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Testim 5 g/packet (testosterone)

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Testim 5 g/packet may cause cholestatic hepatitis (inflammation of the liver with increased "bilirubin" in the bloodstream - usually due to a drug reaction).

This drug may also cause the following symptoms that are related to cholestatic hepatitis:

Medical Source Information
Yellow highlights indicate symptoms related to cholestatic hepatitis.

Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities including hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with high doses of androgen. Tumor regression did not occur in all cases following medication withdrawal. Cholestatic hepatitis, jaundice, and abnormal liver function tests have occurred during androgen therapy. Drug-induced jaundice is usually reversible following drug discontinuation.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using testosterone topical and call your doctor at once if you have any of these serious side effects: burn-like blistering of the skin where the transdermal patch is worn; skin irritation with patch-wearing that does not get better with time; problems with urination; swelling of your ankles; frequent, prolonged, or bothersome erections; or nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics. Less serious side effects may include: redness, itching, burning, or hardened skin where the skin patch is worn; breast swelling or tenderness; increased acne or hair growth; headache, depressed mood; or changes in your sex drive. 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.

The use of testosterone is contraindicated in patients with clinically significant cardiac, hepatic, or renal disease. Sodium and water retention resulting in edema and in some cases requiring diuretic therapy can occur particularly when the drug is given in high dosages or for prolonged periods. Cautious administration and careful monitoring is recommended in patients with conditions aggravated by fluid retention.

Prolonged use of high doses of testosterone has been associated with serious hepatic adverse effects (peliosis hepatitis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis can be a life threatening or fatal event. Long-term therapy with testosterone enanthate has produced multiple hepatic adenomas.

Life-threatening peliosis hepatitis and hepatic abnormalities including hepatic neoplasms and hepatocellular carcinomas have occurred following prolonged therapy with high doses of androgens.

Oncologic side effects have included carcinoma of the prostate, hepatic neoplasms, and hepatocellular carcinomas.

Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):

Monitor testosterone

References

Elevated serum testosterone levels and risk of hepatocellular carcinoma. Yu MW, Chen CJ Cancer Res 1993;53:790-4.
Hepatic angiosarcoma associated with androgenic-anabolic steroids. Falk H, Thomas LB, Popper H, Ishak KG Lancet 1979;2:1120-3.
Peliosis hepatis after long-term androgen therapy. Nuzzo JL, Manz HJ, Maxted WC Urology 1985;25:518-9.
Effects of testosterone enanthate in normal men: experience from a multicenter contraceptive efficacy study. World Health Organizatio Task Force on Methods for the Regulation of Male Fertility. Wu FC, Farley TM, Peregoudov A, Waites GM Fertil Steril 1996;65:626-36.
Product Information. Androderm (testosterone topical). Anonymous SmithKline Beecham, Philadelphia, PA. PROD;
Multiple hepatic adenomas after long-term therapy with testosterone enanthate. Review of the literature. Carrasco D, Prieto M, Pallardo L, Moll JL, Cruz JM, Munoz C, Berenguer J J Hepatol 1985;1:573-8.

Multum version: 154.0 (Jun 16, 2010)

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