• Generic Name: testosterone gel
  • Brand Name: Fortesta
  • Drug Class: ANDROGENS
Last updated on MDtodate: 10/6/2022


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 clinical practice.

In a controlled multicenter, open-label, non-comparative 90-day clinical study, 149 hypogonadal patients were treated with FORTESTA. Adverse reactions occurred in 22.8% (34/149) of patients. The most common adverse reaction reported in this study was skin reactions associated with the site of application (16.1%; 24/149) of which 79% (19/24) were mild and the remainder were moderate (21%; 5/24) (Table 1).

Table 1: Adverse Reactions Reported in >1% of Patients in the US Phase 3 Clinical Trial of FORTESTA

Adverse Reaction Number (%) of Patients
N = 149
Skin reaction 24 (16.1%)
Prostatic specific antigen increased 2 (1.3%)
Abnormal dreams 2 (1.3%)


During the 90-day trial 5 patients (3.4%) discontinued treatment because of adverse reactions. These reactions were: 1 patient with contact dermatitis (considered probably related to FORTESTA application), 1 with application site reaction (considered probably related to FORTESTA application), 1 with gastrointestinal hypomotility (considered possibly related to FORTESTA application), 1 with severe dyspnea (considered not related to FORTESTA application), and 1 with moderate contusion (considered not related to FORTESTA application).

Postmarketing Experience

The following adverse reactions have been identified during post approval use of FORTESTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 2).

Table 2: Adverse Drug Reactions from Post Approval Experience of FORTESTA by System Organ

System Organ Class Adverse Reaction
Blood and lymphatic system disorders Polycythemia
Eye disorders Vitreous detachment
Gastrointestinal disorders Abdominal symptoms
General disorders and administrative site conditions Application site erythema, irritation, pruritus, and swelling; fatigue, influenza like illness, and malaise
Investigations Decreased serum testosterone, increased hematocrit and hemoglobin
Musculoskeletal and connective tissue disorders Pain in extremity
Nervous system disorders Dizziness, headache, and migraine
Reproductive system and breast disorders Erectile dysfunction and priapism
Skin and subcutaneous tissue disorders Allergic dermatitis, erythema, rash, and papular rash
Vascular disorders Venous thromboembolism
Cardiovascular disorders Myocardial infarction and stroke


Secondary Exposure To Testosterone In Children

Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. 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. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. In at least 1 reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user’s shirts and/or other fabric, such as towels and sheets.