Patient Medication Information: uses, side effects, how to take - Jatenzo
What JATENZO is used for:
JATENZO is used in adult men as testosterone replacement therapy when your body is not making enough testosterone. The medical term for this condition is hypogonadism. Your healthcare professional will confirm you have this condition by doing two separate blood testosterone measurements.
How JATENZO works:
JATENZO belongs to a group of medications called androgens. It contains the medicinal ingredient testosterone which helps to raise your blood testosterone to normal levels.
The ingredients in JATENZO are:
Medicinal ingredient: testosterone undecanoate
Non-medicinal ingredients: ammonium hydroxide, borage seed oil, butylated hydroxytoluene, FD&C Yellow #6, gelatin, glycerin, iron oxide red, macrogol, oleic acid, peppermint oil, polyvinyl acetate phthalate, polyoxyl 40 hydrogenated castor oil (Cremophor RH 40), propylene glycol, purified water, sorbitol, titanium dioxide.
Each capsule may also contain lecithin, medium chain triglycerides, and Phosal 53 MCT, which are processing aids (not non-medicinal ingredients) of the drug products.
JATENZO comes in the following dosage forms:
Capsules; 158 mg, 198 mg, and 237 mg
Do not use JATENZO if:
- you are allergic to testosterone, or any of the non-medicinal ingredients in JATENZO (see The ingredients in JATENZO are:)
- you have, or are suspected of having, prostate or breast cancer
- you are a woman. Pregnant women are especially at risk. Testosterone may cause harm to your unborn baby.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JATENZO. Talk about any health conditions or problems you may have, including if you:
- have high blood pressure or are being treated for high blood pressure
- have heart or blood vessel problems or a history of heart attack, stroke or heart failure
- have a blood clotting disorder or have had a blood clot
- have high levels of red blood cells (hematocrit)
- have, or have a family history of, prostate problems, including difficulty urinating due to an enlarged prostate
- have liver or kidney problems
- have cancer
- have a history of mental health problems including suicidal thoughts or actions, depression, anxiety or mood disorders
- have problems breathing while you sleep (sleep apnea), or risk factors for developing sleep apnea such as obesity or lung problems
- are over 65 years of age. You may have a higher risk of having certain side effects.
Other warnings you should know about:
- Age-related hypogonadism: JATENZO is not to be used to treat low levels of testosterone that are age-related. It is only to be used in men who have a medical or genetic reason for their low testosterone levels.
- Drug abuse and dependence: JATENZO contains testosterone, which is a controlled substance. JATENZO has the potential to be abused. You should not use JATENZO in an attempt to improve body composition (i.e. reduce weight and increase muscle) or improve athletic performance as it may cause serious health problems. When taken at higher than prescribed doses, JATENZO can cause serious side effects including potentially fatal heart, liver and mental health problems. Talk to your healthcare professional if you have a history of drug or alcohol abuse or dependence or if you develop symptoms of abuse or dependence while taking JATENZO.
Blood tests and monitoring:
- Your healthcare professional will check your blood testosterone levels before you start taking JATENZO. They will continue to check them regularly while you are being treated with JATENZO to make sure you are taking the correct dose.
- JATENZO can increase your blood pressure. Your healthcare professional will monitor your blood pressure while you are taking JATENZO.
- JATENZO can cause abnormal blood test results. This includes changes to your red blood cell counts, PSA (prostate-specific antigen) levels, liver function and lipid profile. Your healthcare professional will decide when to perform blood tests and will interpret the results.
- Your healthcare professional should check you for prostate cancer or any other prostate problems before you start taking JATENZO. They will monitor the health of your prostate gland during treatment.
Fertility: JATENZO, like other testosterone replacement therapies, can affect your fertility by affecting your testicles and your sperm. It can make you unable to father a child.
- JATENZO can cause testicular atrophy which is a reduction in the size of your testicles.
- JATENZO can affect your sperm production, reduce your sperm count, or cause you to stop making sperm.
- JATENZO is not to be used to treat sexual dysfunction or male infertility.
Benign prostatic hyperplasia (BPH): If you already have an enlarged prostate, your symptoms may worsen while you are taking JATENZO. Talk to your healthcare professional if your BPH symptoms get worse or if you develop new symptoms:
- increased urination at night, change in frequency of urination
- weak stream, dribbling, straining to urinate
- trouble starting your stream, inability to pass urine, passing small amounts of urine
- urinary incontinence
- pain on urination
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with JATENZO:
- insulin and other medicine used to treat diabetes
- medicines used to thin the blood and prevent blood clots, such as warfarin
- corticosteroids, used to treat inflammation and suppress the immune system
- medicines that increase blood pressure such as some cold medicines and pain medicines
How to take JATENZO:
- Take JATENZO exactly as your healthcare professional tells you.
- Take JATENZO by mouth two times daily. Take 1 capsule in the morning and 1 capsule in the evening.
Take JATENZO with food. Swallow the capsules whole, without chewing.
- Your healthcare professional may change your JATENZO dose. Do not change your dose or stop taking JATENZO without talking to your healthcare professional.
Usual dose:
The recommended starting dose for JATENZO is one 237 mg capsule taken twice daily with food, once in the morning and once in the evening. Your healthcare professional will decide on the dose that is right for you.
Overdose:
If you think you, or a person you are caring for, have taken too much JATENZO, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844-POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
Possible side effects from using JATENZO:
These are not all the possible side effects you may have when taking JATENZO. If you experience any side effects not listed here, tell your healthcare professional.
Side effects include:
- burping, nausea, heartburn, diarrhea
- headaches, dizziness
- hot flashes or flushing of the skin
- rash or itching
- confusion
Serious side effects and what to do about them
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Common | |||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations | X | ||
| Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff | X | ||
| Polycythemia (higher than normal levels of all types of blood cells): weakness, tiredness, headache, shortness of breath, sweating at night, itching, vision problems, bleeding, face may be red, blood clots | X | ||
| Prostate problems [including benign prostatic hyperplasia (BPH) and prostate cancer]: enlarged prostate, change in frequency of urination, dribbling, pain on urination, straining, increased urination at night, weak stream, trouble starting your stream, passing small amounts of urine, inability to pass urine, urinary incontinence | X | ||
| Uncommon | |||
| Mood disorders: changes in mood, anxiety, aggressiveness, hostility, irritability, nervousness | X | ||
| Unknown | |||
| Deep vein thrombosis (blood clots in the deep veins of the leg or arm): swelling, pain, arm or leg may be warm to the touch and may appear red | X | ||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide | X | ||
| Gynecomastia (increased breast tissue in one or both breasts): breast enlargement, pain or tenderness, swelling | X | ||
| Liver problems: nausea, vomiting, yellowing of your skin or eyes (jaundice), dark urine, pale stool, right upper stomach pain or swelling, unusual tiredness | X | ||
Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint, irregular heartbeat | X | ||
| Pulmonary embolism (blood clot in the lung): chest pain that may increase with deep breathing, cough, coughing up bloody sputum, shortness of breath | X | ||
| Sleep apnea: stop breathing for short periods during your normal nightly sleep | X | ||
| Stroke: sudden numbness or weakness of your arm, leg, face, especially if only on one side of the body, sudden confusion, difficulty speaking or understanding others, sudden difficulty walking or loss of balance and coordination, dizziness, sudden severe headache with no known cause | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store at room temperature (20°C to 25°C).
- Protect from moisture.
- Avoid refrigerated storage (2°C to 8°C).
Keep out of reach and sight of children.
If you want more information about JATENZO:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.tolmar.ca), or by calling 1-844-986-5627.
Date of Authorization: DEC 12, 2025