Pharmacologic class (EPC) · 3 drug pages

Vitamin C: adverse event reports filed with FDA

8,783 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

8,783
reports across the class: 0% of all reports; 1,256
reports, 12 months to June 2026: 1,746 in the 12 months before; 94.4%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Vitamin C is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 8,783 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

1,256 reports arrived in the 12 months to June 2026, down 28% from 1,746 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 94.4% of the class's reports are marked serious, 40.7% record death among the outcomes and 60% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (36.2%), drug ineffective (29.7%) and pain (27.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Vitamin c	generic	5,714	1,031	95.1%	Off label use
Ascorbic acid	generic	2,233	156	95.1%	Off label use
Vitamin e	generic	836	69	87.6%	Drug ineffective

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Off label useused for a purpose or in a way not on the label36.2%3,181
Drug ineffectivethe medicine did not work as expected29.7%2,609
Painpain, site not specified27.1%2,380
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease25.5%2,241
Fatiguetiredness24.8%2,179
Hypertensionhigh blood pressure24.5%2,155
Infusion related reactiona reaction during or soon after an infusion24.1%2,113
Headachehead pain23.9%2,097
Rashskin rash23.6%2,074
Joint swellinga swollen joint22.7%1,998
Hepatic enzyme increasedraised liver enzymes21.3%1,870
Nauseafeeling sick21%1,847
Drug hypersensitivityan allergic-type reaction to a medicine20.9%1,836
Drug intolerancethe medicine was not tolerated20.8%1,823
Vomitingbeing sick20.7%1,815
Swellingswelling20.6%1,808
Psoriatic arthropathy20.4%1,791
Systemic lupus erythematosuslupus, an autoimmune disease20.3%1,780
General physical health deteriorationgeneral decline in health19.9%1,748
Contraindicated product administered19.9%1,746
Glossodynia19.5%1,713
Fibromyalgia19.5%1,710
Hypersensitivityan allergic-type reaction19.3%1,692
Pemphigus19.3%1,691
Abdominal discomfortstomach discomfort18.9%1,663

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death40.7%3,575

Life-threatening40.9%3,591

Hospitalisation (initial or prolonged)60%5,269

Disability40.4%3,551

Congenital anomaly18.2%1,595

Other serious83%7,294

Not serious5.6%493

Patient age

Under 20.2%20

2 to 111.6%142

12 to 170.6%57

18 to 4431.8%2,792

45 to 6420.2%1,778

65 to 745.1%447

75 and over10.2%892

Age not given30.2%2,655

Who reported

Physician13.9%1,222

Pharmacist2%173

Other health professional69.2%6,077

Lawyer0%2

Consumer or non-health professional13.7%1,203

Not given1.2%106

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Vitamin C reports

Which drugs are in the Vitamin C class on this site?

Vitamin c, Ascorbic acid and Vitamin e. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

8,783 reports through June 2026, 1,256 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

off label use (36.2%), drug ineffective (29.7%), pain (27.1%), rheumatoid arthritis (25.5%) and fatigue (24.8%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.