Androderm (Testosterone Transdermal) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Trials 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 1 shows the adverse reactions that were reported by > 3% of 36 hypogonadal men who were treated with ANDRODERM 2 mg/day, 4 mg/day, or 6 mg/day for 28 days. Of note, all hypogonadal men studied had been stable users of topical testosterone replacement products prior to the study and there was no washout period between therapies. Furthermore, there was only one subject titrated to 6 mg/day and he withdrew from the study prematurely. 

Table 1. Adverse Reactions Seen With the Use of ANDRODERM 2 mg/day, 4 mg/day, or 6 mg/day (> 3%)

Adverse Reaction	Overall N = 36 %
Application site pruritus	17
Application site vesicles	6
Back pain	6

Other less common adverse reactions reported by < 3% of patients included: application site erythema, application site exfoliation, chills, diarrhea, fatigue, gastroesophageal reflux disease, hemarthrosis, hematuria, headache, polyuria, and prostatitis. The overall incidence of application site reactions of any kind was 28% (10 subjects with 13 adverse reactions).

No serious adverse reactions to ANDRODERM 2 mg/day and 4 mg/day were reported during the clinical trial.

Table 2 shows the adverse reactions that were reported in > 3% of 122 patients in clinical studies with ANDRODERM dosage strengths of 2.5 mg/day, 5 mg/day, and 7.5 mg/day. The most common adverse reactions reported were application site reactions. Transient mild to moderate erythema was observed at the site of application in the majority of patients at some time during treatment. The overall incidence of application site reactions of any kind was 48% (59 subjects with 107 adverse reactions).

Table 2. Adverse Reactions Seen With the Use of ANDRODERM 2.5 mg/day, 5 mg/day, or 7.5 mg/day (> 3%)

Adverse Reaction	Overall N = 122 %
Application site pruritus	37
Application site blistering	12
Application site erythema	7
Application site vesicles	6
Prostate abnormalities	5
Headache	4
Contact dermatitis to system	4
Application site burning	3
Application site induration	3
Depression	3

The following reactions occurred in less than 3% of patients: rash, gastrointestinal bleeding, fatigue, body pain, pelvic pain, hypertension, peripheral vascular disease, increased appetite, accelerated growth, anxiety, confusion, decreased libido, paresthesia, thinking abnormalities, vertigo, acne, bullae at application site, mechanical irritation at application site, rash at application site, contamination of application site, prostate carcinoma, dysuria, hematuria, impotence, urinary incontinence, urinary tract infection, and testicular abnormalities.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ANDRODERM. 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.

Vascular Disorders:
Venous thromboembolism [see Warnings and Precautions]

REPORTS OF SUSPECTED ANDRODERM SIDE EFFECTS / ADVERSE REACTIONS

Possible Androderm side effects / adverse reactions in 49 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-11

Patient: 49 year old male

Reactions: Ankle Fracture

Suspect drug(s):
TNF-Alpha Inhibitor
    Indication: Product Used FOR Unknown Indication

Chewable Antacid Extra Strength Assorted Berries
    Indication: Bone Disorder

Alendronate Sodium
    Dosage: unk
    Indication: Bone Disorder

Androderm
    Indication: Hypogonadism

AOV Vitamin D3
    Indication: Bone Disorder

Possible Androderm side effects / adverse reactions in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-07

Patient: 54 year old male

Reactions: Osteonecrosis

Suspect drug(s):
Androderm

Possible Androderm side effects / adverse reactions in 90 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-02

Patient: 90 year old male weighing 81.2 kg (178.6 pounds)

Reactions: Burning Sensation, Rash

Suspect drug(s):
Androderm