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Testosterone (Testosterone) - Side Effect Reports to FDA

 
 



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)Blood Testosterone Abnormal (12)Alopecia (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 Denmark on 2012-07-13

Patient: male

Reactions: Overdose, Deep Vein Thrombosis

Drug(s) suspected as cause:
Testosterone



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

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 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 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 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 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 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

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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