Background: Atopic dermatitis can have detrimental effects on health-related quality of life (QOL). Objective: Our purpose was to examine the QOL impact of tacrolimus ointment in patients with atopic dermatitis. Methods: The Dermatology Life Quality Index (DLQI), Children's DLQI (CDLQI), and Toddler QOL Survey were used to assess QOL in adults (16 years or older), children (5-15 years), and toddlers (2-4 years) enrolled in 12-week, randomized, double-blind studies comparing two concentrations of tacrolimus ointment (0.03% and 0.1%) versus vehicle ointment for treatment of atopic dermatitis. QOL was assessed at baseline, week 3, and week 12/early discontinuation. Results: Of the 985 patients enrolled, 91.5% had evaluable QOL data. Among adults, both tacrolimus ointment groups experienced improved QOL relative to the vehicle control group for all QOL scales (P < .001). Among children and toddlers, both tacrolimus ointment groups demonstrated significant QOL improvements relative to the vehicle control group (P < .05) for all but the Personal Relationships scale in the 0.03% tacrolimus ointment group among children. Conclusion: Tacrolimus ointment is associated with significant QOL benefits in adults, children, and toddlers with atopic dermatitis. (J Am Acad Dermatol 2001;44:S65-72.)