Index of reports
> Life Threatening Events (7)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Androgel (Testosterone Transdermal) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Androgel side effects in male
Reported by a pharmacist from United States on 2012-06-22
Patient: male, weighing 116.8 kg (257.0 pounds)
Reactions: Blood Pressure Increased, Oedema Peripheral
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Androgel
Dosage: 1 application daily top
Administration route: Topical
Indication: Androgen Deficiency
Start date: 2012-05-02
End date: 2012-05-15
Androgel
Dosage: 1 application daily top
Administration route: Topical
Indication: Sexual Dysfunction
Start date: 2012-05-02
End date: 2012-05-15
Other drugs received by patient: Fiber Caps; Gabapentin; Aspirin Adult LOW Strength; Allopurinol; Toprol-XL; Pyridostigmine Bromide; Pravastatin; Novolog; Lantus
Possible Androgel side effects in 59 year old male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: 59 year old male, weighing 72.6 kg (159.7 pounds)
Reactions: Confusional State, Glossodynia, Pruritus, Drug Ineffective, Headache, Oral Discomfort, Fatigue, Impatience, Dizziness, Loss of Libido, Nervousness, Dysphagia, Paraesthesia Oral, Nausea, Skin Disorder, Mental Impairment, Burning Sensation, Anxiety, Hostility, Dysgeusia, Apathy, Blood Glucose Decreased, Disturbance in Attention, Asthenia, Feeling Abnormal
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Testosterone
Dosage: daily 2 pumps
Androgel
Dosage: 40.56 to skin
Indication: Blood Testosterone Decreased
Start date: 2012-04-18
End date: 2012-05-01
Possible Androgel side effects in 49 year old male
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: 49 year old male, weighing 97.5 kg (214.6 pounds)
Reactions: Prostate Cancer
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Androgel
Possible Androgel side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient: male, weighing 72.6 kg (159.8 pounds)
Reactions: Confusional State, Drug Ineffective, Headache, Oral Discomfort, Pruritus Generalised, Impatience, Dizziness, Loss of Libido, Nervousness, Dysphagia, Nausea, Paraesthesia Oral, Skin Disorder, Burning Sensation, Dysgeusia, Hostility, Blood Glucose Decreased, Emotional Distress, Anxiety, Apathy, Syncope, Activities of Daily Living Impaired, Disturbance in Attention, Feeling Abnormal, Asthenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Androgel
Possible Androgel side effects in 59 year old male
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: 59 year old male, weighing 72.6 kg (159.7 pounds)
Reactions: Confusional State, Glossodynia, Pruritus, Headache, Oral Discomfort, Impatience, Product Taste Abnormal, Dizziness, Loss of Libido, Nervousness, Paraesthesia Oral, Nausea, Skin Disorder, Hostility, Burning Sensation, Blood Glucose Decreased, Anxiety, Apathy, Mental Impairment, Syncope, Throat Irritation, Disturbance in Attention, Asthenia, Feeling Abnormal
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Androgel
Dosage: 40.56 to skin daily 2 pumps
Indication: Blood Testosterone Decreased
Start date: 2012-04-18
End date: 2012-05-01
Testosterone
Dosage: daily 2 pumps
Possible Androgel side effects in 67 year old male
Reported by a consumer/non-health professional from United States on 2012-04-26
Patient: 67 year old male, weighing 133.3 kg (293.4 pounds)
Reactions: Product Quality Issue, Prostate Cancer
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Androgel
Possible Androgel side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-29
Patient: 66 year old male
Reactions: Fibrin D Dimer Increased, Thyroid Cancer, Pulmonary Embolism, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Androgel
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