METRONIDAZOLE

Metronidazole Adverse Events Reported to the FDA Over Time

How are Metronidazole adverse event reports trending over time?

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

Most Common Metronidazole Adverse Events Reported to the FDA

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

Pyrexia	343 (1.61%)
Nausea	321 (1.5%)
Vomiting	315 (1.48%)
Diarrhoea	273 (1.28%)
Drug Interaction	267 (1.25%)
Confusional State	200 (.94%)
Paraesthesia	198 (.93%)
Dizziness	196 (.92%)
Abdominal Pain	182 (.85%)
Rash	179 (.84%)
International Normalised Ratio Incr...	169 (.79%)
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Pruritus	168 (.79%)
Headache	162 (.76%)
Neuropathy Peripheral	159 (.74%)
Malaise	152 (.71%)
Convulsion	143 (.67%)
Encephalopathy	143 (.67%)
Drug Ineffective	141 (.66%)
Pain	136 (.64%)
Dysarthria	132 (.62%)
Drug Exposure During Pregnancy	127 (.59%)
Thrombocytopenia	121 (.57%)
Weight Decreased	114 (.53%)
Clostridium Difficile Colitis	113 (.53%)
Gait Disturbance	112 (.52%)
Hypoaesthesia	112 (.52%)
Erythema	110 (.52%)
Dyspnoea	109 (.51%)
Dysgeusia	107 (.5%)
Renal Failure Acute	107 (.5%)
Asthenia	105 (.49%)
Drug Hypersensitivity	98 (.46%)
Ataxia	91 (.43%)
Toxic Encephalopathy	91 (.43%)
Urticaria	91 (.43%)
Insomnia	89 (.42%)
Cerebellar Syndrome	88 (.41%)
Death	88 (.41%)
Neutropenia	87 (.41%)
Haemoglobin Decreased	82 (.38%)
Hypotension	82 (.38%)
Arthralgia	80 (.37%)
Fatigue	79 (.37%)
Metabolic Acidosis	78 (.37%)
Hypersensitivity	77 (.36%)
Alanine Aminotransferase Increased	76 (.36%)
Chills	76 (.36%)
Oedema Peripheral	76 (.36%)
Toxic Epidermal Necrolysis	76 (.36%)
Cholestasis	75 (.35%)
Decreased Appetite	75 (.35%)
Clostridial Infection	74 (.35%)
Condition Aggravated	72 (.34%)
Jaundice	72 (.34%)
Hypoglycaemia	70 (.33%)
Chest Pain	69 (.32%)
Anxiety	68 (.32%)
Tachycardia	68 (.32%)
Coordination Abnormal	67 (.31%)
Pancreatitis Acute	66 (.31%)
Sepsis	65 (.3%)
Tremor	65 (.3%)
Depression	64 (.3%)
Disorientation	64 (.3%)
Pain In Extremity	64 (.3%)
Somnolence	64 (.3%)
White Blood Cell Count Increased	64 (.3%)
Multi-organ Failure	63 (.3%)
Drug Rash With Eosinophilia And Sys...	62 (.29%)
Hepatitis	62 (.29%)
Dehydration	61 (.29%)
Abdominal Pain Upper	60 (.28%)
Anaemia	60 (.28%)
Dysphagia	60 (.28%)
Muscular Weakness	60 (.28%)
Stevens-johnson Syndrome	60 (.28%)
Leukopenia	59 (.28%)
Pancytopenia	59 (.28%)
Aspartate Aminotransferase Increase...	58 (.27%)
Swollen Tongue	58 (.27%)
Pneumonia	57 (.27%)
Anaphylactic Reaction	56 (.26%)
Oedema	56 (.26%)
Acute Hepatic Failure	54 (.25%)
Deep Vein Thrombosis	54 (.25%)
Respiratory Failure	54 (.25%)
Septic Shock	54 (.25%)
Vertigo	54 (.25%)
Balance Disorder	53 (.25%)
Nuclear Magnetic Resonance Imaging ...	53 (.25%)
Atrial Fibrillation	52 (.24%)
Cytolytic Hepatitis	50 (.23%)
Gamma-glutamyltransferase Increased	50 (.23%)
General Physical Health Deteriorati...	50 (.23%)
Liver Function Test Abnormal	50 (.23%)
Pseudomembranous Colitis	50 (.23%)
Rash Maculo-papular	50 (.23%)
Speech Disorder	50 (.23%)
Blood Bilirubin Increased	49 (.23%)
Hypovolaemic Shock	49 (.23%)
Muscle Spasms	49 (.23%)

