NYSTATIN

Nystatin Adverse Events Reported to the FDA Over Time

How are Nystatin adverse event reports trending over time?

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

Most Common Nystatin Adverse Events Reported to the FDA

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

Sepsis Neonatal	26 (2.23%)
Drug Ineffective	23 (1.98%)
Medication Error	22 (1.89%)
Hypersensitivity	19 (1.63%)
Rash	13 (1.12%)
Drug Dispensing Error	12 (1.03%)
Erythema	12 (1.03%)
Candidiasis	11 (.95%)
Alanine Aminotransferase Increased	10 (.86%)
Malaise	10 (.86%)
Nausea	10 (.86%)
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Diarrhoea	9 (.77%)
Dysgeusia	9 (.77%)
Headache	9 (.77%)
Pruritus	9 (.77%)
Aspartate Aminotransferase Increase...	8 (.69%)
Condition Aggravated	8 (.69%)
Heart Rate Increased	8 (.69%)
Oedema Peripheral	8 (.69%)
Oral Candidiasis	8 (.69%)
Oral Pain	8 (.69%)
Urinary Tract Infection	8 (.69%)
Vomiting	8 (.69%)
Lobar Pneumonia	7 (.6%)
Oesophagitis	7 (.6%)
Acute Respiratory Distress Syndrome	6 (.52%)
Blood Alkaline Phosphatase Increase...	6 (.52%)
Blood Bilirubin Increased	6 (.52%)
Convulsion	6 (.52%)
Dry Mouth	6 (.52%)
Pain In Extremity	6 (.52%)
Paraesthesia Oral	6 (.52%)
Pyrexia	6 (.52%)
Respiratory Arrest	6 (.52%)
Sepsis	6 (.52%)
Stomatitis	6 (.52%)
Swelling Face	6 (.52%)
Wrong Drug Administered	6 (.52%)
Abdominal Pain Upper	5 (.43%)
Alopecia	5 (.43%)
Application Site Pain	5 (.43%)
Asthenia	5 (.43%)
Chronic Obstructive Pulmonary Disea...	5 (.43%)
Circumstance Or Information Capable...	5 (.43%)
Cleft Lip And Palate	5 (.43%)
Cough	5 (.43%)
Depressed Level Of Consciousness	5 (.43%)
Drug Interaction	5 (.43%)
Dyspnoea	5 (.43%)
Fungal Infection	5 (.43%)
Heart Rate Irregular	5 (.43%)
Liver Disorder	5 (.43%)
Musculoskeletal Stiffness	5 (.43%)
Off Label Use	5 (.43%)
Pregnancy	5 (.43%)
Respiratory Distress	5 (.43%)
Somnolence	5 (.43%)
Stevens-johnson Syndrome	5 (.43%)
Swollen Tongue	5 (.43%)
Tinnitus	5 (.43%)
Urticaria	5 (.43%)
Vulvovaginal Burning Sensation	5 (.43%)
Abdominal Pain	4 (.34%)
Agitation	4 (.34%)
Agranulocytosis	4 (.34%)
Anaemia	4 (.34%)
Application Site Erythema	4 (.34%)
Blood Lactate Dehydrogenase Increas...	4 (.34%)
Bronchopneumonia	4 (.34%)
Burning Sensation	4 (.34%)
Craniosynostosis	4 (.34%)
Developmental Delay	4 (.34%)
Dizziness	4 (.34%)
Drug Hypersensitivity	4 (.34%)
Drug Prescribing Error	4 (.34%)
Fall	4 (.34%)
Febrile Neutropenia	4 (.34%)
Feeding Disorder	4 (.34%)
Feeling Abnormal	4 (.34%)
Hydrocele	4 (.34%)
Hypotension	4 (.34%)
Intercepted Drug Dispensing Error	4 (.34%)
Iron Deficiency Anaemia	4 (.34%)
Lip Swelling	4 (.34%)
Liver Injury	4 (.34%)
Necrotising Enterocolitis Neonatal	4 (.34%)
Neutropenia	4 (.34%)
Oxygen Saturation Decreased	4 (.34%)
Product Quality Issue	4 (.34%)
Rash Erythematous	4 (.34%)
Rash Pruritic	4 (.34%)
Renal Failure Acute	4 (.34%)
Septic Shock	4 (.34%)
Torticollis	4 (.34%)
Application Site Pruritus	3 (.26%)
Application Site Reaction	3 (.26%)
Arthralgia	3 (.26%)
Bone Marrow Failure	3 (.26%)
Bronchopulmonary Aspergillosis	3 (.26%)
Cardiac Operation	3 (.26%)
Cardiogenic Shock	3 (.26%)

