Drug · FAERS side-effect profile with label screen
Triamcinolone Acetonide side effects: what 30,695 FDA adverse event reports show
Who reports
30,695 reports · 46% serious · 3,066 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic co.
FDA label, Indications and Usage
What it is
DESCRIPTION Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION.
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 40 strongest signals
Labeled (related wording) 4Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 25
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,162 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 154 | 700.0 558.7–876.9ROR 703.5 · calibrated p 3e-15 ✓ | 329.5 EB05 288.1 · IC025 +7.1 3/3 methods agree vs other Corticosteroids: PRR 6.3 (5.4–7.4) | Not in label — unassessed | serious n=154 · ♀ 100% (drug 66%) | not reported in cached trials |
| Hepatic enzyme | 64 | 581.8 416.4–812.8ROR 583.0 · calibrated p 5e-14 ✓ | 285.8 EB05 231.7 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 27.4 (20.6–36.5) | Not in label — unassessed | serious n=64 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Human antichimeric antibody positive | 139 | 477.1 384.0–592.7ROR 479.2 · calibrated p 2e-13 ✓ | 269.2 EB05 233.7 · IC025 +6.8 3/3 methods agree vs other Corticosteroids: only this drug | Lab value / disease marker | serious n=139 · ♀ 100% (drug 66%) | not reported in cached trials |
| Mastitis bacterial | 26 | 460.3 279.5–757.9ROR 460.7 · calibrated p 3e-12 ✓ | 228.0 EB05 163.5 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=26 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Hypocholesterolaemia | 96 | 310.5 243.8–395.3ROR 311.4 · calibrated p 1e-11 ✓ | 204.1 EB05 172.1 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 10.3 (8.3–12.7) | Not in label — unassessed | serious n=95 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 202 | 297.3 252.1–350.8ROR 299.3 · calibrated p 1e-11 ✓ | 202.6 EB05 180.2 · IC025 +6.9 3/3 methods agree vs other Corticosteroids: PRR 3.5 (3.0–4.0) | Lab value / disease marker | serious n=202 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Pseudoendophthalmitis | 27 | 252.3 162.1–392.5ROR 252.5 · calibrated p 3e-10 ✓ | 162.8 EB05 117.5 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Swollen joint count | 65 | 245.6 184.9–326.3ROR 246.2 · calibrated p 1e-10 ✓ | 171.2 EB05 139.0 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 5.2 (4.1–6.7) | Not in label — unassessed | serious n=65 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 26 | 239.6 153.2–374.8ROR 239.8 · calibrated p 5e-10 ✓ | 156.8 EB05 112.4 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 83.6 (48.0–145.6) | Likely indication confounding shares a disease stem with the indications wording | serious n=26 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 229 | 231.0 198.8–268.3ROR 232.7 · calibrated p 1e-10 ✓ | 169.8 EB05 152.1 · IC025 +6.8 3/3 methods agree vs other Corticosteroids: PRR 2.9 (2.6–3.3) | Lab value / disease marker | serious n=229 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Infective scleritis | 23 | 230.9 143.8–370.8ROR 231.1 · calibrated p 9e-10 ✓ | 150.8 EB05 105.9 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 734 | 207.6 191.3–225.4ROR 212.7 · calibrated p 2e-10 ✓ | 158.3 EB05 148.9 · IC025 +7.0 3/3 methods agree vs other Corticosteroids: PRR 3.2 (3.0–3.4) | Not in label — unassessed | serious n=734 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Tender joint count | 19 | 196.6 118.0–327.8ROR 196.8 · calibrated p 4e-9 ✓ | 132.4 EB05 89.6 · IC025 +4.2 3/3 methods agree vs other Corticosteroids: PRR 122.2 (59.3–251.7) | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Lupus vulgaris | 260 | 191.1 166.6–219.3ROR 192.8 · calibrated p 6e-10 ✓ | 147.5 EB05 133.0 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 2.6 (2.3–2.9) | Not in label — unassessed | serious n=260 · ♀ 100% (drug 66%) · 94% clinician | not reported in cached trials |
