Androderm

Androderm

Androderm Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Androderm (testosterone transdermal system) topical (for the skin) is used to treat conditions in men that result from a lack of natural testosterone. Testosterone is a naturally occurring male hormone. Common side effects 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.

The recommended starting dose is one Androderm 4 mg/day system (not two 2 mg/day systems) applied nightly for 24 hours. Androderm may interact with insulin, blood thinners, oxyphenbutazone, or corticosteroids. Other drugs may interact with Androderm topical. Tell your doctor all prescription and over-the-counter medications and supplements you use. Women should not use this medication. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Testosterone can cause birth defects in a fetus. A pregnant woman should avoid coming into contact with testosterone topical gel, or with a man's skin areas where a testosterone topical patch has been worn or the gel has been applied. If contact occurs, wash with soap and water right away.

Our Androderm (testosterone transdermal system) 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 in Detail?

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

Androderm 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 Androderm (Testosterone Transdermal System) »

What is Prescribing information?

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

Androderm FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 1 shows the adverse reactions that were reported by > 3% of 36 hypogonadal men who were treated with ANDRODERM 2 mg/day, 4 mg/day, or 6 mg/day for 28 days. Of note, all hypogonadal men studied had been stable users of topical testosterone replacement products prior to the study and there was no washout period between therapies. Furthermore, there was only one subject titrated to 6 mg/day and he withdrew from the study prematurely.

Table 1: Adverse Reactions Seen With the Use of ANDRODERM 2 mg/day, 4 mg/day, or 6 mg/day (> 3%)

Adverse Reaction Overall
N = 36 %
Application site pruritus 17
Application site vesicles 6
Back pain 6

Other less common adverse reactions reported by < 3% of patients included: application site erythema, application site exfoliation, chills, diarrhea, fatigue, gastroesophageal reflux disease, hemarthrosis, hematuria, headache, polyuria, and prostatitis. The overall incidence of application site reactions of any kind was 28% (10 subjects with 13 adverse reactions).

No serious adverse reactions to ANDRODERM 2 mg/day and 4 mg/day were reported during the clinical trial.

Table 2 shows the adverse reactions that were reported in > 3% of 122 patients in clinical studies with ANDRODERM dosage strengths of 2.5 mg/day, 5 mg/day, and 7.5 mg/day. The most common adverse reactions reported were application site reactions. Transient mild to moderate erythema was observed at the site of application in the majority of patients at some time during treatment. The overall incidence of application site reactions of any kind was 48% (59 subjects with 107 adverse reactions).

Table 2: Adverse Reactions Seen With the Use of ANDRODERM 2.5 mg/day, 5 mg/day, or 7.5 mg/day (> 3%)

Adverse Reaction Overall
N = 122 %
Application site pruritus 37
Application site blistering 12
Application site erythema 7
Application site vesicles 6
Prostate abnormalities 5
Headache 4
Contact dermatitis to system 4
Application site burning 3
Application site induration 3
Depression 3

The following reactions occurred in less than 3% of patients: rash, gastrointestinal bleeding, fatigue, body pain, pelvic pain, hypertension, peripheral vascular disease, increased appetite, accelerated growth, anxiety, confusion, decreased libido, paresthesia, thinking abnormalities, vertigo, acne, bullae at application site, mechanical irritation at application site, rash at application site, contamination of application site, prostate carcinoma, dysuria, hematuria, impotence, urinary incontinence, urinary tract infection, and testicular abnormalities.

Read the entire FDA prescribing information for Androderm (Testosterone Transdermal System) »

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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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