HYDROXYZINE

Hydroxyzine Adverse Events Reported to the FDA Over Time

How are Hydroxyzine adverse event reports trending over time?

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

Most Common Hydroxyzine Adverse Events Reported to the FDA

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

Completed Suicide	410 (2.32%)
Somnolence	243 (1.37%)
Suicide Attempt	230 (1.3%)
Cardiac Arrest	192 (1.08%)
Drug Exposure During Pregnancy	171 (.97%)
Fall	156 (.88%)
Overdose	143 (.81%)
Confusional State	142 (.8%)
Pyrexia	141 (.8%)
Drug Toxicity	134 (.76%)
Drug Ineffective	133 (.75%)
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Respiratory Arrest	132 (.75%)
Hypotension	124 (.7%)
Renal Failure Acute	123 (.69%)
Convulsion	117 (.66%)
Vomiting	115 (.65%)
Anxiety	113 (.64%)
Toxic Skin Eruption	112 (.63%)
Malaise	111 (.63%)
Dyspnoea	106 (.6%)
Drug Interaction	103 (.58%)
Death	100 (.56%)
Tachycardia	99 (.56%)
Pruritus	98 (.55%)
Tremor	97 (.55%)
Loss Of Consciousness	94 (.53%)
Coma	91 (.51%)
Cardio-respiratory Arrest	89 (.5%)
Condition Aggravated	87 (.49%)
Nausea	87 (.49%)
Renal Failure	81 (.46%)
Dizziness	80 (.45%)
Drug Rash With Eosinophilia And Sys...	80 (.45%)
Poisoning	79 (.45%)
Rash	78 (.44%)
Agitation	77 (.43%)
Urticaria	77 (.43%)
Dehydration	76 (.43%)
Thrombocytopenia	74 (.42%)
Insomnia	73 (.41%)
Fatigue	71 (.4%)
Disorientation	70 (.4%)
Feeling Abnormal	70 (.4%)
Headache	69 (.39%)
General Physical Health Deteriorati...	67 (.38%)
Intentional Overdose	67 (.38%)
Medication Error	65 (.37%)
Cytolytic Hepatitis	64 (.36%)
Depression	63 (.36%)
Bradycardia	61 (.34%)
Hypertension	61 (.34%)
Stevens-johnson Syndrome	61 (.34%)
Abnormal Behaviour	59 (.33%)
Septic Shock	59 (.33%)
Erythema	58 (.33%)
Aspartate Aminotransferase Increase...	57 (.32%)
Electrocardiogram Qt Prolonged	56 (.32%)
Pain	55 (.31%)
Blood Creatine Phosphokinase Increa...	54 (.3%)
Hypoglycaemia	54 (.3%)
Intentional Drug Misuse	54 (.3%)
Multiple Drug Overdose	54 (.3%)
Anaemia	53 (.3%)
Alanine Aminotransferase Increased	52 (.29%)
Weight Decreased	52 (.29%)
Diarrhoea	51 (.29%)
Pleural Effusion	50 (.28%)
Urinary Retention	47 (.27%)
Multiple Drug Overdose Intentional	46 (.26%)
Acute Generalised Exanthematous Pus...	45 (.25%)
Lung Disorder	45 (.25%)
Rhabdomyolysis	45 (.25%)
Abdominal Pain	44 (.25%)
Decreased Appetite	44 (.25%)
Dyskinesia	44 (.25%)
Premature Baby	44 (.25%)
Drug Abuse	43 (.24%)
Hypersensitivity	43 (.24%)
Depressed Level Of Consciousness	42 (.24%)
Gamma-glutamyltransferase Increased	42 (.24%)
Hyperhidrosis	42 (.24%)
Injection Site Necrosis	42 (.24%)
Jaundice	42 (.24%)
Aggression	41 (.23%)
Asthenia	41 (.23%)
Respiratory Distress	41 (.23%)
Cholestasis	40 (.23%)
Dysarthria	40 (.23%)
Haemoglobin Decreased	39 (.22%)
Hepatic Function Abnormal	39 (.22%)
Inflammation	39 (.22%)
Shock	39 (.22%)
Vertigo	39 (.22%)
Chest Pain	38 (.21%)
Oedema Peripheral	38 (.21%)
Oxygen Saturation Decreased	38 (.21%)
Blood Pressure Increased	37 (.21%)
Hyperkalaemia	37 (.21%)
Rash Maculo-papular	37 (.21%)
Anaphylactic Shock	36 (.2%)
Disturbance In Attention	36 (.2%)

