"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
AndroGel 1.62 Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
AndroGel 1.62% (testosterone gel) is a form of the male sex hormone testosterone used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). Common side effects of AndroGel 1.62% include:
- hair loss,
- increased hair growth,
- trouble sleeping,
- changes in sexual desire,
- redness/swelling/itching/burning/hardening of the skin where the patch is worn,
- change in skin color,
- breast swelling or tenderness,
- depression, or
Tell your doctor if you have unlikely but serious side effects of AndroGel 1.62% including:
- breast pain,
- swelling of the feet or ankles (edema),
- weight gain,
- very slow/shallow/difficult breathing (possibly while sleeping), or
The recommended starting dose of AndroGel 1.62% is 40.5 mg of testosterone (2 pump actuations) applied topically once daily in the morning to the shoulders and upper arms. AndroGel 1.62% may interact with beta-blockers, blood thinners, corticosteroids, oral diabetes medication, insulin, or oxyphenbutazone. Tell your doctor all medications and supplements you use. This medication should not be used in women. Women accidentally exposed to this medication may have side effects. Tell both of your doctors immediately if you notice symptoms in a woman such as changes in body hair or a large increase in acne. Avoid contact with this medication if you are pregnant or breastfeeding. This medication may cause harm to a fetus or a breastfeeding baby.
Our AndroGel 1.62% (testosterone gel) Side Effects Drug 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 Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
AndroGel 1.62 Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: breast pain/enlargement, swelling of the feet/ankles (edema), weight gain, very slow/shallow/difficult breathing (possibly while sleeping), weakness.
Tell your doctor immediately if any of these rare but very serious side effects occur: trouble urinating, mental/mood changes (e.g., depression, agitation, hostility), change in size/shape of the testicles, testicle pain/tenderness, stomach/abdominal pain, dark urine, yellowing of eyes/skin, change in the amount of urine, calf tenderness/swelling/pain.
In patients with diabetes, especially those taking insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Symptoms of low blood sugar include shakiness, nervousness, rapid pulse, and sweating. If you are experiencing these symptoms, consult your doctor. Your doctor may need to adjust your diabetes medications.
For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for AndroGel 1.62 (Testosterone Gel)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
AndroGel 1.62 FDA Prescribing Information: 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 practice.
AndroGel 1.62% was evaluated in a two-phase, 364-day, controlled clinical study. The first phase was a multi-center, randomized, double-blind, parallel-group, placebo-controlled period of 182 days, in which 234 hypogonadal men were treated with AndroGel 1.62% and 40 received placebo. Patients could continue in an open-label, non-comparative, maintenance period for an additional 182 days [see Clinical Studies].
The most common adverse reaction reported in the double-blind period was increased prostate specific antigen (PSA) reported in 26 AndroGel 1.62%-treated patients (11.1%). In 17 patients, increased PSA was considered an adverse event by meeting one of the two pre-specified criteria for abnormal PSA values, defined as (1) average serum PSA > 4 ng/mL based on two separate determinations, or (2) an average change from baseline in serum PSA of greater than 0.75 ng/Ml on two determinations.
During the 182-day, double-blind period of the clinical trial, the mean change in serum PSA value was 0.14 ng/mL for patients receiving AndroGel 1.62% and -0.12 ng/mL for the patients in the placebo group. During the double-blind period, seven patients had a PSA value > 4.0 ng/mL, four of these seven patients had PSA less than or equal to 4.0 ng/mL upon repeat testing. The other three patients did not undergo repeat PSA testing.
During the 182-day, open-label period of the study, the mean change in serum PSA values was 0.10 ng/mL for both patients continuing on active therapy and patients transitioning onto active from placebo. During the open-label period, three patients had a serum PSA value > 4.0 ng/mL, two of whom had a serum PSA less than or equal to 4.0 ng/mL upon repeated testing. The other patient did not undergo repeat PSA testing. Among previous placebo patients, 3 of 28 (10.7%), had increased PSA as an adverse event in the open-label period.
Table 4 shows adverse reactions reported by > 2% of patients in the 182-day, double-blind period of the AndroGel 1.62% clinical trial and more frequent in the AndroGel 1.62% treated group versus placebo.
