TESTOSTERONE

Testosterone Adverse Events Reported to the FDA Over Time

How are Testosterone adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Testosterone, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Testosterone is flagged as the suspect drug causing the adverse event.

Most Common Testosterone Adverse Events Reported to the FDA

What are the most common Testosterone adverse events reported to the FDA?

Drug Ineffective	153 (3.81%)
Blood Testosterone Decreased	61 (1.52%)
Headache	56 (1.4%)
Poor Quality Drug Administered	54 (1.35%)
Fatigue	47 (1.17%)
Burning Sensation	44 (1.1%)
Rash	40 (1%)
Aggression	39 (.97%)
Blood Testosterone Increased	39 (.97%)
Anxiety	36 (.9%)
Injection Site Pain	36 (.9%)
	Show More
Asthenia	33 (.82%)
Nausea	33 (.82%)
Accidental Exposure	31 (.77%)
Depression	31 (.77%)
Pain	31 (.77%)
Oedema Peripheral	29 (.72%)
Alopecia	28 (.7%)
Blood Pressure Increased	26 (.65%)
Dizziness	26 (.65%)
Dyspnoea	26 (.65%)
Erythema	26 (.65%)
Polycythaemia	26 (.65%)
Prostate Cancer	26 (.65%)
Feeling Abnormal	24 (.6%)
Pulmonary Embolism	24 (.6%)
Acne	23 (.57%)
Blood Testosterone Abnormal	23 (.57%)
Drug Administered At Inappropriate ...	23 (.57%)
Gynaecomastia	23 (.57%)
Hypertension	23 (.57%)
Malaise	23 (.57%)
Libido Decreased	22 (.55%)
Product Quality Issue	22 (.55%)
Insomnia	21 (.52%)
Tremor	21 (.52%)
Erectile Dysfunction	20 (.5%)
Hair Growth Abnormal	19 (.47%)
Hyperhidrosis	19 (.47%)
Myocardial Infarction	19 (.47%)
Rhabdomyolysis	19 (.47%)
Precocious Puberty	18 (.45%)
Pruritus	18 (.45%)
Abnormal Behaviour	17 (.42%)
Arthralgia	17 (.42%)
Chest Pain	17 (.42%)
Hypersensitivity	17 (.42%)
Injection Site Swelling	17 (.42%)
Weight Increased	17 (.42%)
Drug Abuse	16 (.4%)
Flushing	16 (.4%)
Drug Interaction	15 (.37%)
Dysphonia	15 (.37%)
Feeling Hot	15 (.37%)
Loss Of Consciousness	15 (.37%)
Pain In Extremity	15 (.37%)
Pollakiuria	15 (.37%)
Breast Cancer	14 (.35%)
Cellulitis	14 (.35%)
Haematocrit Increased	14 (.35%)
Lethargy	14 (.35%)
Palpitations	14 (.35%)
Weight Decreased	14 (.35%)
Abdominal Pain Upper	13 (.32%)
Back Pain	13 (.32%)
Condition Aggravated	13 (.32%)
Homicide	13 (.32%)
Incorrect Dose Administered	13 (.32%)
Myalgia	13 (.32%)
Renal Failure Acute	13 (.32%)
Diarrhoea	12 (.3%)
Heart Rate Increased	12 (.3%)
Hot Flush	12 (.3%)
Loss Of Libido	12 (.3%)
Therapeutic Response Decreased	12 (.3%)
Atrial Fibrillation	11 (.27%)
Cardiac Failure	11 (.27%)
Cardiomyopathy	11 (.27%)
Deep Vein Thrombosis	11 (.27%)
Fall	11 (.27%)
Injection Site Erythema	11 (.27%)
Intentional Drug Misuse	11 (.27%)
Prostatic Specific Antigen Increase...	11 (.27%)
Sleep Apnoea Syndrome	11 (.27%)
Application Site Reaction	10 (.25%)
Chest Discomfort	10 (.25%)
Drug Effect Decreased	10 (.25%)
Medication Error	10 (.25%)
Muscular Weakness	10 (.25%)
Pyrexia	10 (.25%)
Renal Failure	10 (.25%)
Skin Ulcer	10 (.25%)
Thrombosis	10 (.25%)
Agitation	9 (.22%)
Blood Cholesterol Increased	9 (.22%)
Cardiac Disorder	9 (.22%)
Cough	9 (.22%)
Diabetes Mellitus	9 (.22%)
Dysgeusia	9 (.22%)
Gastrooesophageal Reflux Disease	9 (.22%)
Irritability	9 (.22%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Testosterone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Testosterone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Testosterone

What are the most common Testosterone adverse events reported to the FDA?

