Drug · FAERS side-effect profile with label screen

Ascorbic Acid combination (9 ingredients) side effects: what 627 FDA adverse event reports show

Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid · 13 reaction terms · 197 drug–reaction co-reports · data 2026-09-14

Drug class

Vitamin C

FDA label (Established Pharmacologic Class) · compare the class

Who reports

627 reports · 70% serious · 93 with death outcome · 46% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ascorbic acid injection is indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients, age 5 months and older, for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use Ascorbic acid injection is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.

FDA label, Indications and Usage

What it is

Ascorbic acid injection, USP for intravenous use is a colorless to pale yellow, preservative-free, hypertonic, sterile, non-pyrogenic solution of ascorbic acid. Ascorbic acid injection must be.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 11 strongest signals

Labeled (related wording) 1Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 7

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
End stage renal disease	41	74.7 55.6–100.5ROR 79.9 · χ² 2,905 / p <1e-300	72.1 EB05 55.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 61.1	no trial data cached
Peritonitis bacterial	20	66.7 43.3–102.7ROR 68.9 · χ² 1,227 / p 4e-269	62.8 EB05 42.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 54.7	no trial data cached
Peritonitis	21	34.0 22.3–51.8ROR 35.1 · χ² 640 / p 2e-141	33.0 EB05 22.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 27.9	no trial data cached
Dialysis	13	30.6 17.9–52.5ROR 31.3 · χ² 344 / p 5e-77	29.4 EB05 18.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 26.3	no trial data cached
Blood potassium increased	11	22.7 12.6–40.8ROR 23.1 · χ² 207 / p 3e-47	21.7 EB05 12.5 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 6.6	no trial data cached
Economic problem	9	19.6 10.2–37.4ROR 19.8 · χ² 141 / p 1e-32	18.1 EB05 9.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 17.5	no trial data cached
Chronic kidney disease	38	16.6 12.2–22.6ROR 17.6 · χ² 544 / p 1e-120	16.4 EB05 12.4 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.8	no trial data cached
Fluid overload	6	13.6 6.1–30.2ROR 13.7 · χ² 58 / p 1e-14	10.0 EB05 4.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Anhedonia	10	12.6 6.8–23.4ROR 12.8 · χ² 96 / p 6e-23	10.7 EB05 5.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Plasma cell myeloma	8	6.9 3.4–13.6ROR 6.9 · χ² 34 / p 2e-9	5.2 EB05 2.8 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Inappropriate schedule of drug administration	13	6.0 3.5–10.3ROR 6.1 · χ² 50 / p 8e-13	5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
End stage renal disease	41	74.7 55.6–100.5ROR 79.9 · χ² 2,905 / p <1e-300	72.1 EB05 55.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 61.1	no trial data cached
Chronic kidney disease	38	16.6 12.2–22.6ROR 17.6 · χ² 544 / p 1e-120	16.4 EB05 12.4 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.8	no trial data cached
Peritonitis	21	34.0 22.3–51.8ROR 35.1 · χ² 640 / p 2e-141	33.0 EB05 22.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 27.9	no trial data cached
Peritonitis bacterial	20	66.7 43.3–102.7ROR 68.9 · χ² 1,227 / p 4e-269	62.8 EB05 42.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 54.7	no trial data cached
Inappropriate schedule of drug administration	13	6.0 3.5–10.3ROR 6.1 · χ² 50 / p 8e-13	5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6	no trial data cached
Dialysis	13	30.6 17.9–52.5ROR 31.3 · χ² 344 / p 5e-77	29.4 EB05 18.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 26.3	no trial data cached
Blood potassium increased	11	22.7 12.6–40.8ROR 23.1 · χ² 207 / p 3e-47	21.7 EB05 12.5 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 6.6	no trial data cached
Anhedonia	10	12.6 6.8–23.4ROR 12.8 · χ² 96 / p 6e-23	10.7 EB05 5.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Economic problem	9	19.6 10.2–37.4ROR 19.8 · χ² 141 / p 1e-32	18.1 EB05 9.0 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 17.5	no trial data cached
Plasma cell myeloma	8	6.9 3.4–13.6ROR 6.9 · χ² 34 / p 2e-9	5.2 EB05 2.8 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Fluid overload	6	13.6 6.1–30.2ROR 13.7 · χ² 58 / p 1e-14	10.0 EB05 4.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	no trial data cached
Nephropathy	4	14.3 5.4–37.9ROR 14.4 · χ² 37 / p 6e-10	8.7 EB05 2.8 · IC025 +0.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.5	no trial data cached
Internal haemorrhage	3	8.8 2.8–27.2ROR 8.8 · χ² 14 / p 1e-4	4.6 EB05 1.7 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 7.3	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

End stage renal disease — n=41, PRR 74.7
Peritonitis bacterial — n=20, PRR 66.7
Peritonitis — n=21, PRR 34.0

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Ascorbic Acid?

In FDA FAERS, the most frequently co-reported reaction terms for Ascorbic Acid are end stage renal disease, chronic kidney disease, peritonitis, peritonitis bacterial, dialysis, blood potassium increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Ascorbic Acid have an FDA boxed warning?

No. The FDA label retrieved for Ascorbic Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ascorbic Acid causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 1606e29f-0e80-4069-b688-daab9cbff20a, effective 20251217; matched on openfda.generic_name.exact:"ASCORBIC ACID")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 13 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.