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Androderm (Testosterone Transdermal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Androderm (Testosterone Transdermal) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (10)
Death (1)
Life Threatening Events (1)

Reports by Reaction Type

Pain in Extremity (2)Rash (2)Joint Swelling (2)Drug Dose Omission (1)Scrotal Swelling (1)Pulmonary Embolism (1)Drug Abuse (1)Peripheral Embolism (1)Gynaecomastia (1)Joint Stiffness (1)Oedema Peripheral (1)Eosinophilic Myocarditis (1)

Possible Androderm side effects in 25 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-10

Patient: 25 year old male

Reactions: Eosinophilic Myocarditis, Multi-Organ Disorder, Drug Abuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Androderm



Possible Androderm side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: 62 year old male

Reactions: Pain in Extremity, Arthralgia, Joint Swelling, Oedema Peripheral, Pulmonary Embolism, Pulmonary Thrombosis, Peripheral Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androderm



Possible Androderm side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: male

Reactions: Pain in Extremity, Joint Swelling, Musculoskeletal Stiffness, Joint Stiffness

Drug(s) suspected as cause:
Androgel
    Indication: Blood Testosterone Decreased
    End date: 2011-10-01

Androderm
    Dosage: 1 patch every night
    Indication: Blood Testosterone Decreased
    Start date: 2011-10-20
    End date: 2011-10-21



Possible Androderm side effects in 51 year old male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: 51 year old male, weighing 115.7 kg (254.5 pounds)

Reactions: Testicular Pain

Drug(s) suspected as cause:
Androderm



Possible Androderm side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: male, weighing 98.5 kg (216.7 pounds)

Reactions: Haematocrit Increased, Gynaecomastia

Drug(s) suspected as cause:
Androgel
    Dosage: daily dose: unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-07-01
    End date: 2009-07-01

Androgel
    Dosage: 7.5 gm daily
    End date: 2010-12-01

Androgel
    Dosage: 2.5 gm daily
    Start date: 2010-12-01

Androderm
    Dosage: daily dose: unknown
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01
    End date: 2008-07-01

Androgel
    Dosage: 5 gm daily, once every two days
    Indication: Blood Testosterone Decreased
    Start date: 2001-01-01

Other drugs received by patient: Benazepril Hydrochloride; Levothyroxine Sodium; Keppra; Aspirin; Toprol-XL



Possible Androderm side effects 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

Drug(s) suspected as cause:
Androderm



Possible Androderm side effects 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

Drug(s) suspected as cause:
Androderm



Possible Androderm side effects 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

Drug(s) suspected as cause:
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 in

Reported by a consumer/non-health professional from United Kingdom on 2012-01-03

Patient:

Reactions: Scrotal Swelling, Rash

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Androderm

Other drugs received by patient: Phenoxymethyl Penicillin; Amoxicillin; Cetirizine HCL; Amoxicillin and Clavulanate Potassium



Possible Androderm side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-27

Patient: male, weighing 83.9 kg (184.6 pounds)

Reactions: Economic Problem, Drug Dose Omission

Drug(s) suspected as cause:
Androderm

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