Safety concerns reported by consumers, manufacturers and healthcare professionals: A detailed evaluation of opioid-related adverse drug reactions in the FDA database over 15 years.

To perform an in-depth analysis of opioid-related ADRs reported by consumers, manufacturers and healthcare professionals. Delving into the depth and breadth of reported opioid-related adverse drug reactions (ADRs) provides an opportunity to strategize better clinical management and alleviate safety concerns. Retrospective pharmacovigilance disproportionality analysis for opioid-related ADRs in the FDA Adverse Event Reporting System (FAERS) database was performed. Detailed analysis of patient (sex, age) and report (year of report; reporter: healthcare worker vs consumer) characteristics were conducted using reports from 2004 quarter 1 to 2018 quarter 4. Reporting odds ratios and confidence intervals (RORs,CI) were calculated. Of the 1 916 674 ADR reports, 300 985 indicated opioids as the primary medication. There was a surge in opioid-related ADRs reported in 2018 with six times more reports compared to 2004 and twice the number of reports compared to 2017. The largest ROR among the 20 common ADRs was depression and suicide-self-injury (ROR 3.12, 95% CI 3.01-3.22) for reports in age group ≥65 compared to age group 18 to 64, and lack of efficacy (ROR 6.80, 95% CI 6.61-7.00) for males compared to females. ADRs with the largest RORs for consumers included lack of efficacy/effect (ROR 3.37, 95% CI 3.28-3.46), administration site reactions (ROR 3.21, 95% CI 3.11-3.32), depression and suicide self-injury (ROR 2.26, 95% CI 2.14-2.38) compared to healthcare professionals. Important aspects of opioid ADR voluntary reporting included suicidal ideation in elderly patients and lack of efficacy, especially in male patients. This examination provides insight to better manage safety concerns of opioids.