FAERS (FDA adverse event reporting system)
the FDA's public database of side-effect reports — invaluable for detecting signals, useless for calculating how often anything happens.
two structural limits define it, and most scary numbers you see quoted from it ignore both.
what it is
FAERS collects adverse-event reports from anyone — clinicians, patients, lawyers, manufacturers. It is public and searchable, and this library quotes it with a fixed caveat set.
the two limits
First: no denominator — FAERS counts reports, not patients or prescriptions, so it cannot yield a rate. Second: reporting follows attention — news and litigation reliably inflate reports, which is why our risperidone page notes its top-reported reaction is also its most-litigated one, and why the aripiprazole page calls out the circularity of quoting FAERS counts the lawsuits themselves inflated. What FAERS is genuinely for is signal detection: the gambling signal behind aripiprazole's 2016 warning ran through case reports exactly this way.
somewhere to put it
free. anonymous. people who’ve been where you are 🤍
get Resolv Social — it’s freewant the deeper story? read prescribed to fail
questions
is a FAERS number a risk estimate?
No. 'X thousand reports of Y' is not a rate and cannot become one. If someone quotes it that way, they are misusing the database.
so is FAERS useless?
The opposite — it is how unexpected signals get detected and investigated. It answers 'what should we look into,' never 'how often.'
more from the glossary
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