Androderm (Testosterone) – Transdermal: Uses, Side Effects

2023-02-15 15:21:19 By : Ms. Cherry Tao

Karen Berger, PharmD, is a community pharmacist and medical writer/reviewer.

Femi Aremu, PharmD, is a professional pharmacist with experience in clinical and community pharmacy. He currently practices in Chicago, Illinois.

Androderm (testosterone ) is a prescription transdermal patch that is used to replace endogenous (caused by internal factors) testosterone in adult males 18 and older who have little to no existing levels of endogenous testosterone as a result of certain medical conditions, such as primary hypogonadism or hypogonadotropic hypogonadism.

Androderm contains the ingredient testosterone, which is in a drug class called androgens.

Androgens are also known as sex hormones. In addition to boosting testosterone, these sex hormones can be used to increase reproductive ability, bone growth, and body hair development.

Androderm's testosterone replacement treatment helps with the development and maintenance of male features, such as body hair, sex organs, vocal cords, and body fat distribution.

No therapeutic (generic or brand-name) equivalent to Androderm currently exists.

This article will highlight Androderm, a brand-name drug, as a prescription transdermal patch that is applied to the skin.

Brand Name(s): Androderm

Therapeutic Classification: Endocrine-metabolic agent

Controlled Substance: Schedule III

Dosage Form(s): Transdermal patch

The Food and Drug Administration (FDA) has approved Androderm as a testosterone replacement therapy for adult males with medical conditions associated with little to no endogenous testosterone, including:

Androderm has not been studied in men with age-related hypogonadism (low testosterone levels due to aging).

Androderm is not for use in people assigned female at birth and could cause harm to an unborn baby if used by a parent during pregnancy.

If you are prescribed Androderm:

Use Androderm exactly as directed by your provider. Your provider will tell you how many patches to apply and when to apply them. Do not change your dose unless your healthcare provider instructs you to do so.

Apply Androderm at approximately the same time every night. After applying, wait at least three hours before taking a bath or shower, or going swimming.

Sweating a lot, such as during intense exercise, may cause your patch to become loose and/or fall off. If the patch becomes loose, rub your finger around the edges to secure it again.

Do not use tape. If the patch falls off, and it is before 12 p.m., put on a new patch and wear it until it is time to change your patch at the regular time in the evening.

If the patch falls off after 12 p.m., do not apply a new patch. Wait and put on a new patch at your regular time.

Change your patch every 24 hours. Remove the old patch before applying a new patch. Change the site where you place your patch every day. Do not use the same site for at least seven days.

You may notice skin redness after removing a patch. If this does not go away, notify your healthcare provider.

Androderm contains aluminum and must be taken off before a magnetic resonance imaging scan (MRI) to prevent burns.

Do not use Androderm if the pouch seal is broken or if there is any damage to the patch. Discard the patch and use a new one. Before applying Androderm, ensure the skin you're applying it to is clean and dry.

Make sure there is no broken skin. Avoid areas of skin that are oily, hairy, or where you may sweat. You can place the patch on your back, stomach, upper arm, or thigh.

Do not place an Androderm patch on any other parts of your body, such as the scrotum or buttocks.

When applying the patch, place it flat on the skin with the sticky side down and press down firmly around the edges. Make sure the patch sticks well to the skin.

Store at room temperature, away from heat, direct light, and moisture. Do not store it in the bathroom. Androderm contains testosterone and is a controlled (Schedule III) substance.

Keep this medication where no one else can get to it. Keep it out of the reach and out of the sight of children and pets. Keep Androderm in the sealed pouch until you are ready to use it.

To discard Androderm, fold the used patch in half, so the sticky sides stick together, and discard it in the household trash.

Sometimes Androderm is used off-label for indications that are not FDA-approved.

Healthcare providers may prescribe a testosterone replacement such as Androderm to transgender men (females transitioning to males) to help develop male features and suppress female features.

Testosterone therapy is sometimes prescribed off-label for men who have low testosterone levels, and who are experiencing symptoms, to help replace testosterone and maintain secondary sex characteristics (such as body hair and muscle mass).

