Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS 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.
WARNINGS 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.
Like all medications, Testopel can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: