TRIAMTERENE

78/100 · Elevated

Manufactured by Advanz Pharma (US) Corp.

High Serious Event Rate for Triamterene

Last updated: 2026-05-12

About TRIAMTERENE

TRIAMTERENE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advanz Pharma (US) Corp.. Based on analysis of FDA adverse event reports, TRIAMTERENE has a safety score of 78 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRIAMTERENE.

AI Safety Analysis

Triamterene has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately N/A adverse event reports for this medication, which is primarily manufactured by Advanz Pharma (Us) Corp..

Of classified reports, 55.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. 55.3% of reports are serious, indicating a high risk of severe adverse events.

The majority of reports are from older adults, suggesting potential age-related risks. A diverse range of adverse events are reported, indicating a complex safety profile.

Patients taking Triamterene should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Triamterene may interact with other potassium-sparing diuretics, and caution is advised in patients with renal impairment or hyperkalemia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 78/100

Triamterene received a safety concern score of 78/100 (high concern). This is based on a 55.3% serious event ratio across 7,118 classified reports. The score accounts for N/A total adverse event reports and 0 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.

Key Safety Signals

  • High serious event rate (55.3%)
  • Age distribution skewed towards older adults (60+ years)
  • Diverse range of adverse events reported

Patient Demographics

The most frequently reported age groups are age 64 (181 reports), age 67 (149 reports), age 69 (149 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 7,118 classified reports for TRIAMTERENE:

  • Serious: 3,934 reports (55.3%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 3,184 reports (44.7%)
Serious 55.3%Non-Serious 44.7%

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 Breakdown

Reports by Age

Age 64181 reports
Age 67149 reports
Age 69149 reports
Age 63148 reports
Age 62143 reports
Age 72142 reports
Age 66139 reports
Age 71136 reports
Age 65135 reports
Age 61134 reports
Age 75124 reports
Age 74118 reports
Age 70116 reports
Age 60115 reports
Age 79114 reports
Age 73113 reports
Age 76113 reports
Age 68108 reports
Age 58104 reports
Age 59104 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Triamterene may interact with other potassium-sparing diuretics, and caution is advised in patients with renal impairment or hyperkalemia.

What You Should Know

If you are taking Triamterene, here are important things to know. Monitor patients closely, especially older adults and those with renal impairment or hyperkalemia. Be aware of potential drug interactions, particularly with other potassium-sparing diuretics. 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.

Regulatory Context

The FDA continues to monitor the safety of Triamterene and may require additional safety studies or label changes based on ongoing data.

Frequently Asked Questions

How many adverse event reports has the FDA received for Triamterene?

The FDA has received approximately N/A adverse event reports associated with Triamterene. 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.

What percentage of Triamterene adverse event reports are serious?

Out of 7,118 classified reports, 3,934 (55.3%) were classified as serious and 3,184 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.

What age groups report the most side effects for Triamterene?

The most frequently reported age groups for Triamterene adverse events are: age 64: 181 reports, age 67: 149 reports, age 69: 149 reports, age 63: 148 reports, age 62: 143 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Triamterene?

The primary manufacturer associated with Triamterene adverse event reports is Advanz Pharma (Us) Corp.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

How do I report a side effect from Triamterene?

You can report adverse events from Triamterene 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.

What is Triamterene's safety score and what does it mean?

Triamterene has a safety concern score of 78 out of 100 (high 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. 55.3% of reports are serious, indicating a high risk of severe adverse events.

What are the key safety signals for Triamterene?

Key safety signals identified in Triamterene's adverse event data include: High serious event rate (55.3%). Age distribution skewed towards older adults (60+ years). Diverse range of adverse events reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Triamterene interact with other drugs?

Triamterene may interact with other potassium-sparing diuretics, and caution is advised in patients with renal impairment or hyperkalemia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Triamterene.

What should patients know before taking Triamterene?

Monitor patients closely, especially older adults and those with renal impairment or hyperkalemia. Be aware of potential drug interactions, particularly with other potassium-sparing diuretics.

Are Triamterene side effects well-documented?

Triamterene has N/A adverse event reports on file with the FDA. The majority of reports are from older adults, suggesting potential age-related risks. The volume of reports for Triamterene reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Triamterene?

The FDA continues to monitor the safety of Triamterene and may require additional safety studies or label changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

Related Drugs

Drugs related to TRIAMTERENE based on therapeutic use, drug class, or shared indications:

SpironolactoneAmilorideTriamterene-HydrochlorothiazideAldactoneDyazide
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.