HALOPERIDOL

Haloperidol Adverse Events Reported to the FDA Over Time

How are Haloperidol adverse event reports trending over time?

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

Most Common Haloperidol Adverse Events Reported to the FDA

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

Weight Increased	872 (2.89%)
Extrapyramidal Disorder	746 (2.47%)
Neuroleptic Malignant Syndrome	573 (1.9%)
Drug Interaction	479 (1.59%)
Somnolence	391 (1.3%)
Agitation	359 (1.19%)
Tremor	304 (1.01%)
Psychotic Disorder	256 (.85%)
Confusional State	248 (.82%)
Fall	244 (.81%)
Suicide Attempt	233 (.77%)
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Pyrexia	232 (.77%)
Aggression	228 (.76%)
Self Injurious Behaviour	211 (.7%)
Tachycardia	210 (.7%)
Dystonia	202 (.67%)
Death	198 (.66%)
Blood Creatine Phosphokinase Increa...	197 (.65%)
Convulsion	191 (.63%)
Drug Ineffective	185 (.61%)
Dyskinesia	184 (.61%)
Electrocardiogram Qt Prolonged	179 (.59%)
Overdose	176 (.58%)
Cardiac Arrest	175 (.58%)
Rhabdomyolysis	175 (.58%)
Muscle Rigidity	173 (.57%)
Completed Suicide	171 (.57%)
Dyspnoea	171 (.57%)
Parkinsonism	169 (.56%)
Delirium	161 (.53%)
Restlessness	158 (.52%)
Tardive Dyskinesia	158 (.52%)
Akathisia	152 (.5%)
Dysphagia	152 (.5%)
Coma	147 (.49%)
Cognitive Disorder	144 (.48%)
Salivary Hypersecretion	143 (.47%)
Abnormal Behaviour	137 (.45%)
Catatonia	137 (.45%)
Vomiting	135 (.45%)
Dehydration	131 (.43%)
Gait Disturbance	130 (.43%)
Hallucination	128 (.42%)
Anxiety	126 (.42%)
Hypotension	125 (.41%)
Depressed Level Of Consciousness	124 (.41%)
Fatigue	124 (.41%)
Medication Error	124 (.41%)
Hypertension	123 (.41%)
Pulmonary Embolism	123 (.41%)
Disorientation	121 (.4%)
Condition Aggravated	119 (.39%)
Insomnia	119 (.39%)
Hyperhidrosis	118 (.39%)
Pneumonia	118 (.39%)
Drug Toxicity	117 (.39%)
Suicidal Ideation	116 (.38%)
Drug Exposure During Pregnancy	113 (.37%)
Incorrect Route Of Drug Administrat...	113 (.37%)
Depression	111 (.37%)
Loss Of Consciousness	110 (.36%)
Sedation	108 (.36%)
Weight Decreased	107 (.35%)
Multiple Drug Overdose Intentional	106 (.35%)
Speech Disorder	103 (.34%)
Delusion	101 (.33%)
Accidental Exposure	100 (.33%)
Musculoskeletal Stiffness	100 (.33%)
Dysarthria	99 (.33%)
Hallucination, Auditory	95 (.31%)
Hyponatraemia	95 (.31%)
Bradycardia	93 (.31%)
General Physical Health Deteriorati...	93 (.31%)
Cardio-respiratory Arrest	92 (.3%)
Intentional Overdose	92 (.3%)
Sopor	92 (.3%)
Malaise	90 (.3%)
Respiratory Failure	87 (.29%)
Asthenia	86 (.28%)
Nausea	86 (.28%)
Renal Failure Acute	83 (.27%)
Dizziness	81 (.27%)
Torsade De Pointes	81 (.27%)
Treatment Noncompliance	81 (.27%)
Hospitalisation	80 (.27%)
Accidental Overdose	79 (.26%)
Alanine Aminotransferase Increased	79 (.26%)
Aspartate Aminotransferase Increase...	77 (.26%)
Sluggishness	76 (.25%)
Heart Rate Increased	74 (.25%)
Diabetes Mellitus	70 (.23%)
Hypothermia	69 (.23%)
Headache	68 (.23%)
Urinary Retention	68 (.23%)
Constipation	66 (.22%)
Irritability	66 (.22%)
Renal Failure	65 (.22%)
Lethargy	64 (.21%)
Neutropenia	64 (.21%)
Oedema Peripheral	64 (.21%)
Paranoia	64 (.21%)

