Axiron

Name: Axiron

Axiron Interactions

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

  • A blood thinner such as Coumadin (warfarin)
  • A steroid such as Medrol (methylprednisolone), Sterapred (prednisone), or others
  • Insulin

Axiron Overview

Axiron is a prescription medication used to treat low testosterone levels (hypogonadism) in men who do not produce enough natural testosterone. 

Axiron is a hormone that is usually produced by the body. It controls the growth, development, and function of male sexual organs and characteristics.

This medication comes as a topical solution and is applied to the body once daily, in the morning. 

Common side effects of Axiron include irritation and redness at the site of application, headache, diarrhea, and vomiting.

Uses of Axiron

Axiron is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

How should I use testosterone topical?

Follow all directions on your prescription label. Never use testosterone topical in larger amounts, or for longer than prescribed.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

Different brands of testosterone topical have different instructions for use. Not every brand of this medicine is used on the same skin areas. Some brands are applied to the shoulder, upper arm, or stomach. Other brands are applied to the thighs or to the underarms. Carefully follow the patient instructions provided with your medicine.

Do not apply testosterone topical to your penis or scrotum. Some brands of this medicine should also not be applied to the back, chest, or stomach areas. Apply this medicine only to the skin areas recommended for your specific brand of testosterone topical.

Apply testosterone gel to dry skin after showering or bathing. Allow the medicine to dry for at least 5 minutes before you dress.

Wash your hands with soap and water after applying the gel.

Cover treated skin areas with clothing to keep from getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.

Apply the transdermal skin patch to a flat, clean, dry, and undamaged area of skin on your back, stomach, upper arm, or thigh. Wear the patch for 24 hours and then replace it with a new patch. Choose a different skin area each time you put on a new patch. Do not use the same skin area twice in a 7-day period.

While using testosterone topical, you may need frequent blood tests.

Use testosterone topical regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

Keep each skin patch in the foil pouch until you are ready to use it. Do not use a skin patch that has been cut or damaged After removing a skin patch, fold it closed with the sticky side in, and throw it away in a place where pets and children cannot reach it.

What other drugs will affect testosterone topical?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • insulin;

  • a blood thinner (warfarin, Coumadin, Jantoven); or

  • steroid medicine (methylprednisolone, prednisone, and others.)

This list is not complete. Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Proper Use of testosterone

This section provides information on the proper use of a number of products that contain testosterone. It may not be specific to Axiron. Please read with care.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Androgel® or Fortesta® is available in two forms: individual packets or multi-dose pump. Vogelxo™ is available in three forms: individual packets, multi-dose pump, or tube. If you are using the pump gel for the first time, prime the pump before measuring out your first dose. Hold the pump over a sink and press the pump all the way down at least 3 times (Androgel® or Vogelxo™) or 8 times (Fortesta®) or until the gel begins to flow freely. Rinse the medicine discarded into the sink down the drain. Place the palm of your hand under the pump and press the pump the proper number of times to measure out your correct dose.

If you are using the gel in foil packets, tear the packet completely open along the perforation. Squeeze the entire contents directly onto the skin where you will apply the gel. You may also empty the packet into the palm of your hand and then apply the medicine. Throw away the empty foil packet in a place where children and pets cannot reach it.

Axiron® is available in two forms:

  • Pump actuated metered dose bottle—For first time use, prime it before measuring out your first dose. Hold the bottle over a sink and press the pump all the way down at least 3 times. Rinse the medicine discarded into the sink down the drain. Place the palm of your hand under the pump and press the pump the proper number of times to measure out your correct dose.
  • Twist actuated metered dose bottle—For first time use, prime it before measuring out your first dose. Hold the bottle over a sink and twist the dose dial on the bottle. Rinse the medicine discarded into the sink down the drain. Repeat this two more times. Completely twist (180° turn) the dose dial one time after priming to get your correct dose.

AndroGel® is available in two dosage strengths: AndroGel® 1% and AndroGel® 1.62%. AndroGel® 1% is used differently than AndroGel® 1.62%, even though they are both applied to the skin. Do not change your dose unless your doctor tells you to.

