Drug · FAERS side-effect profile with label screen
Hyaluronic Acid side effects: what 1,146 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,146 reports · 59% serious · 41 with death outcome · 76% female
openFDA FAERS counts, all years, deduplication not applied
Used for
it whenever you need to clean your eyelids
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 31 strongest signals
Reporting / coding artifact 2Lab value / disease marker 3No label text to screen 26
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. 8 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 |
|---|---|---|---|---|---|---|
| Nerve compression | 8 | 15.9 8.0–31.7ROR 16.0 · χ² 97 / p 3e-23 | 13.6 EB05 6.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.8 | no trial data cached |
| Nodule | 10 | 14.0 7.6–26.0ROR 14.1 · χ² 108 / p 1e-25 | 12.2 EB05 6.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial data cached |
| Tenderness | 8 | 14.0 7.0–28.0ROR 14.1 · χ² 84 / p 2e-20 | 11.5 EB05 5.2 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Body temperature decreased | 7 | 12.9 6.2–27.0ROR 13.0 · χ² 65 / p 3e-16 | 9.9 EB05 4.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 13.9 | no trial data cached |
| Eyelid ptosis | 7 | 12.6 6.0–26.4ROR 12.7 · χ² 64 / p 8e-16 | 9.5 EB05 4.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Increased tendency to bruise | 6 | 11.9 5.4–26.5ROR 12.0 · χ² 50 / p 1e-12 | 8.4 EB05 3.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Mass | 9 | 11.8 6.1–22.5ROR 11.8 · χ² 78 / p 5e-19 | 9.4 EB05 4.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 | no trial data cached |
| Nephropathy | 6 | 11.7 5.3–26.0ROR 11.8 · χ² 49 / p 2e-12 | 8.2 EB05 3.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 | no trial data cached |
| Peripheral coldness | 8 | 10.6 5.3–21.2ROR 10.7 · χ² 60 / p 4e-15 | 8.0 EB05 3.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 | no trial data cached |
| Product preparation error | 12 | 10.6 6.0–18.6ROR 10.7 · χ² 95 / p 9e-23 | 8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Nocturia (night-time urination) | 6 | 9.1 4.1–20.1ROR 9.1 · χ² 35 / p 1e-9 | 6.1 EB05 2.9 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Eye discharge | 5 | 9.0 3.7–21.5ROR 9.0 · χ² 28 / p 7e-8 | 5.7 EB05 2.5 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 | no trial data cached |
| Body height decreased | 5 | 8.5 3.5–20.3ROR 8.5 · χ² 26 / p 2e-7 | 5.4 EB05 2.4 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Blood pressure systolic increased | 9 | 8.4 4.4–16.1ROR 8.5 · χ² 52 / p 3e-13 | 6.4 EB05 3.5 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.9 | no trial data cached |
| Blood test abnormal | 6 | 7.8 3.5–17.4ROR 7.9 · χ² 29 / p 3e-8 | 5.4 EB05 2.6 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 | no trial data cached |
| Madarosis | 5 | 7.8 3.3–18.7ROR 7.8 · χ² 23 / p 7e-7 | 5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Hyperthyroidism | 6 | 7.6 3.4–16.9ROR 7.6 · χ² 28 / p 6e-8 | 5.2 EB05 2.5 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Eye disorder | 13 | 7.3 4.2–12.5ROR 7.3 · χ² 64 / p 6e-16 | 6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial data cached |
| Mydriasis | 5 | 7.1 3.0–17.1ROR 7.2 · χ² 21 / p 3e-6 | 4.7 EB05 2.2 · IC025 +0.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 | no trial data cached |
| Eye swelling | 14 | 6.9 4.1–11.7ROR 7.0 · χ² 65 / p 3e-16 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Lip swelling | 12 | 6.6 3.8–11.6ROR 6.7 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Tooth disorder | 8 | 6.6 3.3–13.1ROR 6.6 · χ² 32 / p 7e-9 | 5.0 EB05 2.7 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 | no trial data cached |
| Skin reaction | 5 | 6.5 2.7–15.6ROR 6.5 · χ² 18 / p 1e-5 | 4.4 EB05 2.0 · IC025 +0.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Full blood count decreased | 6 | 5.4 2.5–12.1ROR 5.5 · χ² 18 / p 1e-5 | 4.0 EB05 2.0 · IC025 +0.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.4 | no trial data cached |