Therapeutic And Nontherapeutic Effe...	215 (5.36%)
Medication Errors	177 (4.41%)
Endocrine Investigations	168 (4.19%)
Neurological	165 (4.11%)
Epidermal And Dermal Conditions	154 (3.84%)
Administration Site Reactions	147 (3.66%)
Skin Appendage Conditions	114 (2.84%)
Respiratory	102 (2.54%)
Gastrointestinal Signs	72 (1.79%)
Injuries	71 (1.77%)
Muscle	62 (1.54%)
	Show More
Musculoskeletal And Connective Tiss...	62 (1.54%)
Anxiety Disorders	61 (1.52%)
Headaches	59 (1.47%)
Personality Disorders	57 (1.42%)
Cardiac And Vascular Investigations	53 (1.32%)
Product Quality Issues	51 (1.27%)
Hematology Investigations	50 (1.25%)
Urinary Tract Signs	50 (1.25%)
Sexual Dysfunctions, Disturbances A...	44 (1.1%)
Infections - Pathogen Unspecified	42 (1.05%)
Sexual Function And Fertility	42 (1.05%)
Depressed Mood Disorders	40 (1%)
Mood Disorders	39 (.97%)
Psychiatric	39 (.97%)
Sleep Disorders	38 (.95%)
Physical Examination Topics	37 (.92%)
Renal Disorders	36 (.9%)
Cardiac Arrhythmias	35 (.87%)
Myocardial	35 (.87%)
Breast	34 (.85%)
Bacterial Infectious	33 (.82%)
Legal Issues	32 (.8%)
Coronary Artery	31 (.77%)
Vascular Hypertensive	31 (.77%)
Glucose Metabolism Disorders	30 (.75%)
Movement Disorders	30 (.75%)
Vascular	30 (.75%)
Joint	29 (.72%)
Disturbances In Thinking	28 (.7%)
Nephropathies	27 (.67%)
Pulmonary Vascular	27 (.67%)
Reproductive Neoplasms Male Maligna...	27 (.67%)
Cardiac Disorder Signs	26 (.65%)
Red Blood Cell	26 (.65%)
Penile And Scrotal Disorders	25 (.62%)
Breast Neoplasms Malignant And Unsp...	24 (.6%)
Endocrine Disorders Of Gonadal Func...	24 (.6%)
Hepatic And Hepatobiliary	24 (.6%)
Testicular And Epididymal	24 (.6%)
Allergic Conditions	23 (.57%)
Bone Disorders	22 (.55%)
Gastrointestinal Motility And Defec...	22 (.55%)
Lipid Analyses	22 (.55%)
Psychiatric And Behavioural Symptom...	22 (.55%)
Embolism And Thrombosis	21 (.52%)
Lifestyle Issues	20 (.5%)
Mental Impairment	19 (.47%)
Vision	19 (.47%)
Suicidal And Self-injurious Behavio...	18 (.45%)
Central Nervous System Vascular	17 (.42%)
Lipid Metabolism	17 (.42%)
Metabolic, Nutritional And Blood Ga...	17 (.42%)
Hypothalamus And Pituitary Gland	15 (.37%)
Enzyme	14 (.35%)
Hepatobiliary	14 (.35%)
Manic And Bipolar Mood Disorders	14 (.35%)
Miscellaneous And Site Unspecified ...	14 (.35%)
Upper Respiratory Tract Disorders	14 (.35%)
Decreased And Nonspecific Blood Pre...	13 (.32%)
Heart Failures	13 (.32%)
Water, Electrolyte And Mineral	13 (.32%)
Bone And Joint Injuries	12 (.3%)
Immunology And Allergy	12 (.3%)
Body Temperature Conditions	11 (.27%)
Skin And Subcutaneous Tissue	11 (.27%)
Bronchial Disorders	10 (.25%)
Electrolyte And Fluid Balance Condi...	10 (.25%)
Oral Soft Tissue Conditions	10 (.25%)
Communication Disorders	9 (.22%)
Deliria	9 (.22%)
Procedural And Device Related Injur...	9 (.22%)
Prostatic Disorders	9 (.22%)
Sleep Disturbances	9 (.22%)
Therapeutic Procedures And Supporti...	9 (.22%)
Viral Infectious	9 (.22%)
Encephalopathies	8 (.2%)
Eye	8 (.2%)
Renal And Urinary Tract Investigati...	8 (.2%)
Reproductive Tract	8 (.2%)
Arteriosclerosis, Stenosis, Vascula...	7 (.17%)
Fatal Outcomes	7 (.17%)
Miscellaneous And Site Unspecified ...	7 (.17%)
Angiedema And Urticaria	6 (.15%)
Gastrointestinal Hemorrhages	6 (.15%)
Gastrointestinal Ulceration And Per...	6 (.15%)
Increased Intracranial Pressure And...	6 (.15%)
Skin Vascular Abnormalities	6 (.15%)
Tendon, Ligament And Cartilage	6 (.15%)
Thyroid Gland	6 (.15%)
Tongue Conditions	6 (.15%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Testosterone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Testosterone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.