Short answer: The Tlando label has no placebo group in its own trials. In a 4-month study of 138 men, the most common reactions were high blood pressure (5.1%), increased hematocrit (4.3%) and upper respiratory infection (3.6%). In a 24-day study of 95 men, blood prolactin rose in 6.3%. Mean 24-hour blood pressure went up 4.3/1.4 mmHg. Tlando has no boxed warning.
What Tlando is approved for: Tlando is approved as testosterone replacement in adult males with low or absent natural testosterone due to primary hypogonadism (testicular failure) or hypogonadotropic hypogonadism (a pituitary or hypothalamus cause). The label says safety and effectiveness have not been established in males under 18 or in men with age-related ("late-onset") hypogonadism (section 1).
Source
TLANDO (testosterone undecanoate) capsules, for oral use, CIII, prescribing information and Medication Guide. Verity Pharmaceuticals. DailyMed, version published March 12, 2026. DailyMed setid 4b0b92e9-6d3c-a0e5-e1c7-342999f72580
No. The current Tlando label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Tlando.
| Adverse Reaction | Overall (N=138) n (%) |
|---|---|
| Hypertension | 7 (5.1) |
| Hematocrit increased | 6 (4.3) |
| Upper respiratory tract infection | 5 (3.6) |
Study 18-001 was an uncontrolled (no placebo) blood pressure monitoring study of 138 men with hypogonadism who took Tlando 225 mg twice daily with morning and evening meals for about four months. Median age was 54; 70% were obese and 48% had a history of high blood pressure.
| Adverse Reaction | Overall (N=95) n (%) |
|---|---|
| Blood prolactin increased | 6 (6.3) |
| Weight increased | 2 (2.1) |
| Headache | 2 (2.1) |
| Musculoskeletal pain | 2 (2.1) |
Study 16-002 treated 95 men with hypogonadism with Tlando 225 mg twice daily with morning and evening meals for about 24 days, without changing the dose. Median age was 56; 70% were obese and 50% had a history of high blood pressure.
In Study 18-001, 4 of 138 men (2.9%) stopped early because of side effects: dizziness (1), weight gain (1), trouble sleeping (1) and high blood pressure (2). In the 24-day study, 1 of 95 (1.1%) stopped because of a bleeding stomach ulcer.
In 123 men with usable 24-hour blood pressure recordings, mean systolic pressure rose 4.3 mmHg and diastolic 1.4 mmHg after about 16 weeks. In men with a history of high blood pressure the rise was 4.8/1.6 mmHg (n=60); in men without, 3.9/1.2 mmHg (n=63).
Mean serum prolactin rose 7.0 ng/mL from baseline in the 24-day study (n=93). The 4-month study did not check prolactin after screening.
In TRAVERSE, a heart-outcomes trial of a testosterone gel (not Tlando) in 5198 men aged 45 to 80, major heart events occurred in 7.0% on the gel and 7.3% on placebo. Irregular heart rhythms needing treatment (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%) and bone fracture (3.5% vs 2.5%) were more common on the gel.
After approval, heart attack, stroke and blood clots in the veins have been reported with testosterone replacement products; the label says the frequency cannot be reliably estimated.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Polycythemia (high red blood cells). Testosterone can raise hematocrit, which may raise the risk of blood clots. Hematocrit is checked before starting, about every 3 months in the first year and every 6 months after. If it is high, Tlando is stopped until it comes down, and stopped permanently if it rises again after restarting.
Blood clots in the veins. Deep vein thrombosis and pulmonary embolism have been reported with testosterone products. In TRAVERSE, the testosterone gel had a numerically higher rate of clots than placebo (1.7% vs 1.2%). Tlando is stopped if a clot is suspected.
Enlarged prostate and prostate cancer risk. Men with an enlarged prostate (BPH) may have worse urinary symptoms on androgens, and androgens may raise prostate cancer risk. The label says men are checked for prostate cancer, including PSA, before and during treatment.
Blood pressure increases. Tlando can raise blood pressure, which can raise heart risk over time. Blood pressure is checked periodically, and Tlando is not recommended with uncontrolled high blood pressure.
Abuse. Testosterone has been abused at doses above those approved, often with other anabolic steroids, which can cause serious heart and mental health problems.
Not for use in women. Tlando is not approved for women because of a lack of studies and the risk of masculinizing effects.
Effects on sperm production. Large doses of androgens, including Tlando, may suppress sperm production and lower sperm count.
Liver effects. Tlando is not the 17-alpha-alkyl type of androgen linked to serious liver problems, but the label says signs of liver trouble such as jaundice should be reported, and Tlando is stopped while the cause is checked.
Edema (swelling). Androgens can cause salt and water retention. Swelling, with or without heart failure, can be serious in people with existing heart, kidney or liver disease.
Sleep apnea. Testosterone may worsen sleep apnea, especially in people with obesity or chronic lung disease.
Gynecomastia. Breast enlargement may develop and persist.
Lipid changes. Blood fats can change; the lipid profile is checked periodically, and cholesterol medicines may need adjusting.
High calcium. Androgens are used with caution in cancer patients at risk of high blood calcium, with calcium checked periodically.
Thyroid lab changes. Androgens may lower thyroxine-binding globulin and total T4 on lab tests, but free thyroid hormone stays the same and there is no sign of thyroid disease.
Prolactin increases. Prolactin rose in Tlando trials. It is checked before starting and again 3 to 4 months later, and Tlando is stopped if it stays high.
From the Medication Guide that comes with Tlando:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.