MICONAZOLE

Miconazole Adverse Events Reported to the FDA Over Time

How are Miconazole adverse event reports trending over time?

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

Most Common Miconazole Adverse Events Reported to the FDA

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

Drug Interaction	524 (7.13%)
Drug Ineffective	439 (5.97%)
Vaginal Swelling	393 (5.35%)
International Normalised Ratio Incr...	343 (4.67%)
Vulval Oedema	268 (3.65%)
Vulvovaginal Discomfort	186 (2.53%)
Vulvovaginal Burning Sensation	125 (1.7%)
Vaginal Haemorrhage	113 (1.54%)
Vaginal Discharge	112 (1.52%)
Haematuria	110 (1.5%)
Abdominal Pain	83 (1.13%)
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Vulvovaginal Pruritus	80 (1.09%)
Drug Exposure During Pregnancy	74 (1.01%)
Hypersensitivity	71 (.97%)
Dyspnoea	65 (.88%)
Pain	59 (.8%)
Anaphylactoid Reaction	58 (.79%)
Blister	56 (.76%)
Haematoma	56 (.76%)
Vulvovaginal Pain	54 (.73%)
Haemorrhage Subcutaneous	53 (.72%)
Pruritus	51 (.69%)
Dysuria	45 (.61%)
Nausea	44 (.6%)
Vomiting	42 (.57%)
Medication Error	41 (.56%)
Erythema	40 (.54%)
Genital Burning Sensation	39 (.53%)
Haemorrhage	39 (.53%)
Wrong Technique In Drug Usage Proce...	38 (.52%)
Pyrexia	37 (.5%)
Burning Sensation	36 (.49%)
Oedema Genital	36 (.49%)
Epistaxis	35 (.48%)
Off Label Use	35 (.48%)
Abortion Spontaneous	34 (.46%)
Urticaria	34 (.46%)
Oedema Peripheral	33 (.45%)
Dizziness	32 (.44%)
Rash	32 (.44%)
Contusion	30 (.41%)
Intentional Drug Misuse	30 (.41%)
Product Quality Issue	29 (.39%)
Swelling	29 (.39%)
Application Site Pain	28 (.38%)
Blood Urine Present	28 (.38%)
Hypoplastic Left Heart Syndrome	27 (.37%)
Maternal Drugs Affecting Foetus	27 (.37%)
Skin Exfoliation	27 (.37%)
Anaphylactic Reaction	25 (.34%)
Gastrointestinal Haemorrhage	25 (.34%)
Oedema Mouth	25 (.34%)
Loss Of Consciousness	24 (.33%)
Insomnia	23 (.31%)
Accidental Exposure	22 (.3%)
Drug Prescribing Error	22 (.3%)
Headache	22 (.3%)
Fungal Infection	20 (.27%)
Localised Oedema	20 (.27%)
Metrorrhagia	20 (.27%)
Mouth Haemorrhage	20 (.27%)
Prothrombin Time Prolonged	20 (.27%)
Anaemia	19 (.26%)
Caustic Injury	19 (.26%)
Drug Hypersensitivity	19 (.26%)
Somnolence	19 (.26%)
Application Site Pruritus	18 (.24%)
Drug Administration Error	18 (.24%)
Swelling Face	18 (.24%)
Swollen Tongue	18 (.24%)
Application Site Burn	17 (.23%)
Foreign Body Trauma	17 (.23%)
Incorrect Drug Administration Durat...	17 (.23%)
Amniotic Cavity Disorder	16 (.22%)
Amniotic Fluid Volume Decreased	16 (.22%)
Blindness Transient	16 (.22%)
Deafness Transitory	16 (.22%)
Expired Drug Administered	16 (.22%)
Hyperacusis	16 (.22%)
Hypoglycaemia	16 (.22%)
Malaise	16 (.22%)
Purpura	16 (.22%)
Respiratory Arrest	16 (.22%)
Thermal Burn	16 (.22%)
Abasia	15 (.2%)
Haemoglobin Decreased	15 (.2%)
Melaena	15 (.2%)
Pregnancy	15 (.2%)
Vaginal Infection	15 (.2%)
Application Site Reaction	14 (.19%)
Cough	14 (.19%)
Ecchymosis	14 (.19%)
Feeling Abnormal	14 (.19%)
Increased Tendency To Bruise	14 (.19%)
Pain In Extremity	14 (.19%)
Premature Baby	14 (.19%)
Prothrombin Time Ratio Increased	14 (.19%)
Skin Haemorrhage	14 (.19%)
Abdominal Pain Upper	13 (.18%)
Encephalitis Fungal	13 (.18%)
Fungal Sepsis	13 (.18%)

