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.
Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.
Vascular Disorders: venous thromboembolism
Miscellaneous: Inflammation and pain at the site of intramuscular injection.
Testosterone, like many anabolic steroids, was classified as a controlled substance in 1991. Testosterone is administered parenterally in normal and delayed-release (depot) forms. In September 1995, the FDA approved testosterone transdermal patches (Androderm), and many transdermal forms and brands are now available including implants, gels, and topical solutions. A testosterone buccal system, Striant, was FDA-approved in July 2003; Striant is a mucoadhesive product that adheres to the buccal mucosa and provides a controlled and sustained release of testosterone. In May 2014, the FDA approved an intranasal gel formulation of testosterone (Natesto). A transdermal patch (Intrinsa) for hormone replacement in women is under investigation; the daily dosages used in women are much lower than for products used in males. The FDA refused approval for Intrinsa in 2004 stating that more data regarding safety, especially in relation to cardiovascular and breast health, were required.
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