GSK AUTOINJECTOR

Gsk Autoinjector Adverse Events Reported to the FDA Over Time

How are Gsk Autoinjector adverse event reports trending over time?

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

Most Common Gsk Autoinjector Adverse Events Reported to the FDA

What are the most common Gsk Autoinjector adverse events reported to the FDA?

Product Quality Issue	254 (39.02%)
Device Malfunction	184 (28.26%)
Drug Ineffective	52 (7.99%)
Injection Site Pain	18 (2.76%)
Drug Administration Error	7 (1.08%)
Headache	7 (1.08%)
Migraine	7 (1.08%)
Expired Drug Administered	6 (.92%)
Injection Site Haematoma	5 (.77%)
Contusion	4 (.61%)
Injection Site Irritation	4 (.61%)
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No Adverse Event	4 (.61%)
Burning Sensation	3 (.46%)
Device Failure	3 (.46%)
Injection Site Reaction	3 (.46%)
Medication Error	3 (.46%)
Pain	3 (.46%)
Paraesthesia	3 (.46%)
Therapeutic Response Decreased	3 (.46%)
Asthma	2 (.31%)
Chest Discomfort	2 (.31%)
Chest Pain	2 (.31%)
Emotional Disorder	2 (.31%)
Erythema	2 (.31%)
Haemorrhage	2 (.31%)
Injection Site Haemorrhage	2 (.31%)
Nasal Discomfort	2 (.31%)
Needle Issue	2 (.31%)
Overdose	2 (.31%)
Pharyngeal Oedema	2 (.31%)
Abnormal Sensation In Eye	1 (.15%)
Adverse Drug Reaction	1 (.15%)
Adverse Event	1 (.15%)
Application Site Erythema	1 (.15%)
Application Site Pain	1 (.15%)
Application Site Pruritus	1 (.15%)
Application Site Swelling	1 (.15%)
Arthropathy	1 (.15%)
Asthenopia	1 (.15%)
Back Pain	1 (.15%)
Balance Disorder	1 (.15%)
Condition Aggravated	1 (.15%)
Decreased Activity	1 (.15%)
Dizziness	1 (.15%)
Drug Dispensing Error	1 (.15%)
Drug Effect Decreased	1 (.15%)
Dysuria	1 (.15%)
Ear Pruritus	1 (.15%)
Facial Pain	1 (.15%)
Fatigue	1 (.15%)
Feeling Hot	1 (.15%)
Gallbladder Operation	1 (.15%)
Gastric Disorder	1 (.15%)
Gastrooesophageal Reflux Disease	1 (.15%)
Hospitalisation	1 (.15%)
Hypersensitivity	1 (.15%)
Hypertension	1 (.15%)
Incorrect Dose Administered	1 (.15%)
Inflammation	1 (.15%)
Injection Site Discharge	1 (.15%)
Injection Site Paraesthesia	1 (.15%)
Injection Site Pruritus	1 (.15%)
Injection Site Rash	1 (.15%)
Injection Site Scar	1 (.15%)
Injection Site Swelling	1 (.15%)
Injection Site Vesicles	1 (.15%)
Malaise	1 (.15%)
Medical Device Complication	1 (.15%)
Muscle Tightness	1 (.15%)
Muscular Weakness	1 (.15%)
Pain In Extremity	1 (.15%)
Palpitations	1 (.15%)
Paralysis	1 (.15%)
Pharyngeal Disorder	1 (.15%)
Pharyngeal Inflammation	1 (.15%)
Product Substitution Issue	1 (.15%)
Puncture Site Pain	1 (.15%)
Pyrexia	1 (.15%)
Renal Disorder	1 (.15%)
Road Traffic Accident	1 (.15%)
Therapeutic Response Unexpected	1 (.15%)
Throat Irritation	1 (.15%)
Throat Tightness	1 (.15%)
Tremor	1 (.15%)
Underdose	1 (.15%)
Weight Increased	1 (.15%)

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

What are the most common Gsk Autoinjector adverse events reported to the FDA?

Product Quality Issues	255 (39.17%)
Procedural And Device Related Injur...	190 (29.19%)
Therapeutic And Nontherapeutic Effe...	59 (9.06%)
Administration Site Reactions	44 (6.76%)
Medication Errors	21 (3.23%)
Headaches	14 (2.15%)
Neurological	8 (1.23%)
Injuries	5 (.77%)
Respiratory	4 (.61%)
Upper Respiratory Tract Disorders	4 (.61%)
Bronchial Disorders	2 (.31%)
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Epidermal And Dermal Conditions	2 (.31%)
Mood Disorders	2 (.31%)
Movement Disorders	2 (.31%)
Muscle	2 (.31%)
Musculoskeletal And Connective Tiss...	2 (.31%)
Ocular Sensory Symptoms	2 (.31%)
Vascular Hemorrhagic	2 (.31%)
Allergic Conditions	1 (.15%)
Aural	1 (.15%)
Body Temperature Conditions	1 (.15%)
Cardiac Disorder Signs	1 (.15%)
Changes In Physical Activity	1 (.15%)
Gastrointestinal Conditions	1 (.15%)
Gastrointestinal Motility And Defec...	1 (.15%)
Hepatobiliary Therapeutic Procedure...	1 (.15%)
Joint	1 (.15%)
Physical Examination Topics	1 (.15%)
Renal Disorders	1 (.15%)
Therapeutic Procedures And Supporti...	1 (.15%)
Urinary Tract Signs	1 (.15%)
Vascular Hypertensive	1 (.15%)

Share/Embed Graph Export Data

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