MELATONIN: 4,111 Adverse Event Reports & Safety Profile

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4,111

Total FAERS Reports

812 (19.8%)

Deaths Reported

2,253

Hospitalizations

4,111

As Primary/Secondary Suspect

402

Life-Threatening

288

Disabilities

Professional Complementary ...

Manufacturer

Route: ORAL · Manufacturer: Professional Complementary Health Formulas · HUMAN OTC DRUG · FDA Label: Available

First Report: 1999 · Latest Report: 20250822

What Are the Most Common MELATONIN Side Effects?

#1 Most Reported

Somnolence

642 reports (15.6%)

#2 Most Reported

Intentional overdose

640 reports (15.6%)

#3 Most Reported

Off label use

555 reports (13.5%)

All MELATONIN Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Somnolence	642	15.6%	148	495
Intentional overdose	640	15.6%	13	598
Off label use	555	13.5%	213	312
Intentional self-injury	463	11.3%	0	444
Drug ineffective	458	11.1%	94	243
Gastrooesophageal reflux disease	399	9.7%	13	378
Nausea	377	9.2%	225	164
Vomiting	341	8.3%	228	175
Coma	336	8.2%	6	305
Constipation	313	7.6%	226	127
Hyponatraemia	291	7.1%	246	151
Pneumonia aspiration	288	7.0%	1	277
Dyspnoea	285	6.9%	92	217
Multiple organ dysfunction syndrome	274	6.7%	273	141
Ascites	268	6.5%	238	111
Fatigue	268	6.5%	24	134
Abdominal pain	264	6.4%	229	117
General physical health deterioration	256	6.2%	247	127
Stress	256	6.2%	240	115
Completed suicide	255	6.2%	255	106

Who Reports MELATONIN Side Effects? Age & Gender Data

Gender: 47.8% female, 52.2% male. Average age: 51.4 years. Most reports from: CA. View detailed demographics →

Is MELATONIN Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2000	3	0	1
2004	1	0	1
2007	4	0	0
2008	9	0	4
2009	1	0	0
2010	2	0	1
2011	8	0	1
2012	7	1	4
2013	8	0	5
2014	48	11	19
2015	77	12	37
2016	67	21	29
2017	134	14	41
2018	360	20	291
2019	228	6	137
2020	209	59	105
2021	220	62	146
2022	143	29	88
2023	190	37	70
2024	185	14	109
2025	79	0	43

View full timeline →

What Is MELATONIN Used For?

Indication	Reports
Product used for unknown indication	2,097
Insomnia	363
Sleep disorder	342
Sleep disorder therapy	275
Sleep deficit	104
Intentional product misuse	79
Off label use	52
Suicide attempt	49
Child abuse	45
Autism spectrum disorder	26

MELATONIN vs Alternatives: Which Is Safer?

MELATONIN vs MELOXICAM MELATONIN vs MELPERONE MELATONIN vs MELPHALAN MELATONIN vs MEMANTINE MELATONIN vs MENINGOCOCCAL GROUP B VACCINE MELATONIN vs MENINGOCOCCAL POLYSACCHARIDE VACCINE A\NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE ANTIGEN MELATONIN vs MENOTROPINS MELATONIN vs MENTHOL MELATONIN vs MENTHOL\METHYL SALICYLATE MELATONIN vs MENTHOL\ZINC

Official FDA Label for MELATONIN

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS: May temporarily relieve symptoms associated with reactions to melatonin such as sleeplessness.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage & Administration

DIRECTIONS: Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Warnings

WARNINGS: If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place.

Active Ingredient

ACTIVE INGREDIENT: (in each drop): 20% of Melatonin 6X, 12X, 30X, 12C, 30C.

Inactive Ingredients

INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.