DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Fortesta (Testosterone) - Side Effects and Adverse Reactions



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 [see Clinical Studies ]. 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 3).

Table 3 – Adverse Reactions Reported in >1% 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 4).

Table 4 - Adverse Drug Reactions from Post approval Experience of FORTESTA by System Organ Class
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

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 one 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 [see Warnings and Precautions].


Below is a sample of reports where side effects / adverse reactions may be related to Fortesta. The information is not vetted and should not be considered as verified clinical evidence.

Possible Fortesta side effects / adverse reactions in 56 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-27

Patient: 56 year old male

Reactions: Scrotal Swelling, Rash

Adverse event resulted in: life threatening event

Suspect drug(s):
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-02

    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-02

Other drugs received by patient: Penicillin V

Possible Fortesta side effects / adverse reactions in 54 year old male

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: 54 year old male weighing 178.3 kg (392.2 pounds)

Reactions: Application Site Reaction, Application Site Exfoliation, Application Site Erythema, Application Site Pruritus

Suspect drug(s):

See index of all Fortesta side effect reports >>

Drug label data at the top of this Page last updated: 2014-06-20

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017