Drug · FAERS side-effect profile with label screen
Citric Acid side effects: what 429 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Soothe Chewable
openFDA label
Who reports
429 reports · 85% serious · 139 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the relief of Heartburn, acid indigestion, and upset stomach associated with these symptoms.
FDA label, Indications and Usage
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 3Lab value / disease marker 2No label text to screen 35
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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 25 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 60 | 317.5 250.9–401.9ROR 369.0 · χ² 18,504 / p <1e-300 | 286.6 EB05 230.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 217.7 · ♀ 0% (drug 42%) · 95% clinician | no trial data cached |
| Ventricular fibrillation | 59 | 260.3 205.2–330.1ROR 301.6 · χ² 14,909 / p <1e-300 | 238.9 EB05 192.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 176.5 · ♀ 0% (drug 42%) · 95% clinician | no trial data cached |
| Hyperlipidaemia | 49 | 200.6 154.1–261.3ROR 226.4 · χ² 9,501 / p <1e-300 | 185.5 EB05 145.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 149.7 · ♀ 0% (drug 42%) · 94% clinician | no trial data cached |
| Cardiogenic shock | 58 | 199.5 156.9–253.6ROR 230.5 · χ² 11,217 / p <1e-300 | 186.5 EB05 149.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 135.0 · ♀ 0% (drug 42%) · 95% clinician | no trial data cached |
| Bacterial infection | 74 | 195.5 158.8–240.7ROR 236.1 · χ² 14,083 / p <1e-300 | 185.5 EB05 152.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 153.1 · ♀ 0% (drug 42%) · 96% clinician | no trial data cached |
| Incorrect route of product administration | 66 | 192.7 154.3–240.7ROR 227.6 · χ² 12,357 / p <1e-300 | 181.9 EB05 148.0 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 260.9 · ♀ 0% (drug 42%) · 95% clinician | no trial data cached |
| Vaginal discharge | 36 | 175.8 128.5–240.5ROR 191.8 · χ² 6,064 / p <1e-300 | 160.4 EB05 121.0 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 100% (drug 42%) | no trial data cached |
| Aspiration | 36 | 163.0 119.1–222.9ROR 177.8 · χ² 5,618 / p <1e-300 | 149.7 EB05 112.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 113.5 · ♀ 0% (drug 42%) · 97% clinician | no trial data cached |
| Blood test abnormal | 46 | 160.7 122.2–211.2ROR 179.8 · χ² 7,121 / p <1e-300 | 150.3 EB05 117.2 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 166.8 · ♀ 0% (drug 42%) · 96% clinician | no trial data cached |
| Hypercholesterolaemia | 31 | 158.9 113.1–223.1ROR 171.2 · χ² 4,693 / p <1e-300 | 144.4 EB05 106.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 114.5 · ♀ 0% (drug 42%) · 97% clinician | no trial data cached |
| Ulcer | 50 | 153.9 118.5–199.8ROR 174.0 · χ² 7,423 / p <1e-300 | 145.0 EB05 114.3 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 131.6 · ♀ 0% (drug 42%) · 94% clinician | no trial data cached |
| End stage renal disease | 57 | 151.7 119.1–193.3ROR 174.8 · χ² 8,365 / p <1e-300 | 144.0 EB05 115.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.8 · ♀ 2% (drug 42%) · 91% clinician | no trial data cached |
| Neuralgia | 74 | 149.6 121.5–184.1ROR 180.6 · χ² 10,753 / p <1e-300 | 143.7 EB05 118.2 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 150.6 · ♀ 0% (drug 42%) · 96% clinician | no trial data cached |
| Full blood count abnormal | 32 | 148.8 106.6–207.8ROR 160.7 · χ² 4,539 / p <1e-300 | 136.4 EB05 101.2 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 134.0 · ♀ 0% (drug 42%) · 97% clinician | no trial data cached |
| Macular degeneration | 35 | 144.0 104.8–197.9ROR 156.7 · χ² 4,816 / p <1e-300 | 133.3 EB05 100.2 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.4 · ♀ 100% (drug 42%) | no trial data cached |
| Micturition urgency | 33 | 142.7 102.7–198.1ROR 154.5 · χ² 4,491 / p <1e-300 | 131.6 EB05 98.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 160.2 · ♀ 0% (drug 42%) · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 81 | 142.3 116.9–173.2ROR 175.2 · χ² 11,205 / p <1e-300 | 137.3 EB05 114.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.4 · ♀ 0% (drug 42%) · 95% clinician | no trial data cached |
