Sodium Hyaluronate side effects: what 803 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Sodium Hyaluronate (Shine Ph Essence)
Who reports
803 reports · 94% serious · 53 with death outcome · 61% female
Used for
Step 1 Wash your hands thoroughly before opening the product packaging. Step 2 Hold the handle and partially remove the product. Then pull on the cap portion of the packaging to remove it along with the packaging. Step 3 Holding the handle, press the plunger all the way down to apply the entire contents to the vulva. Step 4 After use, gently rinse with water. Dispose of the used product along with its packaging.
Boxed warning
None in the current label
Causality screen of the 14 strongest signals
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. 3 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Glaucoma | 26 | 35.4 24.2–51.6ROR 36.5 · χ² 834 / p 1e-183 | 34.5 EB05 24.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.3 · ♀ 86% (drug 61%) · 92% clinician | no trial data cached |
| Respiratory depression | 8 | 17.1 8.6–34.1ROR 17.3 · χ² 106 / p 4e-25 | 15.0 EB05 6.6 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Neutrophil count increased | 6 | 15.3 6.9–33.9ROR 15.4 · χ² 66 / p 2e-16 | 11.7 EB05 4.4 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 10.3 | no trial data cached |
| Ejection fraction decreased | 9 | 15.1 7.9–29.0ROR 15.3 · χ² 105 / p 6e-25 | 13.2 EB05 6.2 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 | no trial data cached |
| Poisoning deliberate | 5 | 14.1 5.9–33.7ROR 14.2 · χ² 48 / p 2e-12 | 9.6 EB05 3.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Blood test abnormal | 7 | 13.1 6.2–27.3ROR 13.2 · χ² 66 / p 2e-16 | 10.0 EB05 4.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 12.2 | no trial data cached |
| Carpal tunnel syndrome | 7 | 13.1 6.2–27.3ROR 13.2 · χ² 66 / p 2e-16 | 10.0 EB05 4.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| Sleep disorder due to a general medical condition | 8 | 13.0 6.5–25.8ROR 13.1 · χ² 77 / p 1e-18 | 10.4 EB05 4.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 | no trial data cached |
| Full blood count abnormal | 5 | 12.4 5.2–29.8ROR 12.5 · χ² 42 / p 5e-11 | 8.2 EB05 3.1 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 10.1 | no trial data cached |
| Delusion | 7 | 11.8 5.7–24.8ROR 11.9 · χ² 59 / p 8e-15 | 8.8 EB05 3.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 | no trial data cached |
| Visual acuity reduced | 15 | 11.7 7.1–19.4ROR 11.9 · χ² 137 / p 7e-32 | 10.4 EB05 6.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Coordination abnormal | 6 | 11.2 5.0–24.8ROR 11.3 · χ² 46 / p 6e-12 | 7.7 EB05 3.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial data cached |
| Lymphopenia | 5 | 9.3 3.9–22.3ROR 9.4 · χ² 29 / p 3e-8 | 5.9 EB05 2.6 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 6 | 6.3 2.8–14.0ROR 6.3 · χ² 22 / p 2e-6 | 4.5 EB05 2.2 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Glaucoma | 26 | 35.4 24.2–51.6ROR 36.5 · χ² 834 / p 1e-183 | 34.5 EB05 24.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.3 · ♀ 86% (drug 61%) · 92% clinician | no trial data cached |
| Visual acuity reduced | 15 | 11.7 7.1–19.4ROR 11.9 · χ² 137 / p 7e-32 | 10.4 EB05 6.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Ejection fraction decreased | 9 | 15.1 7.9–29.0ROR 15.3 · χ² 105 / p 6e-25 | 13.2 EB05 6.2 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 | no trial data cached |
| Sleep disorder due to a general medical condition | 8 | 13.0 6.5–25.8ROR 13.1 · χ² 77 / p 1e-18 | 10.4 EB05 4.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 | no trial data cached |
| Respiratory depression | 8 | 17.1 8.6–34.1ROR 17.3 · χ² 106 / p 4e-25 | 15.0 EB05 6.6 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Delusion | 7 | 11.8 5.7–24.8ROR 11.9 · χ² 59 / p 8e-15 | 8.8 EB05 3.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 | no trial data cached |
| Carpal tunnel syndrome | 7 | 13.1 6.2–27.3ROR 13.2 · χ² 66 / p 2e-16 | 10.0 EB05 4.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| Blood test abnormal | 7 | 13.1 6.2–27.3ROR 13.2 · χ² 66 / p 2e-16 | 10.0 EB05 4.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 12.2 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 6 | 6.3 2.8–14.0ROR 6.3 · χ² 22 / p 2e-6 | 4.5 EB05 2.2 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Coordination abnormal | 6 | 11.2 5.0–24.8ROR 11.3 · χ² 46 / p 6e-12 | 7.7 EB05 3.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial data cached |
| Neutrophil count increased | 6 | 15.3 6.9–33.9ROR 15.4 · χ² 66 / p 2e-16 | 11.7 EB05 4.4 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 10.3 | no trial data cached |
| Lymphopenia | 5 | 9.3 3.9–22.3ROR 9.4 · χ² 29 / p 3e-8 | 5.9 EB05 2.6 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Full blood count abnormal | 5 | 12.4 5.2–29.8ROR 12.5 · χ² 42 / p 5e-11 | 8.2 EB05 3.1 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 10.1 | no trial data cached |
| Poisoning deliberate | 5 | 14.1 5.9–33.7ROR 14.2 · χ² 48 / p 2e-12 | 9.6 EB05 3.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Product administered at inappropriate site | 4 | 5.8 2.2–15.3ROR 5.8 · χ² 11 / p 4e-4 | 3.8 EB05 1.7 · IC025 +0.1 | Reporting / coding artifact | serious n=4 | 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.
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 Hyaluronate?
In FDA FAERS, the most frequently co-reported reaction terms for Hyaluronate are glaucoma, visual acuity reduced, ejection fraction decreased, sleep disorder due to a general medical condition, respiratory depression, delusion. 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 Hyaluronate have an FDA boxed warning?
No. The FDA label retrieved for Hyaluronate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hyaluronate 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 2edc4479-fb5a-d8a9-e063-6394a90a0db3, effective 20250223; matched on
openfda.generic_name.exact:"SODIUM HYALURONATE") - 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, 17 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.