| Knee arthroplasty | 6 | 5.3 2.4–11.7ROR 5.3 · χ² 17 / p 2e-5 | 3.9 EB05 2.0 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Application site pain | 5 | 4.2 1.7–10.0ROR 4.2 · χ² 9 / p 0.001 | 3.2 EB05 1.5 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Injection site swelling | 15 | 3.6 2.2–6.0ROR 3.7 · χ² 26 / p 2e-7 | 3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Injection site mass | 7 | 3.5 1.7–7.3ROR 3.5 · χ² 10 / p 8e-4 | 3.0 EB05 1.6 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | no trial data cached |
| Injection site rash | 5 | 3.0 1.3–7.2ROR 3.0 · χ² 5 / p 0.014 | 2.5 EB05 1.2 · IC025 -0.2 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious n=2 | no trial data cached |
| Injection site bruising | 12 | 2.8 1.6–4.9ROR 2.8 · χ² 12 / p 3e-4 | 2.6 EB05 1.6 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Dermatitis atopic | 7 | 2.6 1.2–5.4ROR 2.6 · χ² 5 / p 0.011 | 2.3 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious n=1 | 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 |
|---|---|---|---|---|---|---|
| Injection site swelling | 15 | 3.6 2.2–6.0ROR 3.7 · χ² 26 / p 2e-7 | 3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Eye swelling | 14 | 6.9 4.1–11.7ROR 7.0 · χ² 65 / p 3e-16 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Eye disorder | 13 | 7.3 4.2–12.5ROR 7.3 · χ² 64 / p 6e-16 | 6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial data cached |
| Injection site bruising | 12 | 2.8 1.6–4.9ROR 2.8 · χ² 12 / p 3e-4 | 2.6 EB05 1.6 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | no trial data cached |
| Lip swelling | 12 | 6.6 3.8–11.6ROR 6.7 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Product preparation error | 12 | 10.6 6.0–18.6ROR 10.7 · χ² 95 / p 9e-23 | 8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Nodule | 10 | 14.0 7.6–26.0ROR 14.1 · χ² 108 / p 1e-25 | 12.2 EB05 6.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial data cached |
| Blood pressure systolic increased | 9 | 8.4 4.4–16.1ROR 8.5 · χ² 52 / p 3e-13 | 6.4 EB05 3.5 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.9 | no trial data cached |
| Mass | 9 | 11.8 6.1–22.5ROR 11.8 · χ² 78 / p 5e-19 | 9.4 EB05 4.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 | no trial data cached |
| Tooth disorder | 8 | 6.6 3.3–13.1ROR 6.6 · χ² 32 / p 7e-9 | 5.0 EB05 2.7 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 | no trial data cached |
| Peripheral coldness | 8 | 10.6 5.3–21.2ROR 10.7 · χ² 60 / p 4e-15 | 8.0 EB05 3.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 | no trial data cached |
| Tenderness | 8 | 14.0 7.0–28.0ROR 14.1 · χ² 84 / p 2e-20 | 11.5 EB05 5.2 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Nerve compression | 8 | 15.9 8.0–31.7ROR 16.0 · χ² 97 / p 3e-23 | 13.6 EB05 6.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.8 | no trial data cached |
| Dermatitis atopic | 7 | 2.6 1.2–5.4ROR 2.6 · χ² 5 / p 0.011 | 2.3 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Injection site mass | 7 | 3.5 1.7–7.3ROR 3.5 · χ² 10 / p 8e-4 | 3.0 EB05 1.6 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | 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 Hyaluronic Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Hyaluronic Acid are injection site swelling, eye swelling, eye disorder, injection site bruising, lip swelling, nodule. 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 Hyaluronic Acid have an FDA boxed warning?
No. The FDA label retrieved for Hyaluronic Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hyaluronic 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 cba8f11b-3aeb-46c1-ad2a-7d2535cb1166, effective 20241015; matched on
openfda.generic_name.exact:"HYALURONIC 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, 39 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.