Although Androderm is not approved for age-related low testosterone, older adult males with symptoms may sometimes be prescribed testosterone replacement off-label if the benefits outweigh the risks.

Furthermore, while Androderm is not FDA-approved for use in females, some healthcare providers will prescribe it off-label for people who are postmenopausal (after menopause, when menstrual periods have stopped for at least 12 months in a row). In these cases, Androderm may be used alone or in combination with estrogen to treat hypoactive sexual desire disorder (HSDD), also known as female sexual interest/arousal disorder

In clinical trials, the majority of males who used Androderm had normal testosterone levels within 28 days.

Generally, clinical studies have shown testosterone replacement to start to take effect at around three to four weeks, but it may take several months for the maximum effect to be seen.

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

The most common side effects of Androderm are:

Call your healthcare provider right away if you have serious side effects.

Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

There is little information on the long-term use of Natesto.

However, there is more information about the long-term use of testosterone in general:

Clinical guidelines from the American College of Physicians, published in the Annals of Internal Medicine in 2020, noted that in 20 studies (with a follow-up ranging from less than one year to over ten years), there was no increased risk of death, heart events (such as stroke or heart attacks), prostate cancer, or blood clots in the lungs or legs.

However, the study also noted that there is a lack of evidence of long-term safety and that most studies did not include men with heart disease.

Subsequently, the best course of action would be to consult your healthcare provider, who can consider your individual factors like age, medical conditions, and symptoms, and weigh the risks vs. benefits of testosterone treatment.

Androderm may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your provider may send a report to the FDA MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Potential users should be aware of the following before starting treatment with Andoderm:

Older adults: Males 65 and older should consult their healthcare provider regarding the use of Androderm as there is not enough information in this age group to determine the risk of heart problems and prostate cancer.

Use in females/pregnant and breastfeeding females: Natesto is not approved for use in females of any age (and if used in pregnant/breastfeeding people, Androderm could cause serious harm to the unborn fetus).

Children: Androderm is only approved for use in adult males and should not be used in adolescents under 18 years old.

Kidney/liver issues: Androderm has not been studied in people with kidney or liver problems. Therefore, people with any type of kidney or liver impairment should consult their healthcare provider before starting treatment.

If you miss your regularly scheduled time, apply the patch as soon as you remember. If it is almost time for the next dose, skip the missed dose.

Continue with your regular schedule. Do not apply extra patches to try to make up for a missed dose. In the event that the patch becomes loose, rub your finger firmly around the edges of the patch to secure it.

If a patch falls off, and it is before 12:00 p.m., put on a new patch and wear it until the evening, when you normally change your patch. If the patch falls off later in the day, wait until the evening and replace the patch.

If you are not sure what to do, consult with your healthcare provider.

Wearing too many Androderm patches, or wearing your patches for too long, may cause you to absorb too much testosterone, which may cause symptoms of an overdose, such as decreased libido, impaired erectile function (ED), fatigue, and depression.

If you think you or someone else may have overdosed on Androderm, call a healthcare provider or the Poison Control Center (800-222-1222). If someone collapses or isn't breathing after taking Androderm, call 911 immediately.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check for any problems or unwanted effects that may be caused by this medicine. Blood tests will be needed to check for unwanted effects.

This medicine should not be used by women who are pregnant or might become pregnant. Testosterone may cause birth defects if a pregnant woman comes in contact with the patch or medicine. Make sure your doctor knows if your sexual partner is pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

If a woman comes in contact with the patch, wash the skin area right away with soap and water to remove all the medicine. If the patch sticks to a woman, remove the patch right away and wash her skin thoroughly with soap and water.

If your female partner starts to have male-like changes such as unusual hair growth or increased acne, check with your doctor.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may increase the risk of prostate cancer, especially in older men. Make sure your doctor knows if you have prostate cancer, or if anyone in your family has prostate cancer.

This medicine may cause blood clotting problems. Tell your doctor right away if you have pain, redness, or swelling in the arm or leg, shortness of breath, sharp pains in the chest, or trouble breathing.

