OBJECTIVES:Clinicians learn from prior adverse events through pharmacovigilance allowing for improved medication safety in the medication use process; therefore, adverse drug reaction (ADR) reporting needs to be maximized. This systematic review was conducted to determine whether engaging patients/caregivers in ADR reporting during a patient's hospitalization provides further information about ADRs not obtained from traditional sources of reporting (i.e., voluntary reporting, medical record review). METHODS:This review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A literature search was conducted from January 2018 to June 2019 in PubMed, CINAHL, and Embase. Studies were included if they were (i) conducted in the inpatient setting, (ii) surveyed patients/caregivers, (iii) compared patient/caregiver reporting with another source of reporting, and (iv) evaluated ADRs. Studies completed in an outpatient setting or nursing home were excluded. RESULTS:A total of 11 studies were included. Sources of ADR information from patient/caregiver were obtained through interviews, surveys, questionnaires, or open-ended responses. Patient reporting was compared with medical record reports (7 articles) and health care professional reporting (4 articles). Approximately 11% to 35% of ADRs reported from patients were not identified through voluntary reporting by health care professionals, and 5.6% to 66% of ADRs obtained from patient reporting were not provided in the medical record. CONCLUSIONS:Patients/caregivers are important sources of safety information to improve system and practice of medication use that may not be recorded by other surveillance methods. Administrators and clinicians need to determine the best approach to integrate patients/caregivers into routine reporting for optimal engagement.