TERBINAFINE

Terbinafine Adverse Events Reported to the FDA Over Time

How are Terbinafine adverse event reports trending over time?

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

Most Common Terbinafine Adverse Events Reported to the FDA

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

Aspartate Aminotransferase Increase...	413 (1.84%)
Alanine Aminotransferase Increased	406 (1.81%)
Pyrexia	319 (1.42%)
Pruritus	298 (1.33%)
Rash	290 (1.29%)
Gamma-glutamyltransferase Increased	258 (1.15%)
Nausea	247 (1.1%)
Ageusia	246 (1.1%)
Blood Creatine Phosphokinase Increa...	242 (1.08%)
Blood Alkaline Phosphatase Increase...	236 (1.05%)
Malaise	231 (1.03%)
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Dysgeusia	215 (.96%)
Weight Decreased	212 (.95%)
Drug Interaction	208 (.93%)
Fatigue	188 (.84%)
Asthenia	185 (.83%)
Myalgia	183 (.82%)
Liver Disorder	180 (.8%)
Erythema	179 (.8%)
Blood Lactate Dehydrogenase Increas...	178 (.79%)
Blood Bilirubin Increased	175 (.78%)
Hepatic Function Abnormal	153 (.68%)
Rhabdomyolysis	153 (.68%)
Dizziness	150 (.67%)
Oedema Peripheral	149 (.66%)
Skin Exfoliation	147 (.66%)
Dyspnoea	142 (.63%)
Headache	141 (.63%)
Urticaria	141 (.63%)
Jaundice	140 (.62%)
Pain	139 (.62%)
Anorexia	137 (.61%)
Depression	137 (.61%)
C-reactive Protein Increased	134 (.6%)
Diarrhoea	123 (.55%)
Drug Ineffective	122 (.54%)
Arthralgia	114 (.51%)
Haemoglobin Decreased	111 (.5%)
Platelet Count Decreased	110 (.49%)
Pain In Extremity	109 (.49%)
Blister	106 (.47%)
White Blood Cell Count Decreased	100 (.45%)
Liver Function Test Abnormal	98 (.44%)
Rash Generalised	98 (.44%)
Chromaturia	97 (.43%)
Vomiting	96 (.43%)
White Blood Cell Count Increased	93 (.41%)
Abdominal Pain	92 (.41%)
Rash Erythematous	88 (.39%)
Insomnia	87 (.39%)
Blood Creatinine Increased	85 (.38%)
Cutaneous Lupus Erythematosus	85 (.38%)
Hepatitis	84 (.37%)
Hypersensitivity	84 (.37%)
Anxiety	83 (.37%)
Cholestasis	81 (.36%)
Decreased Appetite	80 (.36%)
Condition Aggravated	79 (.35%)
Rash Pustular	77 (.34%)
Blood Pressure Increased	74 (.33%)
Paraesthesia	73 (.33%)
Anaemia	70 (.31%)
Haematocrit Decreased	70 (.31%)
Hepatic Enzyme Increased	70 (.31%)
Acute Generalised Exanthematous Pus...	67 (.3%)
Hypoaesthesia	66 (.29%)
Drug Exposure During Pregnancy	64 (.29%)
Abdominal Pain Upper	63 (.28%)
Chills	63 (.28%)
Back Pain	62 (.28%)
Erythema Multiforme	61 (.27%)
Feeling Abnormal	61 (.27%)
Pancytopenia	60 (.27%)
Photosensitivity Reaction	60 (.27%)
Rash Papular	60 (.27%)
Red Blood Cell Count Decreased	60 (.27%)
General Physical Health Deteriorati...	59 (.26%)
Pneumonia	58 (.26%)
Renal Impairment	58 (.26%)
Suicidal Ideation	58 (.26%)
Thrombocytopenia	57 (.25%)
Vision Blurred	55 (.25%)
Cough	54 (.24%)
Antinuclear Antibody Positive	52 (.23%)
Drug Eruption	52 (.23%)
Haematuria	50 (.22%)
Inflammation	49 (.22%)
Syncope	49 (.22%)
Dermatitis Exfoliative	48 (.21%)
Lymphadenopathy	48 (.21%)
Toxic Skin Eruption	48 (.21%)
Blood Glucose Increased	47 (.21%)
Leukopenia	47 (.21%)
Burning Sensation	45 (.2%)
Chest Pain	45 (.2%)
Hepatic Failure	45 (.2%)
Panic Attack	45 (.2%)
Psoriasis	45 (.2%)
Neutropenia	44 (.2%)
Disturbance In Attention	43 (.19%)
Medication Error	43 (.19%)

