Testim

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/30/2021
Testim Side Effects Center

What Is Testim?

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.

What Are Side Effects of Testim?

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.

Dosage for Testim

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.

What Drugs, Substances, or Supplements Interact with Testim?

Testim may interact with insulin, blood thinners, oxyphenbutazone, or corticosteroids. Tell your doctor all medications you use.

Testim During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

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

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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;
  • headache;
  • 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)

SLIDESHOW

Low Testosterone (Low T) Treatments See Slideshow
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 doselevels. Adversereactions 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, 6 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 US 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]

Blood And Lymphatic Disorders

Polycythemia [see WARNINGS AND PRECAUTIONS]

DRUG INTERACTIONS

Insulin

Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.

Oral Anticoagulants

Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.

Corticosteroids

The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.

Drug Abuse And Dependence

Controlled Substance

TESTIM contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.

Abuse

Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.

Abuse-Related Adverse Reactions

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression.

The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.

The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.

The followingadverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.

Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dependence

Behaviors Associated With Addiction

Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:

  • Taking greater dosages than prescribed
  • Continued drug use despite medical and social problems due to drug use
  • Spending significant time to obtain the drug when supplies of the drug are interrupted
  • Giving a higher priority to drug use than other obligations
  • Having difficulty in discontinuing the drug despite desires and attempts to do so
  • Experiencing withdrawal symptoms upon abrupt discontinuation of use

Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.

Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

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

© 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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