Drug · FAERS side-effect profile with label screen
Hyaluronate Sodium side effects: what 1,493 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Hyaluronate Sodium (Celistar Microneedling Infusion)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,493 reports · 93% serious · 113 with death outcome · 67% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Antioxidant and skin protectant,Anti aging and wrinkle reducer, Skin moisturizer and conditioner
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 3No label text to screen 34
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. 67 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 |
|---|---|---|---|---|---|---|
| Carpal tunnel syndrome | 117 | 118.0 99.1–140.5ROR 128.0 · χ² 13,352 / p <1e-300 | 114.9 EB05 98.4 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.5 · ♀ 100% (drug 67%) | no trial data cached |
| Blood test abnormal | 116 | 117.0 98.2–139.5ROR 126.8 · χ² 13,124 / p <1e-300 | 113.9 EB05 97.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 110.0 · ♀ 99% (drug 67%) | no trial data cached |
| Sleep disorder due to a general medical condition | 118 | 103.2 86.8–122.8ROR 112.0 · χ² 11,766 / p <1e-300 | 100.8 EB05 86.5 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 122.5 · ♀ 99% (drug 67%) | no trial data cached |
| Full blood count abnormal | 65 | 87.1 68.6–110.6ROR 91.0 · χ² 5,416 / p <1e-300 | 84.5 EB05 68.6 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 71.2 · ♀ 100% (drug 67%) | no trial data cached |
| Sleep apnoea syndrome | 114 | 84.2 70.5–100.5ROR 91.1 · χ² 9,242 / p <1e-300 | 82.6 EB05 70.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.6 · ♀ 100% (drug 67%) | no trial data cached |
| Fibromyalgia | 120 | 69.7 58.7–82.8ROR 75.7 · χ² 8,030 / p <1e-300 | 68.7 EB05 59.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.1 · ♀ 100% (drug 67%) | no trial data cached |
| Nephropathy | 40 | 60.1 44.2–81.7ROR 61.7 · χ² 2,258 / p <1e-300 | 58.3 EB05 44.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.5 · ♀ 100% (drug 67%) | no trial data cached |
| Hypothyroidism | 132 | 58.5 49.7–68.8ROR 64.0 · χ² 7,377 / p <1e-300 | 57.8 EB05 49.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.7 · ♀ 98% (drug 67%) | no trial data cached |
| Renal disorder | 112 | 33.8 28.3–40.4ROR 36.4 · χ² 3,528 / p <1e-300 | 33.5 EB05 28.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.6 · ♀ 99% (drug 67%) | no trial data cached |
| Loss of personal independence in daily activities | 105 | 31.1 25.8–37.4ROR 33.4 · χ² 3,027 / p <1e-300 | 30.9 EB05 26.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.1 · ♀ 99% (drug 67%) | no trial data cached |
| Burning sensation | 125 | 25.1 21.2–29.7ROR 27.3 · χ² 2,870 / p <1e-300 | 25.0 EB05 21.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.0 · ♀ 100% (drug 67%) | no trial data cached |
| Therapeutic product effect incomplete | 122 | 24.3 20.5–28.8ROR 26.3 · χ² 2,703 / p <1e-300 | 24.2 EB05 20.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 28.2 · ♀ 97% (drug 67%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 129 | 22.6 19.2–26.7ROR 24.7 · χ² 2,651 / p <1e-300 | 22.5 EB05 19.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.3 · ♀ 99% (drug 67%) | no trial data cached |
| Eye inflammation | 15 | 22.4 13.5–37.0ROR 22.6 · χ² 285 / p 3e-64 | 21.7 EB05 13.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Wheezing | 94 | 22.3 18.4–27.2ROR 23.8 · χ² 1,898 / p <1e-300 | 22.2 EB05 18.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.1 · ♀ 99% (drug 67%) | no trial data cached |