To use the gel:

  • Make sure that you wash your hands with soap and water before and after applying the gel.
  • Apply AndroGel® 1% to a clean, dry, intact skin of the shoulders, upper arms, or abdomen (stomach), unless your doctor tells you to use it on another part of your body. AndroGel® 1.62% should only be applied to a clean, dry intact skin of the shoulders and upper arms. Fortesta® should be applied to a clean, dry, intact skin of the front or inner thighs. Vogelxo™ should be applied to a clean, dry, intact skin of the shoulders or upper arms. Do not apply Vogelxo™ to your abdomen or stomach. Do not apply this medicine to your scrotum or your penis. Do not use the medicine on skin that has a cut, scrape, or other type of injury.
  • Allow the gel to dry on your skin before you cover it with clothing (eg, shorts, pants, t-shirt).
  • Wait for at least 2 hours (for AndroGel® 1.62%, Fortesta®, and Vogelxo™) or 5 hours (for AndroGel® 1%) after applying this medicine before showering or swimming.

To use the topical solution:

  • Apply an antiperspirant or deodorant spray at least 2 minutes before you apply this medicine.
  • Apply Axiron® to each clean, dry, intact skin of your underarm using an applicator. Do not apply this medicine to your stomach, penis, scrotum, shoulders, or upper arms. Do not use the medicine on skin that has a cut, scrape, or other type of injury. Do not drink this medicine.
  • Wipe any medicine that drips or runs with an applicator. Do not rub the solution with your fingers or hand.
  • Pump actuated metered dose bottle: Rinse the applicator cup with water and pat it dry with a tissue. Put the cup and cap back onto the bottle.
  • Twist actuated metered dose bottle: Rinse the applicator with water and pat it dry with a tissue. Put the lid back on the bottle.
  • Allow the solution to dry for at least 3 minutes before you cover the area with clothing. Do not shower or swim for least 2 hours.
  • If any medicine gets in your eyes, rinse them right away with water and call your doctor. Do not drink the medicine.

The gel or solution form can be transferred to another person if they touch or rub the skin where the medicine was placed or if some of it remains on your hands. To keep this from happening, wash your hands again after applying the medicine. Also, wash the area where you applied the gel with soap and water if you expect to have a skin-to-skin contact with another person.

This medicine is flammable until it dries on the skin. Do not use it near heat, an open flame, or while smoking.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For hormone replacement:
    • For topical dosage form (gel):
      • Adults—
        • AndroGel® 1%: At first, apply 50 milligrams (mg) (two 25 mg packets or a single 50 mg packet) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mg per day.
        • AndroGel® 1.62%: At first, apply 40.5 milligrams (mg) (2 pumps or a single 40.5 mg packet) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 81 mg per day.
        • Fortesta®: At first, apply 40 milligrams (mg) (4 pumps) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 70 mg per day.
        • Vogelxo™: At first, apply 50 milligrams (mg) (1 tube, 1 packet, or 4 pumps) to a clean, dry, intact skin once a day (usually in the morning). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg once a day.
      • Children—Use and dose must be determined by your doctor.
    • For topical dosage form (solution):
      • Adults—At first, apply 60 milligrams (mg) (1 pump or 1 twist actuation of 30 mg) to each clean, dry, intact skin of your underarm once a day (usually in the morning). Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in a safe place. Do not give it to anyone else, even if you have the same symptoms. Throw away the empty pump, tube, or packet in a place where children and pets cannot reach it.

What do I need to tell my doctor BEFORE I take Axiron?

  • If you have an allergy to testosterone or any other part of Axiron (testosterone topical solution).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are male and have breast or prostate cancer.
  • If you have any of these health problems: Heart disease, kidney disease, or liver disease.
  • If you are a woman. This medicine is not approved for use in women. If you are a woman using this medicine, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.
  • If the patient is a child. Do not give Axiron to a child.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Axiron with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Dosage Forms and Strengths

Axiron is a (testosterone) topical solution available as a:

  • metered-dose pump that delivers 30 mg of testosterone per pump.
  • metered-dose pump that delivers 30 mg of testosterone per twist.

Each metered-dose pump is supplied with an applicator.

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, insulin requirement.

Oral anticoagulants

Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.

Corticosteroids

The concurrent use of testosterone with ACTH or corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.

Drug Abuse and Dependence

Controlled Substance

Axiron 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 by 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 following adverse 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.

Axiron - Clinical Pharmacology

Mechanism of Action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics.

Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

Pharmacodynamics

No specific pharmacodynamic studies were conducted using Axiron.

Pharmacokinetics

Absorption Axiron delivers physiologic circulating testosterone that approximate normal concentration range (i.e., 300 - 1050 ng/dL) seen in healthy men following application to the axilla.

On the skin, the ethanol and isopropyl alcohol evaporate leaving testosterone and octisalate. The skin acts as a reservoir from which testosterone is released into the systemic circulation over time (see Figure 1). In general, steady-state serum concentrations are achieved by approximately 14 days of daily dosing.