| Orbital infection | 19 | 188.0 113.0–312.5ROR 188.1 · calibrated p 6e-9 ✓ | 128.4 EB05 86.9 · IC025 +4.2 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Body height below normal | 136 | 180.8 149.7–218.4ROR 181.6 · calibrated p 1e-9 ✓ | 139.9 EB05 121.3 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: only this drug | Reporting / coding artifact | serious n=136 · ♀ 100% (drug 66%) | not reported in cached trials |
| Pseudomeningocele | 31 | 165.5 111.7–245.1ROR 165.7 · calibrated p 7e-9 ✓ | 123.1 EB05 90.9 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=31 · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 365 | 156.3 139.5–175.0ROR 158.2 · calibrated p 3e-9 ✓ | 126.2 EB05 115.7 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 2.1 (1.9–2.3) | Not in label — unassessed | serious n=365 · ♀ 100% (drug 66%) · 94% clinician | not reported in cached trials |
| Necrotising scleritis | 26 | 149.5 97.7–228.6ROR 149.6 · calibrated p 2e-8 ✓ | 112.6 EB05 80.7 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: PRR 200.7 (96.8–416.1) | Not in label — unassessed | serious n=26 · 100% clinician | not reported in cached trials |
| Rheumatic fever | 776 | 147.6 136.7–159.4ROR 151.4 · calibrated p 4e-9 ✓ | 120.9 EB05 113.9 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 2.2 (2.1–2.4) | Likely indication confounding shares a disease stem with the indications wording | serious n=776 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Swollen joint count increased | 539 | 142.8 130.2–156.5ROR 145.3 · calibrated p 6e-9 ✓ | 117.5 EB05 109.4 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 2.2 (2.0–2.4) | Lab value / disease marker | serious n=539 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Retinitis | 277 | 135.9 119.5–154.6ROR 137.1 · calibrated p 1e-8 ✓ | 112.4 EB05 101.7 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 3.2 (2.8–3.6) | Not in label — unassessed | serious n=277 · ♀ 100% (drug 66%) · 95% clinician | not reported in cached trials |
| Non-infectious endophthalmitis | 125 | 117.6 97.3–142.2ROR 118.1 · calibrated p 4e-8 ✓ | 98.8 EB05 85.1 · IC025 +5.9 3/3 methods agree vs other Corticosteroids: PRR 877.2 (473.6–1,624.5) | Not in label — unassessed | serious n=61 · ♀ 44% (drug 66%) · 100% clinician | not reported in cached trials |
| Short stature | 38 | 116.2 82.4–163.9ROR 116.3 · calibrated p 8e-8 ✓ | 94.6 EB05 72.0 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=38 · ♀ 100% (drug 66%) | not reported in cached trials |
| Bone density increased | 58 | 115.8 87.6–152.9ROR 116.0 · calibrated p 6e-8 ✓ | 95.9 EB05 76.9 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: only this drug | Lab value / disease marker | serious n=58 · ♀ 100% (drug 66%) | not reported in cached trials |
| Ankle arthroplasty | 49 | 108.1 79.9–146.1ROR 108.2 · calibrated p 1e-7 ✓ | 90.1 EB05 70.8 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 68.8 (46.8–101.0) | Not in label — unassessed | serious n=49 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 275 | 107.9 95.0–122.5ROR 108.8 · calibrated p 7e-8 ✓ | 92.5 EB05 83.7 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 2.1 (1.8–2.3) | Not in label — unassessed | serious n=275 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 74 | 107.3 84.0–137.1ROR 107.5 · calibrated p 1e-7 ✓ | 90.6 EB05 74.5 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.2–3.6) | Labeled (related wording) related wording | serious n=74 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Peripheral venous disease | 539 | 106.5 97.4–116.6ROR 108.4 · calibrated p 6e-8 ✓ | 91.8 EB05 85.5 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 3.0 (2.7–3.3) | Not in label — unassessed | serious n=539 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Joint destruction | 203 | 101.8 87.9–118.0ROR 102.5 · calibrated p 1e-7 ✓ | 87.9 EB05 78.2 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 70.0 (57.9–84.5) | Not in label — unassessed | serious n=203 · ♀ 100% (drug 66%) · 94% clinician | not reported in cached trials |
