85/100 · Critical
Manufactured by Viatris Specialty LLC
Doxazosin Mesylate Adverse Events: High Serious Reaction Rate
63,337 FDA adverse event reports analyzed
Last updated: 2026-05-12
DOXAZOSIN MESYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 63,337 FDA adverse event reports, DOXAZOSIN MESYLATE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DOXAZOSIN MESYLATE include DYSPNOEA, DIZZINESS, FATIGUE, DIARRHOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOXAZOSIN MESYLATE.
Doxazosin Mesylate has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 63,337 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Dyspnoea, Dizziness, Fatigue. Of classified reports, 82.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Doxazosin Mesylate reports predominantly serious adverse events, with a high percentage of serious reactions.
The most common reactions include dyspnea, dizziness, and fatigue, indicating potential cardiovascular and neurological effects. Reports of acute kidney injury and renal failure are concerning, suggesting potential renal toxicity. Drug interactions and falls are also frequently reported, highlighting the need for caution.
Patients taking Doxazosin Mesylate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Doxazosin Mesylate can cause hypotension and dizziness, increasing the risk of falls. It is important to monitor patients, especially the elderly, for signs of orthostatic hypotension and to avoid driving or operating machinery. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Doxazosin Mesylate received a safety concern score of 85/100 (high concern). This is based on a 82.8% serious event ratio across 34,949 classified reports. The score accounts for 63,337 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 21,376, Female: 11,002, Unknown: 61. The most frequently reported age groups are age 72 (958 reports), age 73 (895 reports), age 65 (873 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 34,949 classified reports for DOXAZOSIN MESYLATE:
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.
Doxazosin Mesylate can cause hypotension and dizziness, increasing the risk of falls. It is important to monitor patients, especially the elderly, for signs of orthostatic hypotension and to avoid driving or operating machinery.
If you are taking Doxazosin Mesylate, here are important things to know. The most commonly reported side effects include dyspnoea, dizziness, fatigue, diarrhoea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be monitored for signs of hypotension and dizziness, particularly when changing positions. Avoid driving or operating machinery until the effects of the medication are known. 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 Doxazosin Mesylate. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 63,337 adverse event reports associated with Doxazosin Mesylate. 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 Doxazosin Mesylate include Dyspnoea, Dizziness, Fatigue, Diarrhoea, Drug Ineffective. By volume, the top reported reactions are: Dyspnoea (1,937 reports), Dizziness (1,686 reports), Fatigue (1,682 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Doxazosin Mesylate.
Out of 34,949 classified reports, 28,923 (82.8%) were classified as serious and 6,026 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 Doxazosin Mesylate break down by patient sex as follows: Male: 21,376, Female: 11,002, Unknown: 61. 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 Doxazosin Mesylate adverse events are: age 72: 958 reports, age 73: 895 reports, age 65: 873 reports, age 77: 851 reports, age 75: 850 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 Doxazosin Mesylate adverse event reports is Viatris Specialty Llc. 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 Doxazosin Mesylate include: Nausea, Hypotension, Asthenia, Acute Kidney Injury, Headache. 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 Doxazosin Mesylate 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.
Doxazosin Mesylate has a safety concern score of 85 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. Doxazosin Mesylate reports predominantly serious adverse events, with a high percentage of serious reactions.
Key safety signals identified in Doxazosin Mesylate's adverse event data include: High percentage of serious reactions (82.8%). Frequent reports of acute kidney injury and renal failure. Common cardiovascular reactions such as hypotension and hypertension. Multiple reports of falls and loss of consciousness. Significant number of drug interaction reports. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Doxazosin Mesylate can cause hypotension and dizziness, increasing the risk of falls. It is important to monitor patients, especially the elderly, for signs of orthostatic hypotension and to avoid driving or operating machinery. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Doxazosin Mesylate.
Patients should be monitored for signs of hypotension and dizziness, particularly when changing positions. Avoid driving or operating machinery until the effects of the medication are known.
Doxazosin Mesylate has 63,337 adverse event reports on file with the FDA. The most common reactions include dyspnea, dizziness, and fatigue, indicating potential cardiovascular and neurological effects. The volume of reports for Doxazosin Mesylate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Doxazosin Mesylate. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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