Opioids and Frequency Counts in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Background: The U.S. Food and Drug Administration Adverse Event Reporting System, FAERS, contains information on adverse events and medication error reports submitted to the FDA through the MedWatch program. Opioid use has been linked to a significant number of adverse events reported in the FAERS database. The focus of this research was to determine the frequency counts and related deaths of opioid drug names in the FAERS database.

Methods: Drug information was obtained from the database's DRUG and OUTCOME files. Morphine, fentanyl, oxycodone, hydrocodone, tramadol, hydromorphone, methadone, codeine, oxymorphone, meperidine, propoxyphene, diphenoxylate, and heroin were among the drugs discovered. The MySQL database management system was used to determine the frequency counts and concomitant deaths of opioid drug names.

Results: Fifteen different opioid drugs were linked to ADEs, including death, in the FAERS database, with three drugs (oxycodone, hydrocodone, and fentanyl) accounting for more than half of the reports. The highest frequency count value for oxycodone was 158,181, representing approximately 20.2 percent of the opioid frequency counts. Dextromethorphan had the lowest frequency count value of 2,161, accounting for approximately 0.3 percent of the total. The opioid with the highest proportion of deaths to drug count was heroin (71.8%), followed by dextromethorphan (55.6%), methadone (37.2%), morphine (26.8%), and propoxyphene (23.7%).

Conclusion: The FAERS database is an important source for detecting and reporting Adverse Drug Events (ADEs), particularly those involving opioids and related drugs. Estimating the true incidence of ADEs for this class of drugs in the general population remains challenging.