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Fortesta

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Fortesta

Fortesta Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Fortesta testosterone gel is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, such as primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). The drug is not available as a generic. Possible side effects with use of Fortesta can include urinary problems or accidents, increased risk of prostate cancer, lower sperm count, swelling, enlarged or painful breasts, blood clots in the legs, and sleep apnea.

Fortesta is available in a gel at a concentration of 10 mg testosterone per pump. The starting dose of Fortesta is 40 mg (4 pumps) applied topically once daily in the morning. Fortesta can be dose adjusted between a minimum of 10 mg of testosterone (1 pump) and a maximum of 70 mg of testosterone (7 pumps) on the basis of total serum testosterone concentrations 2 hours post Fortesta application. In pregnant or breastfeeding women, Fortesta may cause fetal harm. Fortesta may cause serious adverse reactions in nursing infants. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with Fortesta. If a pregnant woman is exposed to Fortesta, she should be apprised of the potential hazard to the fetus. Fortesta may cause adverse reactions if accidently contacted by women or children; it can even be transferred to others topically by clothing. The safety and effectiveness of this drug in the pediatric population has not been studied; children and women should avoid topical contact on skin or clothing.

Our Fortesta Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Fortesta in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using testosterone topical and call your doctor at once if you have any of these serious side effects:

  • burn-like blistering of the skin where the transdermal patch is worn;
  • skin irritation with patch-wearing that does not get better with time;
  • problems with urination;
  • swelling of your ankles;
  • frequent, prolonged, or bothersome erections; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • redness, itching, burning, or hardened skin where the skin patch is worn;
  • breast swelling or tenderness;
  • increased acne or hair growth;
  • headache, depressed mood; or
  • changes in your sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fortesta (Testosterone Gel) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Fortesta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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].

Read the entire FDA prescribing information for Fortesta (Testosterone Gel) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.



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