This medicine may increase your risk of having heart or blood vessel problems, including a heart attack or stroke. Tell your doctor right away if you have chest pain that may spread to your arms, jaw, back, or neck, faintness, headache, nausea, vomiting, trouble breathing, trouble seeing or speaking, or unusual sweating.

In some cases, this medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Tell your doctor if you experience too frequent erection of the penis, nausea, vomiting, yellowing of your skin or the whites of your eyes, or swelling of the ankle.

This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

This medicine may cause changes in the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to adjust the cholesterol and fats. Talk to your doctor if you have concerns.

This medicine contains aluminum that may cause skin burns at the patch site if you have a procedure called a magnetic resonance imaging (MRI) scan while you are wearing the patch. You must remove the patch before your MRI to prevent skin burns.

Check with your doctor immediately if mild, burn-like skin blisters, redness, itching, or swelling occurs at the site of application during or after treatment.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Androderm is not appropriate for everyone.

Before taking Androderm, tell your healthcare provider about all of your medical conditions, your medical history, and your family history.

You should not take this medication if you are allergic to testosterone or any of the inactive ingredients in Androderm.

Other people who should not take Androderm include:

Androderm may be prescribed with caution in some people, only if their healthcare provider determines it is safe. This includes:

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, and vitamins or supplements.

While taking Androderm, do not start any new medications without approval from your healthcare provider.

Some potential drug interactions associated with the use of Androderm include:

Not all drug interactions will prevent Androderm from being used. Conversely, some interactions may require a dosage adjustment and/or increased monitoring.

This is not a full list of drug interactions. Other drug interactions may occur with Androderm. Consult your healthcare provider for a complete list of drug interactions.

There are other various formulations of testosterone, including injections, oral capsules, and patches or gels, that can be used to replace testosterone in men, such as:

The above is a list of drugs also prescribed for testosterone replacement. It is not a list of drugs recommended to take with Androderm.

Androderm is a prescription patch that is applied to the skin. It contains the ingredient testosterone. It is used to replace testosterone in adult males who do not make enough, or any, testosterone, due to certain medical conditions.  

Testosterone levels may return to normal fairly quickly, within about one month. Symptoms may start to resolve at this time, but it may take several months to see the full benefits of the medicine.

Androderm may interact with certain drugs, such as blood pressure medications, insulin, and triptans for migraine.

Before using Androderm, review your medication list with your healthcare provider.

Androderm contains testosterone and is a controlled substance.

This type of testosterone is not used to enhance athletic performance and should not be used for that purpose. It is used in males with certain medical conditions who do not make any, or enough, testosterone. Keep it in a place where no one can get to it.

Topical testosterone can be absorbed through the skin and can cause male features to develop in a woman or child who comes into contact with it. It can also cause harm to an unborn baby and should not be used or handled by pregnant people.

Pregnant people also should not come into contact with the male's skin where the medication has been applied.

If anyone in close contact with you, such as a family member, friend, or caregiver, develops symptoms such as enlarged genitals, increased sex drive, aggression, hair loss, excessive body hair, acne, or irregular periods, contact your healthcare provider.

Some other tips to remember to use Androderm safely and effectively include:

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your doctor before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

Food and Drug Administration. Androderm (testosterone transdermal system) prescribing information.

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Parish SJ, Simon JA, Davis SR, et al. International Society for the Study of Women's Sexual Health clinical practice guideline for the use of systemic testosterone for Hypoactive Sexual Desire Disorder in women. J Sex Med. 2021;18(5):849-867. doi:10.1016/j.jsxm.2020.10.009

Saad F, Aversa A, Isidori AM, Zafalon L, Zitzmann M, Gooren L. Onset of effects of testosterone treatment and time span until maximum effects are achieved. Eur J Endocrinol. 2011;165(5):675-685. doi:10.1530/EJE-11-0221

Ramasamy R, Masterson TA, Best JC, et al. Effect of Natesto on reproductive hormones, semen parameters and hypogonadal symptoms: a single center, open label, single arm trial. J Urol. 2020;204(3):557-563. doi:10.1097/JU.0000000000001078

By Karen Berger, PharmD Karen Berger, PharmD, is a community pharmacist and medical writer/reviewer.

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