Adverse Event Profile: Melatonin
Adverse Event Profile: Melatonin
Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 43 Serious Events: 19 Date Range: 20051201 to 20241115
Top Reported Reactions
- Dyspnoea: 8
- Urticaria: 4
- Diarrhoea: 4
- Nausea: 4
- Abdominal pain upper: 4
- Dizziness: 3
- Vomiting: 3
- Pruritus: 3
- COLON INJURY: 2
- Anxiety: 2
- Constipation: 2
- Feeling cold: 2
- Hypoaesthesia: 2
- Insomnia: 2
- Tremor: 2
- Feeling hot: 2
- Hypersensitivity: 2
- Agitation: 2
- Hallucination: 2
- Hepatic enzyme increased: 2
Outcomes
- Other Serious or Important Medical Event: 24
- Visited Emergency Room: 12
- Visited a Health Care Provider: 12
- Hospitalization: 11
- Other Serious Outcome: 6
- Disability: 5
- Other Outcome: 3
- Life Threatening: 2
- Required Intervention: 1
- Death: 1
Products Involved (15 unique)
- FAST ACTING LIQUID MELATONIN
- MELATONIN
- MELATONIN VITACOST (MELATONIN)
- Melatonin
- NATURE'S BOUNTY MELATONIN
- NATUREMADE MELATONIN
- PURITAN'S PRIDE MELATONIN
- SCHIFF MELATONIN PLUS
- SPRING VALLEY MELATONIN SLEEP SUPPORT
- SUNDOWN MELATONIN 300 MCG TABLETS
- ZARBEE'S NATURALS CHILDREN'S SLEEP WITH MELATONIN
- ZARBEES CHILDRENS SLEEP WITH MELATONIN NATURAL GRA
- ZARBEES NATURALS CHILDRENS SLEEP WITH MELATONIN
- ZZQUIL MELATONIN WITH LAVENDAR AND CHAMOMILE
- melatonin
Disclaimer
This data is from the FDA CAERS database. A report does not mean the supplement caused the adverse event. Reports may be incomplete, duplicated, or unrelated. This is for safety awareness only.