MIRTAZAPINE

Mirtazapine Adverse Events Reported to the FDA Over Time

How are Mirtazapine adverse event reports trending over time?

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

Most Common Mirtazapine Adverse Events Reported to the FDA

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

Completed Suicide	626 (2.04%)
Drug Interaction	435 (1.42%)
Suicide Attempt	350 (1.14%)
Confusional State	347 (1.13%)
Depression	317 (1.04%)
Serotonin Syndrome	316 (1.03%)
Anxiety	291 (.95%)
Fall	291 (.95%)
Somnolence	277 (.9%)
Hyponatraemia	268 (.88%)
Insomnia	267 (.87%)
	Show More
Overdose	255 (.83%)
Agitation	247 (.81%)
Convulsion	238 (.78%)
Cardiac Arrest	226 (.74%)
Dizziness	223 (.73%)
Headache	223 (.73%)
Tremor	214 (.7%)
Pyrexia	205 (.67%)
Condition Aggravated	204 (.67%)
Suicidal Ideation	198 (.65%)
Nausea	195 (.64%)
Fatigue	194 (.63%)
Vomiting	188 (.61%)
Neuroleptic Malignant Syndrome	182 (.59%)
Tachycardia	179 (.58%)
Malaise	175 (.57%)
Loss Of Consciousness	174 (.57%)
Respiratory Arrest	170 (.56%)
Oedema Peripheral	167 (.55%)
Dyspnoea	165 (.54%)
Aggression	156 (.51%)
Drug Ineffective	156 (.51%)
Drug Toxicity	156 (.51%)
Multiple Drug Overdose	153 (.5%)
Weight Increased	149 (.49%)
Intentional Overdose	144 (.47%)
Alanine Aminotransferase Increased	140 (.46%)
Asthenia	139 (.45%)
Hypotension	139 (.45%)
Diarrhoea	138 (.45%)
Rhabdomyolysis	137 (.45%)
Coma	133 (.43%)
Hyperhidrosis	133 (.43%)
Death	125 (.41%)
Restlessness	124 (.4%)
Myalgia	123 (.4%)
Neutropenia	122 (.4%)
Blood Creatine Phosphokinase Increa...	120 (.39%)
Multiple Drug Overdose Intentional	120 (.39%)
White Blood Cell Count Decreased	120 (.39%)
Drug Exposure During Pregnancy	118 (.39%)
Abnormal Behaviour	112 (.37%)
Hallucination	112 (.37%)
Inappropriate Antidiuretic Hormone ...	110 (.36%)
Aspartate Aminotransferase Increase...	108 (.35%)
Decreased Appetite	108 (.35%)
Electrocardiogram Qt Prolonged	108 (.35%)
Restless Legs Syndrome	106 (.35%)
Hypertension	105 (.34%)
Irritability	105 (.34%)
Constipation	103 (.34%)
Delirium	103 (.34%)
Psychotic Disorder	103 (.34%)
Pain In Extremity	98 (.32%)
Paraesthesia	96 (.31%)
Feeling Abnormal	95 (.31%)
Pulmonary Embolism	94 (.31%)
Syncope	94 (.31%)
Depressed Level Of Consciousness	92 (.3%)
Weight Decreased	90 (.29%)
Arthralgia	89 (.29%)
Cardio-respiratory Arrest	89 (.29%)
Renal Failure	89 (.29%)
Renal Failure Acute	89 (.29%)
Disorientation	88 (.29%)
Nightmare	88 (.29%)
Gait Disturbance	87 (.28%)
Pain	87 (.28%)
Muscle Spasms	85 (.28%)
Blood Sodium Decreased	84 (.27%)
Pulmonary Oedema	83 (.27%)
Poisoning	80 (.26%)
Sleep Disorder	80 (.26%)
Drug Abuse	79 (.26%)
Gamma-glutamyltransferase Increased	79 (.26%)
General Physical Health Deteriorati...	79 (.26%)
Pneumonia	78 (.25%)
Maternal Drugs Affecting Foetus	77 (.25%)
Road Traffic Accident	77 (.25%)
Abdominal Pain	74 (.24%)
Hypoaesthesia	74 (.24%)
Speech Disorder	74 (.24%)
Dyskinesia	73 (.24%)
Amnesia	71 (.23%)
Disturbance In Attention	71 (.23%)
Drug Withdrawal Syndrome	71 (.23%)
Palpitations	69 (.23%)
Anaemia	68 (.22%)
Agranulocytosis	67 (.22%)
Cerebrovascular Accident	67 (.22%)