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

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

Movement Disorders	2377 (7.88%)
Neurological	2062 (6.83%)
Medication Errors	1222 (4.05%)
Physical Examination Topics	1074 (3.56%)
Cardiac Arrhythmias	1061 (3.52%)
Therapeutic And Nontherapeutic Effe...	897 (2.97%)
Neuromuscular	762 (2.52%)
Respiratory	752 (2.49%)
Suicidal And Self-injurious Behavio...	749 (2.48%)
Anxiety Disorders	603 (2%)
Muscle	596 (1.97%)
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Gastrointestinal Signs	583 (1.93%)
Disturbances In Thinking	543 (1.8%)
Cardiac And Vascular Investigations	541 (1.79%)
Deliria	530 (1.76%)
Infections - Pathogen Unspecified	466 (1.54%)
Personality Disorders	403 (1.34%)
Changes In Physical Activity	399 (1.32%)
Injuries	379 (1.26%)
Electrolyte And Fluid Balance Condi...	377 (1.25%)
Epidermal And Dermal Conditions	370 (1.23%)
Schizophrenia And Other Psychotic	366 (1.21%)
Mental Impairment	365 (1.21%)
Body Temperature Conditions	362 (1.2%)
Hematology Investigations	326 (1.08%)
Chemical Injury And Poisoning	313 (1.04%)
Hepatobiliary	296 (.98%)
Seizures	293 (.97%)
Musculoskeletal And Connective Tiss...	277 (.92%)
Psychiatric	277 (.92%)
Hepatic And Hepatobiliary	276 (.91%)
Sleep Disorders	268 (.89%)
Renal Disorders	257 (.85%)
Urinary Tract Signs	250 (.83%)
Enzyme	247 (.82%)
Fatal Outcomes	242 (.8%)
Gastrointestinal Motility And Defec...	220 (.73%)
White Blood Cell	219 (.73%)
Lifestyle Issues	209 (.69%)
Psychiatric And Behavioural Symptom...	196 (.65%)
Depressed Mood Disorders	195 (.65%)
Decreased And Nonspecific Blood Pre...	190 (.63%)
Salivary Gland Conditions	190 (.63%)
Appetite And General Nutritional	185 (.61%)
Ocular Neuromuscular	181 (.6%)
Skin Appendage Conditions	174 (.58%)
Metabolic, Nutritional And Blood Ga...	153 (.51%)
Therapeutic Procedures And Supporti...	153 (.51%)
Lower Respiratory Tract Disorders	152 (.5%)
Pulmonary Vascular	152 (.5%)
Mood Disorders	149 (.49%)
Glucose Metabolism Disorders	136 (.45%)
Vascular Hypertensive	134 (.44%)
Central Nervous System Vascular	123 (.41%)
Water, Electrolyte And Mineral	118 (.39%)
Anemias Nonhemolytic And Marrow Dep...	106 (.35%)
Cardiac Disorder Signs	105 (.35%)
Communication Disorders	105 (.35%)
Coronary Artery	104 (.34%)
Toxicology And Therapeutic Drug Mon...	102 (.34%)
Vision	102 (.34%)
Renal And Urinary Tract Investigati...	100 (.33%)
Endocrine Investigations	98 (.32%)
Bacterial Infectious	97 (.32%)
Hypothalamus And Pituitary Gland	93 (.31%)
Heart Failures	90 (.3%)
Tongue Conditions	89 (.29%)
Gastrointestinal Stenosis And Obstr...	85 (.28%)
Joint	79 (.26%)
Embolism And Thrombosis	78 (.26%)
Bone And Joint Injuries	74 (.25%)
Allergic Conditions	73 (.24%)
Breast	73 (.24%)
Headaches	72 (.24%)
Myocardial	71 (.24%)
Manic And Bipolar Mood Disorders	68 (.23%)
Platelet	65 (.22%)
Upper Respiratory Tract Disorders	63 (.21%)
Neonatal And Perinatal Conditions	59 (.2%)
Lipid Analyses	56 (.19%)
Musculoskeletal And Connective Tiss...	56 (.19%)
Encephalopathies	55 (.18%)
Sexual Function And Fertility	50 (.17%)
Gastrointestinal Inflammatory Condi...	48 (.16%)
Acid-base	47 (.16%)
Protein And Chemistry Analyses	47 (.16%)
Neurological, Special Senses And Ps...	45 (.15%)
Administration Site Reactions	44 (.15%)
Hematological And Lymphoid Tissue T...	43 (.14%)
Vascular	42 (.14%)
Bone, Calcium, Magnesium And Phosph...	39 (.13%)
Bronchial Disorders	38 (.13%)
Eye	38 (.13%)
Exocrine Pancreas Conditions	37 (.12%)
Ocular Infections, Irritations And ...	37 (.12%)
Thyroid Gland	37 (.12%)
Bone Disorders	36 (.12%)
Structural Brain	36 (.12%)
Menstrual Cycle And Uterine Bleedin...	34 (.11%)
Neonatal Respiratory	34 (.11%)
Sleep Disturbances	34 (.11%)

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