{ "query": "testosterone", "ingredient": "testosterone", "slug": "testosterone", "rxcui": "10379", "brands": [ "Xyosted", "Jatenzo", "Androgel", "Depo-testosterone", "Testopel", "Testim", "Aveed", "Tlando", "Natesto", "Azmiro", "Fortesta", "Kyzatrex", "Undecatrex", "Vogelxo" ], "names": [ "testosterone", "testosterone (micronized)", "testosterone cypionate", "testosterone decanoate", "testosterone enanthate", "testosterone isocaproate", "testosterone propionate", "testosterone undecanoate" ], "classes": [ { "id": "G03BA", "name": "3-oxoandrosten (4) derivatives" } ], "alternatives": [ "fluoxymesterone", "methyltestosterone" ], "label": { "route_mode": "ORAL", "route_counts": { "INTRAMUSCULAR": 43, "ORAL": 31, "TOPICAL": 18, "TRANSDERMAL": 17, "SUBLINGUAL": 5, "SUBCUTANEOUS": 2, "NASAL": 1 }, "boxed_warning": "", "indications_and_usage": "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 \u201cage-related hypogonadism\u201d (also referred to as \u201clat...", "contraindications": "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\u2019s 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 )", "warnings_and_cautions": "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...", "warnings": "", "adverse_reactions": "Most common adverse reactions (incidence \u2265 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....", "drug_abuse_and_dependence": "9.1 Controlled Substance TLANDO contains testosterone undecanoate, a schedule III controlled substance. 9.2 Abuse Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression. The following adverse reactions have also been reported in men: transient ische...", "controlled_substance": "9.1 Controlled Substance TLANDO contains testosterone undecanoate, a schedule III controlled substance.", "recent_major_changes": "RECENT MAJOR CHANGES SECTION Boxed Warnings, Blood Pressure Increases Removed 07/2025 Indications and Usage, Limitations of Use ( 1 ) 07/2025 Contraindications, Men with \u201cage related hypogonadism\u201d (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", "information_for_patients": "Advise the patients to read the FDA-approved patient labeling ( Medication Guide ). Polycythemia Advise patients that TLANDO can cause an increase in hematocrit levels that may increase the risk of thromboembolic events. Advise patients about the importance of completing laboratory testing as instructed by their health care provider while on TLANDO [see Warnings and Precautions ( 5.1 )]. Venous Thromboembolism Advise patients that TLANDO can cause venous thromboembolism. Advise patients of the signs and symptoms of venous thromboembolism, which may include the following: lower limb pain, edema, or erythema; and dyspnea or chest pain. Advise patients to promptly report the signs and symptoms of venous thromboembolism, discontinue use of TLANDO and seek urgent medical care [see Warnings and Precautions ( 5.2 )] . Blood Pressure Increases Advise patients that TLANDO can increase blood pressure (BP) which can increase cardiovascular risk over time. Advise patients about the importance of monitoring BP periodically while on TLANDO. If BP increases while on TLANDO, antihypertensive medications may need to be started, added, or adjusted to control BP, or TLANDO may need to be discontinued...", "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 02/2026 MEDICATION GUIDE TLANDO \u00ae (Tee-lan-doh) (testosterone undecanoate) capsules, for oral use CIII What is TLANDO? TLANDO is a prescription medicine that contains testosterone. TLANDO is used to treat adult men who have low or no testosterone due to certain medical conditions. It is not known if TLANDO is safe or effective in children younger than 18 years old. Improper use of TLANDO may affect bone growth in children. TLANDO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your TLANDO in a safe place to protect it. Never give your TLANDO to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law. TLANDO is not meant for use by women. Do not take TLANDO if you: have breast cancer. have or might have prostate cancer. are a woman who is pregnant. TLANDO may harm your unborn baby. are allergic to TLANDO or any ingredients in TLANDO. See the end of this Medication Guide for a complete list of ingredients in TLANDO. have low testos...", "clinical_studies": "The efficacy and safety of TLANDO was evaluated in Study 16-002 a multicenter, open-label, single-arm study in adult hypogonadal male patients (NCT03242590). Patients received TLANDO 225 mg, orally twice daily with food for approximately 24 days; no titration was performed to adjust the dosage. A total of 95 hypogonadal men received a dose of TLANDO and were included in the efficacy evaluation. Patients had a median