DEPO TESTOSTERONE

Depo Testosterone Adverse Events Reported to the FDA Over Time

How are Depo Testosterone adverse event reports trending over time?

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

Most Common Depo Testosterone Adverse Events Reported to the FDA

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

Drug Ineffective	54 (4.92%)
Poor Quality Drug Administered	54 (4.92%)
Burning Sensation	34 (3.1%)
Injection Site Pain	32 (2.92%)
Headache	21 (1.91%)
Malaise	18 (1.64%)
Injection Site Swelling	17 (1.55%)
Dyspnoea	14 (1.28%)
Fatigue	14 (1.28%)
Acne	13 (1.19%)
Feeling Abnormal	13 (1.19%)
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Pain	13 (1.19%)
Alopecia	12 (1.09%)
Blood Testosterone Decreased	12 (1.09%)
Feeling Hot	12 (1.09%)
Asthenia	10 (.91%)
Erythema	10 (.91%)
Injection Site Erythema	10 (.91%)
Libido Decreased	10 (.91%)
Depression	9 (.82%)
Dysphonia	9 (.82%)
Pain In Extremity	9 (.82%)
Aggression	8 (.73%)
Cellulitis	8 (.73%)
Hypertension	8 (.73%)
Myocardial Infarction	8 (.73%)
Nausea	8 (.73%)
Rash	8 (.73%)
Anxiety	7 (.64%)
Arthralgia	7 (.64%)
Dizziness	7 (.64%)
Hypersensitivity	7 (.64%)
Pyrexia	7 (.64%)
Tremor	7 (.64%)
Weight Decreased	7 (.64%)
Abscess	6 (.55%)
Chest Pain	6 (.55%)
Gastrooesophageal Reflux Disease	6 (.55%)
Hyperhidrosis	6 (.55%)
Injection Site Abscess	6 (.55%)
Polycythaemia	6 (.55%)
Product Quality Issue	6 (.55%)
Seborrhoea	6 (.55%)
Thirst	6 (.55%)
Abdominal Pain Upper	5 (.46%)
Blood Pressure Increased	5 (.46%)
Blood Testosterone Abnormal	5 (.46%)
Cardiac Disorder	5 (.46%)
Condition Aggravated	5 (.46%)
Hot Flush	5 (.46%)
Injection Site Reaction	5 (.46%)
Muscular Weakness	5 (.46%)
Osteoporosis	5 (.46%)
Palpitations	5 (.46%)
Abnormal Behaviour	4 (.36%)
Accidental Exposure	4 (.36%)
Agitation	4 (.36%)
Blood Cholesterol Increased	4 (.36%)
Blood Testosterone Increased	4 (.36%)
Chromaturia	4 (.36%)
Contusion	4 (.36%)
Diabetes Mellitus	4 (.36%)
Flushing	4 (.36%)
Haematocrit Increased	4 (.36%)
Haemoglobin Increased	4 (.36%)
Increased Appetite	4 (.36%)
Irritability	4 (.36%)
Lethargy	4 (.36%)
Mania	4 (.36%)
Precocious Puberty	4 (.36%)
Prostate Cancer	4 (.36%)
Sleep Disorder	4 (.36%)
Suicidal Ideation	4 (.36%)
Swelling	4 (.36%)
Arthropod Sting	3 (.27%)
Bipolar Disorder	3 (.27%)
Chest Discomfort	3 (.27%)
Chills	3 (.27%)
Cough	3 (.27%)
Drug Abuser	3 (.27%)
Drug Dispensing Error	3 (.27%)
Drug Interaction	3 (.27%)
Hypoaesthesia	3 (.27%)
Incoherent	3 (.27%)
Incorrect Dose Administered	3 (.27%)
Injection Site Mass	3 (.27%)
Injection Site Urticaria	3 (.27%)
Insomnia	3 (.27%)
Intentional Drug Misuse	3 (.27%)
Metabolic Disorder	3 (.27%)
Mood Disorder Due To A General Medi...	3 (.27%)
Myalgia	3 (.27%)
Painful Respiration	3 (.27%)
Paraesthesia	3 (.27%)
Product Deposit	3 (.27%)
Psychosomatic Disease	3 (.27%)
Rhabdomyolysis	3 (.27%)
Scrotal Disorder	3 (.27%)
Skin Burning Sensation	3 (.27%)
Testicular Disorder	3 (.27%)
Ventricular Tachycardia	3 (.27%)

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This graph shows the top adverse events submitted to the FDA for Depo 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 Depo 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 Depo Testosterone