Figure 1: Mean (±SD) Serum Testosterone Concentrations on Day 7 in Patients Following Axiron Once-Daily Application of 30 mg, 60 mg, or 90 mg of Testosterone

When Axiron treatment is discontinued after achieving steady-state, serum testosterone concentrations returned to their pretreatment concentrations by 7 – 10 days after the last application.

Distribution Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin. Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins.

Metabolism Testosterone is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of testosterone are estradiol and dihydrotestosterone (DHT).

DHT concentration increased in parallel with testosterone concentration during Axiron treatment. The mean steady-state DHT/T ratio remained within normal limits and ranged from 0.17 to 0.26 across all doses on Days 15, 60, and 120.

Excretion There is considerable variation in the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes. About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver.

Potential for testosterone transfer: The potential for testosterone transfer from males dosed with Axiron to healthy females was evaluated in a clinical study conducted with a 2% testosterone formulation. 10 males were treated with 60 mg of testosterone in each axilla (the maximum testosterone dose of 120 mg). At 2 hours after the application of Axiron to the males, the females rubbed their outer forearms for 15 minutes on the axilla of the males. The males had covered the application area with a T-shirt. Serum concentrations of testosterone were monitored in the female subjects for 72 hours after the transfer procedure. Study results show a 13% and 17% increase in testosterone exposure (AUC[0-24]) and maximum testosterone concentration (Cmax), respectively, compared to baseline in these females. In a prior clinical study conducted with a 1% testosterone formulation under similar study conditions, direct skin-to-skin transfer showed a 131% and 297% increase in testosterone exposure (AUC[0-72]) and maximum testosterone concentration (Cmax), respectively, compared to when men had covered the application area with a T-shirt.

In a clinical study conducted with a 2% testosterone formulation to evaluate the effect of washing on the residual amount of testosterone at the axilla, 10 healthy male subjects received 60 mg of testosterone to each axilla (the maximum testosterone dose of 120 mg). Following 5 minutes of drying time, the left axilla was wiped with alcohol towelettes which were assayed for testosterone content. Subjects were required to shower with soap and water 30 minutes after application. The right axilla was then wiped with alcohol towelettes which were assayed for testosterone content. A mean (SD) of 3.1 (2.8) mg of residual testosterone (i.e., 92.6% reduction compared to when axilla was not washed) was recovered after washing this area with soap and water. [See Dosage and Administration (2.2) and Warnings and Precautions (5.2)].

Use of deodorants and anti-perspirants: In a parallel designed clinical study evaluating the effect of deodorants and antiperspirants in healthy premenopausal females dosed with Axiron, each subject applied either a combined deodorant/antiperspirant spray (6 subjects) or stick (6 subjects) or a deodorant spray (6 subjects) to a single axilla 2 minutes before the application of 30 mg of testosterone to the same axilla. A control group of 6 subjects only applied 30 mg of testosterone to a single axilla. Blood samples were collected for 72 hours from all subjects following Axiron administration. Although a decrease of up to 33% of testosterone exposure (AUC[0-72]) was observed when antiperspirants or deodorants are used 2 minutes prior to Axiron application, underarm deodorant or antiperspirant spray or stick products may be used 2 minutes prior to Axiron application as part of normal, consistent, and daily routine. [See Dosage and Administration (2.2), and Patient Counseling Information (17.4)].

Effect of showering/washing: In a parallel designed clinical study to evaluate the effect of washing on the testosterone systemic exposure, two groups of 6 healthy premenopausal female subjects were each dosed with 30 mg of testosterone to a single axilla. The application sites of each group were washed with soap and water 2 hours or 6 hours after the application of Axiron. A control group of 6 female subjects applied 30 mg of testosterone to a single axilla and did not wash the application site. Blood samples were collected for 72 hours from all subjects following dosing with Axiron. A decrease of up to 35% of testosterone exposure (AUC[0-72]) was observed when applications sites were washed 2 hours and 6 hours after Axiron application. Patients should be advised to avoid swimming or washing the application site until 2 hours following application of Axiron. [See Dosage and Administration (2.2) and Patient Counseling Information (17.4)].

What should I avoid?

Do not apply Axiron to your stomach area (abdomen), penis, scrotum, shoulders or upper arms.

Do not apply Axiron with your fingers or hands.

Avoid swimming, bathing, or showering for at least 2 hours after applying Axiron solution.

Avoid splashing in the eyes. In case of contact with eyes, flush thoroughly with water. If irritation persists, seek medical advice.