| Iron deficiency anaemia | 13 | 19.9 11.6–34.2ROR 20.1 · χ² 215 / p 7e-49 | 19.1 EB05 11.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 | no trial data cached |
| Cardiac disorder | 123 | 18.4 15.5–21.8ROR 20.0 · χ² 2,015 / p <1e-300 | 18.3 EB05 15.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 · ♀ 98% (drug 67%) | no trial data cached |
| Toxic skin eruption | 12 | 16.7 9.5–29.3ROR 16.8 · χ² 162 / p 3e-37 | 15.6 EB05 8.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial data cached |
| Asthma | 132 | 16.6 14.1–19.5ROR 18.1 · χ² 1,922 / p <1e-300 | 16.5 EB05 14.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 · ♀ 98% (drug 67%) | no trial data cached |
| Brain fog | 17 | 16.4 10.2–26.3ROR 16.6 · χ² 230 / p 3e-52 | 15.7 EB05 9.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.5 | no trial data cached |
| Brain oedema | 14 | 15.6 9.3–26.3ROR 15.7 · χ² 177 / p 1e-40 | 14.6 EB05 8.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Candida infection (yeast infection) | 18 | 15.2 9.6–24.0ROR 15.3 · χ² 224 / p 6e-51 | 14.5 EB05 9.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 | no trial data cached |
| Toothache | 15 | 11.7 7.0–19.3ROR 11.8 · χ² 136 / p 1e-31 | 10.4 EB05 6.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 | no trial data cached |
| Apathy | 12 | 11.6 6.6–20.4ROR 11.7 · χ² 106 / p 4e-25 | 9.9 EB05 5.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial data cached |
| C-reactive protein increased | 29 | 11.2 7.8–16.1ROR 11.4 · χ² 260 / p 1e-58 | 10.6 EB05 7.5 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 · 93% clinician | no trial data cached |
| Metastases to central nervous system | 10 | 11.0 5.9–20.4ROR 11.0 · χ² 81 / p 1e-19 | 8.9 EB05 4.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Tooth infection | 10 | 10.7 5.7–19.8ROR 10.7 · χ² 78 / p 5e-19 | 8.5 EB05 4.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 | no trial data cached |
| Feeding disorder | 15 | 10.6 6.4–17.5ROR 10.7 · χ² 121 / p 2e-28 | 9.2 EB05 5.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 | no trial data cached |
| Skin fissures | 14 | 10.4 6.2–17.6ROR 10.5 · χ² 110 / p 5e-26 | 8.9 EB05 5.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Body temperature increased | 15 | 10.3 6.2–17.0ROR 10.4 · χ² 117 / p 2e-27 | 8.9 EB05 5.4 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 | no trial data cached |
| Hypertension (high blood pressure) | 149 | 9.9 8.5–11.5ROR 10.9 · χ² 1,191 / p 3e-261 | 9.7 EB05 8.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 96% (drug 67%) | no trial data cached |
| Intentional product use issue | 57 | 9.1 7.1–11.7ROR 9.4 · χ² 405 / p 3e-90 | 8.7 EB05 6.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 · ♀ 98% (drug 67%) | no trial data cached |
| Blindness | 26 | 9.0 6.1–13.1ROR 9.1 · χ² 177 / p 1e-40 | 8.2 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 · 92% clinician | no trial data cached |
| Eructation (belching) | 12 | 8.9 5.0–15.6ROR 8.9 · χ² 76 / p 1e-18 | 7.2 EB05 4.2 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Pancreatitis acute | 14 | 8.8 5.2–14.9ROR 8.9 · χ² 89 / p 2e-21 | 7.4 EB05 4.5 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Deafness | 16 | 8.6 5.3–14.0ROR 8.7 · χ² 100 / p 8e-24 | 7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Eye pain | 33 | 8.4 6.0–11.8ROR 8.6 · χ² 208 / p 2e-47 | 7.8 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 | no trial data cached |
| Frequent bowel movements | 16 | 8.4 5.1–13.6ROR 8.4 · χ² 96 / p 5e-23 | 7.1 EB05 4.5 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | no trial data cached |
