This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [see Dosage and Administration ( 2.2 )]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [see Dosage and Administration ( 2.2 )]. Limitations of Use Safety and efficacy of TLANDO in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “lat...
is contraindicated in: Patients 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 )] . Known hypersensitivity to testosterone undecanoate or any of TLANDO’s ingredients [see Description ( 11 )]. Carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 ) Women who are pregnant. Testosterone may cause fetal harm ( 4 , 5.6 , 8.1 ) Hypersensitivity to TLANDO or any of its ingredients ( 4 )
Polycythemia : Monitor hematocrit approximately every 3 months during the first year after beginning TLANDO and then every 6 months thereafter during treatment. Discontinue TLANDO if necessary ( 5.1 ). Venous thromboembolism (VTE) : VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Discontinue TLANDO if VTE is suspected and initiate appropriate workup and management ( 5.2 ). Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer : Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Evaluate patients for prostate cancer, including monitoring prostate specific antigen (PSA) prior to initiating and during treatment with androgens ( 5.3 ) Blood Pressure Increases: TLANDO can increase blood pressure, which can increase cardiovascular risk over time. Measure blood pressure periodically. Not recommended for use in men with uncontrolled hypertension ( 5.4 ) Abuse of Testosterone and Monitoring of Serum Testosterone : If testosterone use at doses higher than recommended for the approved indication and in combination with other anabol...
Most common adverse reactions (incidence ≥ 2%): increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Verity Pharma at 1-844-837-4891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following clinically significant adverse reactions are discussed elsewhere in the labeling: Polycythemia [see Warnings and Precautions ( 5.1 )] Venous Thromboembolism [see Warnings and Precautions ( 5.2 )] Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer [see Warnings and Precautions ( 5.3 )] Blood Pressure Increases [see Warnings and Precautions ( 5.4 )] Hepatic Adverse Effects [see Warnings and Precautions ( 5.8 )] Edema [see Warnings and Precautions ( 5.9 )] Sleep Apnea [see Warnings and Precautions ( 5.10 )] Gynecomastia [see Warnings and Precautions ( 5.11 )] Lipid Changes [see Warnings and Precautions ( 5.12 )] Hypercalcemia [see Warnings and Precautions ( 5.13 )] Decreased Thyroxine-binding Globulin [see Warnings and Precautions ( 5.14 )] Increases in Prolactin [see Warnings and Precautions ( 5.15 )] 6....
RECENT MAJOR CHANGES SECTION Boxed Warnings, Blood Pressure Increases Removed 07/2025 Indications and Usage, Limitations of Use ( 1 ) 07/2025 Contraindications, Men with “age related hypogonadism” (4) Removed 07/2025 Warnings and Precautions, Venous Thromboembolism ( 5.2 ) 07/2025 Warnings and Precautions, Blood Pressure Increases ( 5.4 ) 07/2025 Warnings and Precautions, Cardiovascular Risk (5.4) Removed 07/2025
Source: FDA SPL label for Tlando (Verity Pharmaceuticals Inc.), effective 20260225. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 3,301 | 3,040 | 2,622 | 2,523 | 2,692 | 2,649 | 3,183 | 1,559 |
4,236 reports blaming this drug for every million Medicare prescriptions filled, which is 1.5× the typical drug on this site. (7,371 reports in 2024–2026, against 1,740,041 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 11/2025 | Class III | Teva Pharmaceuticals USA, Inc | Defective Container - A defect in the side-seal which allows leakage of product. |
| 04/2025 | Class II | Eugia US LLC | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. |
| 03/2025 | Class II | Strides Pharma, Inc. | Presence of foreign substance: Presence of Benzene. |
| 03/2025 | Class II | Strides Pharma, Inc. | Presence of foreign substance: Presence of Benzene. |
| 08/2024 | Class II | Teva Pharmaceuticals USA, Inc | Superpotent Drug |
| 11/2023 | Class III | Teva Pharmaceuticals USA, Inc | OOS for viscosity |
| 02/2023 | Class II | Azurity Pharmaceuticals, Inc. | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. |
| 06/2022 | Class II | Teva Pharmaceuticals USA Inc | Superpotent Drug: Out of specification assay result was obtained during stability testing. |
| 06/2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | cGMP - Water leakage |
| 06/2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion |
| 06/2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery. |
| 06/2022 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $819,914 in payments to US physicians and hospitals tied to this drug across 29,367 transactions (Xyosted $482,748, Androgel $101,789, Jatenzo $97,852, Tlando $70,117, Aveed $67,142, Azmiro $266).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Testosterone Cypionate | 1,118,253 | $37 |
| Testosterone | 556,670 | $168 |
| Xyosted | 36,669 | $788 |
| Testosterone Enanthate | 10,421 | $76 |
| Jatenzo | 7,521 | $1,055 |
| Androgel | 3,365 | $1,148 |
| Depo-Testosterone | 2,818 | $58 |
| Testopel | 1,127 | $1,119 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.