APLISOL

Aplisol Adverse Events Reported to the FDA Over Time

How are Aplisol adverse event reports trending over time?

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

Most Common Aplisol Adverse Events Reported to the FDA

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

Injection Site Erythema	125 (12.94%)
Injection Site Induration	78 (8.07%)
False Positive Tuberculosis Test	70 (7.25%)
Injection Site Pruritus	55 (5.69%)
Injection Site Pain	30 (3.11%)
Injection Site Rash	30 (3.11%)
Injection Site Swelling	29 (3%)
Injection Site Warmth	22 (2.28%)
Hypersensitivity	21 (2.17%)
Erythema	20 (2.07%)
Incorrect Route Of Drug Administrat...	20 (2.07%)
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Pain In Extremity	19 (1.97%)
Incorrect Dose Administered	17 (1.76%)
Injection Site Irritation	16 (1.66%)
Injection Site Urticaria	14 (1.45%)
Pruritus	13 (1.35%)
Rash Erythematous	13 (1.35%)
Injection Site Vesicles	9 (.93%)
Wrong Drug Administered	9 (.93%)
Induration	8 (.83%)
Tuberculin Test Positive	8 (.83%)
Accidental Exposure	7 (.72%)
Anaphylactic Reaction	7 (.72%)
Blister	7 (.72%)
Cellulitis	7 (.72%)
Hypoaesthesia	7 (.72%)
Oedema Peripheral	7 (.72%)
Paraesthesia	7 (.72%)
Pyrexia	7 (.72%)
Arthralgia	6 (.62%)
Dyspnoea	6 (.62%)
Pruritus Allergic	6 (.62%)
Chest Pain	5 (.52%)
Dizziness	5 (.52%)
Injection Site Reaction	5 (.52%)
Localised Oedema	5 (.52%)
Rash	5 (.52%)
Chest Discomfort	4 (.41%)
Erythema Multiforme	4 (.41%)
Injection Site Cellulitis	4 (.41%)
Pain	4 (.41%)
Arthritis	3 (.31%)
Chills	3 (.31%)
Condition Aggravated	3 (.31%)
Feeling Hot	3 (.31%)
Gait Disturbance	3 (.31%)
Heart Rate Increased	3 (.31%)
Injection Site Haematoma	3 (.31%)
Injection Site Inflammation	3 (.31%)
Injection Site Oedema	3 (.31%)
Local Reaction	3 (.31%)
Malaise	3 (.31%)
Muscular Weakness	3 (.31%)
Myalgia	3 (.31%)
Nausea	3 (.31%)
Product Quality Issue	3 (.31%)
Rash Papular	3 (.31%)
Scar	3 (.31%)
Sensation Of Heaviness	3 (.31%)
Skin Exfoliation	3 (.31%)
Skin Reaction	3 (.31%)
Swelling	3 (.31%)
Wrong Technique In Drug Usage Proce...	3 (.31%)
Application Site Reaction	2 (.21%)
Asthenia	2 (.21%)
Contusion	2 (.21%)
Convulsion	2 (.21%)
Diarrhoea	2 (.21%)
Drug Hypersensitivity	2 (.21%)
Dysphagia	2 (.21%)
Dysphonia	2 (.21%)
Electrocardiogram T Wave Inversion	2 (.21%)
Hyperhidrosis	2 (.21%)
Injection Site Abscess	2 (.21%)
Injection Site Discolouration	2 (.21%)
Injection Site Necrosis	2 (.21%)
Injection Site Scar	2 (.21%)
Joint Swelling	2 (.21%)
Limb Discomfort	2 (.21%)
Localised Infection	2 (.21%)
Lymphadenitis	2 (.21%)
Lymphadenopathy	2 (.21%)
Paraesthesia Oral	2 (.21%)
Product Contamination Microbial	2 (.21%)
Rash Macular	2 (.21%)
Rash Pruritic	2 (.21%)
Rash Pustular	2 (.21%)
Skin Bacterial Infection	2 (.21%)
Thyroid Disorder	2 (.21%)
Urticaria	2 (.21%)
Vomiting	2 (.21%)
Wheezing	2 (.21%)
Abdominal Distension	1 (.1%)
Abdominal Pain	1 (.1%)
Abdominal Pain Upper	1 (.1%)
Abortion Spontaneous	1 (.1%)
Abscess	1 (.1%)
Acanthosis	1 (.1%)
Adverse Drug Reaction	1 (.1%)
Alanine Aminotransferase Increased	1 (.1%)
Anaphylactic Shock	1 (.1%)

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This graph shows the top adverse events submitted to the FDA for Aplisol, 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 Aplisol 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 Aplisol

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

Administration Site Reactions	433 (44.82%)
Epidermal And Dermal Conditions	98 (10.14%)
Microbiology And Serology	78 (8.07%)
Medication Errors	59 (6.11%)
Allergic Conditions	32 (3.31%)
Musculoskeletal And Connective Tiss...	30 (3.11%)
Neurological	22 (2.28%)
Bacterial Infectious	13 (1.35%)
Infections - Pathogen Unspecified	12 (1.24%)
Respiratory	12 (1.24%)
Joint	11 (1.14%)
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Gastrointestinal Signs	10 (1.04%)
Cardiac And Vascular Investigations	8 (.83%)
Body Temperature Conditions	7 (.72%)
Product Quality Issues	7 (.72%)
Muscle	6 (.62%)
Hepatobiliary	4 (.41%)
Oral Soft Tissue Conditions	4 (.41%)
Spleen, Lymphatic And Reticulendoth...	4 (.41%)
Injuries	3 (.31%)
Vascular	3 (.31%)
Angiedema And Urticaria	2 (.21%)
Bronchial Disorders	2 (.21%)
Gallbladder	2 (.21%)
Gastrointestinal Motility And Defec...	2 (.21%)
Physical Examination Topics	2 (.21%)
Procedural And Device Related Injur...	2 (.21%)
Seizures	2 (.21%)
Skin Appendage Conditions	2 (.21%)
Therapeutic And Nontherapeutic Effe...	2 (.21%)
Thyroid Gland	2 (.21%)
Upper Respiratory Tract Disorders	2 (.21%)
Abortions And Stillbirth	1 (.1%)
Adrenal Gland	1 (.1%)
Anxiety Disorders	1 (.1%)
Appetite And General Nutritional	1 (.1%)
Breast	1 (.1%)
Cardiac Disorder Signs	1 (.1%)
Chemical Injury And Poisoning	1 (.1%)
Cornification And Dystrophic Skin	1 (.1%)
Deliria	1 (.1%)
Eye	1 (.1%)
Headaches	1 (.1%)
Hypothalamus And Pituitary Gland	1 (.1%)
Immunology And Allergy	1 (.1%)
Lower Respiratory Tract Disorders	1 (.1%)
Metabolic, Nutritional And Blood Ga...	1 (.1%)
Movement Disorders	1 (.1%)
Musculoskeletal And Connective Tiss...	1 (.1%)
Mycobacterial Infectious	1 (.1%)
Neurological, Special Senses And Ps...	1 (.1%)
Ocular Infections, Irritations And ...	1 (.1%)
Ocular Sensory Symptoms	1 (.1%)
Pigmentation	1 (.1%)
Pregnancy, Labour, Delivery And Pos...	1 (.1%)
Renal And Urinary Tract Investigati...	1 (.1%)
Respiratory And Pulmonary Investiga...	1 (.1%)
Skin Vascular Abnormalities	1 (.1%)
Viral Infectious	1 (.1%)

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