Adverse Effects of Testosterone Gels

 

The association of an effect with exposure to testosterone gel is established by:

(1) absence of effect prior to exposure

(2) appearance or worsening after exposure

(3) partial or complete reversal on discontinuation of exposure to the gel

(4) recurrence on re-exposure (often not attempted)

 

Adverse effects of testosterone gel to user:

(1) worsening of benign prostatic hypertrophy (BPH) with elevation of PSA

(2) progression of breast or prostate carcinoma

(3) polycythemia (with increase red cell mass)

(4) hypercoagulability (associated with increase in red cell mass)

(5) suppression of spermatogenesis (secondary to reduced FSH)

(6) hepatitis with jaundice

(7) peliosis hepatis

(8) hepatic tumors

(9) sodium and water retention, with or without heart failure

(10) gynecomastia

(11) sleep apnea

(12) burns secondary to accidental ignition (flammability secondary to alcohol in gel)

(13) emotional lability (mood swings, anger, etc)

(14) hypertension

(15) transient application site reactions

(16) hirsutism

(17) headache

(18) skin changes (pruritis, dry skin, sweating, hot flashes)

 

Laboratory abnormalities:

(1) abnormal serum lipids (elevated total cholesterol, elevated triglycerides)

(2) hypercalcemia

(3) reduced thyroxine-binding globulin (TBG). This may reduce total serum T4 concentrations but not free T4.

(4) elevated measures of alcohol exposure

 

Adverse effects of testosterone gel to others who may come into contact with the patient’s application site (children, women):

(1) virilization

(2) advanced bone age

(3) reduced lactation in nursing mothers (and the potential of exposing the infant through the milk)

 

Other effects:

(1) decreased insulin requirements in diabetics

(2) change in response to anticoagulants which may affect the INR