This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Testosterone 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 (365)
Death (5)
Life Threatening Events (7)
Disability (3)
Reports by Reaction Type
Drug Ineffective (56),
Blood Testosterone Decreased (21),
Drug Administered AT Inappropriate Site (19),
Fatigue (15),
Accidental Exposure (15),
Blood Testosterone Increased (14),
Asthenia (14),
Pulmonary Embolism (12),
Headache (12),
Alopecia (12),
Blood Testosterone Abnormal (12),
Dizziness (11)
Below are a few examples of reports where side effects / adverse reactions may be related to Testosterone. For a complete list or a specific selection of reports, please use the links above.
Possible Testosterone side effects in 45 year old male
Reported by a health professional (non-physician/pharmacist) from Slovenia on 2012-08-21
Patient: 45 year old male, weighing 90.0 kg (198.0 pounds)
Reactions: Azoospermia, Infertility Male
Drug(s) suspected as cause:
Testosterone
Possible Testosterone side effects in 83 year old male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 83 year old male
Reactions: Injection Site Mass, Thrombosis, Injection Site Haematoma, Skin Ulcer, Swelling, Erythema, Wound Secretion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Testosterone
Dosage: 200 mg, monthly
Indication: Blood Testosterone Decreased
Start date: 2011-12-01
Testosterone
Dosage: 1 ml, monthly
Start date: 2006-01-01
End date: 2011-12-01
Other drugs received by patient: Losartan Potassium; Verapamil; Hydrochlorothiazide; Aspirin; Pravastatin
Possible Testosterone side effects in 2 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: 2 year old male, weighing 16.0 kg (35.2 pounds)
Reactions: Blood Testosterone Increased, Precocious Puberty, Accidental Exposure
Drug(s) suspected as cause:
Testosterone
Possible Testosterone side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: male
Reactions: Asthma, Headache, Gastric Ulcer, Fatigue, Neuropathy Peripheral, Depression, Myocardial Infarction, Pneumonia, Haemorrhoids, Acquired Immunodeficiency Syndrome, Hernia, Cerebrovascular Accident, Cushing's Syndrome, Bronchitis Chronic, Epididymitis, Cardiac Arrest
Drug(s) suspected as cause:
Acyclovir
Albuterol Sulfate and Ipratropium Bromide
Dosage: 3/5 mg three times a day
Aspirin
Bupropion Hydrochloride
Bystolic
Crestor
Administration route: Oral
Fluorouracil
Dosage: every 12 hours
Folic Acid
Fosamax
Isentress
Lasix
Dosage: 40 mg daily and as needed
MAG Oxide Cypress
Multi-Vitamin
Dosage: daily
Neurontin
Dosage: 300 mg three times a day as needed
Norvir
Oxegen
Dosage: 2 liters while sleeping and as needed
Plavix
Prezista
Prilosec
Administration route: Oral
Prochlorperazine
Spironolactone
Testosterone
Vitamin D
Possible Testosterone side effects in 62 year old male
Reported by a physician from United States on 2012-08-08
Patient: 62 year old male, weighing 83.8 kg (184.4 pounds)
Reactions: Upper Respiratory Tract Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Testosterone
Dosage: weekly, topical
Administration route: Topical
Indication: Hypogonadism
Start date: 2012-06-30
End date: 2012-06-30
Testosterone
Dosage: weekly, topical
Administration route: Topical
Indication: Hypogonadism
Start date: 2012-06-23
End date: 2012-06-23
Testosterone
Dosage: weekly, topical
Administration route: Topical
Indication: Hypogonadism
Start date: 2012-07-07
End date: 2012-07-07
Other drugs received by patient: Albuterol Sulfate; Prednisone TAB; Augmentin / 00756801 / (Amoxicillin Sodium, Clavulanate Potassium)
Possible Testosterone side effects in
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient:
Reactions: Blood Pressure Increased, Heart Rate Increased, Blood Testosterone Decreased, Headache
Drug(s) suspected as cause:
Hydrochlorothiazide (+) Losartan Potassium
Dosage: 100 mg, qd
Testosterone
Dosage: 10 g, qd
Testosterone
Dosage: 5 g, qd
Zocor
Dosage: 20 mg, qd
Other drugs received by patient: Oxycodone HCL; Aspirin; Glucosamine; Zolpidem Tartrate; Celecoxib
Possible Testosterone side effects in 59 year old male
Reported by a physician from Denmark on 2012-07-26
Patient: 59 year old male, weighing 117.9 kg (259.4 pounds)
Reactions: Overdose, Pulmonary Embolism
Drug(s) suspected as cause:
Testosterone
Indication: Product Used FOR Unknown Indication
Start date: 2004-09-20
Testosterone
Start date: 2008-01-09
Other drugs received by patient: Levothyroxine Sodium; Ramipril; Metoprolol Succinate; Fluorometholone; Lercanidipine
Possible Testosterone side effects in 14 year old male
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-24
Patient: 14 year old male
Reactions: Anxiety, Irritability, Dysphemia
Drug(s) suspected as cause:
