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Androgel (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 Androgel (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 (1123)
Death (12)
Life Threatening Events (7)
Disability (1)

Reports by Reaction Type

Drug Ineffective (193)Blood Testosterone Decreased (188)Asthenia (71)Fatigue (70)Drug Administered AT Inappropriate Site (55)Feeling Abnormal (36)Blood Testosterone Increased (35)Oedema Peripheral (34)Libido Decreased (33)Blood Testosterone Abnormal (33)Erectile Dysfunction (31)Incorrect Dose Administered (30)

Below are a few examples of reports where side effects / adverse reactions may be related to Androgel (Testosterone Transdermal). For a complete list or a specific selection of reports, please use the links above.

Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Wrist Fracture

Drug(s) suspected as cause:
Androgel



Possible Androgel side effects in 68 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 68 year old male

Reactions: Road Traffic Accident, Multiple Fractures

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel
    Dosage: pump
    Administration route: Topical
    Indication: Blood Testosterone Decreased
    End date: 2007-01-01

Androgel
    Dosage: 2 packets daily, unknown if 2.5 g or 5 g
    Administration route: Topical
    Start date: 2011-01-01



Possible Androgel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Back Pain, Neck Pain, Drug Ineffective, Blood Testosterone Decreased, Injury, Hyperhidrosis

Drug(s) suspected as cause:
Cyclobenzaprine HCL

Relafen

Indomethacin
    Administration route: Oral

Androgel
    Dosage: 2 pumps per day

Symbicort

Other drugs received by patient: Antimicrobial (Unspecified)



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male

Reactions: Cataract, Retinal Detachment

Drug(s) suspected as cause:
Androgel



Possible Androgel side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: male

Reactions: Loss of Libido, Asthenia, Back Disorder

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Flexeril; Hydrocodone Bitartrate; Vitamin B-12; Trazodone Hydrochloride; Viagra; Prozac; Vitamin B3; Neurontin



Possible Androgel side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: male

Reactions: Diabetes Mellitus

Drug(s) suspected as cause:
Androgel



Possible Androgel side effects in 54 year old male

Reported by a physician on 2012-08-10

Patient: 54 year old male, weighing 113.5 kg (249.7 pounds)

Reactions: Ventricular Extrasystoles, Drug Ineffective, Male Sexual Dysfunction, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Lisinopril; Coreg



Possible Androgel side effects in male

Reported by a physician from United States on 2012-08-10

Patient: male

Reactions: Drug Dose Omission, Loss of Employment, Nuclear Magnetic Resonance Imaging Brain Abnormal, Amnesia, Meningioma

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Cortisone Acetate; Levothyroxine Sodium



Possible Androgel side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient:

Reactions: Back Pain, Drug Ineffective, Neck Pain, Blood Testosterone Decreased, Injury, Hyperhidrosis

Drug(s) suspected as cause:
Indocin

Androgel
    Dosage: 2 pumps per day

Cyclobenzaprine HCL

Symbicort

Relafen

Other drugs received by patient: Antimicrobial (Unspecified)



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male, weighing 85.4 kg (187.8 pounds)

Reactions: Thrombosis, Drug Ineffective, Palpitations, Pulmonary Embolism, Blood Testosterone Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel
    Dosage: 2 packages
    Start date: 2001-01-01

Androgel
    Dosage: 1 packages a day
    Indication: Blood Testosterone Decreased
    Start date: 1999-01-01
    End date: 2001-01-01

Other drugs received by patient: Imodium; Metoprolol Tartrate; Warfarin Sodium; Vitamin D; Vitamin D; Diazepam; Vitamin B-12; Hydroxyzine; Chelated Calcium and Magnesium; Aspirin; Melatonin; Calcium; GAS-X; Calcium Carbonate



Possible Androgel side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: male, weighing 86.3 kg (189.8 pounds)

Reactions: Nephrolithiasis, Renal Impairment, Renal Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Simvastatin; Ranitidine; Amlodipine; Levemir; Novolog



