Testosterone
Testosterone · Say it: tes-TOS-ter-one
A testosterone gel that men with low or missing testosterone from certain medical conditions rub onto the shoulders and upper arms once a day.
Brand names: VogelxoTestopel
⬛ Boxed warning (the FDA's strongest warning)
The boxed warning is about secondary exposure to testosterone. Children who touch the gel on a man's skin, or who have skin contact with a man using it, can develop virilization (signs of male development such as enlarged genitals or body hair). Children should avoid contact with the application site on men who use this gel, especially if the site is unwashed or not covered by clothing. Healthcare providers should tell patients to follow the instructions for use strictly.
Used for
The label says it is used as replacement therapy in adult men who have a deficiency or absence of testosterone. This includes primary hypogonadism, where the testicles do not make enough testosterone, and hypogonadotropic hypogonadism, where the pituitary or hypothalamus does not send the right signals. The label says safety and effectiveness have not been established for age-related (late-onset) low testosterone or for males under 18.
Comes as
Metered-dose pump of 1.62% testosterone gel for topical use; Each pump press (actuation) delivers 20.25 mg of testosterone in 1.25 g of gel
Common side effects
The most common side effect in the clinical trial was an increase in prostate specific antigen (PSA), seen in about 11% of men on the gel versus none on placebo., In the trial, emotional lability (mood swings) was reported in about 2.6% of men on the gel., High blood pressure (hypertension) was reported in about 2.1% of men on the gel.
| Generic name | Testosterone |
|---|---|
| Brand names | Vogelxo, Testopel |
| Type of medicine | An androgen, which is a male hormone medicine |
| How it is sold | Topical gel applied to the skin (transdermal), sold in a metered-dose pump |
| Comes as | Metered-dose pump of 1.62% testosterone gel for topical use; Each pump press (actuation) delivers 20.25 mg of testosterone in 1.25 g of gel; The label describes an 88 g pump |
| Route | transdermal |
| Boxed warning | Yes, see below |
| Label date | 2026-05-12 |
💊 What is Testosterone used for?
- The label says it is used as replacement therapy in adult men who have a deficiency or absence of testosterone. This includes primary hypogonadism, where the testicles do not make enough testosterone, and hypogonadotropic hypogonadism, where the pituitary or hypothalamus does not send the right signals. The label says safety and effectiveness have not been established for age-related (late-onset) low testosterone or for males under 18.
How it works
The label describes testosterone as an androgen (a male hormone) that is used to replace testosterone the body is not making in enough amounts. The label does not describe the details of how it works in the body.
How it is usually taken
- The label says to apply the gel once a day in the morning, after showering or bathing. Apply it only to clean, dry, unbroken skin on the shoulders and upper arms. Do not apply it to the abdomen, genitals, chest, armpits, or knees. Wash your hands with soap and water right after applying it. After the gel has dried, cover the area with clothing. Your prescriber sets the number of pump presses and may change the dose based on blood tests. Do not change the dose without talking to your prescriber. Wash the application area with soap and water before any skin-to-skin contact with another person.
Comes as
- Metered-dose pump of 1.62% testosterone gel for topical use
- Each pump press (actuation) delivers 20.25 mg of testosterone in 1.25 g of gel
- The label describes an 88 g pump
⚠️ Testosterone side effects
Common side effects
- The most common side effect in the clinical trial was an increase in prostate specific antigen (PSA), seen in about 11% of men on the gel versus none on placebo.
- In the trial, emotional lability (mood swings) was reported in about 2.6% of men on the gel.
- High blood pressure (hypertension) was reported in about 2.1% of men on the gel.
- Women or children who touch the gel may have changes in body hair or a rise in acne.
Get medical help right away if
- Get medical help right away if a child or woman shows signs of exposure, such as enlarged penis or clitoris, early pubic hair growth, erections or sexual urges, aggressive or angry behavior, changes in body hair, or more acne. Stop using the gel and call your healthcare provider right away.
- Get medical help right away if you have signs of a blood clot in the leg, such as leg pain, swelling, or redness.
- Get medical help right away if you have signs of a blood clot in the lungs, such as trouble breathing or chest pain.
- Tell your healthcare provider if you have a worsening of prostate symptoms, such as night-time urination, trouble starting urination, a weak stream, or being unable to pass urine.
- Tell your healthcare provider if your blood pressure rises. The label says testosterone can increase blood pressure and that it is not recommended for men with uncontrolled high blood pressure.
- Tell your healthcare provider about swelling (edema), since the label says it may be a complication in people with heart, kidney, or liver disease.
🛑 Who should not take Testosterone, and who should be careful
The label says not to take it if
- You have breast cancer.
- You have or might have prostate cancer.
- You are a woman. The label says the medicine is not meant for use in women.
- You are pregnant. The label says it may harm an unborn baby.
Tell your doctor before taking it if
- Your healthcare provider will test your blood before you start and during use.
- Tell your provider if you have breast cancer, prostate cancer or might have it, urinary problems from an enlarged prostate, heart problems, high blood pressure, kidney or liver problems, or sleep apnea.
- Tell your provider about all medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
- The label says the gel is flammable until it dries.
