Testosterone Undecanoate: uses, dosing, side effects & brands
Testosterone Undecanoate is an androgen sold in the U.S. under 3 brand and generic names, for breast neoplasms, hypogonadism and delayed puberty. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Androgen
- Treats (across its forms)
- Breast Neoplasms, Hypogonadism and Delayed Puberty
- Available as
- Capsule · Injectable
- Sold as
- 3 products — Jatenzo, Aveed and Tlando
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Half-life
- about 10 to 100 minutes
- Boxed warning
- Boxed warning
How Jatenzo is dosed
From the FDA label for Jatenzo (application NDA206089). Other testosterone undecanoate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Prior to initiating JATENZO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2.1 ). Take JATENZO with food ( 2.2 ). Starting dose: 237 mg orally once in the morning and once in the evening. Adjust the dose to a minimum of 158 mg twice daily and a maximum of 396 mg twice daily based on serum testosterone drawn 6 hours after the morning dose at least 7 days after starting treatment or following dose adjustment and periodically thereafter ( 2.2 ). 2.1 Confirmation of Hypogonadism Before Initiation of JATENZO Prior to initiating JATENZO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these testosterone concentrations are below the normal range. 2.2 Dosing and Dose Adjustment Information Individualize the dosage of JATENZO based on the patient's serum testosterone concentration response to the drug. The recommended starting dose is 237 mg taken orally twice daily, once in the morning and once in the evening. Take JATENZO with food. Dose Adjustment To ensure proper dose adjustment, measure serum testosterone concentrations 6 hours after the morning dose in plain tubes, clotted at room temperature for 30…
Everything below is the FDA label for Jatenzo (capsule). Testosterone Undecanoate is also sold as injectable, and those are different medicines to take — follow the label for the one you were prescribed.
Jatenzo side effects
Most common adverse reactions (incidence > 2%): polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, and hypertension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Tolmar, Inc. at 1-844-4TO-LMAR or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of JATENZO was evaluated in a randomized, controlled clinical study with 166 patients treated with JATENZO twice daily with morning and evening meals for approximately 4 months. All patients were started on 237 mg twice daily, then the dose was titrated to 158 mg, 198 mg, 316 mg, or 396 mg twice daily to achieve testosterone concentrations in the eugonadal range. Table 2 summarizes adverse reactions (≥2%) reported in this 4-month study. Table 2: Number (%) of Patients with Adverse Reactions ≥ 2% in a 4-Month Study with JATENZO Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the following adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased…
Who shouldn’t take Jatenzo
JATENZO is contraindicated in: Men with carcinoma of the breast or known or suspected carcinoma of the prostate [ see Warnings and Precautions ( 5.3 ) ]. Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [ see Use in Specific Populations ( 8.1 ) ]. Men with known hypersensitivity to JATENZO or any of its ingredients [ see Description ( 11 ) ]. Men with breast cancer or known or suspected prostate cancer ( 4 , 5.3 ). Women who are pregnant. Testosterone may cause fetal harm ( 4 , 5.6 , 8.1 , 8.2 ). Known hypersensitivity to JATENZO or any of its ingredients ( 4 ).
Jatenzo drug interactions
Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients ( 7.1 ). Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended in patients taking warfarin ( 7.2 ). Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ). Concomitant administration of medications that are known to increase blood pressure may lead to additional increases in blood pressure when used with JATENZO ( 7.4 ). 7.1 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, may necessitate a decrease in the dose of anti-diabetic medication. 7.2 Oral Vitamin K Antagonist Anticoagulants Changes in anticoagulant activity may be seen with androgens; therefore, more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy. 7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease. 7.4 Medications that May Also Increase Blood Pressure Some prescription medications and nonprescription analgesic and cold medications contain drugs known to increase blood pressure. Concomitant administration of these medications with JATENZO may lead to additional increases in blood pressure [see Warnings and Precautions ( 5.4 )].