age of 56 years (range 29-74 years), 81% were White, 16% were Black, 2% were mixed race, and 1% were Asian; 26% were Hispanic. The primary endpoint was the percentage of patients who achieved a 24-hour average serum testosterone concentration (Cavg0-24h) within the normal range of 300-1080 ng/dL on the final visit of the study. Table 3 shows the proportion of subjects, Study 16-002, with an average serum total testosterone concentration in the normal range (300-1080 ng/dL). Table 3: Proportion of Subjects in Study 16-002 With Average Serum Total Testosterone in the Normal Range (300-1080 ng/dL) at Day 24 Parameter N=95 % subjects with testosterone, Cavg0-24h 300 to 1080 ng/dL 80% 95 % Confidence Interval (72%, 88%) Secondary endpoints were the percentage of patients wit...", "brand_name": "Tlando", "manufacturer": "Verity Pharmaceuticals Inc.", "application_number": "NDA208088", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20260225", "set_id": "4b0b92e9-6d3c-a0e5-e1c7-342999f72580", "has_boxed_warning": false, "controlled": true, "mentions_rems": false }, "faers": { "total": 51412, "serious": 27216, "death": 2073, "hospitalization": 10745, "primary_suspect": 51366, "top_reactions": [ [ "Myocardial Infarction", 3804 ], [ "Drug Ineffective", 3796 ], [ "Pain", 2513 ], [ "Cerebrovascular Accident", 2476 ], [ "Deep Vein Thrombosis", 2466 ], [ "Fatigue", 2419 ], [ "Off Label Use", 2335 ], [ "Pulmonary Embolism", 2293 ], [ "Blood Testosterone Decreased", 2083 ], [ "Anxiety", 1796 ], [ "Asthenia", 1590 ], [ "Headache", 1410 ], [ "Nausea", 1352 ], [ "Product Dose Omission Issue", 1249 ], [ "Dyspnoea", 1159 ] ], "by_year": { "2019": 3301, "2020": 3040, "2021": 2622, "2022": 2523, "2023": 2692, "2024": 2649, "2025": 3183, "2026": 1559 }, "by_year_primary": { "2019": 3301, "2020": 3038, "2021": 2620, "2022": 2517, "2023": 2677, "2024": 2638, "2025": 3174, "2026": 1559 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class III", "date": "20251107", "reason": "Defective Container - A defect in the side-seal which allows leakage of product.", "firm": "Teva Pharmaceuticals USA, Inc", "status": "Ongoing" }, { "class": "Class II", "date": "20250410", "reason": "cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.", "firm": "Eugia US LLC", "status": "Ongoing" }, { "class": "Class II", "date": "20250305", "reason": "Presence of foreign substance: Presence of Benzene.", "firm": "Strides Pharma, Inc.", "status": "Ongoing" }, { "class": "Class II", "date": "20250305", "reason": "Presence of foreign substance: Presence of Benzene.", "firm": "Strides Pharma, Inc.", "status": "Ongoing" }, { "class": "Class II", "date": "20240808", "reason": "Superpotent Drug", "firm": "Teva Pharmaceuticals USA, Inc", "status": "Ongoing" }, { "class": "Class III", "date": "20231110", "reason": "OOS for viscosity", "firm": "Teva Pharmaceuticals USA, Inc", "status": "Terminated" }, { "class": "Class II", "date": "20230215", "reason": "cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.", "firm": "Azurity Pharmaceuticals, Inc.", "status": "Terminated" }, { "class": "Class II", "date": "20220629", "reason": "Superpotent Drug: Out of specification assay result was obtained during stability testing.", "firm": "Teva Pharmaceuticals USA Inc", "status": "Terminated" }, { "class": "Class II", "date": "20220621", "reason": "cGMP - Water leakage", "firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "status": "Terminated" }, { "class": "Class II", "date": "20220610", "reason": "Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion", "firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "status": "Terminated" }, { "class": "Class II", "date": "20220603", "reason": "CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.", "firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "status": "Terminated" }, { "class": "Class II", "date": "20220603", "reason": "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.", "firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "status": "Terminated" } ], "recall_total": 25, "drugsfda": { "applications": 84, "nda": 20, "anda": 50, "first_approval": "19531224", "rems": true, "rems_last": "20241008", "labeling_supplements": 114, "labeling_recent": 18, "sponsors": [ "ABBVIE", "ACERUS", "ACTAVIS LABS UT INC", "ALEMBIC", "ALZA", "AM REGENT", "AMNEAL", "ANI PHARMS" ], "unapproved": false, "first_approval_fmt": "12/24/1953" }, "trials": { "total": 1032, "completed": 616, "terminated": 140, "with_results": 230, "industry": 321, "phase3": 181, "results_share": 0.37337662337662336, "terminated_share": 0.13565891472868216 }, "pubmed": { "rct": 1165, "meta": 298, "recent_rct": 172, "cochrane": [ { "pmid": "38837771", "title": "Androgens (dehydroepiandrosterone