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Testim

Last reviewed on RxList: 11/15/2017
Testim Side Effects Center

Last reviewed on RxList 11/15/2017

Testim 1% (testosterone gel) is a form of testosterone, a naturally occurring male hormone, used to treat conditions in men that result from a lack of natural testosterone. Common side effects of Testim 1% include:

  • application site reactions where the skin patch is worn (redness, itching, burning, or hardened skin),
  • breast swelling or tenderness,
  • increased acne or hair growth,
  • headache,
  • depressed mood,
  • increased blood pressure,
  • hot flushes,
  • insomnia,
  • changes in sex drive,
  • increased blood pressure,
  • hot flashes,
  • mood swings,
  • changes in taste or smell,
  • spontaneous erections,
  • increased appetite, and
  • sensitive nipples.

The recommended starting dose of Testim is 5 g of gel (one tube) containing 50 mg of testosterone applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms. Testim may interact with insulin, blood thinners, oxyphenbutazone, or corticosteroids. Tell your doctor all medications you use. Testim should not be used by women. Testosterone can cause birth defects in a fetus. Pregnant women should avoid coming into contact with Testim topical patches or gels, or with a man's skin areas where a patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away. Testim must not be used while breastfeeding.

Our Testim 1% (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.

SLIDESHOW

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Testim 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 deep in the body--swelling, warmth, or redness in an arm or leg.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any 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;
  • increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);
  • increased prostate-specific antigen;
  • increased blood pressure;
  • mood changes, strange dreams;
  • frequent or prolonged erections;
  • nausea, vomiting; or
  • swelling in your lower legs.

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 Testim (Testosterone Gel)

QUESTION

Testosterone is a chemical found only in men. See Answer
Testim Professional Information

SIDE EFFECTS

Clinical Studies 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.

In a controlled clinical study, 304 patients were treated with Testim® 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred-five (205) patients received Testim 50 mg or 100 mg daily and 99 patients received placebo. Subjects could be counted in both Testim treatment groups if they received both 50 mg and 100 mg at different points in the study and experienced an adverse reaction at both dose levels. Adverse reactions reported by ≥ 1% of the Testim patients and greater than placebo are listed in Table 1.

Table 1: Incidence of Adverse Reactions (Reported by ≥ 1% of the Testim Patients and Greater than Placebo) in the Controlled Clinical Trial Through 90 Days

Event Testim 50 mg
(n=103)
Testim 100 mg
(n=149)
Placebo
(n=99)
Application Site Reactions 2% 4% 3%
Blood Pressure Increased 1% 1% 0%
Gynecomastia 1% 0% 0%
Headache 1% 1% 0%
Hematocrit/hemoglobin Increased 1% 2% 0%
Hot Flushes 1% 0% 0%
Insomnia. 1% 0% 0%
Mood Swings 1% 0% 0%
Smell Disorder 1% 0% 0%
Spontaneous Penile Erection 1% 0% 0%
Taste Disorder 1% 1% 0%

The following adverse reactions occurred in fewer than 1% of patients but were greater in Testim groups compared to the placebo group: activated partial thromboplastin time prolonged, blood creatinine increased, prothrombin time prolonged, appetite increased, sensitive nipples, and acne.

In this clinical trial of Testim, six patients had adverse reactions that led to their discontinuation. These events included: depression with suicidal ideation, urinary tract infection, mood swings and hypertension. No Testim patients discontinued due to skin reaction. In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse reaction.

In the pivotal U.S. and European Phase 3 trials combined, at the 50 mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the 100 mg dose group, 2.3% and 2.8% of patients had a clinically notable increase in hemoglobin ( ≥ 19 g/dL) or hematocrit ( ≥ 58%), respectively, compared to 1.0% and 1.5% of patients in the placebo group, respectively.

In the combined US and European open label extension studies, approximately 140 patients received Testim for at least 6 months. The results from these studies are consistent with those reported for the US controlled clinical trial.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of testosterone gel products. 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.

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 of 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].

Vascular Disorders

Venous thromboembolism [see WARNINGS AND PRECAUTIONS]

Cardiovascular Disorders

Myocardial infarction, stroke [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Testim (Testosterone Gel)

Related Resources for Testim

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

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