Share/Embed Graph Export Data

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

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

Neurological	2103 (6.87%)
Suicidal And Self-injurious Behavio...	1235 (4.03%)
Cardiac Arrhythmias	895 (2.92%)
Therapeutic And Nontherapeutic Effe...	853 (2.79%)
Medication Errors	829 (2.71%)
Respiratory	750 (2.45%)
Movement Disorders	745 (2.43%)
Gastrointestinal Signs	729 (2.38%)
Anxiety Disorders	720 (2.35%)
Injuries	661 (2.16%)
Neuromuscular	608 (1.99%)
	Show More
Sleep Disorders	604 (1.97%)
Hepatic And Hepatobiliary	553 (1.81%)
Hematology Investigations	542 (1.77%)
Deliria	540 (1.76%)
Muscle	531 (1.73%)
Depressed Mood Disorders	507 (1.66%)
Hepatobiliary	492 (1.61%)
Electrolyte And Fluid Balance Condi...	468 (1.53%)
Chemical Injury And Poisoning	467 (1.52%)
Epidermal And Dermal Conditions	436 (1.42%)
Seizures	434 (1.42%)
Infections - Pathogen Unspecified	400 (1.31%)
Disturbances In Thinking	394 (1.29%)
Cardiac And Vascular Investigations	393 (1.28%)
Gastrointestinal Motility And Defec...	303 (.99%)
Physical Examination Topics	303 (.99%)
Personality Disorders	297 (.97%)
Musculoskeletal And Connective Tiss...	293 (.96%)
Mental Impairment	284 (.93%)
White Blood Cell	282 (.92%)
Body Temperature Conditions	281 (.92%)
Psychiatric	279 (.91%)
Decreased And Nonspecific Blood Pre...	272 (.89%)
Mood Disorders	254 (.83%)
Urinary Tract Signs	250 (.82%)
Renal Disorders	246 (.8%)
Appetite And General Nutritional	244 (.8%)
Headaches	238 (.78%)
Enzyme	210 (.69%)
Lifestyle Issues	210 (.69%)
Lower Respiratory Tract Disorders	208 (.68%)
Fatal Outcomes	196 (.64%)
Water, Electrolyte And Mineral	186 (.61%)
Central Nervous System Vascular	184 (.6%)
Skin Appendage Conditions	183 (.6%)
Vision	180 (.59%)
Joint	160 (.52%)
Changes In Physical Activity	147 (.48%)
Cardiac Disorder Signs	144 (.47%)
Schizophrenia And Other Psychotic	143 (.47%)
Anemias Nonhemolytic And Marrow Dep...	137 (.45%)
Psychiatric And Behavioural Symptom...	136 (.44%)
Toxicology And Therapeutic Drug Mon...	133 (.43%)
Hypothalamus And Pituitary Gland	128 (.42%)
Vascular Hypertensive	127 (.41%)
Bone And Joint Injuries	116 (.38%)
Acid-base	115 (.38%)
Pulmonary Vascular	114 (.37%)
Renal And Urinary Tract Investigati...	111 (.36%)
Metabolic, Nutritional And Blood Ga...	106 (.35%)
Oral Soft Tissue Conditions	106 (.35%)
Embolism And Thrombosis	103 (.34%)
Myocardial	103 (.34%)
Ocular Neuromuscular	101 (.33%)
Glucose Metabolism Disorders	98 (.32%)
Vascular	97 (.32%)
Manic And Bipolar Mood Disorders	90 (.29%)
Coronary Artery	89 (.29%)
Sexual Dysfunctions, Disturbances A...	85 (.28%)
Allergic Conditions	83 (.27%)
Exocrine Pancreas Conditions	74 (.24%)
Increased Intracranial Pressure And...	71 (.23%)
Platelet	71 (.23%)
Inner Ear And Viiith Cranial Nerve	70 (.23%)
Eye	69 (.23%)
Hematological And Lymphoid Tissue T...	69 (.23%)
Dental And Gingival Conditions	67 (.22%)
Therapeutic Procedures And Supporti...	66 (.22%)
Cardiac And Vascular Disorders Cong...	65 (.21%)
Neonatal And Perinatal Conditions	65 (.21%)
Gastrointestinal Hemorrhages	63 (.21%)
Tongue Conditions	63 (.21%)
Heart Failures	62 (.2%)
Upper Respiratory Tract Disorders	61 (.2%)
Vascular Hemorrhagic	58 (.19%)
Bacterial Infectious	55 (.18%)
Breast	53 (.17%)
Sleep Disturbances	53 (.17%)
Viral Infectious	53 (.17%)
Salivary Gland Conditions	51 (.17%)
Cranial Nerve Disorders	49 (.16%)
Hearing	49 (.16%)
Abortions And Stillbirth	48 (.16%)
Obstetric And Gynecological Therape...	48 (.16%)
Sexual Function And Fertility	48 (.16%)
Encephalopathies	47 (.15%)
Metabolism	47 (.15%)
Dissociative	46 (.15%)
Lipid Metabolism	46 (.15%)
Neurological, Special Senses And Ps...	46 (.15%)

Share/Embed Graph Export Data

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