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Objective: To examine the role of the Five Factor Model (FFM) personality traits in reporting the development of adverse drug reactions (ADRs) when controlling for sociodemographic variables and health status., Design: Prospective cohort study., Setting: The Estonian Biobank of the Estonian Genome Centre, University of Tartu., Participants: 814 women and 543 men (mean age=47.9 years; SD =15.2) who after the initial enrolment in the Estonian Biobank were re-contacted for follow-up purposes about 5.3 years after the enrolment and for whom both self- and informant-reported personality data were available., Main Outcome Measure: Participants who did not report having any ADRs at baseline but who reported ADRs at the follow-up about 5.3 years later versus participants who did not report any ADRs at either time point. The reports of developing ADRs were predicted from the FFM personality traits after statistically controlling for sociodemographic variables (age, gender and education), baseline indicators of health status (number of diagnoses and medicines taken, body mass index and blood pressure), and the change in health status between the two measurements., Results: The results of a hierarchical binary logistic regression analysis showed that participants who reported the development of ADRs between the two measurements had higher levels of conscientiousness, were more likely to be women, were taking more medicines at baseline and had a higher increase in the number of medicines taken during the study period than participants who did not report any ADRs at either time point (all p values <0.05). Higher neuroticism (p=0.067) and a higher number of diagnosed diseases at baseline (p=0.053) also made marginal contributions to predicting the development of ADRs., Conclusions: This study shows for the first time that higher levels of conscientiousness and neuroticism are associated with reporting the development of ADRs., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)