Ascorbic acid: adverse event reports filed with FDA

2,233

reports as suspect product

0% of all reports · about 99 a year

156

reports, 12 months to June 2026

336 in the 12 months before

95.1%

marked serious by the reporter

94.4% across the class

31.7%

record death among outcomes, as reported

707 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Ascorbic acid reports recording the termmedian drug in vitamin c

1. Off label useused for a purpose or in a way not on the label30.3%677
2. Drug ineffectivethe medicine did not work as expected24.9%556
3. Fatiguetiredness22.7%506
4. Painpain, site not specified21.5%479
5. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease21%468
6. Hypertensionhigh blood pressure19.1%426
7. Rashskin rash19.1%426
8. Nauseafeeling sick18.9%422
9. Headachehead pain18.8%420
10. Joint swellinga swollen joint18.6%416
11. Vomitingbeing sick18.5%412
12. Drug hypersensitivityan allergic-type reaction to a medicine18.4%411
13. Condition aggravatedthe condition being treated got worse18.3%409
14. Infusion related reactiona reaction during or soon after an infusion17.6%394
15. Hypersensitivityan allergic-type reaction16.9%377
16. Dyspnoeashortness of breath16.7%372
17. General physical health deteriorationgeneral decline in health16.4%367
18. Arthropathy16.4%366
19. Pyrexiafever16.1%360
20. Swellingswelling16%358
21. Abdominal discomfortstomach discomfort15.7%350
22. Systemic lupus erythematosuslupus, an autoimmune disease15.7%350
23. Hepatic enzyme increasedraised liver enzymes15.6%349
24. Fibromyalgia15.5%347
25. Psoriatic arthropathy15.5%346
26. Arthralgiajoint pain15.4%343
27. Contraindicated product administered15.1%338
28. Glossodynia15%334
29. Drug intolerancethe medicine was not tolerated14.8%330
30. Duodenal ulcer perforation14.6%327

Top 30 of 729 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the vitamin c class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 8,783 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 20% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,233 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ascorbic acid is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the vitamin c class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Ascorbic acid as a suspect or interacting product; reports listing it only as a concomitant medication (20,988) are excluded. 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.