Drug Hypersensitivity Reactions (DHRs) are Adverse Drug Reactions (ADRs) particularly impactful on Health-related Quality of Life (HRQoL) and mental health. Although the role of HRQoL as an important patient-reported outcome has been recognized in the last years, HRQoL and mental health in patients with ADRs is still poorly investigated.

The aim of this systematic review is to evaluate prevalence, severity, and risk factors of HRQoL and mental health in DHRs, with particular focus on drug-induced anaphylaxis.

The Medline, SCOPUS, and American Psychological Association PsychArticles databases were searched to identify all the studies, up to December 31, 2022 that included subjects with at least one episode of DHR and assessments of mental health and/or quality of life. Results were reported as qualitative and quantitative analyses, with meta-analyses after assessment for risk of bias and heterogeneity.

A total of 45 observational studies were included. Overall, a high prevalence of depression (up to 51.4%, OR 2.94, 95%CI: 1.42-6.10) and anxiety (up to 48%, OR 3.92, 95%CI: 1.91-8.05) were reported, compared to healthy subjects. The HRQoL was significantly impacted, especially in case of drug-induced anaphylaxis (mean score +5.88, 95%CI: 0.77-10.98).

Despite the scarce and heterogeneous studies on this topic, the review shows that HRQoL and mental health are markedly impacted after ADRs. A better assessment of HRQoL and characterization of patients’ mental status may improve the efficacy of the therapeutic strategies, that should include also psychological support.