BACTROBAN

Bactroban Adverse Events Reported to the FDA Over Time

How are Bactroban adverse event reports trending over time?

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

Most Common Bactroban Adverse Events Reported to the FDA

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

Drug Ineffective	63 (6.36%)
Hypersensitivity	30 (3.03%)
Pruritus	30 (3.03%)
Rash	27 (2.73%)
Erythema	25 (2.53%)
Swelling	22 (2.22%)
Toxic Epidermal Necrolysis	19 (1.92%)
Burning Sensation	16 (1.62%)
Condition Aggravated	16 (1.62%)
Nasal Discomfort	15 (1.52%)
Headache	13 (1.31%)
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Insomnia	13 (1.31%)
Pain	13 (1.31%)
Infection	12 (1.21%)
Product Quality Issue	12 (1.21%)
Rash Papular	12 (1.21%)
Rash Pruritic	12 (1.21%)
Blister	11 (1.11%)
Dysgeusia	11 (1.11%)
Rash Pustular	11 (1.11%)
Application Site Erythema	10 (1.01%)
Blood Cholesterol Increased	10 (1.01%)
Cerebrovascular Accident	10 (1.01%)
Constipation	10 (1.01%)
Dyspnoea	10 (1.01%)
Pustular Psoriasis	10 (1.01%)
Ulcer	10 (1.01%)
Drug Interaction	9 (.91%)
Eczema	9 (.91%)
Eosinophilia	9 (.91%)
Skin Burning Sensation	9 (.91%)
Epistaxis	8 (.81%)
Dermatitis Atopic	7 (.71%)
Mental Impairment	7 (.71%)
Off Label Use	7 (.71%)
Psychiatric Symptom	7 (.71%)
Rhinalgia	7 (.71%)
Swollen Tongue	7 (.71%)
Urticaria	7 (.71%)
Application Site Irritation	6 (.61%)
Nasal Oedema	6 (.61%)
Rash Erythematous	6 (.61%)
Therapeutic Response Unexpected	6 (.61%)
Ageusia	5 (.51%)
Cough	5 (.51%)
Drug Effect Decreased	5 (.51%)
Drug Hypersensitivity	5 (.51%)
Feeling Abnormal	5 (.51%)
Ill-defined Disorder	5 (.51%)
Nausea	5 (.51%)
Oropharyngeal Pain	5 (.51%)
Throat Irritation	5 (.51%)
Application Site Pruritus	4 (.4%)
Eye Swelling	4 (.4%)
Feeling Hot	4 (.4%)
Incorrect Route Of Drug Administrat...	4 (.4%)
Medication Error	4 (.4%)
Pruritus Generalised	4 (.4%)
Scab	4 (.4%)
Sinus Headache	4 (.4%)
Sinusitis	4 (.4%)
Skin Discolouration	4 (.4%)
Skin Lesion	4 (.4%)
Adverse Event	3 (.3%)
Anxiety	3 (.3%)
Application Site Pain	3 (.3%)
Clostridial Infection	3 (.3%)
Diarrhoea	3 (.3%)
Drug Dispensing Error	3 (.3%)
Ear Pain	3 (.3%)
Eye Disorder	3 (.3%)
Eye Pain	3 (.3%)
Gingival Swelling	3 (.3%)
Hyperaesthesia	3 (.3%)
Inflammation	3 (.3%)
Irritability	3 (.3%)
Medication Residue	3 (.3%)
Oedema Mouth	3 (.3%)
Overdose	3 (.3%)
Pain In Extremity	3 (.3%)
Pain Of Skin	3 (.3%)
Parosmia	3 (.3%)
Pseudomembranous Colitis	3 (.3%)
Sinus Disorder	3 (.3%)
Stevens-johnson Syndrome	3 (.3%)
Swelling Face	3 (.3%)
Wheezing	3 (.3%)
Alopecia	2 (.2%)
Amnesia	2 (.2%)
Anaphylactic Reaction	2 (.2%)
Anosmia	2 (.2%)
Application Site Bleeding	2 (.2%)
Application Site Burn	2 (.2%)
Blindness	2 (.2%)
Cellulitis	2 (.2%)
Chest Discomfort	2 (.2%)
Chest Pain	2 (.2%)
Chills	2 (.2%)
Deafness Unilateral	2 (.2%)
Death	2 (.2%)
Dermatitis Contact	2 (.2%)

