65/100 · Elevated
Manufactured by Professional Complementary Health Formulas
Melatonin Adverse Events: Moderate Safety Concerns
110,180 FDA adverse event reports analyzed
Last updated: 2026-05-12
MELATONIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Professional Complementary Health Formulas. Based on analysis of 110,180 FDA adverse event reports, MELATONIN has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for MELATONIN include FATIGUE, NAUSEA, OFF LABEL USE, DRUG INEFFECTIVE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MELATONIN.
Melatonin has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 110,180 adverse event reports for this medication, which is primarily manufactured by Professional Complementary Health Formulas.
The most commonly reported adverse events include Fatigue, Nausea, Off Label Use. Of classified reports, 65.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and dizziness are the most common adverse events reported.
Serious adverse events, such as death and pneumonia, are reported but at a lower rate. Drug interactions and misuse are significant concerns, especially in elderly patients. The majority of adverse events are non-serious, but the diversity of reactions is notable.
Patients taking Melatonin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Melatonin can interact with other medications, potentially affecting their efficacy. Misuse, including off-label use and intentional overdose, is a significant concern. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Melatonin received a safety concern score of 65/100 (elevated concern). This is based on a 65.6% serious event ratio across 51,323 classified reports. The score accounts for 110,180 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 28,000, Male: 19,380, Unknown: 27. The most frequently reported age groups are age 80 (906 reports), age 64 (842 reports), age 72 (780 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 51,323 classified reports for MELATONIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Melatonin can interact with other medications, potentially affecting their efficacy. Misuse, including off-label use and intentional overdose, is a significant concern.
If you are taking Melatonin, here are important things to know. The most commonly reported side effects include fatigue, nausea, off label use, drug ineffective, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always consult a healthcare provider before using melatonin, especially if you are taking other medications. Follow recommended dosages and use as directed to minimize the risk of adverse events. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with a focus on ensuring proper use and monitoring for serious adverse events, especially in elderly populations.
The FDA has received approximately 110,180 adverse event reports associated with Melatonin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Melatonin include Fatigue, Nausea, Off Label Use, Drug Ineffective, Diarrhoea. By volume, the top reported reactions are: Fatigue (4,195 reports), Nausea (3,592 reports), Off Label Use (3,225 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Melatonin.
Out of 51,323 classified reports, 33,689 (65.6%) were classified as serious and 17,634 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Melatonin break down by patient sex as follows: Female: 28,000, Male: 19,380, Unknown: 27. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Melatonin adverse events are: age 80: 906 reports, age 64: 842 reports, age 72: 780 reports, age 74: 756 reports, age 70: 731 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Melatonin adverse event reports is Professional Complementary Health Formulas. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Melatonin include: Headache, Dyspnoea, Insomnia, Fall, Pain. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Melatonin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Melatonin has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Fatigue and dizziness are the most common adverse events reported.
Key safety signals identified in Melatonin's adverse event data include: Frequent reports of falls and dizziness suggest potential risks, especially in the elderly.. Serious adverse events like death and pneumonia indicate a need for caution, particularly in vulnerable populations.. A wide range of reactions, including psychiatric and gastrointestinal issues, highlight the complexity of melatonin's safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Melatonin can interact with other medications, potentially affecting their efficacy. Misuse, including off-label use and intentional overdose, is a significant concern. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Melatonin.
Always consult a healthcare provider before using melatonin, especially if you are taking other medications. Follow recommended dosages and use as directed to minimize the risk of adverse events.
Melatonin has 110,180 adverse event reports on file with the FDA. Serious adverse events, such as death and pneumonia, are reported but at a lower rate. The volume of reports for Melatonin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on ensuring proper use and monitoring for serious adverse events, especially in elderly populations. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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