| Seronegative arthritis | 145 | 101.3 85.1–120.6ROR 101.8 · calibrated p 1e-7 ✓ | 87.2 EB05 75.9 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 5.0 (4.2–5.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=145 · ♀ 100% (drug 66%) · 93% clinician | not reported in cached trials |
| Rhegmatogenous retinal detachment | 27 | 100.3 67.0–150.3ROR 100.4 · calibrated p 3e-7 ✓ | 82.5 EB05 59.6 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: PRR 160.3 (82.7–310.7) | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Dislocation of vertebra | 285 | 100.3 88.6–113.6ROR 101.3 · calibrated p 1e-7 ✓ | 86.9 EB05 78.8 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 2.1 (1.9–2.4) | Not in label — unassessed | serious n=285 · ♀ 100% (drug 66%) · 93% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 927 | 98.7 92.2–105.6ROR 101.7 · calibrated p 1e-7 ✓ | 86.0 EB05 81.5 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 2.0 (1.9–2.1) | Labeled (related wording) related wording | serious PRR 107.4 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Conjunctival ulcer | 17 | 96.9 58.3–161.1ROR 97.0 · calibrated p 7e-7 ✓ | 77.7 EB05 51.4 · IC025 +3.8 3/3 methods agree vs other Corticosteroids: PRR 77.2 (39.4–151.2) | Labeled (related wording) related wording | serious n=16 | not reported in cached trials |
| Rheumatoid factor positive | 707 | 95.3 88.2–103.1ROR 97.6 · calibrated p 1e-7 ✓ | 83.5 EB05 78.4 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 2.1 (1.9–2.2) | Lab value / disease marker | serious n=707 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Hypothalamic pituitary adrenal axis suppression | 43 | 94.2 68.5–129.6ROR 94.4 · calibrated p 3e-7 ✓ | 79.9 EB05 61.8 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: only this drug | Labeled (related wording) related wording | serious n=40 · 100% clinician | not reported in cached trials |
| X-ray abnormal | 212 | 92.0 79.7–106.2ROR 92.6 · calibrated p 2e-7 ✓ | 80.5 EB05 71.8 · IC025 +5.9 3/3 methods agree vs other Corticosteroids: PRR 2.0 (1.7–2.3) | Lab value / disease marker | serious n=212 · ♀ 100% (drug 66%) · 95% clinician | not reported in cached trials |
| Eye infection toxoplasmal | 47 | 90.9 67.0–123.2ROR 91.0 · calibrated p 4e-7 ✓ | 77.7 EB05 60.8 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: PRR 453.5 (214.3–959.6) | Not in label — unassessed | serious n=47 · 100% clinician | not reported in cached trials |
| Chorioretinal disorder | 22 | 89.2 57.2–139.1ROR 89.2 · calibrated p 9e-7 ✓ | 74.0 EB05 51.5 · IC025 +4.1 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=22 · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Triamcinolone Acetonide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00367133 — Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema (N=840, PHASE3; 189 AE terms posted; arms: Focal/Grid Laser Photocoagulation; 1mg Intravitreal Triamcinolone; 4 mg Intravitreal Triamcinolone)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 ineffective (drug did not work) | 5,246 | 2.7 2.7–2.8ROR 3.1 · calibrated p 0.600 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.6–1.7) | Reporting / coding artifact | serious PRR 4.5 | not reported in cached trials |
| Off label use (used outside approved label) | 2,892 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.851 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 0.8 (0.8–0.9) | Reporting / coding artifact | serious PRR 4.3 | not reported in cached trials |
| Pruritus (itching) | 2,630 | 4.8 4.6–5.0ROR 5.1 · calibrated p 0.221 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Corticosteroids: PRR 2.6 (2.5–2.7) | Not in label — unassessed | serious PRR 5.3 | NCT00367133: 11/254 (4.3%) on Triamcinolone Acetonide |
