FDA Drug Adverse Events
Public post-market safety reports submitted to the FDA through FAERS. A report is a submission, not a finding: it does not establish that the suspect drug caused the event.
Public post-market safety reports submitted to the FDA through FAERS. A report is a submission, not a finding: it does not establish that the suspect drug caused the event.
Total Reports
107,324
Adverse event safety reports
Serious Cases
53,374
50% of cases
Suspect Drugs
157,062
290,243 total drug entries
Reactions
292,108
8,054 distinct MedDRA terms
Deaths
6,466
6% of cases
Hospitalizations
18,752
17% of cases
Source: FDA Adverse Event Reporting System (FAERS) via openFDA · data as of Jun 30, 2026
openFDA FAERS data — partial window, not full historical FAERS
Suspect and matched are each counted out of all mentions, separately: a matched drug need not be a suspect one.
Drug mentions resolved to a product
Low — 0 ambiguous, 0 unresolved
Non-serious | 53,950 | 50.3% |
Serious | 53,374 | 49.7% |
Each report counted once, under its most serious outcome: death, then life-threatening, hospitalization, disabling, congenital anomaly, other serious, else non-serious
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