Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning Androgel, Aveed, Azmiro, Jatenzo, Kyzatrex, Natesto, Testim, Tlando, Vogelxo, and Xyosted.

Side Effect Update for Testosterone Drugs

The medications included in this update are approved for adult males with conditions associated with a deficiency or absence of the male hormone testosterone. These conditions include primary hypogonadism, which occurs when the testes do not function properly, and secondary hypogonadism, which occurs when the problem originates in the pituitary gland. Symptoms of low testosterone, or “Low-T,” include reduced sex drive, erectile dysfunction, fatigue, and mood changes.

Testosterone-containing drugs that treat Low-T include topical gels, transdermal patches, buccal system (applied to upper gum or inner cheek), tablets, capsules and injections. Testosterone is a Class III controlled drug, due to its potential for abuse.

How to Read This Report

This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.

Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.

These safety label updates were made in response to an FDA assessment of a clinical trial study called the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE). The study showed that the use of testosterone drugs did not increase the risk of death from cardiovascular causes more than placebo. The warning about major cardiovascular risks, which had been included on the labels since 2015, was removed in this update.

However, the TRAVERSE study also showed that participants taking testosterone experienced an increased incidence of venous thromboembolism (VTE), including deep vein thrombosis (DVT, a type of vein blockage caused by a blood clot in the leg) and pulmonary embolism (PE, a blockage caused by a blood clot in the lung). Warnings about VTE have been included on the labels since 2014. Updated safety information regarding VTE now includes the TRAVERSE clinical trials results and a warning in the patient counseling section.

Because the TRAVERSE study and additional ambulatory blood pressure (ABPM) studies showed an increased risk of developing high blood pressure among users of testosterone, a new warning about the risk of developing high blood pressure was also added.

Androgel (testosterone gel) 1% for topical use and 1.62% for topical use

Initial FDA Approval: 1953 (testosterone); this formulation was approved in 2000

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

Updated Side Effect/Safety Information: A new warning that testosterone can increase blood pressure, which can increase cardiovascular risk over time. Patients should measure blood pressure regularly. Testosterone is not recommended for use in men with uncontrolled hypertension.

A warning that testosterone can cause venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). Presents results of a recent clinical trial on testosterone and cardiac risks.

FDA Safety Announcement: Androgel 1% FDA Safety Label Change and Revised Drug Label
Androgel 1.62% FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Aveed (testosterone undecanoate) injection, for intramuscular use

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2014

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone. This medication is administered by a healthcare professional in a healthcare setting.

Essential Extras: Aveed is available only through a restricted program called the Aveed REMS Program because of the risk of serious Pulmonary Oil Microembolism (POME) reactions and anaphylaxis during or immediately after receiving the injection. POME reactions involve the urge to cough, dyspnea, throat tightening, chest pain, dizziness, and fainting.

FDA Safety Announcement: Aveed FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Azmiro (testosterone cypionate) injection, solution for intramuscular use

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2022

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

FDA Safety Announcement: Azmiro FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Jatenzo (testosterone undecanoate) capsules

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2019

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

FDA Safety Announcement: Jatenzo FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Kyzatrex (testosterone undecanoate) capsules, liquid filled

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2022

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

FDA Safety Announcement: Kyzatrex FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Natesto (testosterone) nasal gel

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2014

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

FDA Safety Announcement: Natesto FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Testim (testosterone gel) for topical use

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2002

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

FDA Safety Announcement: Testim FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Tlando (testosterone undecanoate) capsule, liquid filled

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2022

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

FDA Safety Announcement: Tlando FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Vogelxo (testosterone) gel, for topical use

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2014

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

FDA Safety Announcement: Vogelxo FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.

Xyosted (testosterone enanthate) autoinjector, subcutaneous

Initial FDA Approval: 1953 (testosterone); this formulation approved in 2018

Side Effect Update Date: July 11, 2025

Medication Description: A testosterone replacement therapy for adult males with conditions associated with a deficiency or absence of testosterone.

FDA Safety Announcement: Xyosted FDA Safety Label Change and Revised Drug Label

The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.