Medical Editor: John P. Cunha, DO, FACOEP
What Is Fortesta?
Fortesta (testosterone) gel is a male hormone (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). Fortesta is available as a generic.
What Are Side Effects of Fortesta?
Fortesta may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- increased urination,
- loss of bladder control,
- painful or difficult urination,
- breast pain or swelling,
- painful or bothersome erections,
- swelling,
- rapid weight gain,
- shortness of breath,
- chest pain or pressure,
- pain spreading to your jaw or shoulder,
- nausea,
- upper stomach pain,
- itching,
- tiredness,
- loss of appetite,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- sudden cough,
- wheezing,
- rapid breathing,
- coughing up blood, and
- swelling, warmth, or redness in an arm or leg
- Specific to children and women:
- enlarged genitals,
- premature pubic hair,
- increased libido,
- aggression,
- male-pattern baldness,
- excessive body hair growth,
- increased acne,
- irregular periods, and
- any other male characteristics
Get medical help right away, if you have any of the symptoms listed above.
Side effects of Fortesta include:
- skin reactions where the patch is worn (redness, itching, burning, or hardened skin),
- increased acne or hair growth, headache,
- depression,
- changes in your sex drive,
- urinary problems or accidents,
- increased risk of prostate cancer,
- lower sperm count,
- swelling/enlarged/painful breasts,
- blood clots in the legs, and
- sleep apnea
Tell your doctor if you have serious side effects of Fortesta including burn-like blistering of the skin where the transdermal patch is worn; skin irritation with patch-wearing that does not get better with time; 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).
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Fortesta
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.
Fortesta During Pregnancy and Breastfeeding
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.
Additional Information
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.
SLIDESHOW
Erectile Dysfunction (ED) Causes and Treatment See SlideshowGet emergency medical help if you have 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:
- increased urination (many times per day), loss of bladder control;
- painful or difficult urination;
- breast pain or swelling;
- painful or bothersome erections;
- swelling, rapid weight gain, shortness of breath during sleep;
- chest pain or pressure, pain spreading to your jaw or shoulder;
- liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
- signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg.
Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.
Common side effects may include:
- redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;
- increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);
- increased prostate-specific antigen;
- increased blood pressure;
- headache;
- mood changes, strange dreams;
- frequent or prolonged erections;
- nausea, vomiting; or
- swelling in your lower legs.
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.
QUESTION
Erectile dysfunction (ED) is… See AnswerSIDE 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% 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 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 |
| 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 [see WARNINGS AND PRECAUTIONS].
DRUG INTERACTIONS
Insulin
Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease insulin requirements.
Oral Anticoagulants
Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
Corticosteroids
The concurrent administration of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal, or hepatic disease.
Drug Abuse And Dependence
Controlled Substance
FORTESTA contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
Abuse
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.
Abuse-Related Adverse Reactions
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression.
The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.
The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dependence
Behaviors Associated With Addiction
Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:
- Taking greater dosages than prescribed
- Continued drug use despite medical and social problems due to drug use
- Spending significant time to obtain the drug when supplies of the drug are interrupted
- Giving a higher priority to drug use than other obligations
- Having difficulty in discontinuing the drug despite desires and attempts to do so
- Experiencing withdrawal symptoms upon abrupt discontinuation of use
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.
Read the entire FDA prescribing information for Fortesta (Testosterone Gel)
© Fortesta Patient Information is supplied by Cerner Multum, Inc. and Fortesta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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