Sleep Supplement

Melatonin

652 adverse event reports submitted to the FDA · 2004–2025 · 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 652 reports. One report may include multiple reactions — reaction totals may exceed the report count.

Nausea
72
Diarrhoea
69
Vomiting
62
Dizziness
53
Dyspnoea
43
Insomnia
42
Pruritus
40
Headache
38
Pain
31
Malaise
31

Reported Outcomes

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

OutcomeReports
Other Serious or Important Medical Event 404
Hospitalization 156
Visited Emergency Room 116
Visited a Health Care Provider 110
Other Serious Outcome 75
Disability 68
Other Outcome 59
Life Threatening 44
Death 13
Allergic Reaction 6
Required Intervention 3
Injury 1
Congenital Anomaly 1

Who Reported

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

Age

Under 18
49
18–34
83
35–49
104
50–64
146
65–79
124
80+
51
Unknown
95

557 reports had age data; 95 unknown.

Gender

Female
422
Male
189
Unknown/Not Reported
41

Reports by Year

Annual report counts from 2004–2025. Spike years may reflect recalls, media coverage, or litigation rather than changes in the product.

'04
'05
'06
'07
'08
'09
'10
'11
'12
'13
'14
'15
'16
'17
'18
'19
'20
'21
'22
'23
'24
'25

Hover bars for exact counts.

Context about this data: Reports have climbed steadily since 2013, with a notable jump in 2020 and a peak around 2022–23. The pattern tracks the mainstream boom in melatonin use as a sleep supplement — it is not associated with a recall or single regulatory event.

More on melatonin

Melatonin Side Effects: What the FDA's Reports Actually Show →

Note: this page aggregates reports across all melatonin products — branded and generic — as named in FDA submissions. It does not represent a single SKU.

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  ·  How to read this data