Botanical Supplement

Kratom

421 adverse event reports submitted to the FDA · 2014–2025 · Data current as of June 3, 2026

These are reports submitted to the FDA. A report does not mean the product caused the effect. Counts reflect reporting activity, not how common an effect is.

Most Reported Reactions

Top 10 reactions from 421 reports. One report may include multiple reactions — reaction totals may exceed the report count.

Dependence
107
Toxicity to various agents
104
Vomiting
34
Overdose
31
Pulmonary oedema
29
Withdrawal syndrome
28
Convulsion
27
Nausea
26
Drug screen positive
22
Drug withdrawal syndrome
21

Reported Outcomes

Outcome categories as recorded in FDA reports. One report may include multiple outcomes.

OutcomeReports
Death 183
Other Serious or Important Medical Event 153
Hospitalization 101
Disability 47
Life Threatening 42
Visited Emergency Room 40
Visited a Health Care Provider 37
Other Outcome 24
Other Serious Outcome 11
Required Intervention 3
Injury 1

Who Reported

Reporter demographics where available. Many reports do not include age or gender data.

Age

Under 18
4
18–34
178
35–49
138
50–64
42
65–79
9
80+
2
Unknown
48

373 reports had age data; 48 unknown.

Gender

Female
100
Male
309
Unknown/Not Reported
12

Reports by Year

Annual report counts from 2014–2025. Spike years may reflect recalls, media coverage, or litigation rather than changes in the product.

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Hover bars for exact counts.

Data Source

This page presents data from the FDA's CFSAN Adverse Event Reporting System (CAERS) via the openFDA API. Reports are voluntary and unverified. The FDA has not concluded that this product caused any reported event.

View openFDA CAERS data ↗  ·  About our methodology