FDA FAERS Data

Quick, parent-friendly summaries from the FDA Adverse Event Reporting System (FAERS) for four products commonly sold in gas stations and vape shops.

Last updated: October 20, 2025
Important context: FAERS is a spontaneous reporting system. Reports are not proof of causation and may be incomplete or duplicative. Even so, they help identify safety signals and trends that deserve public attention.
Kratom • Mitragynine

Mitragynine (Kratom)

Total reports
1,452
Deaths
714
Hospitalizations
362
% with death outcome
49%
Top reported reactions (5)
  • Toxicity to various agents
  • Drug abuse
  • Drug dependence
  • Drug interaction
  • Death

Source: FAERS line listing provided by MAHA.

Antidepressant sold as “supplement”

Tianeptine

Total reports
572
Deaths
76
Hospitalizations
414
% with death outcome
13%
Top reported reactions (5)
  • Drug interaction
  • Toxicity to various agents
  • Fall
  • Overdose
  • Confusional state

Source: FAERS line listing provided by MAHA.

GABA analog

4-amino-3-phenylbutyric acid (Phenibut)

Total reports
85
Deaths
15
Hospitalizations
65
% with death outcome
18%
Top reported reactions (5)
  • Toxicity to various agents
  • Drug abuse
  • Withdrawal syndrome
  • Drug dependence
  • Drug interaction

Note: Phenibut may appear as “4-amino” in FAERS. Source: FAERS line listing provided by MAHA.

Inhalant

Nitrous Oxide

Total reports
1,458
Deaths
210
Hospitalizations
582
% with death outcome
14%
Top reported reactions (5)
  • Drug abuse
  • Subacute combined cord degeneration
  • Cardiac arrest
  • Drug interaction
  • Toxicity to various agents

Source: FAERS line listing provided by MAHA.

How to read FAERS numbers:

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