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

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

Epidermal And Dermal Conditions	86 (7.39%)
Infections - Pathogen Unspecified	77 (6.62%)
Medication Errors	65 (5.58%)
Neurological	47 (4.04%)
Gastrointestinal Signs	42 (3.61%)
Respiratory	41 (3.52%)
Therapeutic And Nontherapeutic Effe...	38 (3.26%)
Fungal Infectious	35 (3.01%)
Oral Soft Tissue Conditions	33 (2.84%)
Administration Site Reactions	31 (2.66%)
Hepatobiliary	31 (2.66%)
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Allergic Conditions	27 (2.32%)
Hepatic And Hepatobiliary	25 (2.15%)
White Blood Cell	18 (1.55%)
Cardiac And Vascular Investigations	16 (1.37%)
Lower Respiratory Tract Disorders	15 (1.29%)
Gastrointestinal Inflammatory Condi...	14 (1.2%)
Vulvovaginal Disorders	14 (1.2%)
Gastrointestinal Motility And Defec...	13 (1.12%)
Musculoskeletal And Connective Tiss...	13 (1.12%)
Product Quality Issues	12 (1.03%)
Renal Disorders	12 (1.03%)
Anemias Nonhemolytic And Marrow Dep...	11 (.95%)
Headaches	11 (.95%)
Muscle	11 (.95%)
Appetite And General Nutritional	10 (.86%)
Bronchial Disorders	10 (.86%)
Enzyme	10 (.86%)
Skin Appendage Conditions	10 (.86%)
Tongue Conditions	10 (.86%)
Eye	9 (.77%)
Musculoskeletal And Connective Tiss...	9 (.77%)
Anxiety Disorders	8 (.69%)
Injuries	8 (.69%)
Angiedema And Urticaria	7 (.6%)
Body Temperature Conditions	7 (.6%)
Cardiac Valve	7 (.6%)
Vascular	7 (.6%)
Chemical Injury And Poisoning	6 (.52%)
Decreased And Nonspecific Blood Pre...	6 (.52%)
Gastrointestinal Tract Disorders Co...	6 (.52%)
Heart Failures	6 (.52%)
Inner Ear And Viiith Cranial Nerve	6 (.52%)
Joint	6 (.52%)
Ocular Infections, Irritations And ...	6 (.52%)
Pregnancy, Labour, Delivery And Pos...	6 (.52%)
Pulmonary Vascular	6 (.52%)
Salivary Gland Conditions	6 (.52%)
Seizures	6 (.52%)
Urinary Tract Signs	6 (.52%)
Bone, Calcium, Magnesium And Phosph...	5 (.43%)
Glucose Metabolism Disorders	5 (.43%)
Therapeutic Procedures And Supporti...	5 (.43%)
Upper Respiratory Tract Disorders	5 (.43%)
Acid-base	4 (.34%)
Bacterial Infectious	4 (.34%)
Depressed Mood Disorders	4 (.34%)
Eye Disorders Congenital	4 (.34%)
Gastrointestinal Ulceration And Per...	4 (.34%)
Hematological	4 (.34%)
Hematology Investigations	4 (.34%)
Metabolic, Nutritional And Blood Ga...	4 (.34%)
Physical Examination Topics	4 (.34%)
Reproductive Tract And Breast Disor...	4 (.34%)
Viral Infectious	4 (.34%)
Cardiac And Vascular Disorders Cong...	3 (.26%)
Cardiac Therapeutic Procedures	3 (.26%)
Central Nervous System Vascular	3 (.26%)
Gastrointestinal Conditions	3 (.26%)
Lifestyle Issues	3 (.26%)
Microbiology And Serology	3 (.26%)
Myocardial	3 (.26%)
Obstetric And Gynecological Therape...	3 (.26%)
Reproductive Tract	3 (.26%)
Skin And Subcutaneous Tissue	3 (.26%)
Abortions And Stillbirth	2 (.17%)
Adrenal Gland	2 (.17%)
Aural	2 (.17%)
Bone Disorders	2 (.17%)
Cardiac Arrhythmias	2 (.17%)
Cutaneous Neoplasms Benign	2 (.17%)
Ear And Labyrinthine Disorders Cong...	2 (.17%)
Economic And Housing Issues	2 (.17%)
Encephalopathies	2 (.17%)
Exocrine Pancreas Conditions	2 (.17%)
Fatal Outcomes	2 (.17%)
Gastrointestinal Hemorrhages	2 (.17%)
Immunology And Allergy	2 (.17%)
Mood Disorders	2 (.17%)
Movement Disorders	2 (.17%)
Nephropathies	2 (.17%)
Neurological Disorders Congenital	2 (.17%)
Neuromuscular	2 (.17%)
Ocular Structural Change, Deposit A...	2 (.17%)
Peritoneal And Retroperitoneal Cond...	2 (.17%)
Placental, Amniotic And Cavity Diso...	2 (.17%)
Procedural And Device Related Injur...	2 (.17%)
Psychiatric And Behavioural Symptom...	2 (.17%)
Skin Vascular Abnormalities	2 (.17%)
Sleep Disturbances	2 (.17%)
Vascular Hypertensive	2 (.17%)

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