| Gout | 50 | 136.4 105.1–177.1ROR 154.3 · χ² 6,573 / p <1e-300 | 129.4 EB05 102.0 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.9 · ♀ 0% (drug 42%) · 96% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 35 | 131.8 95.9–181.2ROR 143.5 · χ² 4,405 / p <1e-300 | 122.8 EB05 92.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 125.3 · ♀ 100% (drug 42%) | no trial data cached |
| Paraesthesia oral | 36 | 122.7 89.7–167.9ROR 133.9 · χ² 4,218 / p <1e-300 | 115.1 EB05 86.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 148.8 · ♀ 100% (drug 42%) | no trial data cached |
| Ascites | 61 | 101.6 80.5–128.2ROR 118.2 · χ² 5,970 / p <1e-300 | 98.3 EB05 79.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.9 · ♀ 2% (drug 42%) · 95% clinician | no trial data cached |
| Transaminases increased | 35 | 77.1 56.1–106.0ROR 83.9 · χ² 2,553 / p <1e-300 | 74.0 EB05 55.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.9 · ♀ 0% (drug 42%) · 94% clinician | no trial data cached |
| Joint injury | 33 | 75.5 54.4–104.9ROR 81.8 · χ² 2,352 / p <1e-300 | 72.4 EB05 53.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.6 · ♀ 0% (drug 42%) · 97% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 86 | 74.9 62.0–90.5ROR 93.4 · χ² 6,204 / p <1e-300 | 73.6 EB05 61.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.2 · ♀ 3% (drug 42%) · 94% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 72 | 67.6 54.7–83.5ROR 81.0 · χ² 4,662 / p <1e-300 | 66.4 EB05 54.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.6 · ♀ 0% (drug 42%) · 96% clinician | no trial data cached |
| Frequent bowel movements | 35 | 63.7 46.3–87.5ROR 69.2 · χ² 2,097 / p <1e-300 | 61.5 EB05 46.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.7 · ♀ 100% (drug 42%) | no trial data cached |
| Cardiovascular disorder | 32 | 61.2 43.9–85.5ROR 66.1 · χ² 1,836 / p <1e-300 | 59.1 EB05 43.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.8 · ♀ 0% (drug 42%) · 97% clinician | no trial data cached |
| Procedural pain | 34 | 60.2 43.6–83.1ROR 65.3 · χ² 1,919 / p <1e-300 | 58.2 EB05 43.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.4 · ♀ 100% (drug 42%) | no trial data cached |
| Coronary artery disease | 35 | 56.1 40.9–77.1ROR 61.0 · χ² 1,841 / p <1e-300 | 54.5 EB05 41.0 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.8 · ♀ 3% (drug 42%) · 97% clinician | no trial data cached |
| Stress | 81 | 55.1 45.3–67.1ROR 67.7 · χ² 4,259 / p <1e-300 | 54.4 EB05 45.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.1 · ♀ 0% (drug 42%) · 95% clinician | no trial data cached |
| Blood cholesterol increased | 51 | 53.5 41.3–69.2ROR 60.6 · χ² 2,578 / p <1e-300 | 52.5 EB05 41.5 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 55.2 · ♀ 5% (drug 42%) · 96% clinician | no trial data cached |
| Lower respiratory tract infection | 47 | 50.7 38.7–66.5ROR 56.9 · χ² 2,245 / p <1e-300 | 49.7 EB05 38.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.5 · ♀ 0% (drug 42%) · 94% clinician | no trial data cached |
| Sleep disorder | 71 | 49.6 40.1–61.4ROR 59.3 · χ² 3,344 / p <1e-300 | 49.0 EB05 40.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.9 · ♀ 2% (drug 42%) · 94% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 15 | 48.7 29.6–80.0ROR 50.4 · χ² 653 / p 2e-144 | 46.0 EB05 29.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 | no trial data cached |
| Diabetes mellitus | 76 | 48.6 39.6–59.5ROR 58.8 · χ² 3,502 / p <1e-300 | 48.0 EB05 39.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.8 · ♀ 1% (drug 42%) · 96% clinician | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 32 | 46.2 33.1–64.5ROR 49.8 · χ² 1,371 / p 2e-300 | 45.0 EB05 33.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.9 · ♀ 0% (drug 42%) · 97% clinician | no trial data cached |
| Thrombosis | 76 | 46.1 37.6–56.5ROR 55.8 · χ² 3,317 / p <1e-300 | 45.5 EB05 37.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.5 · ♀ 1% (drug 42%) · 96% clinician | no trial data cached |
| Colitis | 34 | 44.2 32.0–61.0ROR 47.9 · χ² 1,393 / p <1e-300 | 43.1 EB05 32.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.3 · ♀ 100% (drug 42%) | no trial data cached |
