Vogelxo

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 in your leg--pain, swelling, warmth, or redness in one or both legs.

Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other 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;
• headache, mood changes;
• increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);
• vomiting, diarrhea;
• strange dreams;
• frequent or prolonged erections; or
• high blood pressure--severe headache, blurred vision, pounding in your neck or ears.

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.

Serious side effects have been reported with topical testosterone including the following:

• Swelling of the hands, feet, ankles, and lower legs
• Breathing problems, especially during sleep
• Excessive frequency or duration of penile erections in males
• Difficulty urinating or changes in urination habits
• Changes in skin color
• Liver dysfunction or liver cancer

Serious side effects have been reported with injectable testosterone including the following:

• Virilization in women, which includes amenorrhea or menstrual irregularities, deepening of the voice, clitoral enlargement
• Sexual changes or dysfunction in males, which includes breast enlargement and excessive frequency or duration of penile erections

Do not take testosterone if you:

• are allergic to testosterone or to any of its ingredients
• are a male with breast or prostate cancer
• are a woman who is or may become pregnant

Before taking testosterone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to testosterone or to any of its ingredients
• have or have had prostate cancer or an enlarged prostate
• have or have had breast cancer
• have sleep apnea
• have heart problems
• have diabetes
• have kidney disease
• have lung disease
• have liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Testosterone falls into category X. It has been shown that women taking testosterone during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. Testosterone should never be used by pregnant women.

Take testosterone exactly as prescribed.

Topical:

Testosterone comes in topical forms, including gels and transdermal patches to be applied to the skin, buccal systems to be applied to the upper gum, and gels to be applied into the nose. Testosterone is usually applied one to three times daily, depending on the specific formation.

Injectable:

This medication is available in an injectable form to be given directly into a muscle (IM) by a healthcare professional.

If you miss a dose, apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of testosterone at the same time.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of testosterone topical gel in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of testosterone topical gel in the elderly. However, elderly patients may be at an increased risk for developing heart and blood vessel problems, or prostate problems (including prostate cancer), which may require caution in patients receiving this medicine.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione
• Bupropion
• Dasabuvir
• Dicumarol
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenprocoumon
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to alcohol or soy products or
• Breast cancer (males) or
• Prostate cancer, known or suspected—Should not be used in patients with these conditions.

• Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
• Diabetes or
• Enlarged prostate or
• Heart attack, history of or
• Hypercalcemia (high calcium in the blood) or
• Hyperlipidemia (high lipid or cholesterol in the blood) or
• Lung disease or breathing problems (eg, sleep apnea) or
• Problems with passing urine or
• Stroke, history of—Use with caution. May make these conditions worse.

• Heart disease (eg, congestive heart failure) or
• Kidney disease or
• Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• There may be a higher chance of prostate cancer. Talk with the doctor.
• If you have an enlarged prostate, your signs can get worse while you use Vogelxo. Call your doctor if this happens to you.
• High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
• Treatment with Vogelxo may lead to higher cholesterol and triglycerides. The effect of these changes on heart health is not known. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• This medicine is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine is not approved for treating low testosterone levels caused by getting older. Talk with your doctor.
• This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
• Tell the doctor right away if a child or woman touches the gel or solution and has any bad effects. In children, these are forceful actions, enlarged sex organs, and early growth of pubic hair. In women, these are a deep voice, change in body hair, or pimples.
• If a pregnant woman touches the gel or solution, call the doctor right away.

Vogelxo (testosterone) gel is a clear to translucent hydroalcoholic topical gel for topical use available in unit-dose tubes, unit-dose packets, and multiple-dose metered pumps. Each tube or packet provides 50 mg testosterone in 5 g of gel. One pump actuation delivers 12.5 mg testosterone in 1.25 g of gel (4 actuations = 50 mg testosterone).

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer

• Men with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
• Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications (4)].

Potential for Secondary Exposure to Testosterone

Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. 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. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using Vogelxo [see Dosage and Administration (2.2), Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].

Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified.

Polycythemia

Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.

Venous Thromboembolism

There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as Vogelxo. Evaluate patients who report signs and symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Vogelxo and initiate appropriate workup and management [see Adverse Reactions (6.2)].

