75/100 · Elevated
Manufactured by Jubilant Cadista Pharmacuticals Inc.
High Fatigue and Dyspnoea Reports for Trazodone Hydrochloride
16,956 FDA adverse event reports analyzed
Last updated: 2026-05-12
TERAZOSIN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Jubilant Cadista Pharmacuticals Inc.. Based on analysis of 16,956 FDA adverse event reports, TERAZOSIN HYDROCHLORIDE has a safety score of 75 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 HYDROCHLORIDE include DRUG INEFFECTIVE, FATIGUE, DYSPNOEA, DIARRHOEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TERAZOSIN HYDROCHLORIDE.
Terazosin Hydrochloride has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 16,956 adverse event reports for this medication, which is primarily manufactured by Jubilant Cadista Pharmacuticals Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Dyspnoea. Of classified reports, 69.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and dyspnoea are the most common adverse reactions reported.
Serious adverse events, such as death and acute kidney injury, are concerning. Drug interactions and falls are also frequently reported. Chronic kidney disease and renal failure are significant concerns.
Patients taking Terazosin Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Trazodone hydrochloride can cause hypotension and syncope, which may lead to falls. It is important to monitor blood pressure and be cautious when initiating or adjusting the dose. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Terazosin Hydrochloride received a safety concern score of 75/100 (elevated concern). This is based on a 69.2% serious event ratio across 8,665 classified reports. The score accounts for 16,956 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: Male: 6,839, Female: 1,225, Unknown: 10. The most frequently reported age groups are age 77 (223 reports), age 69 (221 reports), age 80 (218 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 8,665 classified reports for TERAZOSIN HYDROCHLORIDE:
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 hydrochloride can cause hypotension and syncope, which may lead to falls. It is important to monitor blood pressure and be cautious when initiating or adjusting the dose.
If you are taking Terazosin Hydrochloride, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, dyspnoea, diarrhoea, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of hypotension and syncope, especially in elderly patients. Be cautious when adjusting the dose and monitor for any changes in kidney function. 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 has not issued any specific warnings for Trazodone hydrochloride based on this data, but patients should be aware of the potential for serious adverse events and report any unusual symptoms to their healthcare provider.
The FDA has received approximately 16,956 adverse event reports associated with Terazosin Hydrochloride. 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 Hydrochloride include Drug Ineffective, Fatigue, Dyspnoea, Diarrhoea, Dizziness. By volume, the top reported reactions are: Drug Ineffective (536 reports), Fatigue (531 reports), Dyspnoea (489 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 Hydrochloride.
Out of 8,665 classified reports, 5,992 (69.2%) were classified as serious and 2,673 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 Hydrochloride break down by patient sex as follows: Male: 6,839, Female: 1,225, 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 Hydrochloride adverse events are: age 77: 223 reports, age 69: 221 reports, age 80: 218 reports, age 67: 211 reports, age 71: 211 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 Hydrochloride adverse event reports is Jubilant Cadista Pharmacuticals 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 Hydrochloride include: Asthenia, Death, Acute Kidney Injury, Off Label Use, Fall. 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 Hydrochloride 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 Hydrochloride has a safety concern score of 75 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. Fatigue and dyspnoea are the most common adverse reactions reported.
Key safety signals identified in Terazosin Hydrochloride's adverse event data include: Frequent reports of fatigue and dyspnoea. High number of serious adverse events including death and acute kidney injury. Common drug interactions and falls. Significant reports of chronic kidney disease and renal failure. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Trazodone hydrochloride can cause hypotension and syncope, which may lead to falls. It is important to monitor blood pressure and be cautious when initiating or adjusting the dose. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Terazosin Hydrochloride.
Monitor for signs of hypotension and syncope, especially in elderly patients. Be cautious when adjusting the dose and monitor for any changes in kidney function.
Terazosin Hydrochloride has 16,956 adverse event reports on file with the FDA. Serious adverse events, such as death and acute kidney injury, are concerning. The volume of reports for Terazosin Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued any specific warnings for Trazodone hydrochloride based on this data, but patients should be aware of the potential for serious adverse events and report any unusual symptoms to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with TERAZOSIN HYDROCHLORIDE:
Drugs related to TERAZOSIN HYDROCHLORIDE based on therapeutic use, drug class, or shared indications: