LISTERINE

Listerine Adverse Events Reported to the FDA Over Time

How are Listerine adverse event reports trending over time?

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

Most Common Listerine Adverse Events Reported to the FDA

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

Application Site Burn	222 (3.71%)
Incorrect Route Of Drug Administrat...	194 (3.24%)
Intentional Drug Misuse	153 (2.56%)
Oral Discomfort	129 (2.16%)
Product Quality Issue	115 (1.92%)
Glossodynia	94 (1.57%)
Ageusia	90 (1.5%)
Oral Pain	86 (1.44%)
Stomatitis	86 (1.44%)
Lip Swelling	83 (1.39%)
Oral Mucosal Exfoliation	73 (1.22%)
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Application Site Pain	69 (1.15%)
Pain	67 (1.12%)
Burning Sensation	61 (1.02%)
Gingival Pain	61 (1.02%)
Drug Abuse	60 (1%)
Accidental Exposure	59 (.99%)
Oropharyngeal Blistering	58 (.97%)
Tongue Disorder	55 (.92%)
Hypersensitivity	54 (.9%)
Caustic Injury	53 (.89%)
Swelling Face	50 (.84%)
Malaise	49 (.82%)
Dyspnoea	43 (.72%)
Thermal Burn	43 (.72%)
Application Site Vesicles	42 (.7%)
Hypoaesthesia Oral	42 (.7%)
Vomiting	42 (.7%)
Tooth Disorder	41 (.69%)
Swollen Tongue	40 (.67%)
Nausea	38 (.64%)
Incorrect Dose Administered	36 (.6%)
Application Site Irritation	35 (.58%)
Cheilitis	35 (.58%)
Eating Disorder	35 (.58%)
Aphthous Stomatitis	34 (.57%)
Oedema Mouth	34 (.57%)
Dysgeusia	33 (.55%)
Feeling Abnormal	33 (.55%)
Tongue Blistering	33 (.55%)
Glossitis	32 (.53%)
Mouth Ulceration	32 (.53%)
Wrong Technique In Drug Usage Proce...	32 (.53%)
Dysphagia	31 (.52%)
Erythema	31 (.52%)
Loss Of Consciousness	31 (.52%)
Overdose	31 (.52%)
Tongue Discolouration	31 (.52%)
Blister	30 (.5%)
Dizziness	29 (.48%)
Pyrexia	28 (.47%)
Alcohol Poisoning	27 (.45%)
Gingival Bleeding	27 (.45%)
Gingival Disorder	27 (.45%)
Gingival Discolouration	26 (.43%)
Lip Blister	26 (.43%)
Tongue Haemorrhage	25 (.42%)
Tooth Discolouration	25 (.42%)
Abdominal Pain Upper	24 (.4%)
Diarrhoea	24 (.4%)
Oral Disorder	24 (.4%)
Pharyngeal Oedema	24 (.4%)
Expired Drug Administered	23 (.38%)
Feeling Drunk	23 (.38%)
Gingivitis	23 (.38%)
Gingival Erythema	22 (.37%)
Sensitivity Of Teeth	22 (.37%)
Toothache	22 (.37%)
Lip Pain	21 (.35%)
Heart Rate Increased	20 (.33%)
Paraesthesia Oral	20 (.33%)
Wound	20 (.33%)
Application Site Erythema	19 (.32%)
Bacterial Infection	19 (.32%)
Chest Pain	19 (.32%)
Dependence	19 (.32%)
Gingival Swelling	19 (.32%)
Tongue Ulceration	19 (.32%)
Drug Ineffective	18 (.3%)
Off Label Use	18 (.3%)
Rash	18 (.3%)
Weight Decreased	18 (.3%)
Headache	17 (.28%)
Oropharyngeal Pain	17 (.28%)
Speech Disorder	17 (.28%)
Tremor	17 (.28%)
Abdominal Pain	16 (.27%)
Application Site Exfoliation	16 (.27%)
Chemical Injury	16 (.27%)
Condition Aggravated	16 (.27%)
Swelling	16 (.27%)
Asthenia	15 (.25%)
Asthma	15 (.25%)
Convulsion	15 (.25%)
Cough	15 (.25%)
Gingival Blister	15 (.25%)
Infection	15 (.25%)
Tooth Loss	15 (.25%)
Fatigue	14 (.23%)
Gingival Infection	14 (.23%)
Medication Error	14 (.23%)

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

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

Oral Soft Tissue Conditions	840 (14.04%)
Medication Errors	445 (7.44%)
Administration Site Reactions	440 (7.35%)
Dental And Gingival Conditions	376 (6.28%)
Neurological	368 (6.15%)
Tongue Conditions	352 (5.88%)
Psychiatric	257 (4.3%)
Epidermal And Dermal Conditions	203 (3.39%)
Gastrointestinal Signs	200 (3.34%)
Respiratory	195 (3.26%)
Product Quality Issues	163 (2.72%)
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Infections - Pathogen Unspecified	136 (2.27%)
Chemical Injury And Poisoning	118 (1.97%)
Injuries	109 (1.82%)
Allergic Conditions	89 (1.49%)
Upper Respiratory Tract Disorders	67 (1.12%)
Bacterial Infectious	51 (.85%)
Salivary Gland Conditions	49 (.82%)
Injuries By Physical Agents	44 (.74%)
Lifestyle Issues	37 (.62%)
Anxiety Disorders	36 (.6%)
Eating Disorders	35 (.58%)
Fungal Infectious	35 (.58%)
Cardiac And Vascular Investigations	34 (.57%)
Therapeutic And Nontherapeutic Effe...	34 (.57%)
Gastrointestinal Motility And Defec...	31 (.52%)
Eye	30 (.5%)
Body Temperature Conditions	28 (.47%)
Vision	28 (.47%)
Therapeutic Procedures And Supporti...	27 (.45%)
Viral Infectious	27 (.45%)
Metabolic, Nutritional And Blood Ga...	24 (.4%)
Movement Disorders	23 (.38%)
Headaches	22 (.37%)
Musculoskeletal And Connective Tiss...	22 (.37%)
Appetite And General Nutritional	21 (.35%)
Physical Examination Topics	21 (.35%)
Bronchial Disorders	19 (.32%)
Gastrointestinal Neoplasms Malignan...	19 (.32%)
Bone Disorders	18 (.3%)
Gastrointestinal Inflammatory Condi...	18 (.3%)
Head And Neck Therapeutic Procedure...	18 (.3%)
Mental Impairment	18 (.3%)
Water, Electrolyte And Mineral	17 (.28%)
Sleep Disorders	16 (.27%)
Toxicology And Therapeutic Drug Mon...	16 (.27%)
Angiedema And Urticaria	15 (.25%)
Cranial Nerve Disorders	15 (.25%)
Ocular Infections, Irritations And ...	15 (.25%)
Seizures	15 (.25%)
Hematology Investigations	14 (.23%)
Skin Appendage Conditions	14 (.23%)
Suicidal And Self-injurious Behavio...	14 (.23%)
Tissue	14 (.23%)
Muscle	11 (.18%)
Procedural And Device Related Injur...	11 (.18%)
Disturbances In Thinking	10 (.17%)
Cardiac Arrhythmias	9 (.15%)
Gastrointestinal Conditions	9 (.15%)
Gastrointestinal Hemorrhages	9 (.15%)
Renal And Urinary Tract Investigati...	9 (.15%)
Spleen, Lymphatic And Reticulendoth...	9 (.15%)
Vascular	9 (.15%)
Hepatic And Hepatobiliary	8 (.13%)
Lower Respiratory Tract Disorders	8 (.13%)
Psychiatric And Behavioural Symptom...	8 (.13%)
Cardiac Disorder Signs	7 (.12%)
Depressed Mood Disorders	7 (.12%)
Miscellaneous And Site Unspecified ...	7 (.12%)
Mood Disorders	7 (.12%)
Bone And Joint Injuries	6 (.1%)
Coronary Artery	6 (.1%)
Deliria	6 (.1%)
Fatal Outcomes	6 (.1%)
Vascular Hemorrhagic	6 (.1%)
Anemias Nonhemolytic And Marrow Dep...	5 (.08%)
Electrolyte And Fluid Balance Condi...	5 (.08%)
Joint	5 (.08%)
Personality Disorders	5 (.08%)
Respiratory And Mediastinal Neoplas...	5 (.08%)
Vascular Hypertensive	5 (.08%)
Aural	4 (.07%)
Central Nervous System Vascular	4 (.07%)
Economic And Housing Issues	4 (.07%)
Investigations, Imaging And Histopa...	4 (.07%)
Lipid Analyses	4 (.07%)
Renal Disorders	4 (.07%)
Urolithiases	4 (.07%)
Abortions And Stillbirth	3 (.05%)
Breast Neoplasms Malignant And Unsp...	3 (.05%)
Cornification And Dystrophic Skin	3 (.05%)
Decreased And Nonspecific Blood Pre...	3 (.05%)
Embolism And Thrombosis	3 (.05%)
Gastrointestinal Ulceration And Per...	3 (.05%)
Hepatobiliary	3 (.05%)
Legal Issues	3 (.05%)
Myocardial	3 (.05%)
Ocular Neuromuscular	3 (.05%)
Peripheral Neuropathies	3 (.05%)
Anterior Eye Structural Change, Dep...	2 (.03%)
Arteriosclerosis, Stenosis, Vascula...	2 (.03%)

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