Drug · FAERS side-effect profile with label screen
Ascorbic Acid side effects: what 23,116 FDA adverse event reports show
Who reports
23,116 reports · 72% serious · 2,611 with death outcome · 63% 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 40 strongest signals
Reporting / coding artifact 5Lab value / disease marker 8Not in label — unassessed 27
What the badges mean
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,171 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Appendicolith | 111 | 375.9 301.2–469.0ROR 377.7 · calibrated p 2e-12 ✓ | 253.4 EB05 216.2 · IC025 +6.6 3/3 methods agree vs other Vitamin Cs: PRR 2.1 (1.7–2.6) | Not in label — unassessed | serious n=111 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Sleep disorder therapy | 41 | 256.3 181.2–362.6ROR 256.8 · calibrated p 1e-10 ✓ | 182.6 EB05 140.3 · IC025 +5.4 3/3 methods agree vs other Vitamin Cs: PRR 1.3 (0.9–1.9) | Reporting / coding artifact | serious n=41 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Grip strength | 51 | 256.1 187.7–349.6ROR 256.7 · calibrated p 1e-10 ✓ | 185.5 EB05 146.6 · IC025 +5.6 3/3 methods agree vs other Vitamin Cs: PRR 3.3 (2.3–4.8) | Not in label — unassessed | serious n=51 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Antacid therapy | 24 | 225.8 144.3–353.3ROR 226.1 · calibrated p 9e-10 ✓ | 158.0 EB05 111.8 · IC025 +4.6 3/3 methods agree vs other Vitamin Cs: PRR 3.6 (2.1–6.2) | Reporting / coding artifact | serious n=24 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Presbyacusis | 51 | 178.1 131.9–240.5ROR 178.5 · calibrated p 2e-9 ✓ | 140.9 EB05 111.4 · IC025 +5.5 3/3 methods agree vs other Vitamin Cs: only this drug | Not in label — unassessed | serious n=51 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Analgesic therapy | 43 | 147.8 107.1–204.1ROR 148.1 · calibrated p 1e-8 ✓ | 120.3 EB05 93.1 · IC025 +5.2 3/3 methods agree vs other Vitamin Cs: PRR 1.4 (1.0–2.0) | Reporting / coding artifact | serious n=43 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Drug therapy | 40 | 129.6 93.0–180.5ROR 129.8 · calibrated p 3e-8 ✓ | 107.6 EB05 82.4 · IC025 +5.0 3/3 methods agree vs other Vitamin Cs: PRR 1.4 (1.0–2.0) | Reporting / coding artifact | serious n=40 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Deep vein thrombosis postoperative | 245 | 129.5 113.3–148.0ROR 130.9 · calibrated p 2e-8 ✓ | 112.3 EB05 101.0 · IC025 +6.3 3/3 methods agree vs other Vitamin Cs: PRR 1.4 (1.2–1.6) | Not in label — unassessed | serious n=245 · ♀ 100% (drug 63%) · 92% clinician | no trial arm names this drug |
| Swollen joint count | 30 | 125.9 85.9–184.5ROR 126.1 · calibrated p 6e-8 ✓ | 103.4 EB05 75.9 · IC025 +4.7 3/3 methods agree vs other Vitamin Cs: PRR 1.6 (1.1–2.5) | Not in label — unassessed | serious n=30 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Lupus vulgaris | 133 | 114.1 95.3–136.6ROR 114.8 · calibrated p 5e-8 ✓ | 99.9 EB05 86.4 · IC025 +5.9 3/3 methods agree vs other Vitamin Cs: PRR 1.3 (1.0–1.5) | Not in label — unassessed | serious n=133 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| C-reactive protein | 90 | 99.8 80.3–124.1ROR 100.2 · calibrated p 2e-7 ✓ | 88.3 EB05 74.0 · IC025 +5.6 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (0.8–1.3) | Lab value / disease marker | serious n=90 · ♀ 100% (drug 63%) · 90% clinician | no trial arm names this drug |