Every testosterone undecanoate product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 3 | Not yet rated | Prescription | Capsule | No data | — | View → |
What testosterone undecanoate pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
How long testosterone undecanoate keeps
No testosterone undecanoate label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
What people report to the FDA about testosterone undecanoate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 241 reports naming testosterone undecanoate, and the FDA flagged 94% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- atrial fibrillation10 reports
- asthma9 reports
- duodenal ulcer9 reports
- erectile dysfunction9 reports
- pain in extremity9 reports
- weight decreased9 reports
- erosive duodenitis8 reports
- faeces discoloured8 reports
Read these as a signal, not a rate. A report does not mean testosterone undecanoate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 26, 2026.
How long testosterone undecanoate stays in your system
The elimination half-life of testosterone undecanoate is about 10 to 100 minutes. This is the half-life of the natural testosterone hormone itself. The FDA label notes "considerable variation... ranging from 10 to 100 minutes," reflecting how quickly free testosterone is cleared. Two caveats matter for "how long it stays in your system": (1) Formulation dominates. Injectable esters are slow-release depots that far outlast the hormone's own half-life — testosterone cypionate ~8 days, enanthate ~4.5 days, undecanoate weeks — and oral testosterone undecanoate (Jatenzo, Kyzatrex) is a prodrug cleaved to testosterone. The 10-100 minute figure is the hormone's intrinsic clearance, not the duration of a shot. (2) Testosterone converts to active metabolites — dihydrotestosterone (DHT) and estradiol — that circulate on their own timelines. Inactivation occurs primarily in the liver, so hepatic impairment can slow clearance; ~90% is excreted in urine as conjugates. Half-life is not the drug-test detection window: anti-doping tests use the testosterone/epitestosterone ratio and isotope analysis and can flag use for far longer than clearance of the hormone.
AndroGel (testosterone gel) FDA label, DailyMed — Clinical Pharmacology ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Jatenzo?
JATENZO (testosterone undecanoate) for oral use is provided as a gelatin capsule containing testosterone undecanoate, a fatty-acid ester of testosterone. Testosterone undecanoate is a white to off-white yellow crystalline powder. Testosterone, an androgen, is formed by cleavage of the ester side chain of testosterone undecanoate.
What kind of drug is testosterone undecanoate?
The FDA classifies testosterone undecanoate as an androgen. Androgens such as testosterone are male sex hormones that enter cells and bind the androgen receptor, switching on genes that drive male traits, muscle and bone growth, and reproductive function. Some testosterone is also converted in tissues to the more potent DHT. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does testosterone undecanoate stay in your system?
The elimination half-life of testosterone undecanoate is about 10 to 100 minutes — that is how long the body takes to clear half of a dose. This is the half-life of the natural testosterone hormone itself. The FDA label notes "considerable variation... ranging from 10 to 100 minutes," reflecting how quickly free testosterone is cleared. Two caveats matter for "how long it stays in your system": (1) Formulation dominates. Injectable esters are slow-release depots that far outlast the hormone's own half-life — testosterone cypionate ~8 days, enanthate ~4.5 days, undecanoate weeks — and oral testosterone undecanoate (Jatenzo, Kyzatrex) is a prodrug cleaved to testosterone. The 10-100 minute figure is the hormone's intrinsic clearance, not the duration of a shot. (2) Testosterone converts to active metabolites — dihydrotestosterone (DHT) and estradiol — that circulate on their own timelines. Inactivation occurs primarily in the liver, so hepatic impairment can slow clearance; ~90% is excreted in urine as conjugates. Half-life is not the drug-test detection window: anti-doping tests use the testosterone/epitestosterone ratio and isotope analysis and can flag use for far longer than clearance of the hormone. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take testosterone undecanoate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run testosterone undecanoate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is testosterone undecanoate sold under?
We track 3 testosterone undecanoate-containing products in the U.S.: Jatenzo, Aveed and Tlando. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does testosterone undecanoate come in?
Across the brands we track, testosterone undecanoate is currently marketed as capsule and injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic testosterone undecanoate?
We do not currently list a generic-labelled testosterone undecanoate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Testosterone Undecanoate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/testosterone-undecanoate
- MLA
- “Testosterone Undecanoate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/testosterone-undecanoate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for testosterone undecanoate on DailyMed (NIH) ↗ — including its boxed warning in full.