Testim

Testim Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Testim 1% (testosterone gel) is used to treat conditions in men that result from a lack of natural testosterone. It 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 sex drive.

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.

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.

Testim 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 Testim (Testosterone Gel) »

What is Prescribing information?

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

Testim FDA Prescribing Information: Side Effects
(Adverse Reactions)

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]

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

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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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