| Bacteroides infection | 24 | 92.5 60.8–140.8ROR 92.6 · calibrated p 6e-7 ✓ | 78.8 EB05 55.7 · IC025 +4.3 3/3 methods agree vs other Vitamin Cs: only this drug | Not in label — unassessed | serious n=24 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Anticoagulant therapy | 25 | 89.8 59.5–135.4ROR 89.8 · calibrated p 7e-7 ✓ | 77.0 EB05 54.9 · IC025 +4.3 3/3 methods agree vs other Vitamin Cs: PRR 3.7 (2.2–6.2) | Reporting / coding artifact | serious n=25 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Facet joint syndrome | 278 | 87.7 77.6–99.1ROR 88.7 · calibrated p 3e-7 ✓ | 79.5 EB05 72.0 · IC025 +5.9 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.1–1.4) | Not in label — unassessed | serious n=278 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Vaginal flatulence | 26 | 84.2 56.3–125.9ROR 84.3 · calibrated p 1e-6 ✓ | 73.1 EB05 52.4 · IC025 +4.3 3/3 methods agree vs other Vitamin Cs: PRR 1.9 (1.2–3.0) | Not in label — unassessed | serious n=26 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| X-ray abnormal | 151 | 83.8 71.0–98.9ROR 84.3 · calibrated p 5e-7 ✓ | 76.0 EB05 66.3 · IC025 +5.7 3/3 methods agree vs other Vitamin Cs: PRR 1.4 (1.2–1.7) | Lab value / disease marker | serious n=151 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 54 | 79.8 60.4–105.4ROR 80.0 · calibrated p 9e-7 ✓ | 71.6 EB05 56.9 · IC025 +5.0 3/3 methods agree vs other Vitamin Cs: PRR 0.9 (0.7–1.3) | Lab value / disease marker | serious n=54 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Swollen joint count increased | 252 | 79.7 70.1–90.6ROR 80.6 · calibrated p 6e-7 ✓ | 72.9 EB05 65.6 · IC025 +5.8 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (0.9–1.2) | Lab value / disease marker | serious n=252 · ♀ 100% (drug 63%) · 96% clinician | no trial arm names this drug |
| Subcutaneous drug absorption impaired | 42 | 75.7 55.3–103.7ROR 75.8 · calibrated p 2e-6 ✓ | 67.8 EB05 52.3 · IC025 +4.8 3/3 methods agree vs other Vitamin Cs: PRR 1.3 (0.9–1.8) | Not in label — unassessed | serious n=42 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Adjustment disorder with depressed mood | 155 | 75.5 64.1–88.9ROR 76.0 · calibrated p 1e-6 ✓ | 69.1 EB05 60.5 · IC025 +5.6 3/3 methods agree vs other Vitamin Cs: PRR 1.5 (1.2–1.8) | Not in label — unassessed | serious n=154 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Pleural thickening | 52 | 74.9 56.4–99.3ROR 75.0 · calibrated p 1e-6 ✓ | 67.5 EB05 53.5 · IC025 +4.9 3/3 methods agree vs other Vitamin Cs: only this drug | Not in label — unassessed | serious n=52 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Rheumatic fever | 331 | 74.3 66.5–83.1ROR 75.4 · calibrated p 9e-7 ✓ | 68.4 EB05 62.5 · IC025 +5.8 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (0.9–1.1) | Not in label — unassessed | serious n=331 · ♀ 100% (drug 63%) · 91% clinician | no trial arm names this drug |
| Dislocation of vertebra | 138 | 59.9 50.5–71.2ROR 60.3 · calibrated p 5e-6 ✓ | 55.8 EB05 48.4 · IC025 +5.3 3/3 methods agree vs other Vitamin Cs: PRR 1.3 (1.1–1.6) | Not in label — unassessed | serious n=138 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Duodenal ulcer perforation | 446 | 58.6 53.3–64.5ROR 59.8 · calibrated p 4e-6 ✓ | 55.0 EB05 50.8 · IC025 +5.5 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.1–1.3) | Not in label — unassessed | serious PRR 44.3 · ♀ 100% (drug 63%) · 92% clinician | no trial arm names this drug |
| Blood magnesium increased | 53 | 56.5 42.8–74.5ROR 56.6 · calibrated p 9e-6 ✓ | 52.2 EB05 41.5 · IC025 +4.7 3/3 methods agree vs other Vitamin Cs: only this drug | Lab value / disease marker | serious n=53 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Pleural fibrosis | 60 | 56.0 43.2–72.7ROR 56.2 · calibrated p 9e-6 ✓ | 52.0 EB05 41.8 · IC025 +4.8 3/3 methods agree vs other Vitamin Cs: only this drug | Not in label — unassessed | serious n=60 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Crystal nephropathy | 34 | 55.8 39.4–78.8ROR 55.8 · calibrated p 1e-5 ✓ | 51.1 EB05 38.3 · IC025 +4.3 3/3 methods agree vs other Vitamin Cs: only this drug | Not in label — unassessed | serious n=34 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Intramedullary rod insertion | 120 | 55.5 46.2–66.7ROR 55.8 · calibrated p 8e-6 ✓ | 51.9 EB05 44.6 · IC025 +5.1 3/3 methods agree vs other Vitamin Cs: PRR 7.7 (5.7–10.3) | Not in label — unassessed | serious n=120 