Adverse Events · The Data They Suppress

⚠️ Industry spin: "Adverse event reports aren't science." Then why does the FDA collect them? Why do they keep issuing warnings? Because each report is a person who suffered. Return to Evidence →

The Industry's Hidden Files

The kratom industry loves to say there's "no evidence of harm." But the FDA maintains two massive databases – CAERS for dietary supplements, FAERS for drugs – where doctors, patients, and manufacturers are required to report adverse events. And kratom is all over them.

The industry's response? "Spontaneous reporting systems can't prove causation." True – but they exist precisely to detect signals. And the signal from kratom is deafening: hundreds dead, thousands hospitalized, and an industry that does everything it can to keep these numbers out of the news.

FDA CAERS Data (Foods & Dietary Supplements)

Kratom / Mitragynine only

Total Reports

743

Deaths

258

Hospitalizations

191

Serious Cases

404

What CAERS is: The FDA's Center for Food Safety and Applied Nutrition Adverse Event Reporting System. It collects reports of adverse events related to foods, dietary supplements, and cosmetics. These 743 reports are just the tip – many more go unreported.

FDA FAERS Data (Drugs & Biologics)

Kratom / Mitragynine only

Total Reports

1,470

Deaths

722

Hospitalizations

370

% with Death

49%

What FAERS is: The FDA Adverse Event Reporting System – a database that supports the FDA's post-marketing safety surveillance program for drugs and therapeutic biologics. Nearly half of all kratom reports involve death.

📢 Important context – the industry's favorite evasion

Both FAERS and CAERS are spontaneous reporting systems. Figures reflect what was reported; they help identify signals but do not establish incidence or causation. Underreporting is massive. The industry seizes on this to dismiss the numbers entirely.

But here's what they won't say: These are the only national systems tracking harm. When over 2,200 adverse event reports (including nearly 1,000 deaths) pour in for a single unregulated substance, it's not "anecdote" – it's a public health emergency. The FDA uses these same databases to regulate prescription drugs. Kratom gets no such scrutiny.

What These Numbers Really Mean

2,213 total reports across CAERS and FAERS – and that's only what got reported. For every report, dozens more suffer in silence.
980 deaths – almost a thousand people dead, and the industry still says "more research is needed."
561 hospitalizations – people sick enough to require medical care, often in ICUs, because of a product sold next to energy drinks.
404 "serious" cases in CAERS alone – a category that includes life-threatening events, disability, and congenital anomalies.

The industry will tell you these numbers are "unverified" or "could be duplicates." But every single report represents a real person, a real family, a real tragedy. The FDA doesn't collect fairy tales.

⛔ Key Takeaways

The data exists. The FDA has been collecting adverse event reports on kratom for years. The industry just doesn't want you to see them.
Nearly 1,000 deaths. That's not a "signal" – it's a body count. How many more before the industry admits the truth?
Hospitalizations in the hundreds. People aren't just calling poison centers – they're being admitted, sometimes for days or weeks.
"Spontaneous reporting" is not an excuse. If kratom were safe, these databases would be empty. They're not. They're overflowing.

📢 The industry’s talking points, fact‑checked

Industry lie: "Adverse event reports are just anecdotes, not science."
Truth: They're the frontline of pharmacovigilance. The FDA relies on them to detect safety signals for every drug on the market. Kratom should be no exception.

Industry lie: "Most reports are duplicates or unverified."
Truth: The FDA cleans and processes these data. The numbers we present are conservative. If anything, they undercount the true toll.

Industry lie: "Kratom is safer than aspirin."
Truth: Aspirin doesn't have 2,200 adverse event reports and nearly 1,000 deaths. Kratom does.

← Back to Evidence