| Rash | 2,516 | 4.0 3.8–4.1ROR 4.2 · calibrated p 0.335 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.6–1.7) | Labeled adverse reaction exact term | serious PRR 6.6 | not reported in cached trials |
| Pain | 2,186 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.796 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.2–1.3) | Not in label — unassessed | serious PRR 3.8 | NCT00367133: 2/254 (0.8%) on Triamcinolone Acetonide (serious AE) |
| Fatigue (tiredness) | 2,115 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.902 | 1.9 EB05 1.8 · IC025 +0.8 vs other Corticosteroids: PRR 1.0 (0.9–1.0) | Not in label — unassessed | serious PRR 3.4 | not reported in cached trials |
| Nausea | 2,033 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.839 | 1.8 EB05 1.7 · IC025 +0.7 vs other Corticosteroids: PRR 1.2 (1.1–1.2) | Labeled adverse reaction exact term | serious PRR 3.4 | not reported in cached trials |
| Headache | 1,885 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.988 | 2.1 EB05 2.0 · IC025 +1.0 vs other Corticosteroids: PRR 1.3 (1.2–1.3) | Labeled adverse reaction exact term | serious PRR 3.5 · ♀ 86% (drug 66%) | NCT00367133: 1/254 (0.4%) on Triamcinolone Acetonide (serious AE) |
| Condition aggravated | 1,740 | 4.0 3.8–4.1ROR 4.1 · calibrated p 0.355 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.1) | Reporting / coding artifact | serious PRR 5.4 | not reported in cached trials |
| Product use in unapproved indication | 1,727 | 4.9 4.6–5.1ROR 5.1 · calibrated p 0.226 | 4.8 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Corticosteroids: PRR 1.8 (1.7–1.9) | Reporting / coding artifact | serious PRR 8.4 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,722 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.876 | 1.8 EB05 1.8 · IC025 +0.8 vs other Corticosteroids: PRR 1.0 (1.0–1.1) | Labeled adverse reaction exact term | serious PRR 3.1 | NCT00367133: 1/256 (0.4%) on Triamcinolone Acetonide (serious AE) |
| Vomiting | 1,703 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.783 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.3–1.4) | Not in label — unassessed | serious PRR 4.2 · ♀ 93% (drug 66%) | not reported in cached trials |
| Dizziness | 1,590 | 2.2 2.1–2.3ROR 2.2 · calibrated p 0.928 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.5–1.7) | Not in label — unassessed | serious PRR 3.7 | NCT00367133: 1/256 (0.4%) on Triamcinolone Acetonide (serious AE) |
| Arthralgia (joint pain) | 1,542 | 2.5 2.4–2.7ROR 2.6 · calibrated p 0.760 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Corticosteroids: PRR 1.0 (1.0–1.1) | Not in label — unassessed | serious PRR 4.5 | not reported in cached trials |
| Malaise (feeling unwell) | 1,426 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.913 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 1.2 (1.1–1.3) | Labeled adverse reaction exact term | serious PRR 4.0 · ♀ 93% (drug 66%) | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Vaginal flatulence — n=154, PRR 700.0
- Hepatic enzyme — n=64, PRR 581.8
- Mastitis bacterial — n=26, PRR 460.3
- Hypocholesterolaemia — n=96, PRR 310.5
- Pseudoendophthalmitis — n=27, PRR 252.3
- Swollen joint count — n=65, PRR 245.6
- Infective scleritis — n=23, PRR 230.9
- Facet joint syndrome — n=734, PRR 207.6
- Lupus vulgaris — n=260, PRR 191.1
- Pseudomeningocele — n=31, PRR 165.5
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 pruritus, rash, pain, fatigue, nausea, headache. 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 05c2a9cf-a018-48c0-9c73-2d59d52211d2, effective 20251103; matched on
openfda.generic_name.exact:"TRIAMCINOLONE ACETONIDE") - 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, 1,202 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 - ClinicalTrials.gov API v2 (query
TRIAMCINOLONE ACETONIDE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.