This systematic review and meta-analysis of RCTs were conducted to identify treatment emergent adverse events (AEs) associated with pregabalin.

RCTs were indentified from a search of MEDLINE, EMBASE, and Cochrane CENTRAL to February 2010, and also from reference lists of retrieved papers and from online clinical databases. Placebo-controlled, double-blind RCTs investigating the therapeutic effects of pregabalin in adults with any condition were selected, and had to include at least 20 subjects per arm and have a duration of at least 4 weeks.

A total of 38 RCTs were included in the analysis and the following findings were reported:

• Of 39 AEs, 20 (51%) were significantly associated with pregabalin (dizziness, vertigo, incoordination, balance disorder, ataxia, diplopia, blurred vision, amblyopia, tremor, somnolence, confusional state, disturbance in attention, thinking abnormal, euphoria, asthenia, fatigue, oedema, peripheral oedema, dry mouth, constipation).

• The highest RRs were found for cognition/coordination AEs.

• There was no significant association between serious AEs and pregabalin.

• There was a selective dose–response pattern in the onset of pregabalin AEs, with certain AEs appearing at lower doses than others.

Researchers conclude from these findings that patients starting treatment with pregabalin are at increased risk for several AEs, particularly those affecting cognition/coordination, which appear according to a selective dose–response pattern.