A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Androgel Side Effects, and Drug Interactions - Testosterone Gel
Androgel Side Effects, and Drug Interactions - Testosterone Gel
SIDE EFFECTS
In a controlled clinical study, 154 patients were treated with AndroGel® for up to 6 months (see Clinical Studies). Adverse Events possibly, probably or definitely related to the use of AndroGel® and reported by ³1% of the patients are listed in Table 2.
|
TABLE 2: Adverse Events Possibly, Probably or Definitely Related to Use of AndroGel® in the Controlled Clinical Trial |
|
Adverse Event |
Dose of AndroGel® |
| |
5 g |
7.5 g |
10 g |
|
Acne |
1% |
3% |
8% |
|
Alopecia |
1% |
0% |
1% |
|
Application Site Reaction |
5% |
3% |
4% |
|
Asthenia |
0% |
3% |
1% |
|
Depression |
1% |
0% |
1% |
|
Emotional Lability |
0% |
3% |
3% |
|
Gynecomastia |
1% |
0% |
3% |
|
Headache |
4% |
3% |
0% |
|
Hypertension |
3% |
0% |
3% |
|
Lab Test Abnormal* |
6% |
5% |
3% |
|
Libido Decreased |
0% |
3% |
1% |
|
Nervousness |
0% |
3% |
1% |
|
Pain Breast |
1% |
3% |
1% |
|
Prostate Disorder** |
3% |
3% |
5% |
|
Testis Disorder |
3% |
0% |
0% |
|
*Lab test abnormal occurred in nine patients with one or more of the following events: elevated hemoglobin or hematocrit, hyperlipidemia, elevated triglycerides, hypokalemia, decreased HDL, elevated glucose, elevated creatinine, or elevated total bilirubin. |
|
**Prostate disorders included five patients with enlarged prostate, one patient with BPH, and one patient with elevated PSA results. |
The following adverse events possibly related to the use of AndroGel® occurred in fewer than 1% of patients: amnesia, anxiety, discolored hair, dizziness, dry skin, hirsutism, hostility, impaired urination, paresthesia, penis disorder, peripheral edema, sweating, and vasodilation.
In this clinical trial of AndroGel®, skin reactions at the site of application were occasionally reported with AndroGel®, but none was severe enough to require treatment or discontinuation of drug.
Six (4%) patients in this trial had adverse events that led to discontinuation of AndroGel®. These events included the following: cerebral hemorrhage, convulsion (neither of which were considered related to AndroGel® administration), depression, sadness, memory loss, elevated prostate specific antigen and hypertension. No AndroGel® patients discontinued due to skin reactions.
In an uncontrolled pharmacokinetic study of 10 patients, two had adverse events associated with AndroGel®; these were asthenia and depression in one patient and increased libido and hyperkinesia in the other. Among 17 patients in foreign clinical studies there was 1 instance each of acne, erythema and benign prostate adenoma associated with a 2.5% testosterone gel formulation applied dermally.
One hundred six (106) patients have received AndroGel® for up to 12 months in a long-term follow-up study for patients who completed the controlled clinical trial. The preliminary safety results from this study are consistent with those reported for the controlled clinical trial. Table 3 summarizes those adverse events possibly, probably or definitely related to the use of AndroGel® and reported by at least 1% of the total number of patients during long-term exposure to AndroGel®.
|
TABLE 3: Incidence of Adverse Events Possibly, Probably or Definitely Related to the Use of AndroGel® in the Long-Term, Follow-up Study |
|
Adverse Event |
Dose of AndroGel® |
| |
5 g |
7.5 g |
10 g |
|
Lab Test Abnormal* |
4.2% |
0.0% |
6.3% |
|
Peripheral Edema |
1.4% |
0.0% |
3.1% |
|
Acne |
2.8% |
0.0% |
12.5% |
|
Application Site Reaction |
9.7% |
10.0% |
3.1% |
|
Prostate Disorder** |
2.8% |
5.0% |
18.8% |
|
Urination Impaired |
2.8% |
0.0% |
0.0% |
|
* Lab test abnormal included one patient each with elevated GGTP, elevated hematocrit and hemoglobin, increased total bilirubin, worsened hyperlipidemia, decreased HDL, and hypokalemia. |
|
** Prostate disorders included enlarged prostate, elevated PSA results, and in one patient, a new diagnosis of prostate cancer; three patients (one taking 7.5 g daily and two taking 10 g daily) discontinued AndroGel® treatment during the long-term study because of such disorders. |
DRUG ABUSE AND DEPENDENCE
AndroGel® contains testosterone, a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.
Oral ingestion of AndroGel® will not result in clinically significant serum testosterone concentrations due to extensive first-pass metabolism.
DRUG INTERACTIONS
Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
Propranolol: In a published pharmacokinetic study of an injectable testosterone product, administration of testosterone cypionate led to an increased clearance of propranolol in the majority of men tested.
Corticosteroids: The concurrent administration of testosterone with ACTH or corticosteroids may enhance edema formation; thus, these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.
Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
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