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

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

Vulvovaginal Disorders	1419 (19.3%)
Therapeutic And Nontherapeutic Effe...	996 (13.55%)
Hematology Investigations	455 (6.19%)
Epidermal And Dermal Conditions	331 (4.5%)
Medication Errors	233 (3.17%)
Gastrointestinal Signs	227 (3.09%)
Allergic Conditions	183 (2.49%)
Neurological	179 (2.43%)
Respiratory	171 (2.33%)
Urinary Tract Signs	164 (2.23%)
Chemical Injury And Poisoning	135 (1.84%)
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Administration Site Reactions	131 (1.78%)
Skin Vascular Abnormalities	126 (1.71%)
Reproductive Tract	120 (1.63%)
Vascular Hemorrhagic	95 (1.29%)
Oral Soft Tissue Conditions	89 (1.21%)
Injuries	78 (1.06%)
Infections - Pathogen Unspecified	71 (.97%)
Product Quality Issues	67 (.91%)
Gastrointestinal Hemorrhages	55 (.75%)
Fungal Infectious	53 (.72%)
Upper Respiratory Tract Disorders	52 (.71%)
Abortions And Stillbirth	46 (.63%)
Therapeutic Procedures And Supporti...	45 (.61%)
Psychiatric	44 (.6%)
Hepatobiliary	42 (.57%)
Renal And Urinary Tract Investigati...	40 (.54%)
Anemias Nonhemolytic And Marrow Dep...	39 (.53%)
Body Temperature Conditions	37 (.5%)
Angiedema And Urticaria	35 (.48%)
Cardiac And Vascular Disorders Cong...	35 (.48%)
Hearing	33 (.45%)
Menstrual Cycle And Uterine Bleedin...	29 (.39%)
Sleep Disorders	28 (.38%)
Vision	28 (.38%)
Musculoskeletal And Connective Tiss...	27 (.37%)
Bacterial Infectious	26 (.35%)
Injuries By Physical Agents	26 (.35%)
Central Nervous System Vascular	25 (.34%)
Hepatic And Hepatobiliary	24 (.33%)
Tongue Conditions	24 (.33%)
Coagulopathies And Bleeding Diathes...	23 (.31%)
Placental, Amniotic And Cavity Diso...	23 (.31%)
Headaches	22 (.3%)
Ocular Infections, Irritations And ...	22 (.3%)
Joint	21 (.29%)
Muscle	21 (.29%)
Cardiac Arrhythmias	20 (.27%)
Decreased And Nonspecific Blood Pre...	20 (.27%)
Gastrointestinal Motility And Defec...	20 (.27%)
Movement Disorders	20 (.27%)
Pregnancy, Labour, Delivery And Pos...	20 (.27%)
Renal Disorders	20 (.27%)
Fetal And Neonatal	19 (.26%)
Glucose Metabolism Disorders	19 (.26%)
Neonatal And Perinatal Conditions	19 (.26%)
Cardiac And Vascular Investigations	18 (.24%)
Cardiac Disorder Signs	18 (.24%)
Lifestyle Issues	18 (.24%)
Peritoneal And Retroperitoneal Cond...	18 (.24%)
Electrolyte And Fluid Balance Condi...	17 (.23%)
Eye	16 (.22%)
Bronchial Disorders	15 (.2%)
Enzyme	14 (.19%)
Water, Electrolyte And Mineral	14 (.19%)
Deliria	12 (.16%)
Dental And Gingival Conditions	12 (.16%)
Maternal Complications Of Labour An...	12 (.16%)
Neuromuscular	12 (.16%)
Obstetric And Gynecological Therape...	12 (.16%)
Penile And Scrotal Disorders	12 (.16%)
Sexual Function And Fertility	12 (.16%)
Toxicology And Therapeutic Drug Mon...	12 (.16%)
Cervix Disorders	11 (.15%)
Disturbances In Thinking	11 (.15%)
Fetal Complications	11 (.15%)
Viral Infectious	11 (.15%)
White Blood Cell	11 (.15%)
Ocular Hemorrhages And Vascular	10 (.14%)
Salivary Gland Conditions	10 (.14%)
Vascular	10 (.14%)
Vascular Hypertensive	10 (.14%)
Vascular Inflammations	10 (.14%)
Ocular Neuromuscular	9 (.12%)
Procedural And Device Related Injur...	9 (.12%)
Anxiety Disorders	8 (.11%)
Bone And Joint Injuries	8 (.11%)
Microbiology And Serology	8 (.11%)
Ocular Sensory Symptoms	8 (.11%)
Skin And Subcutaneous Tissue	8 (.11%)
External Ear Disorders	7 (.1%)
Investigations, Imaging And Histopa...	7 (.1%)
Metabolic, Nutritional And Blood Ga...	7 (.1%)
Musculoskeletal And Connective Tiss...	7 (.1%)
Myocardial	7 (.1%)
Pericardial	7 (.1%)
Gender Related Factors	6 (.08%)
Protein And Chemistry Analyses	6 (.08%)
Retina, Choroid And Vitreous Hemorr...	6 (.08%)
Seizures	6 (.08%)
Depressed Mood Disorders	5 (.07%)

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