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What is AndroGel (testosterone gel)?
Testosterone is the major male sex hormone responsible for the normal growth and development of the male sex organs and secondary sex characteristics.
These effects include development of the:
- prostate, penis, and scrotum;
- distribution of facial, pubic, chest and axillary hair;
- development of a deep voice and
- alterations in muscle mass and fat distribution.
Low production of testosterone leads to erectile dysfunction, reduced sexual desire, fatigue and loss of energy, depression, regression of secondary sexual characteristics, and weakening of bones (osteoporosis). AndroGel and other testosterone replacement products supplement or replace natural production of testosterone and reverse symptoms of low testosterone.
Common side effects of AndroGel include:
- high blood pressure,
- abnormal lab tests (for example, glucose and cholesterol tests),
- application site reactions (for example, itching, blisters, and redness),
- enlarged prostate, and
- increased serum prostate-specific antigen (PSA) levels.
Testosterone may decrease blood glucose levels and less insulin may be required in diabetic patients.
Combining steroids with testosterone may increase fluid retention.
AndroGel should not be used in women. Women exposed to this medication may have side effects due to testosterone gel.
What are the important side effects of AndroGel (testosterone gel)?
The most common side effects of AndroGel are:
AndroGel (testosterone gel) side effects list for healthcare professionals
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 practice.
Clinical Trials in Hypogonadal Men
Table 2 shows the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with AndroGel 1% and reported by > 1% of patients in a 180 Day, Phase 3 study.
Table 2: Adverse Events Possibly, Probably or Definitely Related to Use of AndroGel 1% in the 180-Day Controlled Clinical Trial
|Adverse Event||Dose of AndroGel 1%|
N = 77
N = 40
N = 178
|Application Site Reaction||5%||3%||4%|
|Lab Test Abnormal*||6%||5%||3%|
|*Lab test abnormal occurred in nine patients with one or more of the following events reported: elevated hemoglobin or hematocrit, hyperlipidemia, elevated triglycerides, hypokalemia, decreased HDL, elevated glucose, elevated creatinine, elevated total bilirubin.|
**Prostate disorders included five patients with enlarged prostate, one with BPH, and one with elevated PSA results.
***Testis disorders were reported in two patients: one with left varicocele and one with slight sensitivity of left testis.
Other less common adverse reactions, reported in fewer than 1% of patients included:
- discolored hair,
- dry skin,
- impaired urination,
- penis disorder,
- peripheral edema,
- sweating, and
In this 180 day clinical trial, skin reactions at the site of application were reported with AndroGel 1%, but none was severe enough to require treatment or discontinuation of drug.
Six patients (4%) in this trial had adverse events that led to discontinuation of AndroGel 1%. These events included:
- cerebral hemorrhage,
- convulsion (neither of which were considered related to AndroGel 1% administration),
- memory loss,
- elevated prostate-specific antigen, and
No AndroGel 1% patient discontinued due to skin reactions.
In a separate uncontrolled pharmacokinetic study of 10 patients, two had adverse events associated with AndroGel 1%; these were asthenia and depression in one patient and increased libido and hyperkinesia in the other.
In a 3 year, flexible dose, extension study, the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with AndroGel 1% and reported by > 1% of patients is shown in Table 3.
Table 3: Adverse Events Possibly, Probably or Definitely Related to Use of AndroGel 1% in the 3 Year, Flexible Dose, Extension Study
|Adverse Event||Percent of Subjects|
(N = 162)
|Lab Test Abnormal+||9.3|
|Application Site Reaction||5.6|
|Carcinoma of Prostate||1.2|
|+Lab test abnormal occurred in 15 patients with one or more of the following events reported: elevated AST, elevated ALT, elevated testosterone, elevated hemoglobin or hematocrit, elevated cholesterol, elevated cholesterol/LDL ratio, elevated triglycerides, elevated HDL, elevated serum creatinine.|
*Urinary symptoms included nocturia, urinary hesitancy, urinary incontinence, urinary retention, urinary urgency and weak urinary stream.
**Testis disorders included three patients. There were two with a non-palpable testis and one with slight right testicular tenderness.
Discontinuation for adverse events in this study included: two patients with application site reactions, one with kidney failure, and five with prostate disorders (including increase in serum PSA in 4 patients, and increase in PSA with prostate enlargement in a fifth patient).
Increases in Serum PSA Observed in Clinical Trials of Hypogonadal Men
During the initial 6-month study, the mean change in PSA values had a statistically significant increase of 0.26 ng/mL. Serum PSA was measured every 6 months thereafter in the 162 hypogonadal men on AndroGel 1% in the 3-year extension study. There was no additional statistically significant increase observed in mean PSA from 6 months through 36 months. However, there were increases in serum PSA observed in approximately 18% of individual patients. The overall mean change from baseline in serum PSA values for the entire group from month 6 to 36 was 0.11 ng/mL.
