April 29, 2017
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Included as part of the PRECAUTIONS section.


Worsening Of Benign Prostatic Hyperplasia (BPH) And Potential Risk Of Prostate Cancer

  • Patients with BPH treated with androgens are at an increased risk of worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
  • Patients treated with androgens may be at increased risk for prostate cancer. Evaluation of the patients for the presence of prostate cancer prior to initiating and during treatment with androgens is appropriate [see CONTRAINDICATIONS].

Potential For Secondary Exposure To Testosterone

Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using FORTESTA [see DOSAGE AND ADMINISTRATION, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified.


Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.

Venous Thromboembolism

There have been Postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as FORTESTA. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with FORTESTA and initiate appropriate workup and management.

Cardiovascular Risk

Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use FORTESTA.

Use In Women

Due to the lack of controlled evaluations in women and potential virilizing effects, FORTESTA is not indicated for use in women [see CONTRAINDICATIONS and Use In Specific Populations].

Potential For Adverse Effects On Spermatogenesis

With large doses of exogenous androgens, including FORTESTA, spermatogenesis may be suppressed through feedback inhibition of pituitary FSH which could possibly lead to adverse effects on semen parameters including sperm count.

Hepatic Adverse Effects

Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e. g. methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with testosterone enanthate has produced multiple hepatic adenomas. FORTESTA is not known to cause these adverse effects.


Androgens, including FORTESTA, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease [see ADVERSE REACTIONS].


Gynecomastia may develop and persist in patients being treated with androgens, including FORTESTA, for hypogonadism.

Sleep Apnea

The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.


Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.


Androgens, including FORTESTA, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.

Decreased Thyroxine-binding globulin

Androgens, including FORTESTA, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4.Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.


Alcohol based products, including FORTESTA, are flammable; therefore, patients should be advised to avoid smoking, fire or flame until the FORTESTA gel has dried.

Patient Counseling Information

See FDA-approved Medication Guide.

Patients should be informed of the following information:

Use In Men With Known Or Suspected Prostate Or Breast Cancer

Men with known or suspected prostate or breast cancer should not use FORTESTA [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Potential For Secondary Exposure To Testosterone And Steps To Prevent Secondary Exposure

Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary exposure to testosterone in children have been reported.

Physicians should advise patients of the reported signs and symptoms of secondary exposure which may include the following:

  • In children; unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior.
  • In women; changes in hair distribution, increase in acne, or other signs of testosterone effects.
  • The possibility of secondary exposure to FORTESTA should be brought to the attention of a healthcare provider.
  • FORTESTA should be promptly discontinued until the cause of virilization is identified.

Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone from FORTESTA in men [see Medication Guide]:

  • Children and women should avoid contact with unwashed or unclothed application site(s) of men using FORTESTA.
  • Patients using FORTESTA should apply the product as directed and strictly adhere to the following:
    • Wash hands with soap and water after application.
    • Cover the application site(s) with clothing after the gel has dried.
    • Wash the application site(s) thoroughly with soap and water prior to any situation where skin-toskin contact of the application site with another person is anticipated.
  • In the event that unwashed or unclothed skin to which FORTESTA has been applied comes in contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Potential Adverse Reactions With Androgens
  • Patients should be informed that treatment with androgens may lead to adverse reactions which include:
  • Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine and weak urine flow.
  • Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
  • Too frequent or persistent erections of the penis.
  • Nausea, vomiting, changes in skin color, or ankle swelling.
Patients Should Be Advised Of The Following Instructions For Use
  • Read the Medication Guide before starting FORTESTA therapy and reread it each time the prescription is renewed.
  • FORTESTA should be applied and used appropriately to maximize the benefits and to minimize the risk of secondary exposure in children and women.
  • Keep FORTESTA out of the reach of children.
  • FORTESTA is an alcohol based product and is flammable; therefore avoid fire, flame or smoking until the gel has dried.
  • It is important to adhere to all recommended monitoring.
  • Report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood.
  • FORTESTA is prescribed to meet the patient's specific needs, therefore, the patient should never share FORTESTA with anyone.
  • Wait 2 hours before swimming or washing following application of FORTESTA. This will ensure that the greatest amount of FORTESTA is absorbed into their system.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, implant induced cervical-uterine tumors metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats. Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays. The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.

Use In Specific Populations


Pregnancy Category X [see CONTRAINDICATIONS].

FORTESTA is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a female fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus.

Nursing Mothers

Although it is not known how much testosterone transfers into human milk, FORTESTA is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Testosterone and other androgens may adversely affect lactation [see CONTRAINDICATIONS].

Pediatric Use

The safety and efficacy of FORTESTA in pediatric patients < 18 years old has not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

Geriatric Use

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing FORTESTA to determine whether efficacy in those over 65 years of age differs from younger subjects. Of the 149 patients enrolled in the pivotal clinical study utilizing FORTESTA, 20 were over 65 years of age. Additionally, there are insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer.

Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH.

Renal Impairment

No studies were conducted in patients with renal impairment.

Hepatic Impairment

No studies were conducted in patients with hepatic impairment.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/9/2016


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