pharmacopeia
GET
/api/v1/drug/testosterone
2D structure
(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one
SMILES C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2O)CCC4=CC(=O)CC[C@]34C
InChIKey MUMGGOZAMZWBJJ-DYKIIFRCSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Androgen Receptor Agonists.

Androgen Receptor

Indications

Sourced from openFDA
  • MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a.

Contraindications

Sourced from openFDA
  • Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate. If administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus.contraindicated

Dosage & administration

Sourced from openFDA

Prior to initiating, TESTOPEL ® (testosterone pellets) 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 serum testosterone concentrations are below the normal range. The suggested dosage for androgens varies depending on the age, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions. The dosage guideline for the testosterone pellets for replacement therapy in androgen-deficient males is 150mg to 450mg subcutaneously every 3 to 6 months. Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower doses initially, gradually increasing the dose as puberty progresses, with or without a decrease in maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosages in delayed puberty generally are in the lower range of that listed above and, for a limited duration, for example 4 to 6 months. The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate determined by a gradual reduction of the amount administered parenterally. The usual dosage is as follows: implant two 75mg pellets for each 25mg testosterone propionate required weekly.

Warnings & precautions

Sourced from openFDA

In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued. Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma (see PRECAUTIONS - Carcinogenesis, Mutagenesis, Impairment of Fertility). Peliosis hepatis can be a life-threatening or fatal complication. Men treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma. There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as TESTOPEL ® (testosterone pellets). Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with TESTOPEL ® (testosterone pellets) and initiate appropriate workup and management (see ADVERSE REACTIONS ). Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use.

Adverse reactions

Sourced from openFDA

The following adverse reactions have been identified during post-approval use of testosterone replacement therapy, including TESTOPEL ® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Implantation Site Infection and Pellet Extrusion: (see WARNINGS) Endocrine and Urogenital, Male. Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages (see CLINICAL PHARMACOLOGY ). Skin and Appendages. Hirsutism, male pattern of baldness, and acne. Cardiovascular Disorders. Myocardial infarction, stroke. Fluid and Electrolyte Disturbances. Retention of sodium, chloride, water, potassium, calcium and inorganic phosphates. Gastrointestinal. Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS ). Hematologic. Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia. Nervous System. Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Metabolic. Increased serum cholesterol. Vascular Disorders: Venous thromboembolism (see WARNINGS ). Miscellaneous. Rarely anaphylactoid reactions.

Overdosage

Sourced from openFDA

There have been no reports of acute overdosage with the androgens.

Approval history

Sourced from openFDA
  • Feb 28, 2000NDANDA021015Besins Hlthcare
  • Oct 31, 2002NDANDA021454Endo Operations
  • Apr 29, 2011NDANDA022309Besins Hlthcare
  • Mar 5, 2014NDANDA022219Endo Operations
  • May 28, 2014NDANDA205488Acerus
  • Jun 4, 2014NDANDA204399Upsher Smith Labs
  • Sep 28, 2018NDANDA209863Antares Pharma Inc
  • Mar 27, 2019NDANDA206089Tolmar

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Testosterone, Gel; Gel, Metered, 16.2 mg/1 g (NDC 0591-2925-30)To be discontinued
    Sponsor: Actavis Pharma, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
51,927 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3,9187.5%
  2. 2Myocardial Infarction3,7127.1%
  3. 3Pain2,6905.2%
  4. 4Fatigue2,5975.0%
  5. 5Deep Vein Thrombosis2,3964.6%
  6. 6Cerebrovascular Accident2,3894.6%
  7. 7Blood Testosterone Decreased2,3234.5%
  8. 8Pulmonary Embolism2,2464.3%
  9. 9Off Label Use2,1134.1%
  10. 10Anxiety1,8773.6%
  11. 11Asthenia1,7373.3%
  12. 12Headache1,4722.8%
  13. 13Nausea1,4572.8%
  14. 14Dyspnoea1,3072.5%
  15. 15Economic Problem1,2322.4%

Literature

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Recent PubMed references pinned to Testosterone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,009 ClinicalTrials.gov registrations naming Testosterone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Testosterone work?
Mechanism-of-action class: Androgen Receptor Agonists.
What is Testosterone used for?
According to FDA labeling, Testosterone carries indications including: MALES Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Testosterone?
Testosterone is classified as 3-oxoandrosten (4) derivatives, Androgen, Androgen Receptor Agonists, Stimulate Penile Development.
What are the brand names for Testosterone?
Testosterone is marketed under brand names including Androderm, Androgel, Aveed, Azmiro, Depo-testosterone, Fortesta, Jatenzo, Kyzatrex.
What are the contraindications for Testosterone?
Testosterone labeling lists contraindications including: Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate. If administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus.. Always consult the full prescribing information and a clinician.
Note. Data for testosterone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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