65/100 · Elevated
Manufactured by Chattem, Inc.
Triamcinolone Acetonide Adverse Events: Moderate Safety Concerns
105,327 FDA adverse event reports analyzed
Last updated: 2026-05-12
TRIAMCINOLONE ACETONIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chattem, Inc.. Based on analysis of 105,327 FDA adverse event reports, TRIAMCINOLONE ACETONIDE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for TRIAMCINOLONE ACETONIDE include DRUG INEFFECTIVE, OFF LABEL USE, PRURITUS, RASH, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRIAMCINOLONE ACETONIDE.
Triamcinolone Acetonide has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 105,327 adverse event reports for this medication, which is primarily manufactured by Chattem, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Pruritus. Of classified reports, 46.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Triamcinolone Acetonide reports include a high number of serious adverse events, particularly infections and gastrointestinal issues.
The drug is frequently reported to be ineffective or used off-label, indicating potential misuse or lack of efficacy. Skin-related reactions, such as rash and pruritus, are common, suggesting a significant dermatological safety profile.
Patients taking Triamcinolone Acetonide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Triamcinolone Acetonide can cause various side effects, including infections and gastrointestinal issues. It should be used with caution, especially in patients with a history of these conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Triamcinolone Acetonide received a safety concern score of 65/100 (elevated concern). This is based on a 46.7% serious event ratio across 28,292 classified reports. The score accounts for 105,327 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 15,964, Male: 8,391, Unknown: 16. The most frequently reported age groups are age 44 (828 reports), age 40 (648 reports), age 43 (588 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,292 classified reports for TRIAMCINOLONE ACETONIDE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Triamcinolone Acetonide can cause various side effects, including infections and gastrointestinal issues. It should be used with caution, especially in patients with a history of these conditions.
If you are taking Triamcinolone Acetonide, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, pruritus, rash, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and use only as directed by a healthcare provider to minimize the risk of adverse effects. Report any unusual symptoms or side effects to your healthcare provider immediately. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of Triamcinolone Acetonide, and regulatory actions may be taken based on ongoing safety data.
The FDA has received approximately 105,327 adverse event reports associated with Triamcinolone Acetonide. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Triamcinolone Acetonide include Drug Ineffective, Off Label Use, Pruritus, Rash, Pain. By volume, the top reported reactions are: Drug Ineffective (4,954 reports), Off Label Use (2,641 reports), Pruritus (2,231 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Triamcinolone Acetonide.
Out of 28,292 classified reports, 13,219 (46.7%) were classified as serious and 15,073 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Triamcinolone Acetonide break down by patient sex as follows: Female: 15,964, Male: 8,391, Unknown: 16. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Triamcinolone Acetonide adverse events are: age 44: 828 reports, age 40: 648 reports, age 43: 588 reports, age 71: 417 reports, age 65: 386 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Triamcinolone Acetonide adverse event reports is Chattem, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Triamcinolone Acetonide include: Fatigue, Nausea, Headache, Condition Aggravated, Product Use In Unapproved Indication. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Triamcinolone Acetonide to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Triamcinolone Acetonide has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Triamcinolone Acetonide reports include a high number of serious adverse events, particularly infections and gastrointestinal issues.
Key safety signals identified in Triamcinolone Acetonide's adverse event data include: High incidence of serious adverse events (46.7%) including infections and gastrointestinal issues.. Frequent reports of drug ineffectiveness and off-label use.. Common skin-related reactions like rash and pruritus.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Triamcinolone Acetonide can cause various side effects, including infections and gastrointestinal issues. It should be used with caution, especially in patients with a history of these conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Triamcinolone Acetonide.
Follow prescribed dosages and use only as directed by a healthcare provider to minimize the risk of adverse effects. Report any unusual symptoms or side effects to your healthcare provider immediately.
Triamcinolone Acetonide has 105,327 adverse event reports on file with the FDA. The drug is frequently reported to be ineffective or used off-label, indicating potential misuse or lack of efficacy. The volume of reports for Triamcinolone Acetonide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Triamcinolone Acetonide, and regulatory actions may be taken based on ongoing safety data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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