Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions (incidence greater than or equal to 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials in Hypogonadal Men Table 2 shows the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with testosterone gel, 1% and reported by greater than 1% of patients in a 180 Day, Phase 3 study.
Table 2: Adverse Events Possibly, Probably or Definitely Related to Use of Testosterone Gel, 1% in the 180-Day Controlled Clinical Trial Adv erse Event Dose of Testosterone Gel, 1% 50 mg 75 mg 100 mg N = 77 N = 40 N = 78 Acne 1% 3% 8% Alopecia 1% 0% 1% Application Site Reaction 5% 3% 4% Asthenia 0% 3% 1% Depression 1% 0% 1% Emotional Lability 0% 3% 3% Gynecomastia 1% 0% 3% Headache 4% 3% 0% Hypertension 3% 0% 3% Lab Test Abnormal* 6% 5% 3% Libido Decreased 0% 3% 1% Nervousness 0% 3% 1% Pain Breast 1% 3% 1% Prostate Disorder** 3% 3% 5% Testis Disorder*** 3% 0% 0% * Lab test abnormal occurred in nine patients with one or more of the following events reported: elevated hemoglobin or hematocrit, hyperlipidemia, elevated triglycerides, hypokalemia, decreased HDL, elevated glucose, elevated creatinine, elevated total bilirubin.** Prostate disorders included five patients with enlarged prostate, one with BPH, and one with elevated PSA results.
*** Testis disorders were reported in two patients: one with left varicocele and one with slight sensitivity of left testis.
Other less common adverse reactions, reported in fewer than 1% of patients included: amnesia,anxiety, discolored hair, dizziness, dry skin, hirsutism, hostility, impaired urination, paresthesia, penis disorder, peripheral edema, sweating, and vasodilation.
In this 180 day clinical trial, skin reactions at the site of application were reported with testosterone gel, 1%, but none was severe enough to require treatment or discontinuation of drug.
Six patients (4%) in this trial had adverse events that led to discontinuation of testosterone gel, 1%.
These events included: cerebral hemorrhage, convulsion (neither of which were considered related to testosterone gel, 1% administration), depression, sadness, memory loss, elevated prostate specific antigen, and hypertension.
5 WARNINGS AND PRECAUTIONS Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH.
( 5.1 ) Avoid unintentional exposure of women or children to testosterone gel, 1%.
Secondary exposure to testosterone can produce signs of virilization.
Testosterone gel, 1% should be discontinued until the cause of virilization is identified.
( 5.2 ) Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products.
Like all medications, Testosterone Gel, 1% can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: