Vogelxo

Last reviewed on RxList: 5/24/2019
Vogelxo Side Effects Center

Last reviewed on RxList 5/24/2019

Vogelxo (testosterone) Gel is testosterone, an androgen, used for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary or hypogonadotropic hypogonadism (congenital or acquired). Common side effects of Vogelxo include:

The recommended starting dose of Vogelxo is 50 mg of testosterone (one tube, one packet, or 4 pump actuations) applied topically once daily at approximately the same time each day to clean, dry intact skin of the shoulders and/or upper arms. Vogelxo may interact with insulin, oral anticoagulants, and corticosteroids. Tell your doctor all medications and supplements you use. Vogelxo is not indicated for use in women, therefore it is unlikely to be used during pregnancy or while breastfeeding. Anabolic steroids, such as testosterone, are often abused. Abuse is often associated with adverse physical and psychological effects. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Vogelxo (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

Low Testosterone (Low T) Treatments See Slideshow
Vogelxo Consumer Information

3 pharmacies near 20147 have coupons for Androderm (Brand Names:Vogelxo for 90ML of 30MG/ACT)

Costco
Costco
$677.99

Est. Regular Price

$601.01

with free coupon

View Coupon
CVS Pharmacy
CVS Pharmacy
$677.99

Est. Regular Price

$601.32

with free coupon

View Coupon
Walgreens
Walgreens
$677.99

Est. Regular Price

$608.08

with free coupon

View Coupon

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 Vogelxo (Testosterone Gel)

QUESTION

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

SIDE EFFECTS

Clinical Trial 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 testosterone gel 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred-five (205) patients received testosterone gel 50 mg or 100 mg daily and 99 patients received placebo. Subjects could be counted in both testosterone gel 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 testosterone gel patients and greater than placebo are listed in Table 3.

Table 3: Incidence of Adverse Reactions (Reported by ≥ 1% of the Testosterone Gel Patients and Greater than Placebo) in the Controlled Clinical Trial Through 90 Days

Event Testosterone Gel 50 mg
(n=103)
Testosterone Gel 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 testosterone gel 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 testosterone gel, six patients had adverse events that led to their discontinuation. These events included: depression with suicidal ideation, urinary tract infection, mood swings and hypertension. No testosterone gel patients discontinued due to skin reaction. In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse event.

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 U.S. and European open label extension studies, approximately 140 patients received testosterone gel for at least 6 months. The results from these studies are consistent with those reported for the U.S. 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 fabrics, such as towels and sheets [see WARNINGS AND PRECAUTIONS].

Cardiovascular Disorders

Myocardial infarction, stroke [see WARNINGS AND PRECAUTIONS]

Vascular Disorders

Venous thromboembolism [see WARNINGS AND PRECAUTIONS].

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

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

Health Solutions From Our Sponsors