WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].
Children should avoid contact with any unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].
Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration (2.2), Warnings and Precautions (5.2) and Patient Counseling Information (17)].
Testosterone gel is a clear, colorless hydroalcoholic gel containing testosterone.
The active pharmacologic ingredient in testosterone gel is testosterone, an androgen.
Testosterone is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary Hypogonadism (congenital or acquired) - testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelters syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
Important limitations of use:
Safety and efficacy of testosterone gel in males less than 18 years old have not been established [ see Use in Specific Populations (8.4) ].
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3)
Media Articles Related to Testosterone
Testosterone Therapy May Have Benefits, But Risks Too
Source: MedicineNet Clinical Trials Specialty [2017.02.22]
Title: Testosterone Therapy May Have Benefits, But Risks Too
Category: Health News
Created: 2/21/2017 12:00:00 AM
Last Editorial Review: 2/22/2017 12:00:00 AM
What are the benefits and risks of testosterone therapy? Studies investigate
Source: Clinical Trials / Drug Trials News From Medical News Today [2017.02.21]
Five studies documenting the health effects of testosterone replacement therapy suggest the hormone improves bone density, but it may pose cardiac risk.
Enzyme that digests vitamin A also may regulate testosterone levels
Source: Prostate / Prostate Cancer News From Medical News Today [2016.12.09]
An enzyme that converts the dietary carotenoid beta carotene into vitamin A in the body may also regulate testosterone levels and growth of the prostate, a new study found.
How highs and lows in testosterone levels 'shock' prostate cancer cells to death
Source: Prostate / Prostate Cancer News From Medical News Today [2016.12.05]
A strategy of alternately flooding and starving the body of testosterone is producing good results in patients who have metastatic prostate cancer that is resistant to treatment by chemical or...
Testosterone Therapy May Be Linked to Serious Blood Clots
Source: MedicineNet Deep Vein Thrombosis Specialty [2016.12.01]
Title: Testosterone Therapy May Be Linked to Serious Blood Clots
Category: Health News
Created: 11/30/2016 12:00:00 AM
Last Editorial Review: 12/1/2016 12:00:00 AM
Published Studies Related to Testosterone
Testosterone replacement therapy in older male subjective memory complainers:
double-blind randomized crossover placebo-controlled clinical trial of
physiological assessment and safety. 
Testosterone replacement therapy (TRT) has been investigated in older men as a
preventative treatment against Alzheimer's disease and dementia. However,
previous studies have been contradictory... Our study suggests TRT is safe and well-tolerated in
this Indonesian cohort, yet longitudinal studies with larger cohorts are needed
to assess TRT further, and to establish whether TRT reduces dementia risk.
Testosterone induces erythrocytosis via increased erythropoietin and suppressed
hepcidin: evidence for a new erythropoietin/hemoglobin set point. 
hematocrit remain unclear... CONCLUSIONS: Testosterone-induced increase in hemoglobin and hematocrit is
Effect of testosterone treatment on constitutional and sexual symptoms in men
with type 2 diabetes in a randomized, placebo-controlled clinical trial. 
constitutional and sexual symptoms in men with type 2 diabetes (T2D)... CONCLUSIONS: In this trial, T treatment did not substantially improve
The role of androgen receptor CAG repeat polymorphism and other factors which
affect the clinical response to testosterone replacement in metabolic syndrome
and type 2 diabetes: TIMES2 sub-study. 
TRT in the TIMES2 study... CONCLUSION: AR CAG affected the response of some variables to TRT in the TIMES2
Mechanical muscle function and lean body mass during supervised strength training
and testosterone therapy in aging men with low-normal testosterone levels. 
24-week study... CONCLUSION: Strength training in aging men with low-normal testosterone levels
Reports of Suspected Testosterone Side Effects
Drug Ineffective (56),
Blood Testosterone Decreased (21),
Drug Administered AT Inappropriate Site (19),
Accidental Exposure (15),
Blood Testosterone Increased (14),
Pulmonary Embolism (12),
Alopecia (12), more >>
Page last updated: 2017-02-22