Testosterone
Possible Testosterone side effects in
Reported by a physician from Germany on 2012-07-24
Patient:
Reactions: Rhabdomyolysis, Abdominal Injury, Respiratory Disorder, Chest Injury, Road Traffic Accident, Limb Injury, Dialysis, Multiple Injuries, Spinal Column Injury, Renal Failure Acute
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Nandrolone Decanoate
Indication: Product Used FOR Unknown Indication
Testosterone
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Cocaine; Amphetamine and Dextroamphetamine Salts
Possible Testosterone side effects in male
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-23
Patient: male, weighing 138.0 kg (303.6 pounds)
Reactions: Penile Size Reduced, Suicidal Ideation
Drug(s) suspected as cause:
Testosterone
Indication: Anorchism
Testosterone
Dosage: gel
Indication: Hypogonadism
Start date: 2008-01-05
Possible Testosterone side effects in 59 year old male
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: 59 year old male
Reactions: Erythema, Skin Irritation
Drug(s) suspected as cause:
Testosterone
Dosage: patch
Yervoy
Possible Testosterone side effects in male
Reported by a physician from United States on 2012-07-13
Patient: male, weighing 90.7 kg (199.6 pounds)
Reactions: Insomnia, Hyperhidrosis
Drug(s) suspected as cause:
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-05-29
Testosterone
Indication: Prophylaxis
Other drugs received by patient: Spironolactone; Crestor; Atenolol; Atenolol; Hydrochlorothiazide; Coreg; Coreg
Possible Testosterone side effects in male
Reported by a physician from Denmark on 2012-07-13
Patient: male
Reactions: Overdose, Deep Vein Thrombosis
Drug(s) suspected as cause:
Testosterone
Possible Testosterone side effects in
Reported by a individual with unspecified qualification from Italy on 2012-07-06
Patient:
Reactions: Mitral Valve Disease, Sudden Cardiac Death, Aortic Arteriosclerosis, Eosinophilic Myocarditis, Ventricular Fibrillation, Cardiac Arrest, Drug Abuse
Adverse event resulted in: death
Drug(s) suspected as cause:
Anabolic Steroids
Dosage: unk, unknown
Indication: Product Used FOR Unknown Indication
Testosterone
Dosage: unk, unknown
Indication: Product Used FOR Unknown Indication
Possible Testosterone side effects in male
Reported by a physician from Denmark on 2012-06-27
Patient: male
Reactions: Overdose, Deep Vein Thrombosis
Drug(s) suspected as cause:
Testosterone
Possible Testosterone side effects in 51 year old male
Reported by a consumer/non-health professional from Israel on 2012-06-26
Patient: 51 year old male
Reactions: Sperm Concentration Zero, Blood Testosterone Decreased
Drug(s) suspected as cause:
Testosterone
Other drugs received by patient: Euthyrox
Possible Testosterone side effects in 3 year old male
Reported by a physician from Spain on 2012-06-26
Patient: 3 year old male
Reactions: Genital Cyst
Drug(s) suspected as cause:
Testosterone
Possible Testosterone side effects in 83 year old male
Reported by a pharmacist from United States on 2012-06-22
Patient: 83 year old male
Reactions: Injection Site Mass, Thrombosis, Skin Ulcer, Injection Site Haematoma, Swelling, Erythema, Wound Secretion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Testosterone
Dosage: 200 mg, monthly
Indication: Blood Testosterone Decreased
Start date: 2011-12-01
Testosterone
Dosage: 1 ml, monthly
Start date: 2006-01-01
End date: 2011-12-01
Other drugs received by patient: Aspirin; Pravastatin; Losartan Potassium; Verapamil; Hydrochlorothiazide
Possible Testosterone side effects in male
Reported by a pharmacist from United States on 2012-06-19
Patient: male
Reactions: Insomnia, Hyperhidrosis
Drug(s) suspected as cause:
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-05-29
Testosterone
Indication: Prophylaxis
Other drugs received by patient: Crestor; Spironolactone; Atenolol; Hydrochlorothiazide; Atenolol; Coreg; Coreg
Possible Testosterone side effects in male
Reported by a physician from Germany on 2012-06-13
Patient: male
Reactions: Condition Aggravated
Drug(s) suspected as cause:
Testosterone
Possible Testosterone side effects in male
Reported by a physician from Sweden on 2012-05-31
Patient: male
Reactions: Therapeutic Response Decreased, Pulmonary Embolism
Drug(s) suspected as cause:
Testosterone
Possible Testosterone side effects in 54 year old male
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: 54 year old male, weighing 77.2 kg (169.8 pounds)
Reactions: Impaired Driving Ability, Pelvic Pain, Groin Pain
Drug(s) suspected as cause:
Androgel
Dosage: 3 pumps per day
Indication: Blood Testosterone Decreased
Start date: 2011-10-01
Testosterone
Indication: Blood Testosterone Decreased
Start date: 2011-06-01
