Testosterone
3-Oxoandrosten (4) Derivatives
Sold as Testopel · NATESTO · ANDROGEL · TESTIM 1%
- Drug class
- 3-Oxoandrosten (4) Derivatives
- Availability
- Prescription and OTC
- Routes
- Transdermal, Nasal, Subcutaneous, Oral, Intramuscular
- Markets covered
- 3
- Products on record
- 30
- FDA reports (12 mo)
- 2,506
Overview
Testosterone is an active pharmaceutical ingredient in the 3-Oxoandrosten (4) Derivatives group (G03BA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 18 | May 15, 2026 |
| CA Canada | Health Canada | 7 | May 27, 2026 |
| US United States | FDA | 5 | July 17, 2025 |
GBUnited Kingdom· MHRA
18 products
Uses
4 Special warnings and precautions for use).
How to take
CACanada· Health Canada
7 products
Uses
ANDROGEL (testosterone) is indicated for: • testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). ANDROGEL should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and if other etiologies responsible for the symptoms have not been excluded.
Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by biochemical assays (Endocrine Society Guidelines recommend two separate tests preferably in the morning) before initiating therapy with any testosterone replacement, including ANDROGEL treatment.
Due to variability in laboratory values, all measures of testosterone should be carried out in the same laboratory. 3 Pediatrics). 2 Geriatrics There are limited controlled clinical study data supporting the use of ANDROGEL in the geriatric population (see 7 WARNINGS AND PRECAUTIONS and 14 CLINICAL TRIALS).
USUnited States· FDA
5 products
Uses
INDICATIONS AND USAGE MALES
Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. a. Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy.
b. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation. If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics.
Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. Safety and efficacy of TESTOPEL ® (testosterone pellets) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Drug interactions
Known interactions involving Testosterone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 350. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL427140002 · revised March 13, 2026
- [2]Health Canada (DPD) · 02245345 · revised August 22, 2025
- [3]FDA DailyMed · 03b9c0b1-5884-11… · revised July 17, 2025 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.