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Androgel (Testosterone Transdermal) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials in Hypogonadal Men

Table 2 shows the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with AndroGel and reported by >1% of patients in a 180 Day, Phase 3 study.

Table 2: Adverse Events Possibly, Probably or Definitely Related to Use of AndroGel in the 180-Day Controlled Clinical Trial

* Lab test abnormal occurred in nine patients with one or more of the following events reported: elevated hemoglobin or hematocrit, hyperlipidemia, elevated triglycerides, hypokalemia, decreased HDL, elevated glucose, elevated creatinine, elevated total bilirubin.

** Prostate disorders included five patients with enlarged prostate, one with BPH, and one with elevated PSA results.

*** Testis disorders were reported in two patients: one with left varicocele and one with slight sensitivity of left testis.

Adverse Event Dose of AndroGel
5 g 7.5 g 10 g
N = 77 N = 40 N = 78
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%

Other less common adverse reactions, reported in fewer than 1% of patients included: amnesia, anxiety, discolored hair, dizziness, dry skin, hirsutism, hostility, impaired urination, paresthesia, penis disorder, peripheral edema, sweating, and vasodilation.

In this 180 day clinical trial, skin reactions at the site of application were reported with AndroGel, but none was severe enough to require treatment or discontinuation of drug.

Six patients (4%) in this trial had adverse events that led to discontinuation of AndroGel. These events included: cerebral hemorrhage, convulsion (neither of which were considered related to AndroGel administration), depression, sadness, memory loss, elevated prostate specific antigen, and hypertension No AndroGel patient discontinued due to skin reactions.

In a separate 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.

In a 3 year, flexible dose, extension study, the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with AndroGel and reported by > 1% of patients is shown in Table 3.

Table 3: Adverse Events Possibly, Probably or Definitely Related to Use of AndroGel in the 3 Year, Flexible Dose, Extension Study

+ Lab test abnormal occurred in 15 patients with one or more of the following events reported: elevated AST, elevated ALT, elevated testosterone, elevated hemoglobin or hematocrit, elevated cholesterol, elevated cholesterol/LDL ratio, elevated triglycerides, elevated HDL, elevated serum creatinine.

* Urinary symptoms included nocturia, urinary hesitancy, urinary incontinence, urinary retention, urinary urgency and weak urinary stream.

** Testis disorders included three patients. There were two with a non-palpable testis and one with slight right testicular tenderness.

Adverse Event Percent of Subjects
(N = 162)
Lab Test Abnormal+ 9.3
Skin dry 1.9
Application Site Reaction 5.6
Acne 3.1
Pruritus 1.9
Enlarged Prostate 11.7
Carcinoma of Prostate 1.2
Urinary Symptoms* 3.7
Testis Disorder** 1.9
Gynecomastia 2.5
Anemia 2.5

Two patients reported serious adverse events considered possibly related to treatment: deep vein thrombosis (DVT) and prostate disorder requiring a transurethral resection of the prostate (TURP).

Discontinuation for adverse events in this study included: two patients with application site reactions, one with kidney failure, and five with prostate disorders (including increase in serum PSA in 4 patients, and increase in PSA with prostate enlargement in a fifth patient).

Increases in Serum PSA Observed in Clinical Trials of Hypogonadal Men

During the initial 6-month study, the mean change in PSA values had a statistically significant increase of 0.26 ng/mL. Serum PSA was measured every 6 months thereafter in the 162 hypogonadal men on AndroGel in the 3-year extension study. There was no additional statistically significant increase observed in mean PSA from 6 months through 36 months. However, there were increases in serum PSA observed in approximately 18% of individual patients. The overall mean change from baseline in serum PSA values for the entire group from month 6 to 36 was 0.11 ng/mL.