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

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

Epidermal And Dermal Conditions	220 (22.22%)
Therapeutic And Nontherapeutic Effe...	86 (8.69%)
Respiratory	61 (6.16%)
Neurological	40 (4.04%)
Allergic Conditions	37 (3.74%)
Infections - Pathogen Unspecified	36 (3.64%)
Administration Site Reactions	34 (3.43%)
Upper Respiratory Tract Disorders	27 (2.73%)
Medication Errors	25 (2.53%)
Headaches	17 (1.72%)
Product Quality Issues	17 (1.72%)
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Eye	14 (1.41%)
Sleep Disorders	14 (1.41%)
Gastrointestinal Motility And Defec...	13 (1.31%)
Tongue Conditions	12 (1.21%)
Oral Soft Tissue Conditions	11 (1.11%)
Central Nervous System Vascular	10 (1.01%)
Gastrointestinal Signs	10 (1.01%)
Lipid Analyses	10 (1.01%)
Tissue	10 (1.01%)
White Blood Cell	10 (1.01%)
Angiedema And Urticaria	9 (.91%)
Mental Impairment	9 (.91%)
Therapeutic Procedures And Supporti...	9 (.91%)
Bacterial Infectious	8 (.81%)
Injuries	8 (.81%)
Musculoskeletal And Connective Tiss...	8 (.81%)
Ocular Infections, Irritations And ...	8 (.81%)
Psychiatric And Behavioural Symptom...	8 (.81%)
Vision	7 (.71%)
Cranial Nerve Disorders	6 (.61%)
Anxiety Disorders	5 (.51%)
Aural	4 (.4%)
Cardiac And Vascular Investigations	4 (.4%)
Fungal Infectious	4 (.4%)
Hematology Investigations	4 (.4%)
Skin Appendage Conditions	4 (.4%)
Body Temperature Conditions	3 (.3%)
Bronchial Disorders	3 (.3%)
Hearing	3 (.3%)
Injuries By Physical Agents	3 (.3%)
Muscle	3 (.3%)
Salivary Gland Conditions	3 (.3%)
Anterior Eye Structural Change, Dep...	2 (.2%)
Bone And Joint Injuries	2 (.2%)
Dental And Gingival Conditions	2 (.2%)
Exocrine Pancreas Conditions	2 (.2%)
Fatal Outcomes	2 (.2%)
Joint	2 (.2%)
Metabolism	2 (.2%)
Mood Disorders	2 (.2%)
Skin And Subcutaneous Tissue	2 (.2%)
Vascular	2 (.2%)
Vascular Hemorrhagic	2 (.2%)
Vulvovaginal Disorders	2 (.2%)
Water, Electrolyte And Mineral	2 (.2%)
Appetite And General Nutritional	1 (.1%)
Bone, Calcium, Magnesium And Phosph...	1 (.1%)
Cardiac Disorder Signs	1 (.1%)
Central Nervous System Infections A...	1 (.1%)
Changes In Physical Activity	1 (.1%)
Chemical Injury And Poisoning	1 (.1%)
Communication Disorders	1 (.1%)
External Ear Disorders	1 (.1%)
Gastrointestinal Conditions	1 (.1%)
Hepatic And Hepatobiliary	1 (.1%)
Inner Ear And Viiith Cranial Nerve	1 (.1%)
Investigations, Imaging And Histopa...	1 (.1%)
Iron And Trace Metal Metabolism	1 (.1%)
Metabolic, Nutritional And Blood Ga...	1 (.1%)
Miscellaneous And Site Unspecified ...	1 (.1%)
Movement Disorders	1 (.1%)
Musculoskeletal And Connective Tiss...	1 (.1%)
Neonatal And Perinatal Conditions	1 (.1%)
Neonatal Respiratory	1 (.1%)
Neurological, Special Senses And Ps...	1 (.1%)
Ocular Neuromuscular	1 (.1%)
Ocular Sensory Symptoms	1 (.1%)
Platelet	1 (.1%)
Pleural	1 (.1%)
Protein And Chemistry Analyses	1 (.1%)
Pulmonary Vascular	1 (.1%)
Red Blood Cell	1 (.1%)
Renal And Urinary Tract Investigati...	1 (.1%)
Renal Disorders	1 (.1%)
Reproductive Tract	1 (.1%)
Respiratory Disorders Congenital	1 (.1%)
Schizophrenia And Other Psychotic	1 (.1%)
Seizures	1 (.1%)
Soft Tissue Sarcomas	1 (.1%)
Somatoform And Factitious	1 (.1%)
Thyroid Gland	1 (.1%)
Urinary Tract Signs	1 (.1%)

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