🔀 Testosterone with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- Androgens may lower blood sugar and may lower insulin needs in people with diabetes. Insulin use may need to be watched.
- Changes in anticoagulant (blood-thinner) activity may happen. The label recommends more frequent INR and prothrombin time checks, especially when starting or stopping treatment.
- Using testosterone with corticosteroids or ACTH may cause fluid retention, so use requires careful monitoring, especially in people with heart, kidney, or liver disease.
Alcohol and food
The label does not give advice about drinking alcohol or eating with this medicine. The gel itself contains ethyl alcohol and is flammable until dry.
🤰 Testosterone in pregnancy and breastfeeding
Pregnancy
The label says this medicine is contraindicated in pregnant women. Testosterone may cause fetal harm, and it can cause virilization of a female fetus. Pregnant women should avoid contact with the area of skin where the gel has been applied.
Breastfeeding
The label does not say.
🗓️ Storage, missed doses and taking too much
Storage
Store at controlled room temperature, 68 to 77 degrees F (20 to 25 degrees C). Short excursions from 59 to 86 degrees F are permitted. The label describes this medicine as a controlled substance (CIII), so keep it in a safe place and never give it to anyone else.
If a dose is missed
The label does not say.
If too much is taken
The label reports one case of acute overdose from a different testosterone product given by injection, with very high testosterone levels linked to a stroke. There were no overdose reports in the gel trial. The label says treatment would include stopping the medicine, washing the application site with soap and water, and supportive care.
🗒️ Questions to ask about Testosterone
🎯 Check what you understood
1. Where does the label say this gel should be applied?
2. Which group is this medicine NOT meant for?
3. What does the label say to do if a child touches the area where the gel was applied?
❓ Testosterone: frequently asked questions
What is testosterone gel used for?
The label says it is used to replace testosterone in adult men who have low or missing testosterone from certain medical conditions. It is not established as safe or effective for age-related low testosterone or for children under 18.
Why is there a warning about children and women?
The boxed warning says children and women can develop virilization after secondary exposure to the gel. Children should avoid contact with unwashed or unclothed application sites on men who use the gel.
Where should I put the gel on my body?
The label says to apply it only to the shoulders and upper arms, and not to the abdomen, genitals, chest, armpits, or knees. The area should be covered with clothing after the gel dries.
Can pregnant women use testosterone gel?
No. The label says it is contraindicated in pregnant women and may cause fetal harm. Pregnant women should avoid contact with the area where the gel has been applied.
🧪 Tests and reports linked to Testosterone
The label text mentions these. If you have one of these reports, get every line of it explained.
- HbA1c and glucose
a test or report linked to this medicine
- Metabolic panel (BMP, CMP)
a test or report linked to this medicine
- Kidney function tests
a test or report linked to this medicine
- Clotting tests (PT, INR)
a test or report linked to this medicine
- Complete blood count (CBC)
a test or report linked to this medicine
- Liver function tests
a test or report linked to this medicine
📖 Medical words used on this page
- Acute vs chronic
Acute means something started recently or suddenly. Chronic means it has lasted a long time or keeps coming back.
- Angina
Angina is chest pain or tightness caused by the heart muscle not getting enough blood and oxygen, usually from narrowed heart arteries.
- Anticoagulant
An anticoagulant is a medicine that slows blood clotting, used to prevent or treat harmful clots. It raises the risk of bleeding.
- Benign prostatic hyperplasia
Benign prostatic hyperplasia (BPH) is non-cancerous growth of the prostate gland, common with age, which can make passing urine harder.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- Contraindication
A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.
- Controlled substance
A controlled substance is a medicine or drug whose making, prescribing and supply are tightly regulated by law because it can be misused or cause dependence.
- Corticosteroid
A corticosteroid is a medicine similar to the body's own hormone cortisol, used to reduce inflammation and calm the immune system.
- Deep vein thrombosis
Deep vein thrombosis (DVT) is a blood clot in a deep vein, usually in the leg, which can cause swelling and pain and needs prompt medical care.
- Edema
Edema is swelling caused by extra fluid trapped in the body's tissues, often in the feet, ankles and legs.
- Exacerbation
An exacerbation is a flare-up: a period when a long-term condition, such as asthma, COPD or hepatitis, suddenly gets worse.
- Hypertension
Hypertension means high blood pressure: the force of blood against artery walls stays higher than it should over time.
- Hypogonadism
Hypogonadism means the testes or ovaries make too little of their sex hormones, such as testosterone or estrogen.
- INR (International Normalized Ratio)
INR is a standardised measure of how long your blood takes to clot, often used to check blood-thinning medicines such as warfarin.
📖 Medical words on this page
⚖️ Compare
Have the leaflet or prescription in front of you?
Explain my leafletDecode my prescription🔗 Trusted sources about Testosterone
- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Testosterone on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Search the NHS website for Testosterone ↗
UK National Health Service
Report a side effect or check safety alerts
- Report a side effect in the US (FDA MedWatch) ↗
- Report a side effect in the UK (Yellow Card) ↗
- FDA recalls and safety alerts ↗
Explain your own documents
Source: official FDA drug label (label updated 2026-05-12). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.