End date: 2011-10-01
Other drugs received by patient: Unknown Medications
Possible Testosterone side effects in 31 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25
Patient: 31 year old male
Reactions: Muscle Hypertrophy, Chest Discomfort, Dyspnoea, Left Ventricular Hypertrophy, Gynaecomastia, Flushing, Anxiety, Diarrhoea, Palpitations, Ejection Fraction Decreased, LOW Density Lipoprotein Increased, Hypertension, Haemoglobin Increased
Drug(s) suspected as cause:
Caffeine
Dosage: po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Clomiphene Citrate
Indication: Product Used FOR Unknown Indication
Human Growth Hormone, Recombinant
Indication: Product Used FOR Unknown Indication
Methenolone Acetate
Indication: Product Used FOR Unknown Indication
Testosterone
Dosage: qw; qd
Indication: Product Used FOR Unknown Indication
Possible Testosterone side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: male, weighing 61.2 kg (134.7 pounds)
Reactions: Muscle Atrophy, Drug Ineffective, Pain, Product Packaging Quantity Issue, Fall, Thinking Abnormal, Peroneal Nerve Palsy, Blood Testosterone Decreased, Back Disorder, Spinal Operation, Product Label Confusion, Muscular Weakness, Hypoaesthesia, Hepatic Enzyme Increased, Renal Failure, Alopecia, Dehydration, Facial Bones Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Duragesic-100
Start date: 2012-04-05
Duragesic-100
Start date: 2009-01-01
Duragesic-100
Start date: 1999-01-01
Duragesic-100
Indication: Back Pain
Start date: 2005-12-01
Duragesic-100
End date: 2005-12-01
Fentanyl-100
Indication: Back Pain
Testosterone
Administration route: Topical
Indication: Blood Testosterone Decreased
Other drugs received by patient: Soma; Corticosteroids; Dilaudid; Dalmane; Valium
Possible Testosterone 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:
Androgel
Dosage: 40.56 to skin
Indication: Blood Testosterone Decreased
Start date: 2012-04-18
End date: 2012-05-01
Testosterone
Dosage: daily 2 pumps
Possible Testosterone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: female
Reactions: Drug Effect Decreased
Drug(s) suspected as cause:
Prometrium
Indication: Product Used FOR Unknown Indication
Testosterone
Indication: Product Used FOR Unknown Indication
Possible Testosterone side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-15
Patient: male, weighing 89.0 kg (195.8 pounds)
Reactions: Rhabdomyolysis, Polycythaemia, Pseudomonas Infection, Coagulopathy, Toxicity To Various Agents, Accidental Overdose, Haemodialysis, Liver Transplant, Cardio-Respiratory Arrest, Hepatic Encephalopathy, Acute Hepatic Failure, Liver Transplant Rejection, Brain Oedema, Hallucination, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Extra Strength Tylenol
Dosage: ingested 40 pills in 2 days 1500mg-2000mg every 3 hours
Administration route: Oral
Indication: Headache
Start date: 2008-04-01
End date: 2008-05-09
Extra Strength Tylenol
Dosage: ingested 40 pills in 2 days 1500mg-2000mg every 3 hours
Administration route: Oral
Indication: Ear Pain
Start date: 2008-04-01
End date: 2008-05-09
Prasterone
Indication: Product Used FOR Unknown Indication
Testosterone
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Sudafed 12 Hour; Vitamin B-12; Creatine; Ibuprofen (Advil); Botox; Vitamin; Sudafed 12 Hour; Glutamine
Possible Testosterone side effects in
Reported by a individual with unspecified qualification from United States on 2012-05-10
Patient:
Reactions: Dyslipidaemia, Left Ventricular Hypertrophy, Drug Abuse, Gynaecomastia, Anxiety, Flushing, Blood Follicle Stimulating Hormone Decreased, Diarrhoea, Ejection Fraction Decreased, Blood Luteinising Hormone Decreased, Hypertension
Drug(s) suspected as cause:
Primobolan-Depot INJ
Dosage: unk, unknown
Indication: Product Used FOR Unknown Indication
Testosterone
Dosage: unk, weekly injections
Testosterone
Dosage: unk, daily injections
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Caffeine Citrate; Clomiphene Citrate; Human Growth Hormone, Recombinant
Possible Testosterone side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2012-05-07
Patient: male
Reactions: Confusional State, Drug Ineffective, Groin Pain, Myalgia, Middle Insomnia, Genital Pain, Pollakiuria, Asthenia, Loss of Libido, Prostatic Pain, Lethargy
Drug(s) suspected as cause:
Testosterone
Dosage: gel
Indication: Loss of Libido
Start date: 2009-01-01
Testosterone
Indication: Blood Testosterone Decreased
Possible Testosterone side effects in male
Reported by a physician from United Kingdom on 2012-05-07
Patient: male
Reactions: Aggression
Drug(s) suspected as cause:
Testosterone
Other drugs received by patient: Morphine
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