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Androderm

Last reviewed on RxList: 11/7/2016
Androderm Side Effects Center

Last reviewed on RxList 01/06/2017

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

  • redness, itching, burning, irritation, 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.

Tell your doctor if you have serious side effects of Androderm 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,
  • problems with urination,
  • swelling of your ankles,
  • frequent/prolonged erections,
  • nausea,
  • stomach pain,
  • low fever,
  • loss of appetite,
  • dark urine,
  • clay-colored stools, or
  • jaundice (yellowing of the skin or eyes).

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 breastfeeding. 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.

Androderm Consumer Information

Get 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 in your leg--pain, swelling, warmth, or redness in one or both legs.

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other 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;
  • headache, mood changes;
  • increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);
  • vomiting, diarrhea;
  • strange dreams;
  • frequent or prolonged erections; or
  • high blood pressure--severe headache, blurred vision, pounding in your neck or ears.

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)

Androderm Professional Information

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.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ANDRODERM. 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.

Vascular Disorders

Venous thromboembolism [see WARNINGS AND PRECAUTIONS]

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

Related Resources for Androderm

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© Androderm Patient Information is supplied by Cerner Multum, Inc. and Androderm Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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