May 25, 2017
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Testopel

"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.

New safety information from published literature and case reports on the risks "...

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Testopel




Testopel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/31/2016

Testopel (testosterone pellets), the male sex hormone, is a steroid used for testosterone replacement therapy in adult males for conditions associated with low or absent testosterone in the body such as primary hypogonadism (congenital or acquired), hypogonadotrophic hypogonadism (congenital or acquired), and to stimulate puberty in carefully selected males with clearly delayed puberty. Common side effects of Testopel include more erections than normal or erections that last a long time, nausea, vomiting, changes in skin color, ankle swelling, changes in body hair, male pattern baldness, acne, suppression of certain clotting factors, bleeding in patients on blood thinners, increase or decrease in libido (sex drive), headache, anxiety, depression, inflammation and pain at the implantation site, and rarely, a serious allergic reaction (anaphylaxis).

The dosage guideline for Testopel testosterone pellets for replacement therapy in androgen deficient males is 150mg to 450mg subcutaneously every 3 to 6 months. Testopel may interact with anticoagulants, oxyphenbutazone, and insulin. Tell your doctor all medications and supplements you use. Testopel is not indicated for use in women, therefore it is unlikely to be used during pregnancy or while breastfeeding.

Our Testopel (testosterone pellets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Testopel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Read the entire FDA prescribing information for Testopel (Testosterone Pellets)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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