65/100 · Elevated
Manufactured by Actavis Pharma, Inc.
Triamterene and Hydrochlorothiazide Adverse Events: Moderate Safety Concerns
11,979 FDA adverse event reports analyzed
Last updated: 2026-05-12
TRIAMTERENE AND HYDROCHLOROTHIAZIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Actavis Pharma, Inc.. Based on analysis of 11,979 FDA adverse event reports, TRIAMTERENE AND HYDROCHLOROTHIAZIDE 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 TRIAMTERENE AND HYDROCHLOROTHIAZIDE include DRUG INEFFECTIVE, NAUSEA, FATIGUE, PAIN, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRIAMTERENE AND HYDROCHLOROTHIAZIDE.
Triamterene And Hydrochlorothiazide 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 11,979 adverse event reports for this medication, which is primarily manufactured by Actavis Pharma, Inc..
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 54.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea, fatigue, and pain are the most frequently reported adverse events.
Serious adverse events, such as renal failure and pneumonia, account for nearly 54.4% of all reports. The majority of reports are from older adults, with the highest number of reports from those aged 61-78. Drug ineffectiveness and off-label use are also reported, indicating potential misuse or inefficacy issues.
Patients taking Triamterene And Hydrochlorothiazide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other diuretics and potassium-sparing agents are a known risk, and patients should be monitored for electrolyte imbalances and blood pressure changes. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Triamterene And Hydrochlorothiazide received a safety concern score of 65/100 (elevated concern). This is based on a 54.4% serious event ratio across 6,033 classified reports. The score accounts for 11,979 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: 4,191, Male: 1,556, Unknown: 4. The most frequently reported age groups are age 61 (121 reports), age 64 (116 reports), age 68 (112 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 6,033 classified reports for TRIAMTERENE AND HYDROCHLOROTHIAZIDE:
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.
Interactions with other diuretics and potassium-sparing agents are a known risk, and patients should be monitored for electrolyte imbalances and blood pressure changes.
If you are taking Triamterene And Hydrochlorothiazide, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, pain, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any unusual symptoms to their healthcare provider immediately. Regular monitoring of blood pressure, electrolyte levels, and kidney function is recommended. 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 this drug, and healthcare providers should be vigilant in managing patient symptoms and monitoring for serious adverse events.
The FDA has received approximately 11,979 adverse event reports associated with Triamterene And Hydrochlorothiazide. 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 Triamterene And Hydrochlorothiazide include Drug Ineffective, Nausea, Fatigue, Pain, Dizziness. By volume, the top reported reactions are: Drug Ineffective (407 reports), Nausea (404 reports), Fatigue (396 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Triamterene And Hydrochlorothiazide.
Out of 6,033 classified reports, 3,282 (54.4%) were classified as serious and 2,751 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 Triamterene And Hydrochlorothiazide break down by patient sex as follows: Female: 4,191, Male: 1,556, Unknown: 4. 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 Triamterene And Hydrochlorothiazide adverse events are: age 61: 121 reports, age 64: 116 reports, age 68: 112 reports, age 63: 111 reports, age 67: 109 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 Triamterene And Hydrochlorothiazide adverse event reports is Actavis Pharma, 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 Triamterene And Hydrochlorothiazide include: Diarrhoea, Dyspnoea, Headache, Asthenia, Arthralgia. 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 Triamterene And Hydrochlorothiazide 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.
Triamterene And Hydrochlorothiazide 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. Nausea, fatigue, and pain are the most frequently reported adverse events.
Key safety signals identified in Triamterene And Hydrochlorothiazide's adverse event data include: Renal failure and pneumonia are among the most serious adverse events.. Pain and dizziness are common, suggesting potential side effects that could impact quality of life.. A significant number of reports involve cardiovascular issues, including atrial fibrillation and congestive heart failure.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other diuretics and potassium-sparing agents are a known risk, and patients should be monitored for electrolyte imbalances and blood pressure changes. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Triamterene And Hydrochlorothiazide.
Patients should report any unusual symptoms to their healthcare provider immediately. Regular monitoring of blood pressure, electrolyte levels, and kidney function is recommended.
Triamterene And Hydrochlorothiazide has 11,979 adverse event reports on file with the FDA. Serious adverse events, such as renal failure and pneumonia, account for nearly 54.4% of all reports. The volume of reports for Triamterene And Hydrochlorothiazide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of this drug, and healthcare providers should be vigilant in managing patient symptoms and monitoring for serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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