| Visual acuity reduced | 19 | 8.0 5.1–12.5ROR 8.1 · χ² 109 / p 8e-26 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Cataract | 33 | 7.8 5.6–11.0ROR 8.0 · χ² 190 / p 2e-43 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | 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 |
|---|---|---|---|---|---|---|
| Hypertension (high blood pressure) | 149 | 9.9 8.5–11.5ROR 10.9 · χ² 1,191 / p 3e-261 | 9.7 EB05 8.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 96% (drug 67%) | no trial data cached |
| Asthma | 132 | 16.6 14.1–19.5ROR 18.1 · χ² 1,922 / p <1e-300 | 16.5 EB05 14.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 · ♀ 98% (drug 67%) | no trial data cached |
| Hypothyroidism | 132 | 58.5 49.7–68.8ROR 64.0 · χ² 7,377 / p <1e-300 | 57.8 EB05 49.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.7 · ♀ 98% (drug 67%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 129 | 22.6 19.2–26.7ROR 24.7 · χ² 2,651 / p <1e-300 | 22.5 EB05 19.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.3 · ♀ 99% (drug 67%) | no trial data cached |
| Burning sensation | 125 | 25.1 21.2–29.7ROR 27.3 · χ² 2,870 / p <1e-300 | 25.0 EB05 21.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.0 · ♀ 100% (drug 67%) | no trial data cached |
| Cardiac disorder | 123 | 18.4 15.5–21.8ROR 20.0 · χ² 2,015 / p <1e-300 | 18.3 EB05 15.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 · ♀ 98% (drug 67%) | no trial data cached |
| Therapeutic product effect incomplete | 122 | 24.3 20.5–28.8ROR 26.3 · χ² 2,703 / p <1e-300 | 24.2 EB05 20.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 28.2 · ♀ 97% (drug 67%) | no trial data cached |
| Fibromyalgia | 120 | 69.7 58.7–82.8ROR 75.7 · χ² 8,030 / p <1e-300 | 68.7 EB05 59.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.1 · ♀ 100% (drug 67%) | no trial data cached |
| Sleep disorder due to a general medical condition | 118 | 103.2 86.8–122.8ROR 112.0 · χ² 11,766 / p <1e-300 | 100.8 EB05 86.5 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 122.5 · ♀ 99% (drug 67%) | no trial data cached |
| Carpal tunnel syndrome | 117 | 118.0 99.1–140.5ROR 128.0 · χ² 13,352 / p <1e-300 | 114.9 EB05 98.4 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.5 · ♀ 100% (drug 67%) | no trial data cached |
| Blood test abnormal | 116 | 117.0 98.2–139.5ROR 126.8 · χ² 13,124 / p <1e-300 | 113.9 EB05 97.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 110.0 · ♀ 99% (drug 67%) | no trial data cached |
| Sleep apnoea syndrome | 114 | 84.2 70.5–100.5ROR 91.1 · χ² 9,242 / p <1e-300 | 82.6 EB05 70.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.6 · ♀ 100% (drug 67%) | no trial data cached |
| Renal disorder | 112 | 33.8 28.3–40.4ROR 36.4 · χ² 3,528 / p <1e-300 | 33.5 EB05 28.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.6 · ♀ 99% (drug 67%) | no trial data cached |
| Loss of personal independence in daily activities | 105 | 31.1 25.8–37.4ROR 33.4 · χ² 3,027 / p <1e-300 | 30.9 EB05 26.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.1 · ♀ 99% (drug 67%) | no trial data cached |
| Wheezing | 94 | 22.3 18.4–27.2ROR 23.8 · χ² 1,898 / p <1e-300 | 22.2 EB05 18.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.1 · ♀ 99% (drug 67%) | 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 hypertension, asthma, hypothyroidism, gastrooesophageal reflux disease, burning sensation, cardiac disorder. 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 53de46a7-3947-70a7-e063-6294a90ab829, effective 20260609; matched on
openfda.generic_name.exact:"HYALURONATE SODIUM") - 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, 107 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.