MIDAZOLAM

Midazolam Adverse Events Reported to the FDA Over Time

How are Midazolam adverse event reports trending over time?

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

Most Common Midazolam Adverse Events Reported to the FDA

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

Hypotension	216 (2.2%)
Drug Ineffective	189 (1.93%)
Cardiac Arrest	123 (1.26%)
Oxygen Saturation Decreased	119 (1.21%)
Anaphylactic Reaction	107 (1.09%)
Drug Interaction	98 (1%)
Tachycardia	94 (.96%)
Bradycardia	92 (.94%)
Agitation	91 (.93%)
Convulsion	89 (.91%)
Medication Error	78 (.8%)
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Loss Of Consciousness	73 (.74%)
Respiratory Arrest	72 (.73%)
Drug Rash With Eosinophilia And Sys...	69 (.7%)
Blood Pressure Decreased	68 (.69%)
Depressed Level Of Consciousness	63 (.64%)
Sedation	63 (.64%)
Rhabdomyolysis	61 (.62%)
Anaphylactic Shock	60 (.61%)
Vomiting	60 (.61%)
Hypoxia	59 (.6%)
Cardio-respiratory Arrest	58 (.59%)
Confusional State	58 (.59%)
Respiratory Depression	57 (.58%)
Urticaria	57 (.58%)
Nausea	56 (.57%)
Somnolence	56 (.57%)
Unresponsive To Stimuli	56 (.57%)
Procedural Complication	55 (.56%)
Erythema	54 (.55%)
Pyrexia	52 (.53%)
Overdose	51 (.52%)
Respiratory Failure	51 (.52%)
Dyspnoea	50 (.51%)
Coma	48 (.49%)
Post Procedural Complication	48 (.49%)
Anaesthetic Complication	47 (.48%)
Circulatory Collapse	46 (.47%)
Hypertension	46 (.47%)
Anxiety	45 (.46%)
Heart Rate Increased	45 (.46%)
Dyskinesia	44 (.45%)
Hyperhidrosis	43 (.44%)
Toxic Epidermal Necrolysis	43 (.44%)
Ventricular Tachycardia	43 (.44%)
Tremor	41 (.42%)
Renal Failure Acute	39 (.4%)
Drug Exposure During Pregnancy	38 (.39%)
Stevens-johnson Syndrome	38 (.39%)
Ventricular Fibrillation	38 (.39%)
Apnoea	37 (.38%)
Disseminated Intravascular Coagulat...	37 (.38%)
Renal Failure	36 (.37%)
Alanine Aminotransferase Increased	35 (.36%)
Aspartate Aminotransferase Increase...	35 (.36%)
Shock	35 (.36%)
Serotonin Syndrome	34 (.35%)
Depression	33 (.34%)
Drug Effect Decreased	33 (.34%)
Respiratory Distress	33 (.34%)
Completed Suicide	32 (.33%)
Cyanosis	32 (.33%)
Headache	32 (.33%)
Death	31 (.32%)
Insomnia	31 (.32%)
Metabolic Acidosis	31 (.32%)
Delirium	30 (.31%)
Pneumonia	30 (.31%)
Aggression	29 (.3%)
Bronchospasm	29 (.3%)
Condition Aggravated	29 (.3%)
Delayed Recovery From Anaesthesia	29 (.3%)
Drug Toxicity	29 (.3%)
Mental Status Changes	29 (.3%)
Myoclonus	29 (.3%)
Pain	29 (.3%)
Amnesia	28 (.29%)
Disorientation	28 (.29%)
Suicide Attempt	28 (.29%)
Acute Respiratory Distress Syndrome	27 (.28%)
Cytolytic Hepatitis	27 (.28%)
Drug Withdrawal Syndrome	27 (.28%)
Rash	27 (.28%)
Dizziness	26 (.27%)
Drug Hypersensitivity	26 (.27%)
Mydriasis	26 (.27%)
Restlessness	26 (.27%)
Thrombocytopenia	26 (.27%)
Septic Shock	25 (.26%)
Sinus Tachycardia	25 (.26%)
Blood Creatine Phosphokinase Increa...	24 (.24%)
Blood Creatinine Increased	24 (.24%)
Blood Pressure Increased	24 (.24%)
Cardiac Failure	24 (.24%)
Muscle Rigidity	24 (.24%)
Pulmonary Embolism	24 (.24%)
Chills	23 (.23%)
Electrocardiogram Qt Prolonged	22 (.22%)
Encephalopathy	22 (.22%)
Haemorrhage	22 (.22%)
Pruritus	22 (.22%)

