60/100 · Moderate
Manufactured by CAUSE FOR CHANGE LLC
Moderate Safety Concerns with Vitamin A Supplementation
19,850 FDA adverse event reports analyzed
Last updated: 2026-05-12
VITAMIN A is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CAUSE FOR CHANGE LLC. Based on analysis of 19,850 FDA adverse event reports, VITAMIN A has a safety score of 60 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 VITAMIN A include FATIGUE, NAUSEA, DRUG INEFFECTIVE, PAIN, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VITAMIN A.
Vitamin A has a safety concern score of 60 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 19,850 adverse event reports for this medication, which is primarily manufactured by Cause For Change Llc.
The most commonly reported adverse events include Fatigue, Nausea, Drug Ineffective. Of classified reports, 66.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and nausea are the most commonly reported adverse events.
A significant portion of reported reactions are serious, with 66.8% classified as such. The diversity of reactions indicates a broad range of potential side effects. The majority of reports come from adults, with the highest concentration in the 60-70 age range.
Patients taking Vitamin A should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Vitamin A should not be used off-label without medical supervision, as it can cause serious adverse events. Patients should be monitored for signs of respiratory and gastrointestinal issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Vitamin A received a safety concern score of 60/100 (elevated concern). This is based on a 66.8% serious event ratio across 6,023 classified reports. The score accounts for 19,850 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: 3,855, Male: 1,582, Unknown: 3. The most frequently reported age groups are age 64 (179 reports), age 43 (158 reports), age 40 (155 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 6,023 classified reports for VITAMIN A:
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.
Vitamin A should not be used off-label without medical supervision, as it can cause serious adverse events. Patients should be monitored for signs of respiratory and gastrointestinal issues.
If you are taking Vitamin A, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, pain, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and consult a healthcare provider before using Vitamin A supplements, especially if you have pre-existing conditions. Report any unusual symptoms to your healthcare provider promptly. 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 closely monitors Vitamin A safety, and any unusual symptoms should be reported to healthcare providers. Patients should follow prescribed dosages and consult with a healthcare professional before using Vitamin A supplements.
The FDA has received approximately 19,850 adverse event reports associated with Vitamin A. 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 Vitamin A include Fatigue, Nausea, Drug Ineffective, Pain, Headache. By volume, the top reported reactions are: Fatigue (585 reports), Nausea (540 reports), Drug Ineffective (489 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Vitamin A.
Out of 6,023 classified reports, 4,023 (66.8%) were classified as serious and 2,000 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 Vitamin A break down by patient sex as follows: Female: 3,855, Male: 1,582, Unknown: 3. 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 Vitamin A adverse events are: age 64: 179 reports, age 43: 158 reports, age 40: 155 reports, age 65: 104 reports, age 75: 97 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 Vitamin A adverse event reports is Cause For Change 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 Vitamin A include: Diarrhoea, Off Label Use, Dyspnoea, Arthralgia, Dizziness. 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 Vitamin A 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.
Vitamin A has a safety concern score of 60 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 nausea are the most commonly reported adverse events.
Key safety signals identified in Vitamin A's adverse event data include: Frequent reports of fatigue and nausea suggest these may be common side effects.. A high percentage of serious reactions indicates potential for severe adverse events.. A wide range of reactions, including respiratory and gastrointestinal issues, suggests a complex safety profile.. Reports of conditions like pneumonia and systemic lupus erythematosus raise concerns about potential immune system impacts.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Vitamin A should not be used off-label without medical supervision, as it can cause serious adverse events. Patients should be monitored for signs of respiratory and gastrointestinal issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Vitamin A.
Follow prescribed dosages and consult a healthcare provider before using Vitamin A supplements, especially if you have pre-existing conditions. Report any unusual symptoms to your healthcare provider promptly.
Vitamin A has 19,850 adverse event reports on file with the FDA. A significant portion of reported reactions are serious, with 66.8% classified as such. The volume of reports for Vitamin A reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Vitamin A safety, and any unusual symptoms should be reported to healthcare providers. Patients should follow prescribed dosages and consult with a healthcare professional before using Vitamin A supplements. 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 VITAMIN A:
Drugs related to VITAMIN A based on therapeutic use, drug class, or shared indications: