45/100 · Moderate
Manufactured by Oncora Pharma, LLC
Multivitamin Reports Show Common Mild Reactions, with Serious Events Noting Potential Concerns
91,072 FDA adverse event reports analyzed
Last updated: 2026-05-12
MULTIVITAMIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Oncora Pharma, LLC. Based on analysis of 91,072 FDA adverse event reports, MULTIVITAMIN has a safety score of 45 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 MULTIVITAMIN include FATIGUE, NAUSEA, DRUG INEFFECTIVE, DIARRHOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MULTIVITAMIN.
Multivitamin has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 91,072 adverse event reports for this medication, which is primarily manufactured by Oncora Pharma, Llc.
The most commonly reported adverse events include Fatigue, Nausea, Drug Ineffective. Of classified reports, 48.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include fatigue, nausea, and headache, indicating mild to moderate side effects.
Serious events such as pneumonia, death, and renal failure are noted, but occur less frequently. The majority of reactions are non-serious, but the diversity of reactions suggests a complex safety profile. Age distribution shows a higher number of reports from individuals aged 60 and above.
Patients taking Multivitamin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Multivitamins can interact with other medications, potentially affecting their efficacy. Consumers should consult healthcare providers before starting any new supplement regimen. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Multivitamin received a safety concern score of 45/100 (moderate concern). This is based on a 48.1% serious event ratio across 49,502 classified reports. The score accounts for 91,072 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 32,133, Male: 16,550, Unknown: 68. The most frequently reported age groups are age 65 (876 reports), age 62 (860 reports), age 63 (851 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 49,502 classified reports for MULTIVITAMIN:
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.
Multivitamins can interact with other medications, potentially affecting their efficacy. Consumers should consult healthcare providers before starting any new supplement regimen.
If you are taking Multivitamin, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, diarrhoea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting a multivitamin regimen, especially if you are taking other medications. Monitor for any new or worsening symptoms and report them to your healthcare provider. 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.
The FDA continues to monitor multivitamin safety. Consumers should report any adverse reactions to the FDA's MedWatch program.
The FDA has received approximately 91,072 adverse event reports associated with Multivitamin. 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 Multivitamin include Fatigue, Nausea, Drug Ineffective, Diarrhoea, Headache. By volume, the top reported reactions are: Fatigue (3,678 reports), Nausea (3,245 reports), Drug Ineffective (3,150 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Multivitamin.
Out of 49,502 classified reports, 23,798 (48.1%) were classified as serious and 25,704 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 Multivitamin break down by patient sex as follows: Female: 32,133, Male: 16,550, Unknown: 68. 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 Multivitamin adverse events are: age 65: 876 reports, age 62: 860 reports, age 63: 851 reports, age 61: 842 reports, age 64: 841 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 Multivitamin adverse event reports is Oncora Pharma, Llc. 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 Multivitamin include: Dizziness, Dyspnoea, Pain, Asthenia, Arthralgia. 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 Multivitamin 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.
Multivitamin has a safety concern score of 45 out of 100 (moderate 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. The most common reactions include fatigue, nausea, and headache, indicating mild to moderate side effects.
Key safety signals identified in Multivitamin's adverse event data include: Frequent reactions like fatigue and nausea suggest potential gastrointestinal and general discomfort.. Serious events like pneumonia and renal failure indicate a need for careful monitoring.. A wide range of reactions, including neurological and cardiovascular issues, suggest a complex safety profile.. The presence of multiple serious events, though less frequent, raises concerns about potential adverse effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Multivitamins can interact with other medications, potentially affecting their efficacy. Consumers should consult healthcare providers before starting any new supplement regimen. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Multivitamin.
Consult a healthcare provider before starting a multivitamin regimen, especially if you are taking other medications. Monitor for any new or worsening symptoms and report them to your healthcare provider.
Multivitamin has 91,072 adverse event reports on file with the FDA. Serious events such as pneumonia, death, and renal failure are noted, but occur less frequently. The volume of reports for Multivitamin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor multivitamin safety. Consumers should report any adverse reactions to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with MULTIVITAMIN:
Drugs related to MULTIVITAMIN based on therapeutic use, drug class, or shared indications: