Axiron

Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/4/2021
Axiron Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Axiron?

Axiron (testosterone) is a male hormone (an androgen) used as a testosterone replacement for men who are testosterone deficient.

What Are Side Effects of Axiron?

Common side effects of Axiron include:

  • skin redness or irritation at the application site,
  • increased red blood cell count,
  • headache,
  • diarrhea,
  • vomiting,
  • increase in PSA (prostate-specific antigen),
  • increase in blood hematocrit,
  • weakness,
  • mood changes,
  • watery eyes,
  • breast tenderness,
  • increased blood pressure, and
  • increased blood testosterone.

Dosage for Axiron

The recommended dosage of Axiron is 60 mg applied once daily.

What Drugs, Substances, or Supplements Interact with Axiron?

Insulin, oral anticoagulants, and corticosteroids can interact with Axiron. Tell your doctor all medications you take.

Axiron During Pregnancy and Breastfeeding

Women and children should avoid contact with Axiron. Axiron is not indicated for women of child bearing years and should not be used while pregnant or breastfeeding.

Additional Information

Our Axiron (testosterone) 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
Axiron 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;
  • 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 Axiron (Testosterone Topical Solution)

SLIDESHOW

Low Testosterone (Low T) Treatments See Slideshow
Axiron 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.

Clinical Trials In Hypogonadal Men

Table 2 shows the treatment emergent adverse reactions that were reported by either >4% of 155 patients in a 120 day, Phase 3 study or by >4% of 71 patients who continued to use AXIRON for up to 180 days. These data reflect the experience primarily with a testosterone dose of 60 mg, which was taken by all patients at the start of the study, and was the maintenance dose for 97 patients. However, the doses used varied from 30 mg to 120 mg.

Table 2: Adverse Reactions Seen With the Use of AXIRON in either the 120 Day Clinical Trial or in the Extension to 180 Days (>4%)

Event 120 Days
(155 Patients)
180 Days
(71 Patients)
Application Site Irritation 11 (7%) 6 (8%)
Application Site Erythema 8 (5%) 5 (7%)
Headache 8 (5%) 4 (6%)
Hematocrit Increased 6 (4%) 5 (7%)
Diarrhea 4 (3%) 3 (4%)
Vomiting 4 (3%) 3 (4%)
PSA Increased 2 (1%) 3 (4%)

Other less common adverse reactions reported by at least 2 patients in the 120 day trial included: application site edema, application site warmth, increased hemoglobin, hypertension, erythema (general), increased blood glucose, acne, nasopharyngitis, anger and anxiety. Other less common adverse reactions reported in fewer than 1% of patients in the 120 day trial included: asthenia, affect lability, folliculitis, increased lacrimation, breast tenderness, increased blood pressure, increased blood testosterone, neoplasm prostate and elevated red blood cell count.

During the 120 day trial one patient discontinued treatment because of affect lability/anger which was considered possibly related to AXIRON administration. During the 120 day clinical trial there was an increase in mean PSA values of 0.13 ± 0.68 ng/mL from baseline. At the end of the 180 day extension clinical trial, there was an overall increase in mean PSA values of 0.1 ± 0.54 ng/mL.

Following the 120 day study, seventy-one (71) patients entered a two-month extension study with AXIRON. Two patients (3%) had adverse reactions that led to discontinuation of treatment during the period from Day 120 to Day 180. These reactions were: one patient with application site irritation (considered possibly related to AXIRON application) and one patient with dry skin and erythema, but not at the application site (considered not related to AXIRON administration) and application site erythema (considered possibly related to AXIRON administration).

No serious adverse reactions to AXIRON were reported during either the 120 day trial, or the extension to 180 days.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of AXIRON. Because these 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.

Cardiovascular Disorders: myocardial infarction, stroke [see WARNINGS AND PRECAUTIONS].

Vascular Disorders: Venous thromboembolism [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Axiron (Testosterone Topical Solution)

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

Health Solutions From Our Sponsors