CLOTRIMAZOLE

Clotrimazole Adverse Events Reported to the FDA Over Time

How are Clotrimazole adverse event reports trending over time?

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

Most Common Clotrimazole Adverse Events Reported to the FDA

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

Vaginal Haemorrhage	103 (5.84%)
Drug Exposure During Pregnancy	44 (2.5%)
Pruritus	27 (1.53%)
Dizziness	26 (1.47%)
Candidiasis	22 (1.25%)
Drug Ineffective	22 (1.25%)
Maternal Drugs Affecting Foetus	22 (1.25%)
Cardiac Failure Congestive	21 (1.19%)
Chronic Obstructive Pulmonary Disea...	21 (1.19%)
Erythema	21 (1.19%)
Hypersensitivity	21 (1.19%)
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Abdominal Pain	20 (1.13%)
Hyperacusis	20 (1.13%)
Blindness Transient	18 (1.02%)
Deafness Transitory	18 (1.02%)
Abortion Spontaneous	17 (.96%)
Drug Hypersensitivity	16 (.91%)
Dyspnoea	16 (.91%)
Vaginal Discharge	16 (.91%)
Feeling Abnormal	15 (.85%)
Rash	15 (.85%)
Swelling Face	14 (.79%)
Cystitis	13 (.74%)
Pain	13 (.74%)
Cardiac Failure	12 (.68%)
Condition Aggravated	12 (.68%)
Genital Haemorrhage	12 (.68%)
Metrorrhagia	12 (.68%)
Abdominal Discomfort	11 (.62%)
Headache	11 (.62%)
Loss Of Consciousness	11 (.62%)
Abortion Induced	10 (.57%)
Haemorrhage	10 (.57%)
Intra-uterine Death	10 (.57%)
Pyrexia	10 (.57%)
Auricular Swelling	9 (.51%)
Back Pain	9 (.51%)
Caesarean Section	9 (.51%)
Fatigue	9 (.51%)
Pancreatitis Acute	9 (.51%)
Peritonitis	9 (.51%)
Rash Pruritic	9 (.51%)
Blood Pressure Increased	8 (.45%)
Dysmenorrhoea	8 (.45%)
Kidney Malformation	8 (.45%)
Medication Error	8 (.45%)
Nausea	8 (.45%)
Pelvic Pain	8 (.45%)
Plantar Fasciitis	8 (.45%)
Abdominal Pain Upper	7 (.4%)
Anaphylactic Shock	7 (.4%)
Congenital Anomaly	7 (.4%)
Congenital Cardiovascular Anomaly	7 (.4%)
Heart Rate Increased	7 (.4%)
Insomnia	7 (.4%)
Malaise	7 (.4%)
Ovarian Cyst	7 (.4%)
Swelling	7 (.4%)
Swollen Tongue	7 (.4%)
Urticaria	7 (.4%)
Vaginal Disorder	7 (.4%)
Vulvovaginal Candidiasis	7 (.4%)
Accidental Exposure	6 (.34%)
Ageusia	6 (.34%)
Aptyalism	6 (.34%)
Arthralgia	6 (.34%)
Burning Sensation	6 (.34%)
Diarrhoea	6 (.34%)
Drug Dispensing Error	6 (.34%)
Dysphagia	6 (.34%)
Oedema Peripheral	6 (.34%)
Off Label Use	6 (.34%)
Pruritus Generalised	6 (.34%)
Skin Exfoliation	6 (.34%)
Somnolence	6 (.34%)
Vulvovaginal Burning Sensation	6 (.34%)
Anxiety	5 (.28%)
Blood Creatinine Increased	5 (.28%)
Blood Potassium Decreased	5 (.28%)
Convulsion	5 (.28%)
Cough	5 (.28%)
Drug Interaction	5 (.28%)
Hypospadias	5 (.28%)
Limb Reduction Defect	5 (.28%)
Local Swelling	5 (.28%)
Oedema Mouth	5 (.28%)
Oral Candidiasis	5 (.28%)
Renal Failure	5 (.28%)
Skin Discolouration	5 (.28%)
Spina Bifida Occulta	5 (.28%)
Urinary Incontinence	5 (.28%)
Urinary Retention	5 (.28%)
Vulvovaginal Discomfort	5 (.28%)
Vulvovaginal Pain	5 (.28%)
Abdominal Pain Lower	4 (.23%)
Adjustment Disorder	4 (.23%)
Aggression	4 (.23%)
Anorexia	4 (.23%)
Antisocial Behaviour	4 (.23%)
Application Site Ulcer	4 (.23%)
Blister	4 (.23%)