Cardiovascular Risk

Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Vogelxo.

Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence (9)].

If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

Use in Women

Due to lack of controlled evaluations in women and potential virilizing effects, Vogelxo is not indicated for use in women.

Potential for Adverse Effects on Spermatogenesis

With large doses of exogenous androgens, including Vogelxo, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.

Hepatic Adverse Effects

Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate, which elevate blood levels for prolonged periods, has produced multiple hepatic adenomas. Vogelxo is not known to produce these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Vogelxo while the cause is evaluated.

Edema

Androgens, including Vogelxo, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

Gynecomastia

Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism [see Adverse Reactions (6.1)].

Sleep Apnea

The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

Lipids

Changes in the serum lipid profile may occur. Monitor the lipid profile periodically, particularly after starting testosterone therapy and after any dose increases.

Hypercalcemia

Androgens, including Vogelxo, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.

Decreased Thyroxine-binding Globulin

Androgens, including Vogelxo, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Flammability

Alcohol-based products, including Vogelxo, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the Vogelxo has dried.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.

Mutagenesis

Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.

Impairment of Fertility

The administration of exogenous testosterone has been reported to suppress spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.

Vogelxo ™ (voh-JELKS-oh), CIII

(testosterone) gel

Read this Medication Guide that comes with Vogelxo before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Vogelxo?

Signs and symptoms of early puberty in a child may include:

• enlarged penis or clitoris
• early development of pubic hair
• increased erections or sex drive
• aggressive behavior

Vogelxo can transfer from your body to others.

Stop using Vogelxo and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to Vogelxo.

Signs and symptoms of exposure to Vogelxo in children may include:

• enlarged penis or clitoris
• early development of pubic hair
• increased erections or sex drive
• aggressive behavior

Signs and symptoms of exposure to Vogelxo in women may include:

• changes in body hair
• a large increase in acne

To lower the risk of transfer of Vogelxo from your body to others, you should follow these important instructions:

• Apply Vogelxo only to the areas of your shoulders and upper arms that will be covered by a short sleeve T-shirt.
• Wash your hands right away with soap and water after applying Vogelxo.
• After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
• If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
• If a woman or child makes contact with the Vogelxo application area, that area on the woman or child should be washed well with soap and water right away.

What is Vogelxo?

Vogelxo is a prescription medicine that contains testosterone. Vogelxo is used to treat adult males who have low or no testosterone due to certain medical conditions.

Your healthcare provider will test your blood before you start and while you are taking Vogelxo.

It is not known if Vogelxo is safe or effective to treat men who have low testosterone due to aging.

It is not known if Vogelxo is safe or effective in children younger than 18 years old. Improper use of Vogelxo may affect bone growth in children.

Vogelxo is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Vogelxo in a safe place to protect it. Never give your Vogelxo to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.

Vogelxo is not meant for use in women.

Who should not use Vogelxo?

Do not use Vogelxo if you:

• have breast cancer
• have or might have prostate cancer
• are pregnant or may become pregnant or are breastfeeding. Vogelxo may harm your unborn or breastfeeding baby.
• Women who are pregnant or who may become pregnant should avoid contact with the area of skin where Vogelxo has been applied.

Talk to your healthcare provider before using this medicine if you have any of the above conditions.

What should I tell my healthcare provider before using Vogelxo?

Before you use Vogelxo, tell your healthcare provider if you:

• have breast cancer
• have or might have prostate cancer
• have urinary problems due to an enlarged prostate
• have heart problems
• have liver or kidney problems
• have problems breathing while you sleep (sleep apnea)
• have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Vogelxo and certain other medicines you take can affect each other.

Especially, tell your healthcare provider if you take:

• insulin
• medicines that decrease blood clotting
• corticosteroids

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Vogelxo?