Axiron solution is flammable until dry. Let the solution dry before smoking or going near an open flame.

For Healthcare Professionals

Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, nasal gel, subcutaneous implant, transdermal cream, transdermal film extended release, transdermal gel, transdermal ointment, transdermal solution

General

The most frequently reported side effects with this drug are edema, acne, site pain, injection site erythema, cough or dyspnea during or immediately after injection.

The most frequently reported side effects with testosterone (the active ingredient contained in Axiron) topical are skin reaction (16.1%) and allergic contact dermatitis (up to 37%).[Ref]

Dermatologic

Very common (10% or more): Testosterone topical: Skin reaction (16.1%), burn-like blisters (12%), itching, allergic contact dermatitis (up to 37%)
Common (1% to 10%): Acne, induration, burning
Uncommon (0.1% to 1%): Alopecia, erythema, rash (including rash popular), pruritus, dry skin, folliculitis (testosterone (the active ingredient contained in Axiron) topical)
Frequency not reported: Seborrhea, urticaria, male pattern baldness, hirsutism injection site inflammation
Postmarketing reports: Angioedema, angioneurotic edema, hyperhidrosis, discolored hair, leukocytoclastic vasculitis[Ref]

Endocrine

Very common (10% or more): Accelerated growth
Common (1% to 10%): Increased estradiol, hypogonadism
Uncommon (0.1% to 1%): Increased blood testosterone (the active ingredient contained in Axiron) Frequency not reported: Signs of virilization in women (e.g., hoarseness, acne, hirsutism, menstrual irregularity, clitoral enlargement, and alopecia), precocious puberty (in prepubertal males)
Postmarketing reports: Hyperparathyroidism, prolactin increased, testosterone increased[Ref]

Gastrointestinal

Very common (10% or more): Testosterone (the active ingredient contained in Axiron) buccal film: Gingivitis (32.6%)
Common (1% to 10%): Diarrhea, oily stools (due to IM injection oily solvent); Testosterone topical: Gastroesophageal reflux disease, gastrointestinal bleeding, gum or mouth irritation (9.2%), taste bitter, gum pain, gum tenderness, gum edema, taste perversion
Uncommon (0.1% to 1%): Nausea
Rare (less than 0.1%): Abdominal pain
Frequency not reported: Abdominal disorder, intraabdominal hemorrhage
Postmarketing reports: Vomiting; Testosterone buccal film: Dry mouth, gingival swelling, lip swelling, mouth ulceration, stomatitis[Ref]

The majority of gum-related adverse events were transient.[Ref]

Local

Very common (10% or more): Testosterone topical: Application site pruritus (up to 37%), application site blistering (12%)
Common (1% to 10%): Injection site pain, injection site discomfort, injection site pruritus, erythema, injection site hematoma, injection site irritation, injection site inflammation; injection site reaction; Topical testosterone (the active ingredient contained in Axiron) Application site erythema, application site warmth, application site irritation, application site vesicles, application site exfoliation, application site burning, application site induration, bullae at application site, mechanical irritation at application site, rash at application site, contamination of application site
Postmarketing reports: Injection site abscess, procedural pain, application site swelling (topical testosterone)[Ref]

Cardiovascular

Common (1% to 10%): Hot flush, hypertension
Uncommon (0.1% to 1%): Cardiovascular disorder
Frequency not reported: Venous thromboembolism
Postmarketing reports: Angina pectoris, cardiac arrest, cardiac failure, coronary artery disease, coronary artery occlusion, myocardial infarction, tachycardia, cerebral infarction, cerebrovascular accident, circulatory collapse, deep venous thrombosis, syncope, thromboembolism, thrombosis, venous insufficiency, stroke[Ref]

Genitourinary

Common (1% to 10%): Abnormal prostate examination, benign prostate hyperplasia (BPH), ejaculation disorder, prostatitis
Uncommon (0.1% to 1%): Prostate induration, prostatic disorder, testicular pain, decreased urine flow, urinary retention, urinary tract disorder, nocturia, dysuria
Rare (less than 0.1%): Micturition disorders, epididymitis, bladder irritability, impotence, inhibition of testicular function and testicular atrophy
Frequency not reported: Oligospermia, priapism, benign prostatic hyperplasia (prostatic growth to eugonadal state), excessive frequency and duration of erections; Pediatrics: Precocious sexual development, an increased frequency of erections, phallic enlargement
Postmarketing reports: Prostate infection, calculus urinary, dysuria, hematuria, urinary tract disorder, pollakiuria[Ref]

