Drug · FAERS side-effect profile with label screen
Triamcinolone Hexacetonide side effects: what 52,547 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Triamcinolone Acetonide (Trilona)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
52,547 reports · 54% serious · 4,898 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
FDA label, Indications and Usage
What it is
DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class.
FDA label, Description section
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 29 strongest signals
Reporting / coding artifact 7Lab value / disease marker 3No label text to screen 19
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. 1 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 |
|---|---|---|---|---|---|---|
| Red blood cell sedimentation rate increased | 134 | 978.8 868.3–1,103.5ROR 2,002.5 · χ² 128,397 / p <1e-300 | 848.7 EB05 734.8 · IC025 +7.4 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Adrenal insufficiency | 142 | 960.8 858.3–1,075.5ROR 2,096.5 · χ² 133,638 / p <1e-300 | 840.8 EB05 731.0 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Obesity | 139 | 703.4 627.0–789.1ROR 1,497.1 · χ² 96,007 / p <1e-300 | 635.7 EB05 551.9 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Synovitis | 138 | 616.7 549.3–692.3ROR 1,301.9 · χ² 83,630 / p <1e-300 | 563.8 EB05 489.2 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Bone density decreased | 132 | 334.9 296.8–377.8ROR 673.9 · χ² 43,490 / p <1e-300 | 318.1 EB05 275.1 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| C-reactive protein increased | 139 | 307.1 273.9–344.3ROR 652.9 · χ² 42,008 / p <1e-300 | 293.5 EB05 254.8 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Immunodeficiency | 53 | 289.0 227.1–367.8ROR 362.0 · χ² 14,881 / p <1e-300 | 260.9 EB05 207.1 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Septic shock | 139 | 258.2 230.3–289.5ROR 548.9 · χ² 35,317 / p <1e-300 | 248.6 EB05 215.8 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Quality of life decreased | 43 | 257.0 195.4–337.9ROR 307.2 · χ² 10,681 / p <1e-300 | 230.0 EB05 177.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Gastroenteritis viral | 53 | 234.9 184.6–298.9ROR 294.3 · χ² 12,088 / p <1e-300 | 216.1 EB05 171.5 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Hypocalcaemia (low calcium) | 53 | 225.3 177.1–286.7ROR 282.2 · χ² 11,591 / p <1e-300 | 207.9 EB05 165.0 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Joint injury | 59 | 221.4 176.8–277.3ROR 285.5 · χ² 12,704 / p <1e-300 | 206.1 EB05 165.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Contraindicated product administered | 70 | 186.2 152.3–227.6ROR 253.7 · χ² 12,695 / p <1e-300 | 176.8 EB05 144.7 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Arthropathy | 123 | 176.9 155.5–201.2ROR 332.5 · χ² 21,342 / p <1e-300 | 171.8 EB05 147.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Loss of personal independence in daily activities | 95 | 160.2 136.4–188.1ROR 250.8 · χ² 14,874 / p <1e-300 | 154.9 EB05 130.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Prescribed underdose | 38 | 152.8 113.8–205.0ROR 178.5 · χ² 5,573 / p <1e-300 | 141.7 EB05 107.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Mobility decreased | 134 | 150.0 133.2–168.9ROR 306.0 · χ² 19,717 / p <1e-300 | 146.6 EB05 127.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Liver function test abnormal | 52 | 142.4 111.6–181.7ROR 177.5 · χ² 7,160 / p <1e-300 | 135.2 EB05 107.1 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Arthritis | 121 | 123.1 108.0–140.3ROR 227.9 · χ² 14,564 / p <1e-300 | 120.6 EB05 103.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Drug intolerance | 145 | 120.8 108.3–134.7ROR 269.2 · χ² 17,154 / p <1e-300 | 118.7 EB05 103.4 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Impaired quality of life | 21 | 117.0 77.6–176.3ROR 127.1 · χ² 2,298 / p <1e-300 | 105.8 EB05 73.