Triamcinolone Acetonide… side effects: what 859 FDA adverse event reports show
Drug class
Extended-release synthetic corticosteroid
Label matched
Triamcinolone Acetonide Extended-Release Injectable Suspension (Zilretta)
Who reports
859 reports · 20% serious · 10 with death outcome · 66% female
Used for
ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. ZILRETTA is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.
What it is
ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is a microsphere formulation of triamcinolone acetonide, a corticosteroid, to be administered by intra-articular injection.
Boxed warning
None in the current label
Causality screen of the 8 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
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 |
|---|---|---|---|---|---|---|
| Therapeutic response shortened | 44 | 33.8 25.3–45.1ROR 35.6 · χ² 1,368 / p 1e-299 | 33.3 EB05 25.8 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 84% consumer | no trial data cached |
| Joint stiffness | 13 | 12.1 7.1–20.8ROR 12.3 · χ² 122 / p 1e-28 | 10.6 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| Ocular discomfort | 5 | 11.2 4.7–26.9ROR 11.3 · χ² 37 / p 6e-10 | 7.2 EB05 2.9 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Product use complaint | 7 | 11.0 5.3–23.1ROR 11.1 · χ² 54 / p 9e-14 | 8.0 EB05 3.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| No adverse event | 78 | 10.7 8.7–13.3ROR 11.7 · χ² 685 / p 3e-151 | 10.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 92% clinician | no trial data cached |
| Joint swelling | 47 | 9.5 7.2–12.6ROR 10.0 · χ² 352 / p 7e-79 | 9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.9 | no trial data cached |
| Drug effect less than expected | 5 | 8.7 3.6–20.8ROR 8.7 · χ² 27 / p 1e-7 | 5.5 EB05 2.4 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Expired product administered | 8 | 5.9 3.0–11.7ROR 5.9 · χ² 28 / p 7e-8 | 4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | – | 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 |
|---|---|---|---|---|---|---|
| No adverse event | 78 | 10.7 8.7–13.3ROR 11.7 · χ² 685 / p 3e-151 | 10.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 92% clinician | no trial data cached |
| Joint swelling | 47 | 9.5 7.2–12.6ROR 10.0 · χ² 352 / p 7e-79 | 9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.9 | no trial data cached |
| Therapeutic response shortened | 44 | 33.8 25.3–45.1ROR 35.6 · χ² 1,368 / p 1e-299 | 33.3 EB05 25.8 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 84% consumer | no trial data cached |
| Joint stiffness | 13 | 12.1 7.1–20.8ROR 12.3 · χ² 122 / p 1e-28 | 10.6 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| Expired product administered | 8 | 5.9 3.0–11.7ROR 5.9 · χ² 28 / p 7e-8 | 4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product use complaint | 7 | 11.0 5.3–23.1ROR 11.1 · χ² 54 / p 9e-14 | 8.0 EB05 3.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Drug effect less than expected | 5 | 8.7 3.6–20.8ROR 8.7 · χ² 27 / p 1e-7 | 5.5 EB05 2.4 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Ocular discomfort | 5 | 11.2 4.7–26.9ROR 11.3 · χ² 37 / p 6e-10 | 7.2 EB05 2.9 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Synovitis | 3 | 4.1 1.3–12.6ROR 4.1 · χ² 4 / p 0.020 | 2.8 EB05 1.1 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Affect lability | 3 | 7.6 2.4–23.4ROR 7.6 · χ² 11 / p 4e-4 | 4.1 EB05 1.6 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 19.9 | no trial data cached |
| Blood thyroid stimulating hormone increased | 3 | 7.9 2.6–24.6ROR 8.0 · χ² 12 / p 3e-4 | 4.3 EB05 1.6 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Lab value / disease marker | serious n=3 | 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 Triamcinolone Acetonide…?
In FDA FAERS, the most frequently co-reported reaction terms for Triamcinolone Acetonide… are joint swelling, joint stiffness, ocular discomfort, synovitis, affect lability, blood thyroid stimulating hormone increased. 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 Triamcinolone Acetonide… have an FDA boxed warning?
No. The FDA label retrieved for Triamcinolone Acetonide… has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Triamcinolone Acetonide… 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 cd5c4673-21f2-4126-9556-da847b3a228b, effective 20260603; matched on
openfda.generic_name.exact:"TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION") - 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, 11 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.