85/100 · Critical
Manufactured by ASCEND Therapeutics U.S., LLC
Testosterone therapy linked to significant cardiovascular and thrombotic events, with high rates of serious outcomes.
67,752 FDA adverse event reports analyzed
Testosterone 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 67,752 adverse event reports for this medication, which is primarily manufactured by Ascend Therapeutics U.S., Llc.
The most commonly reported adverse events include Myocardial Infarction, Drug Ineffective, Pain. Of classified reports, 56.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Cardiovascular events like myocardial infarction and cerebrovascular accidents are prominent serious adverse reactions.
Thrombotic events, including deep vein thrombosis and pulmonary embolism, are frequently reported. A substantial proportion of reports (56.2%) indicate serious outcomes, highlighting potential risks.
Patients taking Testosterone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are detailed in this dataset, but testosterone can interact with anticoagulants and corticosteroids. Patients should inform their healthcare provider of all medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Testosterone received a safety concern score of 85/100 (high concern). This is based on a 56.2% serious event ratio across 40,935 classified reports. The score accounts for 67,752 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: 34,483, Female: 3,658, Unknown: 174. The most frequently reported age groups are age 60 (617 reports), age 55 (616 reports), age 62 (603 reports). These demographics reflect reporting patterns and may not represent the full patient population.
No specific drug interactions are detailed in this dataset, but testosterone can interact with anticoagulants and corticosteroids. Patients should inform their healthcare provider of all medications.
If you are taking Testosterone, here are important things to know. The most commonly reported side effects include myocardial infarction, drug ineffective, pain, deep vein thrombosis, blood testosterone decreased. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Discuss all potential risks and benefits with your doctor before starting testosterone therapy. Report any new or worsening symptoms, especially chest pain, shortness of breath, or signs of a blood clot, immediately to your healthcare provider. 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.
Testosterone products are subject to FDA regulation, and adverse event reporting helps monitor their safety profile post-market. The FDA may issue safety alerts or require label changes based on accumulating data.
The FDA has received approximately 67,752 adverse event reports associated with Testosterone. 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 Testosterone include Myocardial Infarction, Drug Ineffective, Pain, Deep Vein Thrombosis, Blood Testosterone Decreased. By volume, the top reported reactions are: Myocardial Infarction (3,268 reports), Drug Ineffective (2,963 reports), Pain (2,379 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Testosterone.
Out of 40,935 classified reports, 22,992 (56.2%) were classified as serious and 17,943 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 Testosterone break down by patient sex as follows: Male: 34,483, Female: 3,658, Unknown: 174. 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 Testosterone adverse events are: age 60: 617 reports, age 55: 616 reports, age 62: 603 reports, age 57: 586 reports, age 63: 578 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 Testosterone adverse event reports is Ascend Therapeutics U.S., 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 Testosterone include: Cerebrovascular Accident, Pulmonary Embolism, Fatigue, Anxiety, Off Label Use. 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 Testosterone 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.
Testosterone 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. Cardiovascular events like myocardial infarction and cerebrovascular accidents are prominent serious adverse reactions.
Key safety signals identified in Testosterone's adverse event data include: MYOCARDIAL INFARCTION. CEREBROVASCULAR ACCIDENT. DEEP VEIN THROMBOSIS. PULMONARY EMBOLISM. THROMBOSIS. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are detailed in this dataset, but testosterone can interact with anticoagulants and corticosteroids. Patients should inform their healthcare provider of all medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Testosterone.
Discuss all potential risks and benefits with your doctor before starting testosterone therapy. Report any new or worsening symptoms, especially chest pain, shortness of breath, or signs of a blood clot, immediately to your healthcare provider.
Testosterone has 67,752 adverse event reports on file with the FDA. Thrombotic events, including deep vein thrombosis and pulmonary embolism, are frequently reported. The volume of reports for Testosterone reflects both the drug's usage level and the vigilance of the reporting community.
Testosterone products are subject to FDA regulation, and adverse event reporting helps monitor their safety profile post-market. The FDA may issue safety alerts or require label changes based on accumulating data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.