Twenty-nine patients (18%) met the per-protocol criterion for increase in serum PSA, defined as > 2X the baseline or any single serum PSA > 6 ng/mL. Most of these (25/29) met this criterion by at least doubling of their PSA from baseline. In most cases where PSA at least doubled (22/25), the maximum serum PSA value was still < 2 ng/mL. The first occurrence of a pre-specified, post-baseline increase in serum PSA was seen at or prior to Month 12 in most of the patients who met this criterion (23 of 29; 79%).
Four patients met this criterion by having a serum PSA > 6 ng/mL and in these, maximum serum PSA values were 6.2 ng/mL, 6.6 ng/mL, 6.7 ng/mL, and 10.7 ng/mL. In two of these patients, prostate cancer was detected on biopsy. The first patient's PSA levels were 4.7 ng/mL and 6.2 ng/mL at baseline and at Month 6/Final, respectively. The second patient's PSA levels were 4.2 ng/mL, 5.2 ng/mL, 5.8 ng/mL, and 6.6 ng/mL at baseline, Month 6, Month 12, and Final, respectively.
The following adverse reactions have been identified during post-approval use of AndroGel 1%. Because the 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 Postmarketing Experience of AndroGel 1% by MedDRA System Organ Class
|Blood and the lymphatic system disorders:||Elevated Hgb, Hct (polycythemia)|
|Cardiovascular disorders:||Myocardial infarction, stroke|
|General disorders and administration site reactions:||Asthenia, edema, malaise|
|Genitourinary disorders:||Impaired urination|
|Hepatobiliary disorders:||Abnormal liver function tests (e.g. transaminases, elevated GGTP, bilirubin)|
|Investigations:||Elevated PSA, electrolyte changes (nitrogen, calcium, potassium, phosphorus, sodium), changes in serum lipids (hyperlipidemia, elevated triglycerides, decreased HDL), impaired glucose tolerance, fluctuating testosterone concentrations, weight increase|
|Neoplasms benign, malignant and unspecified (cysts and polyps):||Prostate cancer|
|Nervous system:||Headache, dizziness, sleep apnea, insomnia|
|Psychiatric disorders:||Depression, emotional lability, decreased libido, nervousness, hostility, amnesia, anxiety|
|Reproductive system and breast disorders:||Gynecomastia, mastodynia, prostatic enlargement, testicular atrophy, oligospermia, priapism (frequent or prolonged erections)|
|Skin and subcutaneous tissue disorders:||Acne, alopecia, application site reaction (pruritus, dry skin, erythema, rash, discolored hair, paresthesia), sweating|
|Vascular disorders:||Hypertension, vasodilation (hot flushes), venous thromboembolism|
Secondary Exposure to Testosterone in Children
Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance. 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.
What drugs interact with Androgel (testosterone gel)?
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.
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.
The concurrent use 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
AndroGel 1% contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
Anabolic steroids, such as testosterone, are abused. Abuse is often associated with adverse physical and psychological effects.
Although drug dependence is not documented in individuals using therapeutic doses of anabolic steroids for approved indications, dependence is observed in some individuals abusing high doses of anabolic steroids. In general, anabolic steroid dependence is characterized by any three of the following:
- Taking more drug than intended
- Continued drug use despite medical and social problems
- Significant time spent in obtaining adequate amounts of drug
- Desire for anabolic steroids when supplies of the drugs are interrupted
- Difficulty in discontinuing use of the drug despite desires and attempts to do so
- Experience of a withdrawal syndrome upon discontinuation of anabolic steroid use
AndroGel (testosterone gel) is an androgen administered topically (on the skin) to treat low testosterone levels. Common side effects of Androgel include headache, high blood pressure, acne, abnormal lab tests (for example, glucose and cholesterol tests), application site reactions (for example, itching, blisters, and redness), enlarged prostate, and increased serum prostate specific antigen (PSA) levels. Androgel should not be used in women. Androgel should not be used by nursing mothers because of the possibility of adverse effects in the nursing infant. Avoid contact with Androgel if you are pregnant or breastfeeding.
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Related Disease Conditions
Low Testosterone (Low-T)
Low testosterone (low-T) can be caused by conditions such as type 2 diabetes, obesity, liver or kidney disease, hormonal disorders, certain infections, and hypogonadism. Signs and symptoms that a person may have low-T include insomnia, increased body fat, weight gain, reduced muscle, infertility, decreased sex drive, depression, and worsening of congestive heart failure or sleep apnea. Low-T can be treated with testosterone therapy in the form of gels, injections, pellets, or skin patches. Side effects of testosterone treatment include acne, anxiety, hair loss, headache, and change in sex drive (libido).
Treatment & Diagnosis
Medications & Supplements
- testosterone gel (Androgel)
- testosterone - intramuscular, Delatestryl, Tesamone
- testosterone undecanoate (Aveed)
- Testim 1% (testosterone gel)
- testosterone topical solution (Axiron)
- testosterone - transdermal, Androderm
- methyltestosterone - oral, Android, Testred
- methyltestosterone w/ estrogen - oral, Estratest
- Side Effects of Aveed (testosterone undecanoate)
- testosterone sustained-release - buccal, Striant
- Side Effects of Axiron (testosterone solution)
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.