Hematologic

Common (1% to 10%): Polycythemia, hematocrit increased
Uncommon (0.1% to 1%): Increased red blood cell count, increased hemoglobin, prolonged activated partial thromboplastin time, prolonged prothrombin time
Frequency not reported: Blood and lymphatic system disorders, suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy
Postmarketing reports: Thrombocytopenia, anemia[Ref]

Metabolic

Common (1% to 10%): Weight increased, appetite increased, fluid retention (sodium, chloride, water, potassium, calcium, and inorganic phosphates)
Uncommon (0.1% to 1%): Increased glycosylated hemoglobin, hypercholesterolemia, increased triglyceride
Frequency not reported: Abnormal lipids (decrease in serum LDL, HDL, and triglycerides), metabolism and nutrition disorders, hypercalcemia
Postmarketing reports: Hypoglycemia, diabetes mellitus, fluid retention, hyperlipidemia, hypertriglyceridemia, blood glucose increased[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, hemarthrosis (testosterone (the active ingredient contained in Axiron) topical)
Uncommon (0.1% to 1%): Arthralgia, pain in extremity, muscle spasm, muscle strain, myalgia, musculoskeletal stiffness, increased creatine phosphokinase
Frequency not reported: Pediatrics: Premature epiphyseal closure, increased bone formation
Postmarketing reports: Musculoskeletal chest pain, musculoskeletal pain, myalgia, osteopenia, osteoporosis, systemic lupus erythematosus[Ref]

Nervous system

Common (1% to 10%): Headache, vertigo (topical testosterone (the active ingredient contained in Axiron)
Uncommon (0.1% to 1%): Migraine, tremor, dizziness
Frequency not reported: Nervousness, paresthesia
Postmarketing reports: Cerebrovascular insufficiency, reversible ischemic neurological deficiency, transient ischemic attack, amnesia[Ref]

Oncologic

Common (1% to 10%): Prostatic specific antigen (PSA) increased, prostate cancer
Uncommon (0.1% to 1%): Prostatic intraepithelial neoplasia
Rare (less than 0.1%): Neoplasms benign, malignant, and unspecified (including cysts and polyps)[Ref]

Other

Common (1% to 10%): Fatigue, hyperhidrosis; chills, body pain, smell disorder
Uncommon (0.1% to 1%): Breast induration, breast pain, sensitive nipples, gynecomastia, increased estradiol, increased testosterone (the active ingredient contained in Axiron) asthenia, night sweats
Rare (less than 0.1%): Fever, malaise
Frequency not reported: Edema
Postmarketing reports: Sudden hearing loss, tinnitus, Influenza like illness[Ref]

Psychiatric

Common (1% to 10%): Irritability, insomnia, mood swings, aggression,
Uncommon (0.1% to 1%): Depression, emotional disorder, restlessness, increased libido, decreased libido
Frequency not reported: Hostility, anxiety
Postmarketing reports: Korsakoff's psychosis nonalcoholic, male orgasmic disorder, restlessness, sleep disorder[Ref]

Respiratory

Common (1% to 10%): Sinusitis, nasopharyngitis, upper respiratory tract infection, bronchitis
Uncommon (0.1% to 1%): Cough, dyspnea, snoring, dysphonia
Rare (less than 0.1%): Pulmonary microembolism (POME) (cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope) caused by oily solutions
Frequency not reported: Sleep apnea
Postmarketing reports: Chest pain, asthma, chronic obstructive pulmonary disease, hyperventilation, obstructive airway disorder, pharyngeal edema, pharyngolaryngeal pain, pulmonary embolism, respiratory distress, rhinitis, sleep apnea syndrome[Ref]

Signs and symptoms of pulmonary microemboli may occur during or immediately after the injections and are reversible.[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal LFT, increased AST
Rare (less than 0.1%): Abnormal hepatic function
Frequency not reported: Jaundice, benign liver tumor, malignant liver tumor, liver enlargement, peliosis hepatitis
Postmarketing reports: ALT increased, AST increased, bilirubin increased, transaminases increased, gamma-glutamyltransferase increased[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions
Frequency not reported: Anaphylactic reactions
Postmarketing reports: Anaphylactic shock[Ref]

Ocular

Uncommon (0.1% to 1%): Testosterone (the active ingredient contained in Axiron) topical: Lacrimation increased
Postmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment[Ref]

Renal

Postmarketing reports: Nephrolithiasis, renal colic, renal pain[Ref]

Some side effects of Axiron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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