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Sensitisation | 44 | 55.2 40.8–74.9ROR 55.3 · calibrated p 1e-5 ✓ | 51.0 EB05 39.6 · IC025 +4.5 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (0.7–1.3) | Not in label — unassessed | serious n=44 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Retinitis | 92 | 52.9 42.8–65.2ROR 53.1 · calibrated p 1e-5 ✓ | 49.5 EB05 41.6 · IC025 +5.0 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (0.9–1.5) | Not in label — unassessed | serious n=91 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Ejection fraction | 32 | 52.5 36.8–75.0ROR 52.6 · calibrated p 2e-5 ✓ | 48.3 EB05 35.8 · IC025 +4.2 3/3 methods agree vs other Vitamin Cs: PRR 0.9 (0.6–1.3) | Not in label — unassessed | serious n=32 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Peripheral venous disease | 211 | 50.6 44.0–58.0ROR 51.0 · calibrated p 1e-5 ✓ | 47.7 EB05 42.5 · IC025 +5.2 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (0.9–1.2) | Not in label — unassessed | serious n=211 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Rheumatoid factor positive | 289 | 47.8 42.5–53.8ROR 48.4 · calibrated p 2e-5 ✓ | 45.3 EB05 41.1 · IC025 +5.2 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (1.0–1.3) | Lab value / disease marker | serious n=289 · ♀ 100% (drug 63%) · 95% clinician | no trial arm names this drug |
| Temperature regulation disorder | 107 | 46.7 38.4–56.6ROR 46.9 · calibrated p 2e-5 ✓ | 44.1 EB05 37.5 · IC025 +4.9 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (0.9–1.4) | Not in label — unassessed | serious n=107 · ♀ 100% (drug 63%) | no trial arm names this drug |
| C-reactive protein abnormal | 311 | 46.2 41.3–51.8ROR 46.9 · calibrated p 2e-5 ✓ | 43.9 EB05 40.0 · IC025 +5.2 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.1–1.4) | Lab value / disease marker | serious n=311 · ♀ 100% (drug 63%) · 91% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody positive | 337 | 45.1 40.5–50.3ROR 45.8 · calibrated p 2e-5 ✓ | 42.9 EB05 39.2 · IC025 +5.2 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (0.9–1.2) | Lab value / disease marker | serious PRR 34.7 · ♀ 100% (drug 63%) · 91% clinician | no trial arm names this drug |
| Muscle injury | 385 | 44.6 40.3–49.4ROR 45.3 · calibrated p 3e-5 ✓ | 42.4 EB05 39.0 · IC025 +5.2 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.0–1.3) | Not in label — unassessed | serious PRR 37.1 · ♀ 100% (drug 63%) · 91% clinician | no trial arm names this drug |
| Sleep disorder due to general medical condition, insomnia type | 286 | 42.1 37.4–47.4ROR 42.6 · calibrated p 4e-5 ✓ | 40.2 EB05 36.4 · IC025 +5.0 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.1–1.4) | Not in label — unassessed | serious n=286 · ♀ 100% (drug 63%) · 94% clinician | no trial arm names this drug |
| Folliculitis | 458 | 42.0 38.3–46.1ROR 42.9 · calibrated p 4e-5 ✓ | 40.1 EB05 37.1 · IC025 +5.1 3/3 methods agree vs other Vitamin Cs: PRR 1.3 (1.1–1.4) | Not in label — unassessed | serious PRR 38.0 · ♀ 100% (drug 63%) · 92% clinician | no trial arm names this drug |
| Open reduction of fracture | 50 | 40.8 30.8–54.2ROR 40.9 · calibrated p 6e-5 ✓ | 38.6 EB05 30.4 · IC025 +4.4 3/3 methods agree vs other Vitamin Cs: PRR 6.2 (4.0–9.4) | Not in label — unassessed | serious n=50 · ♀ 100% (drug 63%) | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Ascorbic Acid only as a background or rescue medication (NCT00135707, NCT00064753); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 2,337 | 2.7 2.6–2.8ROR 2.9 · calibrated p 0.650 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Vitamin Cs: PRR 0.8 (0.7–0.8) | Not in label — unassessed | serious PRR 3.2 | no trial arm names this drug |
| Pain | 2,100 | 3.1 3.0–3.2ROR 3.3 · calibrated p 0.533 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (0.9–1.0) | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 84% (drug 63%) | no trial arm names this drug |
