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What is the most important information I should know about testosterone?

This medication can cause birth defects in an unborn baby if it is used by a woman during pregnancy. Do not receive testosterone injection if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not receive this medication if you have prostate cancer, male breast cancer, if you are pregnant, or if you have ever had an allergic reaction to a hormone treatment.

Before receiving testosterone injection, tell your doctor if you have benign prostatic hypertrophy (BPH), a bleeding or blood clotting disorder, high cholesterol, any type of cancer, liver or kidney disease, or heart disease, coronary artery disease, or a history of heart attack.

Warning

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What is testosterone?

Testosterone is a naturally occurring sex hormone that is produced in a man’s testicles. Small amounts of testosterone are also produced in a woman’s ovaries and adrenal system.

Testosterone injection is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty, impotence, or other hormonal imbalances. Testosterone injection is also used in women to treat breast cancer that has spread to other parts of the body.

Testosterone injection may also be used for other purposes not listed in this medication guide.


Precautions

You should not receive this medication if you have:

  • prostate cancer;
  • male breast cancer;
  • if you are pregnant; or
  • if you have ever had an allergic reaction to a hormone treatment.

Before receiving testosterone injection, tell your doctor if you are allergic to any drugs, or if you have:

  • benign prostatic hypertrophy (BPH);
  • any type of cancer;
  • high cholesterol;
  • a bleeding or blood clotting disorder;
  • liver or kidney disease; or
  • heart disease, coronary artery disease (hardened arteries), congestive heart failure, or a history of heart attack.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use testosterone injection.

FDA pregnancy category X. This medication can cause birth defects. Do not receive testosterone injection if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are receiving this medication.

It is not known whether testosterone injection passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using testosterone injection.

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Instructions

Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of testosterone injection is not expected to produce life-threatening symptoms.

Call your doctor if you miss an appointment for your testosterone injection.

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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.

Call your doctor at once if you have any of these serious side effects:

  • swelling, rapid weight gain;
  • increased or ongoing erection of the penis;
  • bone pain, increased thirst, memory problems, restless feeling, confusion, nausea, loss of appetite, increased urination, weakness, muscle twitching; or
  • nausea, vomiting, stomach pain, loss of appetite, and jaundice (yellowing of the skin or eyes).

Women receiving testosterone injection may develop male characteristics, which could be irreversible if testosterone treatment is continued. Call your doctor as soon as possible if you notice any of these signs of excess testosterone:

  • acne;
  • changes in your menstrual periods;
  • male-pattern hair growth (such as on the chin or chest);
  • male pattern baldness;
  • enlarged clitoris; or
  • increase or decrease in sex drive.

Less serious side effects may include:

  • breast swelling in men;
  • headache, anxiety, depressed mood;
  • numbness or tingly feeling; or
  • pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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Interactions

Before receiving testosterone injection, tell your doctor if you are using any of the following drugs:

  • the blood thinner warfarin (Coumadin);
  • insulin or diabetes medication you take by mouth such as glimepiride (Amaryl, Duetact, Avandaryl), glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), metformin (Actoplus Met, Avandamet, Fortamet, Glucophage Janumet), rosiglitazone (Avandia), and others; or
  • steroid medicine such as methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisone (Deltasone, Orasone, others), and others.

This list is not complete and there may be other drugs that can interact with testosterone injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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