OBJECTIVES: To identify risks associated with delivery of treatment with oral antineoplastic agents in an outpatient setting and to evaluate additional value and feasibility of engaging patients in a proactive risk analysis. METHODS: We conducted 2 separate but parallel failure mode and effects analyses (FMEAs) among patients and health care professionals (HCPs) at a clinical oncology department in Denmark. Comparative analyses were performed using the FMEA process maps and risk priority numbers (RPNs) as main outcome measures. The FMEAs were augmented by semistructured interviews with HCPs and patients on acceptability and feasibility of FMEAs analyzed using systematic text condensation. RESULTS: Patients and HCPs found failures in information regarding treatment (cause, aim, and plan) to be of high risk. Also, HCPs found failures in checking for potential interactions to be of high risk. HCPs focused on the in-hospitals procedures, whereas patients identified risks related to both the hospital and the home setting. Both HCPs and patients found participation in the FMEA process meaningful but found the use of RPNs difficult. CONCLUSIONS: Patient engagement in proactive risk analysis using FMEA is acceptable, meaningful, and feasible, with patients providing a different perspective on the risks associated with oral antineoplastic treatment compared with HCPs.