Twenty-nine patients (18%) met the per-protocol criterion for increase in serum PSA, defined as >2X the baseline or any single serum PSA >6 ng/mL. Most of these (25/29) met this criterion by at least doubling of their PSA from baseline. In most cases where PSA at least doubled (22/25), the maximum serum PSA value was still <2 ng/mL. The first occurrence of a pre-specified, post-baseline increase in serum PSA was seen at or prior to Month 12 in most of the patients who met this criterion (23 of 29; 79%).

Four patients met this criterion by having a serum PSA >6 ng/mL and in these, maximum serum PSA values were 6.2 ng/mL, 6.6 ng/mL, 6.7 ng/mL, and 10.7 ng/mL. In two of these patients, prostate cancer was detected on biopsy. The first patient's PSA levels were 4.7 ng/mL and 6.2 ng/mL at baseline and at Month 6/Final, respectively. The second patient's PSA levels were 4.2 ng/mL, 5.2 ng/mL, 5.8 ng/mL, and 6.6 ng/mL at baseline, Month 6, Month 12, and Final, respectively.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of AndroGel. Because the 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.

Hypogonadal Men

Table 4 includes adverse reactions that have been identified postmarketing.

Table 4: Adverse Drug Reactions from Postmarketing Experience of AndroGel by MedDRA System Organ Class
Blood and the lymphatic system disorders: Elevated Hgb, Hct (polycythemia)
Endocrine disorders: Hirsutism
Gastrointestinal disorders: Nausea
General disorders and administration site reactions: Asthenia, edema, malaise
Genitourinary disorders: Impaired urination
Hepatobiliary disorders: Abnormal liver function tests (e.g. transaminases, elevated GCTP, bilirubin)
Investigations: Elevated PSA, electrolyte changes (nitrogen, calcium, potassium, phosphorus, sodium), changes in serum lipids (hyperlipidemia, elevated triglycerides, decreased HDL), impaired glucose tolerance, fluctuating testosterone levels, weight increase
Neoplasms benign, malignant and unspecified (cysts and polyps): Prostate cancer
Nervous system: Headache, dizziness, sleep apnea, insomnia
Psychiatric disorders: Depression, emotional lability, decreased libido, nervousness, hostility, amnesia, anxiety
Reproductive system and breast disorders: Gynecomastia, mastodynia, prostatic enlargement, testicular atrophy, oligospermia, priapism (frequent or prolonged erections)
Respiratory disorders: Dyspnea
Skin and subcutaneous tissue disorders: Acne, alopecia, application site reaction (pruritus, dry skin, erythema, rash, discolored hair, paresthesia), sweating
Vascular disorders: Hypertension, vasodilation (hot flushes)



REPORTS OF SUSPECTED ANDROGEL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Androgel. The information is not vetted and should not be considered as verified clinical evidence.

Possible Androgel side effects / adverse reactions in 60 year old male

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 60 year old male weighing 95.5 kg (210.0 pounds)

Reactions: Anxiety

Suspect drug(s):
Androgel
    Dosage: 1.25 g, qd
    Indication: Blood Testosterone Decreased
    Start date: 2010-01-01

Cipro
    Dosage: unk
    Indication: Sinusitis
    Start date: 2010-12-01
    End date: 2010-12-01

Other drugs received by patient: Alprazolam; Diovan HCT



Possible Androgel side effects / adverse reactions in 77 year old male

Reported by a consumer/non-health professional from United States on 2011-10-12

Patient: 77 year old male weighing 86.3 kg (189.8 pounds)

Reactions: Osteoarthritis, Arthralgia

Adverse event resulted in: hospitalization

Suspect drug(s):
Androgel

Other drugs received by patient: Many Unknown Medications



Possible Androgel side effects / adverse reactions in 38 year old male

Reported by a physician from United States on 2011-11-18

Patient: 38 year old male

Reactions: Pulmonary Embolism, Deep Vein Thrombosis

Suspect drug(s):
Androgel



See index of all Androgel side effect reports >>

Drug label data at the top of this Page last updated: 2009-04-28

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