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

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

Epidermal And Dermal Conditions	2516 (11.22%)
Hepatobiliary	1550 (6.91%)
Neurological	1091 (4.87%)
Hepatic And Hepatobiliary	1047 (4.67%)
Hematology Investigations	966 (4.31%)
Gastrointestinal Signs	735 (3.28%)
Enzyme	693 (3.09%)
Infections - Pathogen Unspecified	494 (2.2%)
Muscle	442 (1.97%)
Respiratory	410 (1.83%)
Therapeutic And Nontherapeutic Effe...	402 (1.79%)
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Body Temperature Conditions	332 (1.48%)
Musculoskeletal And Connective Tiss...	312 (1.39%)
Physical Examination Topics	294 (1.31%)
Appetite And General Nutritional	252 (1.12%)
White Blood Cell	228 (1.02%)
Joint	227 (1.01%)
Urinary Tract Signs	222 (.99%)
Renal And Urinary Tract Investigati...	208 (.93%)
Medication Errors	194 (.87%)
Gastrointestinal Motility And Defec...	187 (.83%)
Depressed Mood Disorders	184 (.82%)
Anxiety Disorders	172 (.77%)
Anemias Nonhemolytic And Marrow Dep...	171 (.76%)
Cardiac And Vascular Investigations	170 (.76%)
Renal Disorders	170 (.76%)
Skin Vascular Abnormalities	169 (.75%)
Angiedema And Urticaria	167 (.75%)
Protein And Chemistry Analyses	167 (.75%)
Immunology And Allergy	161 (.72%)
Vision	161 (.72%)
Cardiac Arrhythmias	153 (.68%)
Allergic Conditions	147 (.66%)
Headaches	147 (.66%)
Fungal Infectious	146 (.65%)
Skin Appendage Conditions	144 (.64%)
Injuries	138 (.62%)
Bacterial Infectious	130 (.58%)
Oral Soft Tissue Conditions	130 (.58%)
Sleep Disorders	107 (.48%)
Mental Impairment	105 (.47%)
Chemical Injury And Poisoning	103 (.46%)
Movement Disorders	101 (.45%)
Gastrointestinal Hemorrhages	100 (.45%)
Water, Electrolyte And Mineral	99 (.44%)
Viral Infectious	98 (.44%)
Metabolic, Nutritional And Blood Ga...	97 (.43%)
Eye	90 (.4%)
Platelet	85 (.38%)
Lifestyle Issues	82 (.37%)
Exocrine Pancreas Conditions	81 (.36%)
Electrolyte And Fluid Balance Condi...	80 (.36%)
Hearing	80 (.36%)
Microbiology And Serology	80 (.36%)
Tongue Conditions	77 (.34%)
Disturbances In Thinking	76 (.34%)
Lipid Analyses	76 (.34%)
Cranial Nerve Disorders	70 (.31%)
Suicidal And Self-injurious Behavio...	70 (.31%)
Cardiac Disorder Signs	69 (.31%)
Seizures	68 (.3%)
Upper Respiratory Tract Disorders	68 (.3%)
Ocular Infections, Irritations And ...	67 (.3%)
Spleen, Lymphatic And Reticulendoth...	67 (.3%)
Coronary Artery	66 (.29%)
Administration Site Reactions	62 (.28%)
Therapeutic Procedures And Supporti...	61 (.27%)
Lower Respiratory Tract Disorders	60 (.27%)
Gastrointestinal Inflammatory Condi...	59 (.26%)
Central Nervous System Vascular	55 (.25%)
Connective Tissue Disorders	54 (.24%)
Decreased And Nonspecific Blood Pre...	54 (.24%)
Glucose Metabolism Disorders	54 (.24%)
Salivary Gland Conditions	54 (.24%)
Mood Disorders	49 (.22%)
Psychiatric	48 (.21%)
Bronchial Disorders	47 (.21%)
Gallbladder	45 (.2%)
Gastrointestinal	40 (.18%)
Inner Ear And Viiith Cranial Nerve	39 (.17%)
Gastrointestinal Conditions	38 (.17%)
Menstrual Cycle And Uterine Bleedin...	38 (.17%)
Vascular Hypertensive	38 (.17%)
Hematological And Lymphoid Tissue T...	37 (.17%)
Vascular Inflammations	37 (.17%)
Cornification And Dystrophic Skin	36 (.16%)
Deliria	36 (.16%)
Hematological	36 (.16%)
Pigmentation	35 (.16%)
Investigations, Imaging And Histopa...	33 (.15%)
Leukemias	33 (.15%)
Myocardial	33 (.15%)
Skin And Subcutaneous Tissue	33 (.15%)
Bone Disorders	32 (.14%)
Fatal Outcomes	32 (.14%)
Musculoskeletal And Soft Tissue Inv...	32 (.14%)
Obstetric And Gynecological Therape...	31 (.14%)
Abortions And Stillbirth	30 (.13%)
Schizophrenia And Other Psychotic	30 (.13%)
Vascular	30 (.13%)
Gastrointestinal Ulceration And Per...	29 (.13%)

Share/Embed Graph Export Data

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