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: male, weighing 86.3 kg (189.8 pounds)

Reactions: Nephrolithiasis, Renal Impairment, Renal Cancer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Ranitidine; Amlodipine; Levemir; Simvastatin; Novolog



Possible Androgel side effects in

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient:

Reactions: Pruritus, Muscular Weakness, Mobility Decreased

Drug(s) suspected as cause:
Androgel

Zocor
    Administration route: Oral

Other drugs received by patient: Flomax; Cozaar; Trental; Synthroid; Aspirin



Possible Androgel side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 54 year old female, weighing 109.1 kg (240.0 pounds)

Reactions: Blood Testosterone Increased, Menorrhagia, Accidental Exposure

Drug(s) suspected as cause:
Androgel
    Dosage: 35gm daily;16 pumps in morning,12 pumps in afternoon, via pump

Androgel
    Dosage: via pump
    Indication: Accidental Exposure
    Start date: 2004-01-01



Possible Androgel side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 62 year old male, weighing 55.4 kg (121.9 pounds)

Reactions: Myalgia, Arthralgia, Dysuria, Dehydration, Pollakiuria, Testicular Pain, Nerve Compression, Mobility Decreased

Drug(s) suspected as cause:
Androgel
    Dosage: stopped it since last thur since severe attack, 2 pumps daily
    Administration route: Topical
    Indication: Blood Testosterone Decreased
    End date: 2012-07-19

Androgel
    Indication: Muscle Atrophy

Androgel
    Indication: Weight Increased

Other drugs received by patient: Isentress; Truvada; Vicodin; Selzentry; Cymbalta; Sulsamethoxazole / Trimethoprim



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: male, weighing 79.0 kg (173.8 pounds)

Reactions: Pain, Blood Testosterone Decreased, Aortic Rupture

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Vitamin D; Calcium with Vitamin D; Medication FOR Overactive Bladder; Zocor; Metoprolol; Terazosin Hydrochloride; Clarinex; Vitamin B Complex CAP; Levothyroxine Sodium; Luxiq; Multi-Vitamins; Aspirin; Citrical Fiber; Losartan Potassium



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: male, weighing 109.0 kg (239.7 pounds)

Reactions: Road Traffic Accident, Tendon Rupture, Musculoskeletal Pain, Joint Injury, Exostosis

Drug(s) suspected as cause:
Androgel
    Dosage: 17 pump actuations per day
    Indication: Blood Testosterone Decreased
    Start date: 2005-01-01
    End date: 2012-04-01

Androgel
    Dosage: 11 pump actuations per day
    Indication: Blood Testosterone Decreased
    Start date: 2012-04-01

Other drugs received by patient: Amlodipine; Losartan Potassium; Hydrochlorothiazide; Niaspan; Atorvastatin; Thyroid TAB



Possible Androgel side effects in 86 year old male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: 86 year old male, weighing 96.2 kg (211.6 pounds)

Reactions: Weight Increased, Oedema Peripheral, Urine Flow Decreased

Drug(s) suspected as cause:
Androgel



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: male, weighing 85.4 kg (187.8 pounds)

Reactions: Palpitations, Drug Ineffective, Pulmonary Embolism, Blood Testosterone Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel
    Dosage: 1 packages a day
    Indication: Blood Testosterone Decreased
    Start date: 1999-01-01
    End date: 2001-01-01

Androgel
    Dosage: 2 packages
    Start date: 2001-01-01

Other drugs received by patient: Warfarin Sodium; Vitamin D; Metoprolol Succinate; Vitamin B-12; VIT D3; Calcium



Possible Androgel side effects in male

Reported by a physician from United States on 2012-07-20

Patient: male, weighing 110.8 kg (243.7 pounds)

Reactions: Skin Cancer, Melanocytic Naevus, Application Site Dryness

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Folic Acid; Diovan; Toprol-XL; Ddavp; Aspirin



Possible Androgel side effects in 83 year old male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 83 year old male

Reactions: Haematochezia, Coagulopathy

Drug(s) suspected as cause:
Androgel
    Dosage: 1 df: 2 pumps
    Indication: Blood Testosterone Decreased
    Start date: 2011-10-18
    End date: 2012-03-09

Coumadin
    Dosage: 1 df:4/3mg alternating every other day,therapy dates:2000-29feb12:ongoing
    Indication: Heart Rate Irregular
    Start date: 2000-01-01

Other drugs received by patient: Cyclosporine



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: male, weighing 61.3 kg (134.8 pounds)

Reactions: Abdominal Rigidity, Nerve Root Injury Lumbar, Joint Swelling, Abdominal Distension, Intervertebral Disc Displacement

Drug(s) suspected as cause:
Androgel



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: male, weighing 111.2 kg (244.7 pounds)

Reactions: Blindness Unilateral, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel
    Start date: 2012-07-01

Androgel
    Indication: Blood Testosterone Decreased
    Start date: 2002-01-01
    End date: 2012-04-05

Other drugs received by patient: Unknown Diabetes Medication



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: male, weighing 179.3 kg (394.5 pounds)

Reactions: Dysphonia, Thyroid Cancer, Musculoskeletal Pain, Blood Testosterone Decreased, Aggression

Drug(s) suspected as cause:
Androgel
    Dosage: gel
    Indication: Blood Testosterone Decreased
    Start date: 2012-01-01

Androgel
    Dosage: 8 pumps, gel
    Indication: Blood Testosterone Decreased
    Start date: 2010-09-01
    End date: 2012-01-01

Other drugs received by patient: Lisinopril; Lisinopril; Glyburide; Levoxyl; Metformin Hydrochloride



Possible Androgel side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-07-10

Patient: 57 year old male

Reactions: Weight Decreased, Skin Burning Sensation

Drug(s) suspected as cause:
Testosterone Cypionate
    Dosage: unk

Depo-Testosterone
    Indication: Blood Testosterone Decreased

Depo-Testosterone
    Indication: Anxiety

Androgel
    Dosage: unk

Testosterone Cypionate
    Dosage: unk

Depo-Testosterone
    Dosage: unk
    Indication: Hypogonadism

Depo-Testosterone
    Indication: Depression



Possible Androgel side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-09

Patient:

Reactions: Incorrect Route of Drug Administration, Medication Error

Drug(s) suspected as cause:
Androgel



Possible Androgel side effects in male

Reported by a physician from United States on 2012-07-06

Patient: male

Reactions: Diabetic Complication

Adverse event resulted in: death

Drug(s) suspected as cause:
Androgel



Possible Androgel side effects in male

Reported by a physician from United States on 2012-07-03

Patient: male, weighing 104.4 kg (229.7 pounds)

Reactions: Thrombosis, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Multiple Medications



Possible Androgel side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: male, weighing 77.2 kg (169.8 pounds)

Reactions: Abdominal Pain, Atrial Flutter, Atrial Fibrillation, Fall, Sleep Apnoea Syndrome, Appendicitis

Drug(s) suspected as cause:
Androgel
    Dosage: 4 pumps per day, 3 pumps
    Indication: Blood Testosterone Decreased
    Start date: 2005-01-01

Surmontil
    Indication: Sleep Disorder
    Start date: 2005-01-01
    End date: 2005-01-01

Androgel

Other drugs received by patient: Tamsulosin HCL; Nasonex; Omeprazole; Vytorin



Possible Androgel side effects in male

Reported by a physician from United States on 2012-06-29

Patient: male, weighing 93.1 kg (204.8 pounds)

Reactions: Nephrolithiasis, Urinary Sediment Present, Blood Testosterone Abnormal, Chromaturia, Renal Pain, Asthenia

Drug(s) suspected as cause:
Androgel

Other drugs received by patient: Zocor; Niacin; Metoprolol Succinate; Aspirin; Plavix; Norvasc

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