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

Administration Site Reactions	83 (7.57%)
Medication Errors	73 (6.65%)
Neurological	67 (6.11%)
Therapeutic And Nontherapeutic Effe...	61 (5.56%)
Skin Appendage Conditions	42 (3.83%)
Respiratory	34 (3.1%)
Epidermal And Dermal Conditions	28 (2.55%)
Endocrine Investigations	25 (2.28%)
Infections - Pathogen Unspecified	22 (2.01%)
Gastrointestinal Signs	21 (1.91%)
Headaches	21 (1.91%)
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Anxiety Disorders	18 (1.64%)
Muscle	18 (1.64%)
Musculoskeletal And Connective Tiss...	18 (1.64%)
Product Quality Issues	18 (1.64%)
Personality Disorders	15 (1.37%)
Depressed Mood Disorders	14 (1.28%)
Injuries	14 (1.28%)
Bacterial Infectious	13 (1.19%)
Hematology Investigations	12 (1.09%)
Cardiac And Vascular Investigations	11 (1%)
Cardiac Disorder Signs	10 (.91%)
Coronary Artery	10 (.91%)
Joint	10 (.91%)
Sexual Dysfunctions, Disturbances A...	10 (.91%)
Urinary Tract Signs	10 (.91%)
Allergic Conditions	9 (.82%)
Gastrointestinal Motility And Defec...	9 (.82%)
Movement Disorders	9 (.82%)
Physical Examination Topics	9 (.82%)
Vascular	9 (.82%)
Vascular Hypertensive	9 (.82%)
Bone Disorders	8 (.73%)
Disturbances In Thinking	8 (.73%)
Manic And Bipolar Mood Disorders	8 (.73%)
Mood Disorders	8 (.73%)
Body Temperature Conditions	7 (.64%)
Lipid Metabolism	7 (.64%)
Renal Disorders	7 (.64%)
Sleep Disorders	7 (.64%)
Lifestyle Issues	6 (.55%)
Lipid Analyses	6 (.55%)
Psychiatric	6 (.55%)
Red Blood Cell	6 (.55%)
Suicidal And Self-injurious Behavio...	6 (.55%)
Tendon, Ligament And Cartilage	6 (.55%)
Testicular And Epididymal	6 (.55%)
Cardiac Arrhythmias	5 (.46%)
Endocrine Disorders Of Gonadal Func...	5 (.46%)
Myocardial	5 (.46%)
Psychiatric And Behavioural Symptom...	5 (.46%)
Sexual Function And Fertility	5 (.46%)
Appetite And General Nutritional	4 (.36%)
Glucose Metabolism Disorders	4 (.36%)
Mental Impairment	4 (.36%)
Penile And Scrotal Disorders	4 (.36%)
Reproductive Neoplasms Male Maligna...	4 (.36%)
Somatoform And Factitious	4 (.36%)
Therapeutic Procedures And Supporti...	4 (.36%)
Bone And Joint Injuries	3 (.27%)
Breast	3 (.27%)
Bronchial Disorders	3 (.27%)
Central Nervous System Vascular	3 (.27%)
Electrolyte And Fluid Balance Condi...	3 (.27%)
Exocrine Pancreas Conditions	3 (.27%)
Impulse Control	3 (.27%)
Legal Issues	3 (.27%)
Metabolism	3 (.27%)
Miscellaneous And Site Unspecified ...	3 (.27%)
Procedural And Device Related Injur...	3 (.27%)
Skin Vascular Abnormalities	3 (.27%)
Breast Neoplasms Malignant And Unsp...	2 (.18%)
Decreased And Nonspecific Blood Pre...	2 (.18%)
Embolism And Thrombosis	2 (.18%)
Enzyme	2 (.18%)
Gastrointestinal Inflammatory Condi...	2 (.18%)
Hepatic And Hepatobiliary	2 (.18%)
Hepatobiliary	2 (.18%)
Hypothalamus And Pituitary Gland	2 (.18%)
Increased Intracranial Pressure And...	2 (.18%)
Oral Soft Tissue Conditions	2 (.18%)
Pulmonary Vascular	2 (.18%)
Reproductive Organ And Breast Inves...	2 (.18%)
Schizophrenia And Other Psychotic	2 (.18%)
Upper Respiratory Tract Disorders	2 (.18%)
Vascular Hemorrhagic	2 (.18%)
Acid-base	1 (.09%)
Angiedema And Urticaria	1 (.09%)
Bone, Calcium, Magnesium And Phosph...	1 (.09%)
Demyelinating	1 (.09%)
Endocrine Neoplasms Benign	1 (.09%)
Endocrine Neoplasms Malignant And U...	1 (.09%)
Hematopoietic Neoplasms	1 (.09%)
Iron And Trace Metal Metabolism	1 (.09%)
Menstrual Cycle And Uterine Bleedin...	1 (.09%)
Metabolic, Nutritional And Blood Ga...	1 (.09%)
Musculoskeletal And Soft Tissue Inv...	1 (.09%)
Neuromuscular	1 (.09%)
Ocular Structural Change, Deposit A...	1 (.09%)
Peritoneal And Retroperitoneal Cond...	1 (.09%)
Pleural	1 (.09%)

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This graph shows the top categories of adverse events submitted to the FDA for Depo 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 Depo 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.