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

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

Cardiac Arrhythmias	629 (6.42%)
Neurological	617 (6.3%)
Respiratory	545 (5.56%)
Therapeutic And Nontherapeutic Effe...	425 (4.34%)
Epidermal And Dermal Conditions	424 (4.33%)
Decreased And Nonspecific Blood Pre...	318 (3.25%)
Cardiac And Vascular Investigations	311 (3.17%)
Medication Errors	280 (2.86%)
Procedural And Device Related Injur...	272 (2.78%)
Allergic Conditions	233 (2.38%)
Hepatic And Hepatobiliary	186 (1.9%)
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Movement Disorders	179 (1.83%)
Metabolic, Nutritional And Blood Ga...	175 (1.79%)
Seizures	169 (1.72%)
Anxiety Disorders	167 (1.7%)
Gastrointestinal Signs	159 (1.62%)
Muscle	147 (1.5%)
Renal Disorders	135 (1.38%)
Infections - Pathogen Unspecified	125 (1.28%)
Deliria	116 (1.18%)
Hepatobiliary	109 (1.11%)
Hematology Investigations	105 (1.07%)
Body Temperature Conditions	97 (.99%)
Lower Respiratory Tract Disorders	95 (.97%)
Chemical Injury And Poisoning	92 (.94%)
Psychiatric	90 (.92%)
Suicidal And Self-injurious Behavio...	88 (.9%)
Neuromuscular	76 (.78%)
Vascular	73 (.74%)
Bronchial Disorders	69 (.7%)
Injuries	69 (.7%)
Physical Examination Topics	68 (.69%)
Angiedema And Urticaria	67 (.68%)
Mental Impairment	67 (.68%)
Central Nervous System Vascular	61 (.62%)
Coronary Artery	59 (.6%)
Sleep Disorders	59 (.6%)
Enzyme	57 (.58%)
Vascular Hypertensive	57 (.58%)
Urinary Tract Signs	56 (.57%)
Ocular Neuromuscular	55 (.56%)
Acid-base	53 (.54%)
Skin Appendage Conditions	53 (.54%)
Depressed Mood Disorders	51 (.52%)
Electrolyte And Fluid Balance Condi...	51 (.52%)
Fatal Outcomes	51 (.52%)
Cardiac Disorder Signs	49 (.5%)
Headaches	49 (.5%)
Myocardial	49 (.5%)
Heart Failures	45 (.46%)
Musculoskeletal And Connective Tiss...	45 (.46%)
Personality Disorders	45 (.46%)
Coagulopathies And Bleeding Diathes...	44 (.45%)
Disturbances In Thinking	43 (.44%)
Encephalopathies	42 (.43%)
Product Quality Issues	42 (.43%)
Changes In Physical Activity	41 (.42%)
Renal And Urinary Tract Investigati...	41 (.42%)
Upper Respiratory Tract Disorders	40 (.41%)
Viral Infectious	40 (.41%)
Gastrointestinal Motility And Defec...	39 (.4%)
Gastrointestinal Hemorrhages	38 (.39%)
Mood Disorders	36 (.37%)
Pulmonary Vascular	36 (.37%)
Administration Site Reactions	35 (.36%)
Embolism And Thrombosis	35 (.36%)
Bacterial Infectious	34 (.35%)
Hematological And Lymphoid Tissue T...	34 (.35%)
White Blood Cell	34 (.35%)
Toxicology And Therapeutic Drug Mon...	30 (.31%)
Pleural	29 (.3%)
Water, Electrolyte And Mineral	29 (.3%)
Immunology And Allergy	28 (.29%)
Oral Soft Tissue Conditions	28 (.29%)
Platelet	27 (.28%)
Vascular Hemorrhagic	26 (.27%)
Exocrine Pancreas Conditions	25 (.26%)
Lifestyle Issues	24 (.24%)
Spleen, Lymphatic And Reticulendoth...	23 (.23%)
Protein And Chemistry Analyses	22 (.22%)
Schizophrenia And Other Psychotic	22 (.22%)
Anemias Nonhemolytic And Marrow Dep...	21 (.21%)
Glucose Metabolism Disorders	21 (.21%)
Obstetric And Gynecological Therape...	20 (.2%)
Psychiatric And Behavioural Symptom...	19 (.19%)
Somatoform And Factitious	19 (.19%)
Tongue Conditions	19 (.19%)
Abortions And Stillbirth	18 (.18%)
Communication Disorders	18 (.18%)
Gastrointestinal Ulceration And Per...	18 (.18%)
Therapeutic Procedures And Supporti...	18 (.18%)
Thyroid Gland	18 (.18%)
Cardiac Valve	17 (.17%)
Vision	17 (.17%)
Arteriosclerosis, Stenosis, Vascula...	16 (.16%)
Gastrointestinal	16 (.16%)
Skin Vascular Abnormalities	16 (.16%)
Neurological, Special Senses And Ps...	15 (.15%)
Neonatal And Perinatal Conditions	12 (.12%)
Adrenal Gland	11 (.11%)
Eye	11 (.11%)

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