65/100 · Elevated
Manufactured by Amneal Pharmaceuticals of New York LLC
Moderate Safety Concerns with Tamsulosin Hydrochloride
41,649 FDA adverse event reports analyzed
Last updated: 2026-05-12
TAMSULOSIN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals of New York LLC. Based on analysis of 41,649 FDA adverse event reports, TAMSULOSIN HYDROCHLORIDE 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 TAMSULOSIN HYDROCHLORIDE include FATIGUE, DYSPNOEA, DIZZINESS, DIARRHOEA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TAMSULOSIN HYDROCHLORIDE.
Tamsulosin Hydrochloride 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 41,649 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Of New York Llc.
The most commonly reported adverse events include Fatigue, Dyspnoea, Dizziness. Of classified reports, 76.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Frequent reports of serious adverse events such as falls, respiratory issues, and cardiovascular events.
Significant number of drug interactions and ineffective drug reports. Common side effects include fatigue, dizziness, and gastrointestinal issues. Age distribution shows a higher number of reports in older adults. Sex distribution indicates a higher number of reports for males.
Patients taking Tamsulosin Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tamsulosin Hydrochloride can interact with other medications, potentially leading to adverse effects. Patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tamsulosin Hydrochloride received a safety concern score of 65/100 (elevated concern). This is based on a 76.1% serious event ratio across 18,607 classified reports. The score accounts for 41,649 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: 15,914, Female: 816, Unknown: 12. The most frequently reported age groups are age 75 (531 reports), age 77 (526 reports), age 74 (521 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 18,607 classified reports for TAMSULOSIN 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.
Tamsulosin Hydrochloride can interact with other medications, potentially leading to adverse effects. Patients should inform their healthcare provider of all medications they are taking.
If you are taking Tamsulosin Hydrochloride, here are important things to know. The most commonly reported side effects include fatigue, dyspnoea, dizziness, diarrhoea, off label use. 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 new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug ineffectiveness or adverse events. 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 Tamsulosin Hydrochloride. Healthcare providers should be vigilant in monitoring patients for serious adverse events and drug interactions.
The FDA has received approximately 41,649 adverse event reports associated with Tamsulosin 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 Tamsulosin Hydrochloride include Fatigue, Dyspnoea, Dizziness, Diarrhoea, Off Label Use. By volume, the top reported reactions are: Fatigue (1,417 reports), Dyspnoea (1,332 reports), Dizziness (1,132 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tamsulosin Hydrochloride.
Out of 18,607 classified reports, 14,164 (76.1%) were classified as serious and 4,443 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 Tamsulosin Hydrochloride break down by patient sex as follows: Male: 15,914, Female: 816, Unknown: 12. 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 Tamsulosin Hydrochloride adverse events are: age 75: 531 reports, age 77: 526 reports, age 74: 521 reports, age 80: 490 reports, age 72: 477 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 Tamsulosin Hydrochloride adverse event reports is Amneal Pharmaceuticals Of New York 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 Tamsulosin Hydrochloride include: Drug Ineffective, Headache, Asthenia, Fall, Nausea. 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 Tamsulosin 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.
Tamsulosin Hydrochloride 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. Frequent reports of serious adverse events such as falls, respiratory issues, and cardiovascular events.
Key safety signals identified in Tamsulosin Hydrochloride's adverse event data include: Falls and syncope are common, indicating potential for falls and dizziness.. Respiratory issues like pneumonia and wheezing are reported frequently.. Cardiovascular events such as atrial fibrillation and hypertension are notable.. Serious adverse events like death and sepsis are reported, though less frequently.. Drug interactions and ineffectiveness are significant concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tamsulosin Hydrochloride can interact with other medications, potentially leading to adverse effects. Patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tamsulosin Hydrochloride.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug ineffectiveness or adverse events.
Tamsulosin Hydrochloride has 41,649 adverse event reports on file with the FDA. Significant number of drug interactions and ineffective drug reports. The volume of reports for Tamsulosin Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Tamsulosin Hydrochloride. Healthcare providers should be vigilant in monitoring patients for serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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