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 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 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
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 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 2012-08-03
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 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 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 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 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 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 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 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
|
