Sold as Zilretta, Oralone, Aller-Cort, AllerNaze, Hexatrione and 7 more.
Class: Corticosteroids for local oral treatment; Corticosteroids; Corticosteroids, moderately potent (group II); Glucocorticoids; Corticosteroids; Glucocorticoids; Corticosteroids, plain.
First FDA approval 12/03/1957: 69 years on the US market.
This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
B
Score breakdown (85/100)
Safety ×35%
A
Evidence ×25%
C
Regulatory ×15%
B
Money & lawsuits ×15%
B
Options ×10%
A
Safety: 95
2,701 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site
Death share in reports is near or below the FAERS average (0.9x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 65
563 randomized trials and 48 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Only 38% of completed registered trials posted results (-8)
'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)
Regulatory history: 86
Recalls since 2016: 0 Class I, 4 Class II, 0 Class III across 104 generic makers (-6)
7 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 85
Pharma paid doctors $479,206 tied to this drug last year (-15)
Not named in any pending federal MDL
Options: 100
Generic versions approved (104 applications)
39 same-class alternatives exist
What the FDA label says
Approved uses
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Contraindications
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Warnings and precautions
Not available.
Adverse reactions (label)
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Source: FDA SPL label for Triamcinolone Acetonide (Proficient Rx LP), effective 20231201.
Full label on DailyMed.
Side-effect reports sent to the FDA
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
63,122reports that mention this drug
63,025of those blame this drug, not another one the person was taking
49%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
7.7%of reports include a death, from any cause (average for all drugs: 9.1%)
Problems reported most often
Drug Ineffective · 10,320Off Label Use · 5,296Rash · 4,716Pruritus · 4,559Fatigue · 3,958Pain · 3,927Nausea · 3,920Diarrhoea · 3,499Headache · 3,258Product Use In Unapproved Indication · 3,207Arthralgia · 3,083Condition Aggravated · 2,948Vomiting · 2,821Dizziness · 2,737Psoriasis · 2,703
Reports per year
2019
2020
2021
2022
2023
2024
2025
2026
4,636
4,820
4,809
5,264
7,975
7,118
7,117
3,754
2,701 reports blaming this drug for every million Medicare prescriptions filled, which is 1.0× the typical drug on this site. (17,951 reports in 2024–2026, against 6,647,245 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Recalls and regulatory record
5recall actions on file
21 / 104brand / generic applications
7label changes since 2021
NoREMS program
Date
Class
Firm
Reason
09/2023
Class II
Eugia US LLC
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
08/2022
Class II
Padagis US LLC
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
04/2022
Class II
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
03/2021
Class II
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
01/2014
Class III
Fougera Pharmaceuticals Inc.
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Evidence base
563randomized trials (PubMed)
48systematic reviews
1,155registered trials
38%of completed trials posted results
13%terminated or withdrawn
20%industry-funded
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
Money and lawsuits
In 2024, drug companies reported $479,206 in payments to US physicians and hospitals tied to this drug across 1,557 transactions (Zilretta $303,184, Xipere $175,710, Triesence $313).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
Who takes it and what it costs
3,906,562Medicare Part D patients (2024)
6,647,245prescriptions filled
$10average cost per fill
$70Mtotal Medicare spend
Product
Fills
$/fill
Triamcinolone Acetonide
6,643,424
$10
Zilretta
2,092
$927
Kenalog-40
867
$21
Kenalog-80
492
$33
Kenalog-10
284
$23
Oralone
86
$40
Same-class alternatives
1 drug in the same class grades a letter or more higher than triamcinolone on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.
Questions to ask your prescriber
The most-reported problems in FDA's adverse event data are rash, pruritus. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
Why this one over alclometasone, beclomethasone, betamethasone? What would make you pick one of those instead?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)