82/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
High Safety Concerns with Trazodone, Particularly for Serious Adverse Events
14,235 FDA adverse event reports analyzed
Last updated: 2026-05-12
TERAZOSIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 14,235 FDA adverse event reports, TERAZOSIN has a safety score of 82 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 TERAZOSIN include DRUG INEFFECTIVE, FATIGUE, DIARRHOEA, DIZZINESS, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TERAZOSIN.
Terazosin has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 14,235 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Diarrhoea. Of classified reports, 68.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The drug is associated with a high number of serious adverse events, including death and renal failure.
Fatigue and dizziness are common, affecting a significant portion of users. There is a notable risk of falls and gastrointestinal issues.
Patients taking Terazosin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Trazodone can cause hypotension and syncope, and it may interact with other drugs, leading to adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Terazosin received a safety concern score of 82/100 (high concern). This is based on a 68.5% serious event ratio across 7,435 classified reports. The score accounts for 14,235 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: 5,875, Female: 1,047, Unknown: 10. The most frequently reported age groups are age 77 (196 reports), age 80 (191 reports), age 69 (180 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 7,435 classified reports for TERAZOSIN:
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.
Trazodone can cause hypotension and syncope, and it may interact with other drugs, leading to adverse effects.
If you are taking Terazosin, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, diarrhoea, dizziness, dyspnoea. 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. Follow prescribed dosages and do not alter the medication without consulting a healthcare professional. 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 oversight is ongoing, with the FDA requiring post-marketing studies to further evaluate safety.
The FDA has received approximately 14,235 adverse event reports associated with Terazosin. 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 Terazosin include Drug Ineffective, Fatigue, Diarrhoea, Dizziness, Dyspnoea. By volume, the top reported reactions are: Drug Ineffective (474 reports), Fatigue (466 reports), Diarrhoea (395 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Terazosin.
Out of 7,435 classified reports, 5,096 (68.5%) were classified as serious and 2,339 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 Terazosin break down by patient sex as follows: Male: 5,875, Female: 1,047, Unknown: 10. 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 Terazosin adverse events are: age 77: 196 reports, age 80: 191 reports, age 69: 180 reports, age 71: 179 reports, age 74: 174 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 Terazosin adverse event reports is Ani Pharmaceuticals, 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 Terazosin include: Asthenia, Acute Kidney Injury, Death, Chronic Kidney Disease, Renal Failure. 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 Terazosin 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.
Terazosin has a safety concern score of 82 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. The drug is associated with a high number of serious adverse events, including death and renal failure.
Key safety signals identified in Terazosin's adverse event data include: Acute kidney injury and chronic kidney disease are key safety signals.. Death and renal failure are among the most serious reported outcomes.. Drug interactions and label warnings are important considerations.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Trazodone can cause hypotension and syncope, and it may interact with other drugs, leading to adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Terazosin.
Patients should report any unusual symptoms to their healthcare provider immediately. Follow prescribed dosages and do not alter the medication without consulting a healthcare professional.
Terazosin has 14,235 adverse event reports on file with the FDA. Fatigue and dizziness are common, affecting a significant portion of users. The volume of reports for Terazosin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA requiring post-marketing studies to further evaluate safety. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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