Testosterone Undecanoate — uses, dosing, side effects & the brands that sell it · pharmaranks
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.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Androgen
Treats
Breast Neoplasms, Hypogonadism and Delayed Puberty
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…
Testosterone Undecanoate 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…
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.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Testosterone Undecanoate pill imprints
Imprint
Strength
Colour
Shape
Maker
112
112.5 mg
white
capsule
—
MP100
100 mg
white
capsule
—
MP150
150 mg
white
capsule
—
MP200
200 mg
white
capsule
—
158
158 mg
red
capsule
—
198
198 mg
Frequently asked questions
What is testosterone undecanoate?
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. Testosterone undecanoate is chemically described as 17β-hydroxyandrost-4-en-3-one undecanoate. It has the empirical formula of C 30 H 48 O 3 and the molecular weight of 456.7. The structural formula for testosterone undecanoate is presented in Figure 1. Figure 1: Testosterone Undecanoate JATENZO capsules are available in three strengths of 158 mg, 198 mg, and 237 mg. The 158 mg strength is an opaque red capsule that contains 158 mg of testosterone undecanoate and is imprinted with “158” in white ink. The 198 mg strength is an opaque white capsule that contains 198 mg of testosterone undecanoate and is imprinted with “198” in red ink. The 237 mg strength is an opaque orange capsule that contains 237 mg of testosterone undecanoate and is imprinted with “237” in white ink. All capsule strengths also contain oleic acid, polyoxyl 40 hydrogenated castor oil (Cremophor RH 40), borage seed oil, peppermint oil, and butylated hydroxytoluene as inactive ingredients. Gelatin capsule shells are composed of the following inactive ingredients:…
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.
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.
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.
Who shouldn’t take testosterone undecanoate
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 ).
Testosterone Undecanoate 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…
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.