35/100 · Moderate
Manufactured by FlexiGo Inc
Vitamin C Adverse Events: Mostly Mild, with Serious Cases Notable
292,848 FDA adverse event reports analyzed
Last updated: 2026-05-12
VITAMIN C is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by FlexiGo Inc. Based on analysis of 292,848 FDA adverse event reports, VITAMIN C has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for VITAMIN C include FATIGUE, HEADACHE, PAIN, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VITAMIN C.
Vitamin C has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 292,848 adverse event reports for this medication, which is primarily manufactured by Flexigo Inc.
The most commonly reported adverse events include Fatigue, Headache, Pain. Of classified reports, 58.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reported reactions are mild to moderate in severity.
Serious adverse events account for nearly 60% of all reports, indicating a need for careful monitoring. A wide variety of reactions are reported, suggesting potential for diverse side effects.
Patients taking Vitamin C should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Vitamin C is generally well-tolerated, but users should be aware of potential serious reactions and consult a healthcare provider if symptoms persist or worsen. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Vitamin C received a safety concern score of 35/100 (moderate concern). This is based on a 58.8% serious event ratio across 87,330 classified reports. The score accounts for 292,848 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: 55,956, Male: 25,212, Unknown: 46. The most frequently reported age groups are age 64 (1,531 reports), age 66 (1,484 reports), age 71 (1,474 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 87,330 classified reports for VITAMIN C:
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 C is generally well-tolerated, but users should be aware of potential serious reactions and consult a healthcare provider if symptoms persist or worsen.
If you are taking Vitamin C, here are important things to know. The most commonly reported side effects include fatigue, headache, pain, nausea, diarrhoea. 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 taking Vitamin C if you have any underlying health conditions or are taking other medications. Monitor for any unusual 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 Vitamin C for safety, and updates will be provided as necessary. Consumers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 292,848 adverse event reports associated with Vitamin C. 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 C include Fatigue, Headache, Pain, Nausea, Diarrhoea. By volume, the top reported reactions are: Fatigue (10,538 reports), Headache (7,515 reports), Pain (7,359 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 C.
Out of 87,330 classified reports, 51,359 (58.8%) were classified as serious and 35,971 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 C break down by patient sex as follows: Female: 55,956, Male: 25,212, Unknown: 46. 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 C adverse events are: age 64: 1,531 reports, age 66: 1,484 reports, age 71: 1,474 reports, age 70: 1,438 reports, age 72: 1,432 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 C adverse event reports is Flexigo Inc. 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 C include: Drug Ineffective, 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 C 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 C has a safety concern score of 35 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. Most reported reactions are mild to moderate in severity.
Key safety signals identified in Vitamin C's adverse event data include: High number of reports of fatigue, headache, and pain.. Significant number of serious reactions including pneumonia, asthma, and death.. Diverse range of reactions including gastrointestinal, respiratory, and musculoskeletal issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Vitamin C is generally well-tolerated, but users should be aware of potential serious reactions and consult a healthcare provider if symptoms persist or worsen. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Vitamin C.
Consult a healthcare provider before taking Vitamin C if you have any underlying health conditions or are taking other medications. Monitor for any unusual symptoms and report them to your healthcare provider.
Vitamin C has 292,848 adverse event reports on file with the FDA. Serious adverse events account for nearly 60% of all reports, indicating a need for careful monitoring. The volume of reports for Vitamin C reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Vitamin C for safety, and updates will be provided as necessary. Consumers should report any adverse events 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 VITAMIN C:
Drugs related to VITAMIN C based on therapeutic use, drug class, or shared indications: