Drug · FAERS side-effect profile with label screen
Boric Acid side effects: what 345 FDA adverse event reports show
Drug class
Not stated in label
Brand names
V-Bella
openFDA label
Who reports
345 reports · 82% serious · 42 with death outcome · 82% female
openFDA FAERS counts, all years, deduplication not applied
Used for
treats and relieves symptoms of vaginal and urinary infections. rebalances vaginal pH and restores normal vaginal health. helps relieve symptoms of external and internal vaginal burning, itching, irritation and dryness. helps reduce vaginal odor due to vaginal infections.
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 7No label text to screen 33
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.
- 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. 11 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 |
|---|---|---|---|---|---|---|
| Hepatotoxicity (liver damage) | 109 | 300.3 257.0–351.0ROR 438.6 · χ² 32,095 / p <1e-300 | 284.0 EB05 242.0 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 214.1 · 94% clinician | no trial data cached |
| Joint injury | 105 | 299.9 255.5–352.0ROR 430.7 · χ² 30,859 / p <1e-300 | 283.0 EB05 240.4 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 271.7 · 95% clinician | no trial data cached |
| Joint stiffness | 97 | 225.5 190.4–267.1ROR 313.3 · χ² 21,402 / p <1e-300 | 215.2 EB05 181.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 281.0 · 95% clinician | no trial data cached |
| Therapy non-responder | 106 | 144.9 123.6–169.8ROR 208.7 · χ² 14,998 / p <1e-300 | 140.9 EB05 119.8 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 165.8 · 95% clinician | no trial data cached |
| Musculoskeletal pain | 108 | 124.5 106.5–145.6ROR 180.8 · χ² 13,116 / p <1e-300 | 121.6 EB05 103.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.3 · 95% clinician | no trial data cached |
| Neoplasm malignant | 108 | 98.6 84.3–115.3ROR 143.0 · χ² 10,349 / p <1e-300 | 96.8 EB05 82.4 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.6 · 95% clinician | no trial data cached |
| Arthropathy | 90 | 98.2 82.2–117.3ROR 132.5 · χ² 8,572 / p <1e-300 | 96.1 EB05 80.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.9 · 96% clinician | no trial data cached |
| Folliculitis | 15 | 88.4 53.9–145.0ROR 92.3 · χ² 1,209 / p 4e-265 | 79.6 EB05 51.2 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.8 | no trial data cached |
| Flank pain | 13 | 84.5 49.6–144.2ROR 87.8 · χ² 990 / p 1e-217 | 75.4 EB05 46.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.7 | no trial data cached |
| Deformity | 13 | 84.4 49.5–143.9ROR 87.7 · χ² 989 / p 3e-217 | 75.3 EB05 46.8 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.7 | no trial data cached |
| Atelectasis | 13 | 81.6 47.8–139.1ROR 84.7 · χ² 955 / p 6e-210 | 73.1 EB05 45.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.8 | no trial data cached |
| Treatment failure | 107 | 79.3 67.8–92.9ROR 114.6 · χ² 8,219 / p <1e-300 | 78.2 EB05 66.5 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 105.9 · 95% clinician | no trial data cached |
| Contraindicated product administered | 39 | 78.7 58.5–105.8ROR 88.6 · χ² 2,914 / p <1e-300 | 75.8 EB05 57.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 66.9 · 97% clinician | no trial data cached |
| Musculoskeletal stiffness | 110 | 76.4 65.4–89.1ROR 111.6 · χ² 8,129 / p <1e-300 | 75.3 EB05 64.2 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.7 · 95% clinician | no trial data cached |
| Tenderness | 13 | 75.8 44.4–129.2ROR 78.7 · χ² 885 / p 9e-195 | 68.4 EB05 42.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Therapeutic product effect incomplete | 87 | 74.9 62.4–89.8ROR 99.8 · χ² 6,281 / p <1e-300 | 73.6 EB05 61.5 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 98.7 · 95% clinician | no trial data cached |
| Helicobacter infection | 12 | 71.6 41.1–124.9ROR 74.2 · χ² 766 / p 7e-169 | 64.5 EB05 39.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.1 | no trial data cached |
| Bursitis | 14 | 70.6 42.2–118.0ROR 73.5 · χ² 892 / p 3e-196 | 64.6 EB05 40.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.3 | no trial data cached |
| Hand deformity | 14 | 65.1 39.0–108.8ROR 67.8 · χ² 820 / p 1e-180 | 60.0 EB05 38.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.6 | no trial data cached |
| Quality of life decreased | 14 | 63.4 37.9–105.9ROR 66.0 · χ² 798 / p 7e-176 | 58.5 EB05 37.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.7 | no trial data cached |
| Nodule | 13 | 60.6 35.5–103.3ROR 62.9 · χ² 703 / p 3e-155 | 55.8 EB05 34.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.8 | no trial data cached |
| Joint range of motion decreased | 13 | 59.2 34.7–100.9ROR 61.4 · χ² 686 / p 2e-151 | 54.6 EB05 34.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.9 | no trial data cached |
| Therapeutic product effect decreased | 42 | 57.6 43.4–76.4ROR 65.4 · χ² 2,281 / p <1e-300 | 56.1 EB05 43.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 79.7 · 98% clinician | no trial data cached |
| Joint swelling | 112 | 56.6 48.6–65.9ROR 83.3 · χ² 6,086 / p <1e-300 | 56.0 EB05 47.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.8 · 94% clinician | no trial data cached |
| Drug intolerance | 88 | 55.6 46.4–66.6ROR 74.3 · χ² 4,683 / p <1e-300 | 54.9 EB05 46.0 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 63.6 · 94% clinician | no trial data cached |
| Ulcer | 14 | 53.4 32.0–89.3ROR 55.7 · χ² 669 / p 8e-148 | 50.0 EB05 31.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.3 | no trial data cached |
| Conjunctivitis | 15 | 49.7 30.3–81.5ROR 51.9 · χ² 667 / p 2e-147 | 46.9 EB05 30.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.6 | no trial data cached |
| Infection | 110 | 46.4 39.8–54.1ROR 67.7 · χ² 4,871 / p <1e-300 | 46.0 EB05 39.2 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.9 · 95% clinician | no trial data cached |
| Feeling jittery | 14 | 44.6 26.7–74.5ROR 46.4 · χ² 554 / p 9e-123 | 42.2 EB05 26.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Inflammation | 37 | 43.8 32.3–59.4ROR 49.0 · χ² 1,509 / p <1e-300 | 42.9 EB05 32.5 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.1 · 95% clinician | no trial data cached |
| Photophobia (light sensitivity) | 13 | 42.3 24.8–72.2ROR 44.0 · χ² 484 / p 1e-107 | 40.0 EB05 24.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.1 | no trial data cached |
| Rash maculo-papular | 15 | 41.2 25.1–67.5ROR 43.0 · χ² 549 / p 1e-121 | 39.3 EB05 25.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 | no trial data cached |
| Sciatica | 10 | 38.3 20.8–70.6ROR 39.5 · χ² 327 / p 2e-73 | 35.9 EB05 20.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.1 | no trial data cached |
| Impaired work ability | 13 | 36.9 21.6–62.8ROR 38.3 · χ² 419 / p 2e-93 | 35.1 EB05 21.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 | no trial data cached |
| Fibromyalgia | 14 | 35.1 21.0–58.6ROR 36.5 · χ² 430 / p 8e-96 | 33.6 EB05 21.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.3 | no trial data cached |
| Rheumatoid arthritis | 61 | 32.8 26.1–41.2ROR 39.6 · χ² 1,858 / p <1e-300 | 32.5 EB05 26.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.7 · 95% clinician | no trial data cached |
| Skin ulcer | 13 | 30.6 18.0–52.2ROR 31.8 · χ² 344 / p 5e-77 | 29.4 EB05 18.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.6 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 11 | 29.9 16.7–53.5ROR 30.9 · χ² 279 / p 5e-63 | 28.5 EB05 16.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.4 | no trial data cached |
| Drug hypersensitivity | 93 | 29.1 24.5–34.6ROR 39.5 · χ² 2,519 / p <1e-300 | 29.0 EB05 24.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.7 · 96% clinician | no trial data cached |
| Impaired healing | 15 | 27.8 16.9–45.6ROR 29.0 · χ² 361 / p 8e-81 | 26.9 EB05 17.3 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 23.6 | 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 |
|---|---|---|---|---|---|---|
| Joint swelling | 112 | 56.6 48.6–65.9ROR 83.3 · χ² 6,086 / p <1e-300 | 56.0 EB05 47.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.8 · 94% clinician | no trial data cached |
| Infection | 110 | 46.4 39.8–54.1ROR 67.7 · χ² 4,871 / p <1e-300 | 46.0 EB05 39.2 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.9 · 95% clinician | no trial data cached |
| Musculoskeletal stiffness | 110 | 76.4 65.4–89.1ROR 111.6 · χ² 8,129 / p <1e-300 | 75.3 EB05 64.2 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.7 · 95% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 109 | 300.3 257.0–351.0ROR 438.6 · χ² 32,095 / p <1e-300 | 284.0 EB05 242.0 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 214.1 · 94% clinician | no trial data cached |
| Neoplasm malignant | 108 | 98.6 84.3–115.3ROR 143.0 · χ² 10,349 / p <1e-300 | 96.8 EB05 82.4 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.6 · 95% clinician | no trial data cached |
| Musculoskeletal pain | 108 | 124.5 106.5–145.6ROR 180.8 · χ² 13,116 / p <1e-300 | 121.6 EB05 103.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.3 · 95% clinician | no trial data cached |
| Treatment failure | 107 | 79.3 67.8–92.9ROR 114.6 · χ² 8,219 / p <1e-300 | 78.2 EB05 66.5 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 105.9 · 95% clinician | no trial data cached |
| Therapy non-responder | 106 | 144.9 123.6–169.8ROR 208.7 · χ² 14,998 / p <1e-300 | 140.9 EB05 119.8 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 165.8 · 95% clinician | no trial data cached |
| Joint injury | 105 | 299.9 255.5–352.0ROR 430.7 · χ² 30,859 / p <1e-300 | 283.0 EB05 240.4 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 271.7 · 95% clinician | no trial data cached |
| Joint stiffness | 97 | 225.5 190.4–267.1ROR 313.3 · χ² 21,402 / p <1e-300 | 215.2 EB05 181.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 281.0 · 95% clinician | no trial data cached |
| Drug hypersensitivity | 93 | 29.1 24.5–34.6ROR 39.5 · χ² 2,519 / p <1e-300 | 29.0 EB05 24.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.7 · 96% clinician | no trial data cached |
| Arthropathy | 90 | 98.2 82.2–117.3ROR 132.5 · χ² 8,572 / p <1e-300 | 96.1 EB05 80.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.9 · 96% clinician | no trial data cached |
| Drug intolerance | 88 | 55.6 46.4–66.6ROR 74.3 · χ² 4,683 / p <1e-300 | 54.9 EB05 46.0 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 63.6 · 94% clinician | no trial data cached |
| Therapeutic product effect incomplete | 87 | 74.9 62.4–89.8ROR 99.8 · χ² 6,281 / p <1e-300 | 73.6 EB05 61.5 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 98.7 · 95% clinician | no trial data cached |
| Rheumatoid arthritis | 61 | 32.8 26.1–41.2ROR 39.6 · χ² 1,858 / p <1e-300 | 32.5 EB05 26.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.7 · 95% 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 Boric Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Boric Acid are joint swelling, infection, musculoskeletal stiffness, hepatotoxicity, neoplasm malignant, musculoskeletal pain. 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 Boric Acid have an FDA boxed warning?
No. The FDA label retrieved for Boric Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Boric 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 3c3a423c-805d-4146-b16e-0138617a8dc6, effective 20221117; matched on
openfda.generic_name.exact:"BORIC 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, 51 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.