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

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

Neurological	1851 (8.67%)
Epidermal And Dermal Conditions	1371 (6.42%)
Gastrointestinal Signs	1110 (5.2%)
Hepatic And Hepatobiliary	660 (3.09%)
Infections - Pathogen Unspecified	590 (2.76%)
Therapeutic And Nontherapeutic Effe...	551 (2.58%)
Hematology Investigations	544 (2.55%)
Bacterial Infectious	484 (2.27%)
Respiratory	408 (1.91%)
Body Temperature Conditions	377 (1.77%)
Gastrointestinal Motility And Defec...	376 (1.76%)
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Hepatobiliary	353 (1.65%)
Cardiac Arrhythmias	327 (1.53%)
Allergic Conditions	312 (1.46%)
Peripheral Neuropathies	307 (1.44%)
Deliria	306 (1.43%)
White Blood Cell	300 (1.41%)
Encephalopathies	259 (1.21%)
Muscle	256 (1.2%)
Renal Disorders	234 (1.1%)
Seizures	206 (.97%)
Anxiety Disorders	191 (.89%)
Chemical Injury And Poisoning	189 (.89%)
Musculoskeletal And Connective Tiss...	189 (.89%)
Cardiac And Vascular Investigations	186 (.87%)
Anemias Nonhemolytic And Marrow Dep...	185 (.87%)
Movement Disorders	182 (.85%)
Headaches	175 (.82%)
Decreased And Nonspecific Blood Pre...	173 (.81%)
Physical Examination Topics	170 (.8%)
Electrolyte And Fluid Balance Condi...	157 (.74%)
Gastrointestinal Inflammatory Condi...	153 (.72%)
Vision	152 (.71%)
Appetite And General Nutritional	148 (.69%)
Medication Errors	141 (.66%)
Oral Soft Tissue Conditions	141 (.66%)
Injuries	139 (.65%)
Platelet	139 (.65%)
Joint	138 (.65%)
Disturbances In Thinking	128 (.6%)
Tongue Conditions	127 (.59%)
Angiedema And Urticaria	126 (.59%)
Sleep Disorders	126 (.59%)
Exocrine Pancreas Conditions	125 (.59%)
Gastrointestinal Hemorrhages	121 (.57%)
Skin Vascular Abnormalities	117 (.55%)
Urinary Tract Signs	117 (.55%)
Mental Impairment	116 (.54%)
Depressed Mood Disorders	113 (.53%)
Fungal Infectious	111 (.52%)
Upper Respiratory Tract Disorders	111 (.52%)
Lower Respiratory Tract Disorders	109 (.51%)
Renal And Urinary Tract Investigati...	105 (.49%)
Glucose Metabolism Disorders	98 (.46%)
Fatal Outcomes	96 (.45%)
Acid-base	93 (.44%)
Lifestyle Issues	92 (.43%)
Neurological, Special Senses And Ps...	91 (.43%)
Inner Ear And Viiith Cranial Nerve	85 (.4%)
Peritoneal And Retroperitoneal Cond...	82 (.38%)
Skin Appendage Conditions	77 (.36%)
Embolism And Thrombosis	73 (.34%)
Enzyme	72 (.34%)
Vascular	70 (.33%)
Abortions And Stillbirth	69 (.32%)
Cardiac Disorder Signs	69 (.32%)
Coagulopathies And Bleeding Diathes...	67 (.31%)
Metabolic, Nutritional And Blood Ga...	62 (.29%)
Procedural And Device Related Injur...	62 (.29%)
Suicidal And Self-injurious Behavio...	62 (.29%)
Schizophrenia And Other Psychotic	61 (.29%)
Ocular Neuromuscular	60 (.28%)
Gastrointestinal	59 (.28%)
Viral Infectious	58 (.27%)
Vulvovaginal Disorders	56 (.26%)
Gastrointestinal Conditions	54 (.25%)
Central Nervous System Vascular	53 (.25%)
Gastrointestinal Ulceration And Per...	53 (.25%)
Bronchial Disorders	52 (.24%)
Coronary Artery	52 (.24%)
Therapeutic Procedures And Supporti...	49 (.23%)
Vascular Hypertensive	49 (.23%)
Water, Electrolyte And Mineral	49 (.23%)
Hearing	47 (.22%)
Personality Disorders	47 (.22%)
Ureteric	46 (.22%)
Gastrointestinal Therapeutic Proced...	45 (.21%)
Administration Site Reactions	44 (.21%)
Spleen, Lymphatic And Reticulendoth...	44 (.21%)
Protein And Chemistry Analyses	40 (.19%)
Vascular Hemorrhagic	40 (.19%)
Cranial Nerve Disorders	39 (.18%)
Eye	39 (.18%)
Mood Disorders	39 (.18%)
Neonatal And Perinatal Conditions	38 (.18%)
Psychiatric	38 (.18%)
Microbiology And Serology	36 (.17%)
Ocular Infections, Irritations And ...	36 (.17%)
Skin And Subcutaneous Tissue	32 (.15%)
Changes In Physical Activity	31 (.15%)
Heart Failures	31 (.15%)

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