| Intentional product misuse | 75 | 42.2 34.4–51.9ROR 51.0 · χ² 2,988 / p <1e-300 | 41.8 EB05 34.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 64.3 · ♀ 1% (drug 42%) · 96% clinician | no trial data cached |
| Swelling | 78 | 40.9 33.4–49.9ROR 49.7 · χ² 3,004 / p <1e-300 | 40.5 EB05 33.5 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.1 · ♀ 3% (drug 42%) · 94% clinician | 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 |
|---|---|---|---|---|---|---|
| Anaemia (low red blood cells) | 115 | 29.5 25.2–34.5ROR 39.9 · χ² 3,161 / p <1e-300 | 29.3 EB05 25.1 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.9 · 90% clinician | no trial data cached |
| Drug hypersensitivity | 105 | 26.4 22.4–31.2ROR 34.7 · χ² 2,567 / p <1e-300 | 26.3 EB05 22.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.9 · ♀ 17% (drug 42%) · 90% clinician | no trial data cached |
| Sepsis (blood infection) | 92 | 40.3 33.6–48.3ROR 51.1 · χ² 3,505 / p <1e-300 | 40.0 EB05 33.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.6 · ♀ 6% (drug 42%) · 92% clinician | no trial data cached |
| General physical health deterioration | 86 | 36.6 30.3–44.2ROR 45.5 · χ² 2,958 / p <1e-300 | 36.3 EB05 30.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 29.1 · ♀ 3% (drug 42%) · 95% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 86 | 74.9 62.0–90.5ROR 93.4 · χ² 6,204 / p <1e-300 | 73.6 EB05 61.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.2 · ♀ 3% (drug 42%) · 94% clinician | no trial data cached |
| Stress | 81 | 55.1 45.3–67.1ROR 67.7 · χ² 4,259 / p <1e-300 | 54.4 EB05 45.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.1 · ♀ 0% (drug 42%) · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 81 | 142.3 116.9–173.2ROR 175.2 · χ² 11,205 / p <1e-300 | 137.3 EB05 114.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.4 · ♀ 0% (drug 42%) · 95% clinician | no trial data cached |
| Swelling | 78 | 40.9 33.4–49.9ROR 49.7 · χ² 3,004 / p <1e-300 | 40.5 EB05 33.5 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.1 · ♀ 3% (drug 42%) · 94% clinician | no trial data cached |
| Drug intolerance | 77 | 39.1 32.0–47.9ROR 47.5 · χ² 2,834 / p <1e-300 | 38.8 EB05 32.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 43.4 · ♀ 3% (drug 42%) · 96% clinician | no trial data cached |
| Thrombosis | 76 | 46.1 37.6–56.5ROR 55.8 · χ² 3,317 / p <1e-300 | 45.5 EB05 37.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.5 · ♀ 1% (drug 42%) · 96% clinician | no trial data cached |
| Diabetes mellitus | 76 | 48.6 39.6–59.5ROR 58.8 · χ² 3,502 / p <1e-300 | 48.0 EB05 39.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.8 · ♀ 1% (drug 42%) · 96% clinician | no trial data cached |
| Intentional product misuse | 75 | 42.2 34.4–51.9ROR 51.0 · χ² 2,988 / p <1e-300 | 41.8 EB05 34.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 64.3 · ♀ 1% (drug 42%) · 96% clinician | no trial data cached |
| Neuralgia | 74 | 149.6 121.5–184.1ROR 180.6 · χ² 10,753 / p <1e-300 | 143.7 EB05 118.2 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 150.6 · ♀ 0% (drug 42%) · 96% clinician | no trial data cached |
| Bacterial infection | 74 | 195.5 158.8–240.7ROR 236.1 · χ² 14,083 / p <1e-300 | 185.5 EB05 152.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 153.1 · ♀ 0% (drug 42%) · 96% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 72 | 36.9 29.9–45.5ROR 44.1 · χ² 2,488 / p <1e-300 | 36.5 EB05 30.0 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.2 · ♀ 2% (drug 42%) · 96% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ 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 Citric Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Citric Acid are anaemia, drug hypersensitivity, sepsis, hyponatraemia, stress, multiple organ dysfunction syndrome. 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 Citric Acid have an FDA boxed warning?
No. The FDA label retrieved for Citric Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Citric 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 04a27a71-b7b2-12aa-e063-6294a90a312f, effective 20250115; matched on
openfda.generic_name.exact:"CITRIC 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, 65 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.