Table 4: Adverse Reactions
Reported in > 2% of Patients in the 182-Day, Double-Blind Period of AndroGel
1.62% Clinical Trial
|Adverse Reaction||Number (%) of Patients|
|PSA increased*||26 (11.1%)||0%|
|Emotional lability**||6 (2.6%)||0%|
|Hematocrit or hemoglobin increased||5 (2.1%)||0%|
|Contact dermatitis***||5 (2.1%)||0%|
|*PSA increased includes:
PSA values that met pre-specified criteria for abnormal PSA values (an average
change from baseline > 0.75 ng/mL and/or an average PSA value > 4.0 ng/mL
based on two measurements) as well as those reported as adverse events.
**Emotional lability includes: mood swings, affective disorder, impatience, anger, and aggression.
***Contact dermatitis includes: 4 patients with dermatitis at non-application sites.
Other adverse reactions occurring in less than or equal to 2% of AndroGel 1.62%-treated patients and more frequently than placebo included: frequent urination, and hyperlipidemia.
In the open-label period of the study (N=191), the most commonly reported adverse reaction (experienced by greater than 2% of patients) was increased PSA (n=13; 6.2%) and sinusitis. Other adverse reactions reported by less than or equal to 2% of patients included increased hemoglobin or hematocrit, hypertension, acne, libido decreased, insomnia, and benign prostatic hypertrophy.
During the 182-day, double-blind period of the clinical trial, 25 AndroGel 1.62%-treated patients (10.7%) discontinued treatment because of adverse reactions. These adverse reactions included 17 patients with PSA increased and 1 report each of: hematocrit increased, blood pressure increased, frequent urination, diarrhea, fatigue, pituitary tumor, dizziness, skin erythema and skin nodule (same patient - neither at application site), vasovagal syncope, and diabetes mellitus. During the 182-day, open-label period, 9 patients discontinued treatment because of adverse reactions. These adverse reactions included 6 reports of PSA increased, 2 of hematocrit increased, and 1 each of triglycerides increased and prostate cancer.
Application Site Reactions
In the 182-day double-blind period of the study, application site reactions were reported in two (2/234; 0.9%) patients receiving AndroGel 1.62%, both of which resolved. Neither of these patients discontinued the study due to application site adverse reactions. In the open-label period of the study, application site reactions were reported in three (3/219; 1.4%) additional patients that were treated with AndroGel 1.62%. None of these subjects were discontinued from the study due to application site reactions.
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 5).
Table 5: Adverse Reactions
from Post Approval Experience of AndroGel 1% by System Organ Class
|System Organ Class||Adverse Reaction|
|Blood and lymphatic system disorders:||Elevated hemoglobin or hematocrit, polycythemia, anemia|
|Cardiovascular disorders:||Myocardial infarction, stroke|
|General disorders:||Asthenia, edema, malaise|
|Genitourinary disorders:||Impaired urination*|
|Hepatobiliary disorders:||Abnormal liver function tests|
|Investigations:||Lab test abnormal**, elevated PSA, electrolyte changes (nitrogen, calcium, potassium [includes hypokalemia], phosphorus, sodium), impaired glucose tolerance, hyperlipidemia, HDL, fluctuating testosterone levels, weight increase|
|Nervous system disorders:||Dizziness, headache, insomnia, sleep apnea|
|Psychiatric disorders:||Amnesia, anxiety, depression, hostility, emotional lability, decreased libido, nervousness|
|Reproductive system and breast disorders:||Gynecomastia, mastodynia, oligospermia, priapism (frequent or prolonged erections), prostate enlargement, BPH, testis disorder***|
|Skin and subcutaneous tissue disorders:||Acne, alopecia, application site reaction (discolored hair, dry skin, erythema, paresthesia, pruritus, rash), skin dry, pruritus, sweating|
|Vascular disorders:||Hypertension, vasodilation (hot flushes), venous thromboembolism|
|* Impaired urination includes nocturia, urinary hesitancy, urinary incontinence, urinary retention, urinary
urgency and weak urinary stream
**Lab test abnormal includes elevated AST, elevated ALT, elevated testosterone, elevated hemoglobin or hematocrit, elevated cholesterol, elevated cholesterol/LDL ratio, elevated triglycerides, or elevated serum creatinine
***Testis disorder includes atrophy or non-palpable testis, varicocele, testis sensitivity or Tenderness
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 AndroGel 1.62 (Testosterone Gel)
Additional AndroGel 1.62 Information
AndroGel 1.62 - User Reviews
AndroGel 1.62 User Reviews
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