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

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

Vulvovaginal Disorders	147 (8.34%)
Epidermal And Dermal Conditions	140 (7.94%)
Neurological	76 (4.31%)
Chemical Injury And Poisoning	70 (3.97%)
Gastrointestinal Signs	69 (3.91%)
Infections - Pathogen Unspecified	49 (2.78%)
Allergic Conditions	48 (2.72%)
Fungal Infectious	47 (2.67%)
Hearing	46 (2.61%)
Medication Errors	36 (2.04%)
Heart Failures	33 (1.87%)
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Respiratory	33 (1.87%)
Therapeutic And Nontherapeutic Effe...	30 (1.7%)
Administration Site Reactions	29 (1.64%)
Abortions And Stillbirth	28 (1.59%)
Reproductive Tract	25 (1.42%)
Bronchial Disorders	24 (1.36%)
Cardiac And Vascular Investigations	22 (1.25%)
Vision	21 (1.19%)
Menstrual Cycle And Uterine Bleedin...	20 (1.13%)
Oral Soft Tissue Conditions	20 (1.13%)
Musculoskeletal And Connective Tiss...	19 (1.08%)
Obstetric And Gynecological Therape...	19 (1.08%)
Urinary Tract Signs	19 (1.08%)
Renal Disorders	15 (.85%)
Headaches	14 (.79%)
Personality Disorders	14 (.79%)
Musculoskeletal And Connective Tiss...	13 (.74%)
Hepatic And Hepatobiliary	12 (.68%)
Product Quality Issues	12 (.68%)
Water, Electrolyte And Mineral	12 (.68%)
Cardiac Arrhythmias	11 (.62%)
Joint	11 (.62%)
Mental Impairment	11 (.62%)
Peritoneal And Retroperitoneal Cond...	11 (.62%)
Salivary Gland Conditions	11 (.62%)
Tongue Conditions	11 (.62%)
Body Temperature Conditions	10 (.57%)
Cardiac And Vascular Disorders Cong...	10 (.57%)
Exocrine Pancreas Conditions	10 (.57%)
External Ear Disorders	10 (.57%)
Renal And Urinary Tract Disorders C...	10 (.57%)
Vascular Hemorrhagic	10 (.57%)
Aural	9 (.51%)
Congenital And Hereditary	9 (.51%)
Gastrointestinal Motility And Defec...	9 (.51%)
Neurological Disorders Congenital	9 (.51%)
Renal And Urinary Tract Investigati...	9 (.51%)
Angiedema And Urticaria	8 (.45%)
Injuries	8 (.45%)
Therapeutic Procedures And Supporti...	8 (.45%)
Upper Respiratory Tract Disorders	8 (.45%)
White Blood Cell	8 (.45%)
Anxiety Disorders	7 (.4%)
Hematology Investigations	7 (.4%)
Inner Ear And Viiith Cranial Nerve	7 (.4%)
Ovarian And Fallopian Tube	7 (.4%)
Sleep Disorders	7 (.4%)
Spleen, Lymphatic And Reticulendoth...	7 (.4%)
Bacterial Infectious	6 (.34%)
Bone, Calcium, Magnesium And Phosph...	6 (.34%)
Cardiac Disorder Signs	6 (.34%)
Skin Appendage Conditions	6 (.34%)
Appetite And General Nutritional	5 (.28%)
Bone Disorders	5 (.28%)
Electrolyte And Fluid Balance Condi...	5 (.28%)
Embolism And Thrombosis	5 (.28%)
Glucose Metabolism Disorders	5 (.28%)
Physical Examination Topics	5 (.28%)
Pregnancy, Labour, Delivery And Pos...	5 (.28%)
Reproductive Tract And Breast Disor...	5 (.28%)
Seizures	5 (.28%)
Adjustment Disorders	4 (.23%)
Fetal Complications	4 (.23%)
Gastrointestinal Inflammatory Condi...	4 (.23%)
Hepatobiliary	4 (.23%)
Lifestyle Issues	4 (.23%)
Maternal Complications Of Pregnancy	4 (.23%)
Movement Disorders	4 (.23%)
Muscle	4 (.23%)
Neonatal And Perinatal Conditions	4 (.23%)
Peripheral Neuropathies	4 (.23%)
Procedural And Device Related Injur...	4 (.23%)
Psychiatric	4 (.23%)
Adrenal Gland	3 (.17%)
Cornification And Dystrophic Skin	3 (.17%)
Deliria	3 (.17%)
Dental And Gingival Conditions	3 (.17%)
Eye	3 (.17%)
Eye Disorders Congenital	3 (.17%)
Increased Intracranial Pressure And...	3 (.17%)
Metabolic, Nutritional And Blood Ga...	3 (.17%)
Middle Ear Disorders	3 (.17%)
Ocular Infections, Irritations And ...	3 (.17%)
Ocular Neuromuscular	3 (.17%)
Platelet	3 (.17%)
Psychiatric And Behavioural Symptom...	3 (.17%)
Tissue	3 (.17%)
Uterine, Pelvic And Broad Ligament	3 (.17%)
Viral Infectious	3 (.17%)
Anal And Rectal Conditions	2 (.11%)

Share/Embed Graph Export Data

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