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Therapy non-responder | 55 | 98.9 78.2–125.1ROR 124.9 · χ² 5,236 / p <1e-300 | 95.6 EB05 76.2 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Hypokalaemia (low potassium) | 53 | 92.5 72.7–117.7ROR 115.7 · χ² 4,712 / p <1e-300 | 89.5 EB05 71.1 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Psoriasis | 137 | 84.0 74.8–94.3ROR 174.9 · χ² 11,204 / p <1e-300 | 82.9 EB05 71.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Therapeutic product effect decreased | 39 | 70.4 52.7–94.0ROR 82.5 · χ² 2,602 / p <1e-300 | 68.1 EB05 52.0 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Pleural effusion | 53 | 69.7 54.8–88.7ROR 87.1 · χ² 3,527 / p <1e-300 | 68.0 EB05 54.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Underdose | 45 | 49.3 37.8–64.3ROR 59.3 · χ² 2,088 / p <1e-300 | 48.3 EB05 37.6 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Intentional product use issue | 51 | 46.4 36.3–59.4ROR 57.4 · χ² 2,230 / p <1e-300 | 45.7 EB05 36.1 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Rheumatoid arthritis | 41 | 29.0 21.9–38.5ROR 34.2 · χ² 1,087 / p 1e-238 | 28.7 EB05 22.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | 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 |
|---|---|---|---|---|---|---|
| Drug intolerance | 145 | 120.8 108.3–134.7ROR 269.2 · χ² 17,154 / p <1e-300 | 118.7 EB05 103.4 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Adrenal insufficiency | 142 | 960.8 858.3–1,075.5ROR 2,096.5 · χ² 133,638 / p <1e-300 | 840.8 EB05 731.0 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Septic shock | 139 | 258.2 230.3–289.5ROR 548.9 · χ² 35,317 / p <1e-300 | 248.6 EB05 215.8 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| C-reactive protein increased | 139 | 307.1 273.9–344.3ROR 652.9 · χ² 42,008 / p <1e-300 | 293.5 EB05 254.8 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Obesity | 139 | 703.4 627.0–789.1ROR 1,497.1 · χ² 96,007 / p <1e-300 | 635.7 EB05 551.9 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Synovitis | 138 | 616.7 549.3–692.3ROR 1,301.9 · χ² 83,630 / p <1e-300 | 563.8 EB05 489.2 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Psoriasis | 137 | 84.0 74.8–94.3ROR 174.9 · χ² 11,204 / p <1e-300 | 82.9 EB05 71.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Mobility decreased | 134 | 150.0 133.2–168.9ROR 306.0 · χ² 19,717 / p <1e-300 | 146.6 EB05 127.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Red blood cell sedimentation rate increased | 134 | 978.8 868.3–1,103.5ROR 2,002.5 · χ² 128,397 / p <1e-300 | 848.7 EB05 734.8 · IC025 +7.4 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Bone density decreased | 132 | 334.9 296.8–377.8ROR 673.9 · χ² 43,490 / p <1e-300 | 318.1 EB05 275.1 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Arthropathy | 123 | 176.9 155.5–201.2ROR 332.5 · χ² 21,342 / p <1e-300 | 171.8 EB05 147.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Arthritis | 121 | 123.1 108.0–140.3ROR 227.9 · χ² 14,564 / p <1e-300 | 120.6 EB05 103.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Loss of personal independence in daily activities | 95 | 160.2 136.4–188.1ROR 250.8 · χ² 14,874 / p <1e-300 | 154.9 EB05 130.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Contraindicated product administered | 70 | 186.2 152.3–227.6ROR 253.7 · χ² 12,695 / p <1e-300 | 176.8 EB05 144.7 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Joint injury | 59 | 221.4 176.8–277.3ROR 285.5 · χ² 12,704 / p <1e-300 | 206.1 EB05 165.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | 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 Hexacetonide?
In FDA FAERS, the most frequently co-reported reaction terms for Triamcinolone Hexacetonide are adrenal insufficiency, septic shock, c-reactive protein increased, obesity, synovitis, psoriasis. 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 Hexacetonide have an FDA boxed warning?
No. The FDA label retrieved for Triamcinolone Hexacetonide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Triamcinolone Hexacetonide 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 00cb6cd0-da04-4c87-a60c-c891666a6574, effective 20260414; matched on
openfda.generic_name:"TRIAMCINOLONE") - 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, 30 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.