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Sublingual immunotherapy (SLIT) has been used since several decades, but the safety of this drug in patients with respiratory diseases is still under discussion. The aim of this study was to evaluate the safety of SLIT in patients with respiratory allergy. The safety of one sublingual tablet of 100, 250, or 400 m Uni-Allergen® (ALK, Hørsholm, Denmark) (ARA/Alvesco®, SPT Bayer, São Paulo, Brazil) was prospectively evaluated in a randomized, double blind, placebo-controlled trial of parallel design. Only subjects with a diagnosis of asthma or allergic rhinitis, for which theophylline was contraindicated were included, since some patients cannot tolerate standard doses of this drug. Individuals with atopy, defined as a positive skin prick test to common aeroallergens, were randomized in 3 groups to receive one tablet of each dose of the SLIT with 100, 250 or 400 m Uni-Allergen for 6 months. The incidence of adverse reactions (by severity) and changes in pulmonary function were studied. A total of 67 subjects were included in the study. The incidence of adverse reactions was similar between the placebo and SLIT groups for the whole sample (P = 0.574, overall significance). Nevertheless, an increase in blood pressure and a decrease in forced vital capacity and forced expiratory volume during 1 s were observed in the SLIT groups, which were not statistically different from those observed in the placebo group. No other adverse reactions were identified. In conclusion, SLIT was safe for patients with respiratory allergies, as demonstrated by the absence of adverse reactions and by the maintenance of pulmonary function
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