FDA CAERS Data

Summaries from the FDA CFSAN Adverse Event Reporting System (CAERS) for products often sold in gas stations and vape shops. Parent-friendly, signal-focused.

Last updated: October 21, 2025
Important context: CAERS is a spontaneous reporting system for foods and dietary supplements. Reports may be incomplete or duplicative and do not prove causation. They do help detect safety signals that deserve attention.
Kratom • Mitragynine

Mitragynine (Kratom)

Total reports
733
Deaths
258
Hospitalizations
191
Serious cases
404
Top reported reactions (5)
  • Death
  • Dependence
  • Toxicity to various agents
  • Vomiting
  • Withdrawal syndrome

Source: CAERS JSON (uploaded to MAHA).

Antidepressant sold as “supplement”

Tianeptine

Total reports
65
Deaths
9
Hospitalizations
28
Serious cases
47
Top reported reactions (5)
  • Dependence
  • Toxicity to various agents
  • Confusional state
  • Drug abuse
  • Withdrawal syndrome

Source: CAERS JSON (uploaded to MAHA).

GABA analog

4-amino-3-phenylbutyric acid (Phenibut)

Total reports
22
Deaths
4
Hospitalizations
10
Serious cases
12
Top reported reactions (5)
  • Loss of consciousness
  • Tachycardia
  • Mydriasis
  • Blood pressure increased
  • Poisoning

Note: often appears as “4-amino-3-phenylbutyric acid.” Source: CAERS JSON (uploaded to MAHA).

Mushroom • Ibotenic/Muscimol

Amanita muscaria

Total reports
6
Deaths
0
Hospitalizations
1
Serious cases
1
Top reported reactions (5)
  • Nausea
  • Vomiting
  • Hallucination
  • Confusional state
  • Dizziness

Source: CAERS JSON (uploaded to MAHA).

Mushroom • Psilocybin

Mushroom hallucinogen (psilocybin/psilocin)

Total reports
28
Deaths
0
Hospitalizations
2
Serious cases
5
Top reported reactions (5)
  • Hallucination
  • Anxiety
  • Nausea
  • Vomiting
  • Dizziness

Source: CAERS JSON (uploaded to MAHA).

Inhalant

Nitrous Oxide

Total reports
1
Deaths
0
Hospitalizations
1
Serious cases
1
Top reported reactions (5)
  • Balance disorder
  • Brain injury
  • Central nervous system lesion
  • Confusional state
  • Cystitis

Source: CAERS JSON (uploaded to MAHA).

How to read CAERS numbers:

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