Androgel Side Effects
Generic Name: testosterone,depo-testosterone,testosterone cypionate,testosterone enanthate
Please note - some side effects for Androgel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Androgel - for the Consumer
AndroGel Gel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using AndroGel Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using AndroGel Gel:Skin irritation at the application site.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast tenderness or enlargement; calf or leg pain, swelling, or redness; change in the size or shape of the testicles; dark urine; excessive daytime sleepiness; frequent, prolonged, or painful erections; interrupted breathing while sleeping; loss of appetite; memory problems; mood or mental changes (eg, anxiety, depression, hostility, suicidal thoughts); nausea; new or worsening trouble urinating (eg, frequent urination, inability to urinate, weak urine stream); pale stools; severe or persistent headache; shortness of breath; skin discoloration; stomach pain; swelling of the ankles, feet, or legs; trouble sleeping or other sleep changes; unexplained or unusual weight gain; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopAndrogel Side Effects - for the Professional
AndroGel
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 and reported by >1% of patients in a 180 Day, Phase 3 study.
Other less common adverse reactions, reported in fewer than 1% of patients included: amnesia, anxiety, discolored hair, dizziness, dry skin, hirsutism, hostility, impaired urination, paresthesia, penis disorder, peripheral edema, sweating, and vasodilation.
In this 180 day clinical trial, skin reactions at the site of application were reported with AndroGel, 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. These events included: cerebral hemorrhage, convulsion (neither of which were considered related to AndroGel administration), depression, sadness, memory loss, elevated prostate specific antigen, and hypertension. No AndroGel patient discontinued due to skin reactions.
In a separate uncontrolled pharmacokinetic study of 10 patients, two had adverse events associated with AndroGel; 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 and reported by > 1% of patients is shown in Table 3.
Two patients reported serious adverse events considered possibly related to treatment: deep vein thrombosis (DVT) and prostate disorder requiring a transurethral resection of the prostate (TURP).
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 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.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of AndroGel. 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.
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 [see Warnings and Precautions (5.2)].
Table 4 includes adverse reactions that have been identified postmarketing.
| Blood and the lymphatic system disorders: | Elevated Hgb, Hct (polycythemia) |
| Endocrine disorders: | Hirsutism |
| Gastrointestinal disorders: | Nausea |
| 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 levels, 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) |
| Respiratory disorders: | Dyspnea |
| 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) |
Side Effects by Body System - for Healthcare Professionals
Cardiovascular
Cardiovascular side effects have included hypertension, and edema with and without congestive heart failure.
Endocrine
Endocrine side effects have included gynecomastia as a frequent and sometimes persistent side effect. Cautious use is recommended in patients with existing gynecomastia.
During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous androgens may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH).
Androgens may decrease levels of thyroxin binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.
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, insulin requirements.
Virilization of children has been reported due to secondary exposure to testosterone. Signs and symptoms have included inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone. 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.
Renal
Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.
Hepatic
Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities including hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with high doses of androgen. Tumor regression did not occur in all cases following medication withdrawal.
Cholestatic hepatitis, jaundice, and abnormal liver function tests have occurred during androgen therapy. Drug-induced jaundice is usually reversible following drug discontinuation.
Genitourinary
Genitourinary side effects following chronic administration and/or large dosages of testosterone have included oligospermia and decreased ejaculatory volume. Elderly male patients have experienced prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation has developed. Other urinary side effects have included nocturia, urinary hesitancy, urinary incontinence, urinary retention, urinary urgency, and weak urinary system.
In female patients the use of androgens has resulted in virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of testosterone at signs of mild virilization may prevent irreversible virilization.
Metabolic
Metabolic side effects have included osteolytic-induced hypercalcemia in immobilized patients or those with metastatic breast disease. Increased cholesterol levels and acute intermittent porphyria have been reported.
Other
Other side effects have included virilization in female patients. Virilization included deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities.
Female sexual partners of men using topical testosterone (residual on skin) have reported virilization.
Dermatologic
Dermatologic side effects have included hirsutism, acne, male-patterned baldness and seborrhea. Dermal reactions have been the most commonly reported side effects for transdermal testosterone and occur primarily at the site of application. Dermal effects have included 3 types: irritation including mild to moderate erythema (to 6%), induration (3%), itching (12%), and burning (3%); allergic contact dermatitis including pruritus (to 37%), vesicles (6%), and rash (2%); and burn-like blisters (12%).
Discontinuation rates for transdermal testosterone were as follows: due to chronic skin irritation (5%), allergic dermal reactions (4%), and burn-like, usually a single site (0%).
Triamcinolone 1% cream applied sparingly to skin under the reservoir reduced irritation and did not interfere with testosterone absorption. Ointment formulations reduce testosterone absorption.
Gastrointestinal
Gastrointestinal side effects have included nausea and vomiting.
Musculoskeletal
Testosterone is involved in termination of linear bone growth by closure of the epiphyseal growth centers. Appropriate monitoring of bone age is recommended during testosterone use in healthy males with delayed puberty.
Musculoskeletal side effects have included myalgia and pain.
Hematologic
Hematologic side effects have included alteration in clotting factors II, V, VII and X and polycythemia due to increased red cell production. Anemia has also been reported.
Hypersensitivity
Hypersensitivity side effects have included rash and anaphylactoid reactions.
Local
Local side effects have included inflammation and pain at injection or dermal application site.
Nervous system
Nervous system side effects have included altered libido (increased/decreased), headache (to 5%), anxiety, depression, generalized paresthesia, or sleep apnea syndrome.
Oncologic
Oncologic side effects have included carcinoma of the prostate, hepatic neoplasms, and hepatocellular carcinomas.
Respiratory
Respiratory side effects have included reports of potentiation of sleep apnea, particularly in obese patients or those with chronic lung disease. There have been rare postmarketing reports of transient reactions involving urge to cough, coughing fits, and respiratory distress immediately after the injection of testosterone enanthate, an oil-based depot preparation.
TopMore Androgel resources
- Androgel Consumer Overview
- Androgel Advanced Consumer (Micromedex) - Includes Dosage Information
- Testosterone Monograph (AHFS DI)
- Testosterone Prescribing Information (FDA)
- Testosterone Professional Patient Advice (Wolters Kluwer)
- AndroGel Prescribing Information (FDA)
- AndroGel Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Androderm Advanced Consumer (Micromedex) - Includes Dosage Information
- Androderm Prescribing Information (FDA)
- Androderm Patch MedFacts Consumer Leaflet (Wolters Kluwer)
- Axiron Solution MedFacts Consumer Leaflet (Wolters Kluwer)
- Axiron Consumer Overview
- Axiron Prescribing Information (FDA)
- Delatestryl Prescribing Information (FDA)
- Delatestryl MedFacts Consumer Leaflet (Wolters Kluwer)
- Depo-Testosterone Prescribing Information (FDA)
- Depo-Testosterone MedFacts Consumer Leaflet (Wolters Kluwer)
- Fortesta Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Fortesta Consumer Overview
- Striant Prescribing Information (FDA)
- Striant Advanced Consumer (Micromedex) - Includes Dosage Information
- Striant MedFacts Consumer Leaflet (Wolters Kluwer)
- Striant Consumer Overview
- Testim Prescribing Information (FDA)
- Testim Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Testosterone Cypionate Prescribing Information (FDA)
- Testosterone Enanthate Prescribing Information (FDA)
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