| Nausea | 1,998 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.847 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Vitamin Cs: PRR 0.9 (0.9–0.9) | Labeled adverse reaction exact term | serious PRR 2.9 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,827 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.726 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Vitamin Cs: PRR 0.9 (0.8–0.9) | Not in label — unassessed | serious PRR 3.0 | no trial arm names this drug |
| Headache | 1,808 | 2.6 2.5–2.7ROR 2.8 · calibrated p 0.709 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Vitamin Cs: PRR 0.8 (0.8–0.9) | Labeled adverse reaction exact term | serious PRR 3.5 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 1,774 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.468 | 1.2 EB05 1.2 · IC025 +0.2 vs other Vitamin Cs: PRR 0.9 (0.8–0.9) | Reporting / coding artifact | serious PRR 2.1 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,692 | 2.7 2.6–2.8ROR 2.9 · calibrated p 0.676 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (0.9–1.1) | Not in label — unassessed | serious PRR 2.6 | no trial arm names this drug |
| Vomiting | 1,565 | 3.0 2.9–3.2ROR 3.2 · calibrated p 0.570 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Vitamin Cs: PRR 1.2 (1.1–1.2) | Not in label — unassessed | serious PRR 3.3 | no trial arm names this drug |
| Off label use (used outside approved label) | 1,552 | 1.6 1.5–1.7ROR 1.7 · calibrated p 0.749 | 1.6 EB05 1.6 · IC025 +0.6 vs other Vitamin Cs: PRR 0.8 (0.8–0.9) | Reporting / coding artifact | serious PRR 2.0 | no trial arm names this drug |
| Asthenia (weakness) | 1,473 | 3.6 3.4–3.7ROR 3.7 · calibrated p 0.430 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (1.0–1.1) | Not in label — unassessed | serious PRR 3.7 | no trial arm names this drug |
| Rash | 1,414 | 3.0 2.8–3.1ROR 3.1 · calibrated p 0.597 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (1.0–1.1) | Not in label — unassessed | serious PRR 4.2 · ♀ 84% (drug 63%) | no trial arm names this drug |
| Dizziness | 1,347 | 2.5 2.3–2.6ROR 2.5 · calibrated p 0.793 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Vitamin Cs: PRR 0.8 (0.8–0.9) | Labeled adverse reaction exact term | serious PRR 2.7 | no trial arm names this drug |
| Arthralgia (joint pain) | 1,288 | 2.8 2.7–3.0ROR 2.9 · calibrated p 0.649 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Vitamin Cs: PRR 0.8 (0.8–0.8) | Not in label — unassessed | serious PRR 3.4 · ♀ 83% (drug 63%) | no trial arm names this drug |
| Pruritus (itching) | 1,160 | 2.8 2.6–3.0ROR 2.9 · calibrated p 0.665 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Vitamin Cs: PRR 1.0 (0.9–1.0) | Not in label — unassessed | serious PRR 3.9 | no trial arm names this drug |
| Pyrexia (fever) | 1,144 | 3.0 2.8–3.2ROR 3.1 · calibrated p 0.593 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Vitamin Cs: PRR 1.1 (1.1–1.2) | Not in label — unassessed | serious PRR 2.8 | no trial arm names this drug |
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.
- Appendicolith — n=111, PRR 375.9
- Grip strength — n=51, PRR 256.1
- Presbyacusis — n=51, PRR 178.1
- Deep vein thrombosis postoperative — n=245, PRR 129.5
- Swollen joint count — n=30, PRR 125.9
- Lupus vulgaris — n=133, PRR 114.1
- Bacteroides infection — n=24, PRR 92.5
- Facet joint syndrome — n=278, PRR 87.7
- Vaginal flatulence — n=26, PRR 84.2
- Subcutaneous drug absorption impaired — n=42, PRR 75.7
✓ 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 fatigue, pain, nausea, diarrhoea, headache, dyspnoea. 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, fieldpatient.drug.openfda.generic_name.exact, 1,211 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 - ClinicalTrials.gov API v2 (query
ASCORBIC ACID, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.