Effects of pregabalin (PGB) on patient-reported health outcomes were assessed in 65 PGB-naive subjects with trigeminal neuralgia refractory to previous analgesic therapy in a prospective, multicentre observational study carried out in primary care. Twelve weeks' monotherapy with PGB (n = 36) or add-on (n = 29), reduced baseline intensity of pain by a mean +/- S.D. of -40.0 +/- 22.1 mm [-55.4%, effect size (ES) 2.32; P < 0.0001] with 59.4% of responders (pain reduction >or= 50%), and produced 34.6 +/- 29.3 additional days with no/mild pain. Anxiety/depression symptoms decreased by -3.8 +/- 3.5 and -4.5 +/- 4.2 points (ES 0.95 and 1.02; P < 0.0001), respectively. PGB improved sleep by -17.9 +/- 19.6 points (ES 1.18; P < 0.0001) and improved patient functioning (Sheehan Disability Index) by decreasing overall scoring by -8.6 +/- 5.9 points (ES 1.59; P < 0.0001). Health state (EQ-5D) increased by 31.6 +/- 22.2 mm (ES 1.67; P < 0.0001), with 0.0388 +/- 0.0374 gained quality-adjusted life-years. In spite of the small sample size, results support the effectiveness of PGB for the improvement in pain and related health symptoms.