscular weakness 4.9 1.7
Pain in extremity 3.3 2.3
Neck pain 2.7 1.1
Back pain 2.2 1.7
Joint swelling 2.2 0
Nervous system disorders 
Somnolence 35.7 11.5
Dizziness 20.9 6.9
Disturbance in attention 3.8 0
Memory impairment 3.3 1.1
Paresthesia 2.2 0.6
Psychiatric disorders  
Insomnia 3.8 2.9
Euphoric mood 2.2 0.6
Renal and urinary disorders 
Urinary incontinence 2.7 1.1
Skin and subcutaneous tissue disorders 
Decubitus ulcer 2.7 1.1
Vascular disorders 
Hypertension 2.2 1.1
Hypotension 2.2 0
Other Adverse Reactions Observed During the Clinical Studies of LYRICA

Following is a list of treatment-emergent adverse reactions reported by patients treated with LYRICA during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients. Events of major clinical importance are described in the Warnings and Precautions se