• It is important that you apply Vogelxo exactly as your healthcare provider tells you to.
• Your healthcare provider will tell you how much Vogelxo to apply and when to apply it.
• Your healthcare provider may change your Vogelxo dose. Do not change your Vogelxo dose without talking to your healthcare provider.
• Vogelxo is to be applied only to the areas of your shoulders and upper arms that will be covered by a short sleeve t-shirt. Do not apply Vogelxo to any other parts of your body such as your penis, scrotum, or stomach area (abdomen).
• Apply Vogelxo at the same time each day. Vogelxo should be applied after showering or bathing.
• Wash your hands right away with soap and water after applying Vogelxo.
• Avoid showering, swimming, or bathing for at least 2 hours after you apply Vogelxo.
• Vogelxo is flammable until dry. Let Vogelxo dry before smoking or going near an open flame.
• Let the application areas dry before putting on a t-shirt.

Applying Vogelxo:

Vogelxo comes in tubes, packets, or in a pump.

• Before applying Vogelxo, make sure that your shoulders and upper arms are clean, dry, and there is no broken skin.
• The application sites for Vogelxo are the shoulders and the upper arms that will be covered by a short sleeve t-shirt (See Figure A).

If you are using Vogelxo tubes:

• Remove the cap from the tube and use the top of the cap to puncture the metal seal on the top of the tube.
• Squeeze from the bottom of the tube to the top.
• Squeeze all of the Vogelxo out of the tube into the palm of your hand.
• Apply Vogelxo to the application site. Rub the gel onto your skin for several seconds. Let the application site dry for a few minutes before putting on a T-shirt.
• Wash your hands with soap and water right away.
• Put the cap back on the tube.

If you are using Vogelxo packets:

• Tear open the packet completely at the notch on the top edge. Squeeze from the bottom of the packet to the top.
• Squeeze all of the Vogelxo out of the packet into the palm of your hand. Apply Vogelxo to the application site. Rub the gel onto your skin for several seconds. Let the application site dry for a few minutes before putting on a T-shirt.
• Wash your hands with soap and water right away.

If you are using the Vogelxo pump:

• Before using a new bottle of Vogelxo for the first time, you will need to prime the pump. To prime the Vogelxo pump, remove the cap and slowly push the pump all the way down 3 times.
• Do not use any Vogelxo that came out while priming. Wash it down the sink to avoid accidental exposure to others. Your Vogelxo pump is now ready to use.
• Remove the cap from the pump. Then position the nozzle over the palm of your hand and slowly push the pump all the way down. Your healthcare provider will tell you the number of times to press the pump for each dose.
• Apply Vogelxo to the application site. Rub the gel onto your skin for several seconds. Let the application site dry for a few minutes before putting on a T-shirt.
• Wash your hands with soap and water right away.
• Put the cap back on the pump.

What are the possible side effects of Vogelxo?

Vogelxo can cause serious side effects including:

• See "What is the most important information I should know about Vogelxo?"
• If you already have enlargement of your prostate gland your signs and symptoms can get worse while using Vogelxo. This can include:
  • increased urination at night
  • trouble starting your urine stream
  • having to pass urine many times during the day
  • having an urge that you have to go to the bathroom right away
  • having a urine accident
  • being unable to pass urine or weak urine flow
• Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use Vogelxo.
• Blood clots in your legs or lungs. Signs and symptoms of a blood clot in your legs can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Possible increased risk of heart attack or stroke.
• In large doses Vogelxo may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure.
• Enlarged or painful breasts.
• Having problems breathing while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of Vogelxo include:

• skin irritation where Vogelxo is applied
• increased red blood cell count
• headache
• increased blood pressure

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vogelxo. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Vogelxo?

• Store Vogelxo between 68ºF to 77ºF (20ºC to 25ºC).
• Safely throw away used Vogelxo containers in household trash. Be careful to prevent accidental exposure of children or pets.
• Keep Vogelxo away from fire.

Keep Vogelxo and all medicines out of the reach of children.

General information about the safe and effective use of Vogelxo.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vogelxo for a condition for which it was not prescribed. Do not give Vogelxo to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Vogelxo. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Vogelxo that is written for health professionals.

For more information, go to www.upsher-smith.com or call 1-888-650-3789.

What are the ingredients in Vogelxo?

Active ingredient: testosterone

Inactive ingredients: carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by
UPSHER-SMITH LABORATORIES, INC.
Maple Grove, MN 55369

MADE IN CANADA

Revised 0515

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