or testosterone) for women undergoing assisted reproduction", "year": "2024" }, { "pmid": "38224135", "title": "Testosterone replacement in men with sexual dysfunction", "year": "2024" }, { "pmid": "33482034", "title": "Effect of atorvastatin on testosterone levels", "year": "2021" }, { "pmid": "26608695", "title": "Androgens (dehydroepiandrosterone or testosterone) for women undergoing assisted reproduction", "year": "2015" }, { "pmid": "17636833", "title": "Testosterone for schizophrenia", "year": "2007" }, { "pmid": "16235365", "title": "Testosterone for peri- and postmenopausal women", "year": "2005" } ] }, "payments": { "year": "2024", "usd": 819913.6900000001, "records": 29367, "by_name": [ [ "Xyosted", 482747.7 ], [ "Androgel", 101789.49 ], [ "Jatenzo", 97851.84 ], [ "Tlando", 70116.67 ], [ "Aveed", 67141.6 ], [ "Azmiro", 266.39 ] ], "names_checked": [ "testosterone", "Xyosted", "Jatenzo", "Androgel", "Depo-testosterone", "Testopel", "Testim", "Aveed", "Tlando", "Natesto", "Azmiro", "Fortesta", "Kyzatrex", "Undecatrex", "Vogelxo" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 1740041, "beneficiaries": 430778, "spend": 181475029.85, "by_brand": [ { "brand": "Testosterone Cypionate", "claims": 1118253, "per_claim": 37.011926791, "is_generic": true }, { "brand": "Testosterone", "claims": 556670, "per_claim": 167.84604117, "is_generic": true }, { "brand": "Xyosted", "claims": 36669, "per_claim": 788.20455616, "is_generic": false }, { "brand": "Testosterone Enanthate", "claims": 10421, "per_claim": 76.402779964, "is_generic": true }, { "brand": "Jatenzo", "claims": 7521, "per_claim": 1055.0355431, "is_generic": false }, { "brand": "Androgel", "claims": 3365, "per_claim": 1148.4990401, "is_generic": false }, { "brand": "Depo-Testosterone", "claims": 2818, "per_claim": 57.617661462, "is_generic": false }, { "brand": "Testopel", "claims": 1127, "per_claim": 1118.582724, "is_generic": false }, { "brand": "Testim", "claims": 882, "per_claim": 1101.0535261, "is_generic": false }, { "brand": "Aveed", "claims": 846, "per_claim": 1867.7406028, "is_generic": false }, { "brand": "Tlando", "claims": 802, "per_claim": 836.53699501, "is_generic": false }, { "brand": "Natesto", "claims": 634, "per_claim": 772.14970032, "is_generic": false }, { "brand": "Androderm", "claims": 33, "per_claim": 554.40818182, "is_generic": false } ], "per_claim": 104.29353667528524 }, "mdl": [], "dsc": [ { "date": "20150303", "title": "FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm436259.htm", "kind": "drug", "matched": "testosterone" } ], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "testosterone", "matched": "testosterone", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 7371, "fills": 1740041, "per_million": 4236.107080235466, "ratio": 1.529860581412364, "median": 2768.949753790441 }, "scores": { "safety": { "score": 68, "letter": "C", "why": [ "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2015 (-8)", "4,236 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-4)", "Subject to a REMS safety program: FDA requires special controls to use it (-10)", "Federally controlled substance: dependence and misuse risk (-10)", "Death share in reports is near or below the FAERS average (0.4x)" ], "weight": 0.35 }, "evidence": { "score": 91, "letter": "A", "why": [ "1165 randomized trials and 298 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "6 independent Cochrane review(s) exist", "Only 37% of completed registered trials posted results (-8)" ], "weight": 0.25 }, "regulatory": { "score": 70, "letter": "C", "why": [ "Recalls since 2016: 0 Class I, 17 Class II, 8 Class III across 50 generic makers (-7)", "REMS program in force (-10)", "18 label changes approved since 2021: the safety story is still moving (-8)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 85, "letter": "B", "why": [ "Pharma paid doctors $819,914 tied to this drug last year (-15)", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 90, "letter": "A", "why": [ "Generic versions approved (50 applications)", "2 same-class alternative(s) (-10)" ], "weight": 0.1 } }, "total": 79, "grade": "B", "questions": [ "In 2015 the FDA issued a safety communication about this drug (FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to ). Does that risk apply to me?", "This is a controlled substance. What is the plan for how long I take it and how I stop?", "This drug has a REMS safety program. What monitoring does that require from us?", "The most-reported problems in FDA's adverse event data are myocardial infarction, pain, cerebrovascular accident. How would we recognize and handle those?", "Why this one over fluoxymesterone, methyltestosterone? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }