FDA Adverse Events Reports (FAERS) Summary for TRIAMCINOLONE ACETONIDE
These tables and charts are based on 23,526 total reports for TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.
This FAERS total includes 22,904 pharmaceutical company-submitted and non-U.S. FAERS reports and 622 U.S. consumer or healthcare provider-submitted
MedWatch reports. For a separate summary of the 622 U.S. reports
filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch TRIAMCINOLONE ACETONIDE summary report.
(See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)
Top 20 Adverse Effects Associated with TRIAMCINOLONE ACETONIDE (reported in FAERS Database) Latest Known Outcomes for Reactions Reported for TRIAMCINOLONE ACETONIDE Side Effect # of FDA Reports 1 DRUG INEFFECTIVE 3700 2 OFF LABEL USE 2681 3 ITCHING 2352 4 RASH 2332 5 PAIN 2024 6 FATIGUE 1931 7 NAUSEA 1835 8 PRODUCT USE IN UNAPPROVED INDICATION 1624 9 CONDITION AGGRAVATED 1619 10 DIARRHEA 1605 11 VOMITING 1592 12 HEADACHE 1504 13 JOINT PAIN 1402 14 DIZZINESS 1326 15 FEVER 1302 16 MALAISE 1296 17 INFUSION RELATED REACTION 1287 18 JOINT INFLAMMATION 1269 19 RHEUMATOID ARTHRITIS 1249 20 HIVES 1248 Latest Known Outcome for Reported Reactions Number of Cases 1 Unknown Outcome 14844 2 Patient has not recovered/symtoms have not resolved 4933 3 Patient recovered 4368 4 Patient died 2737 5 Patient is recovering/symptoms resolving 2354 6 Patient has recovered but has consequent health issues 106
TRIAMCINOLONE ACETONIDE Total Reports
| Male | Female | Unknown | Total |
|---|---|---|---|
| 7191 | 13545 | 2790 | 23,526 |
Top Countries Reporting
| Country | Number of Reports | |
|---|---|---|
| 1 | United States | 15793 |
| 2 | Canada | 4093 |
| 3 | Japan | 370 |
| 4 | United Kingdom | 247 |
| 5 | China | 230 |
| 6 | India | 226 |
| 7 | Netherlands | 152 |
| 8 | Germany | 148 |
| 9 | Spain | 95 |
| 10 | Italy | 90 |
Outcomes for Reports
Serious: 12993
Not Serious: 10514
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
| Top Indications | |
| Product used for unknown indication | |
| Psoriasis | |
| Intervertebral disc protrusion | |
| JOINT PAIN | |
| Multiple sclerosis | |
Top Companies Reporting
| PADAGIS | |
| ENCUBE ETHICALS | |
| BRISTOL MYERS SQUIBB | |
| CHATTEM | |
| SANDOZ | |
| GLENMARK | |
| ALKEM | |
| BRISTOL-MYERS SQUIBB COMPANY | |
| QUAGEN PHARMACEUTICALS | |
FDA Approval Date: 1987-10-16 KENALOG-10 (TRIAMCINOLONE ACETONIDE) Rx Drug: KENALOG-40 (TRIAMCINOLONE ACETONIDE) Rx Drug: ZILRETTA (TRIAMCINOLONE ACETONIDE) Rx Drug: For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the
MedWatch voluntary reporting form.
This report, created by AskaPatient.com, is derived from the cases for TRIAMCINOLONE ACETONIDE reported to the United States Food and Drug Administration (FDA)
FDA Safety Information and Adverse Event Reporting System (FAERS) and
obtained from Open FDA. Data was last
updated with reports received through April 28, 2026.
Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers).
Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting)
report to the FDA directly through the MedWatch program. Those MedWatch
reports are coded and included in the FAERS database. This report mainly
consists of the mandatory reports, because the MedWatch reports are a small
percentage (3 - 5%) of total reports. Link to the MedWatch summary report at
the top of the page for a summary of the directly reported
(voluntary) adverse events for this drug.The number of reports included here might differ
somewhat from the number of reports in the downloadable quarterly FAERS
reports and in the online FAERS dashboard, due to lags in reporting, drug
name differences,
duplicates, and other factors. Open FDA states that it only includes the
most recent version of a case report. It also adds the disclaimer:
"Do not rely on openFDA to make
decisions regarding medical care. While we make every effort to ensure that
data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions or comments about this report.
Safety-Related FDA Updates
Risk of infection with various pathogens, including viral, bacterial, fungal, protozoan, or helminthic (parasitic) Safety-related Labeling Changes
Have experience (good or bad) with KENALOG-10? Rate KENALOG-10 at Ask a Patient.
Safety-related Labeling Changes
Have experience (good or bad) with KENALOG-40? Rate KENALOG-40 at Ask a Patient.
Safety-related Labeling Changes
Have experience (good or bad) with ZILRETTA? Rate ZILRETTA at Ask a Patient.
Notes
This summary includes ALL reports where the
drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority
of these reports are mandatory reports submitted by pharmaceutical
companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most
frequently occuring events in the database for a drug related to the event.
This report also features counts of latest known outcomes associated with
reported side effects, but does not provide the specific outcomes for specific
adverse events.