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

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

Epidermal And Dermal Conditions	1081 (6.11%)
Neurological	1026 (5.79%)
Suicidal And Self-injurious Behavio...	691 (3.9%)
Cardiac Arrhythmias	682 (3.85%)
Respiratory	616 (3.48%)
Medication Errors	543 (3.07%)
Hepatic And Hepatobiliary	454 (2.56%)
Chemical Injury And Poisoning	441 (2.49%)
Gastrointestinal Signs	413 (2.33%)
Therapeutic And Nontherapeutic Effe...	358 (2.02%)
Renal Disorders	324 (1.83%)
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Infections - Pathogen Unspecified	308 (1.74%)
Anxiety Disorders	282 (1.59%)
Cardiac And Vascular Investigations	278 (1.57%)
Injuries	272 (1.54%)
Hematology Investigations	266 (1.5%)
Movement Disorders	262 (1.48%)
Hepatobiliary	241 (1.36%)
Deliria	231 (1.3%)
Decreased And Nonspecific Blood Pre...	200 (1.13%)
Electrolyte And Fluid Balance Condi...	198 (1.12%)
Body Temperature Conditions	196 (1.11%)
Muscle	193 (1.09%)
Psychiatric	188 (1.06%)
Seizures	188 (1.06%)
Administration Site Reactions	174 (.98%)
Allergic Conditions	165 (.93%)
Enzyme	149 (.84%)
Lower Respiratory Tract Disorders	145 (.82%)
White Blood Cell	137 (.77%)
Fatal Outcomes	130 (.73%)
Musculoskeletal And Connective Tiss...	129 (.73%)
Physical Examination Topics	126 (.71%)
Mental Impairment	125 (.71%)
Urinary Tract Signs	122 (.69%)
Sleep Disorders	121 (.68%)
Bacterial Infectious	116 (.66%)
Gastrointestinal Motility And Defec...	115 (.65%)
Metabolic, Nutritional And Blood Ga...	113 (.64%)
Neuromuscular	108 (.61%)
Appetite And General Nutritional	103 (.58%)
Angiedema And Urticaria	99 (.56%)
Anemias Nonhemolytic And Marrow Dep...	96 (.54%)
Procedural And Device Related Injur...	94 (.53%)
Toxicology And Therapeutic Drug Mon...	91 (.51%)
Lifestyle Issues	89 (.5%)
Vision	86 (.49%)
Headaches	85 (.48%)
Platelet	84 (.47%)
Glucose Metabolism Disorders	83 (.47%)
Neonatal And Perinatal Conditions	82 (.46%)
Vascular Hypertensive	82 (.46%)
Joint	80 (.45%)
Cardiac Disorder Signs	77 (.43%)
Depressed Mood Disorders	77 (.43%)
Personality Disorders	73 (.41%)
Skin Vascular Abnormalities	73 (.41%)
Disturbances In Thinking	70 (.4%)
Coronary Artery	69 (.39%)
Central Nervous System Vascular	68 (.38%)
Water, Electrolyte And Mineral	68 (.38%)
Hematological And Lymphoid Tissue T...	67 (.38%)
Psychiatric And Behavioural Symptom...	66 (.37%)
Upper Respiratory Tract Disorders	66 (.37%)
Bone And Joint Injuries	64 (.36%)
Protein And Chemistry Analyses	63 (.36%)
Skin Appendage Conditions	63 (.36%)
Encephalopathies	62 (.35%)
Ocular Neuromuscular	62 (.35%)
Bronchial Disorders	56 (.32%)
Myocardial	56 (.32%)
Oral Soft Tissue Conditions	56 (.32%)
Acid-base	55 (.31%)
Therapeutic Procedures And Supporti...	55 (.31%)
Gastrointestinal Stenosis And Obstr...	51 (.29%)
Mood Disorders	51 (.29%)
Pleural	51 (.29%)
Obstetric And Gynecological Therape...	50 (.28%)
Renal And Urinary Tract Investigati...	49 (.28%)
Vascular	48 (.27%)
Heart Failures	47 (.27%)
Inner Ear And Viiith Cranial Nerve	45 (.25%)
Pulmonary Vascular	45 (.25%)
Gastrointestinal Inflammatory Condi...	44 (.25%)
Immunology And Allergy	42 (.24%)
Abortions And Stillbirth	40 (.23%)
Cardiac Valve	40 (.23%)
Musculoskeletal And Connective Tiss...	40 (.23%)
Gastrointestinal Conditions	39 (.22%)
Cardiac And Vascular Disorders Cong...	37 (.21%)
Neonatal Respiratory	37 (.21%)
Ocular Infections, Irritations And ...	37 (.21%)
Exocrine Pancreas Conditions	36 (.2%)
Eye	36 (.2%)
Gastrointestinal Hemorrhages	35 (.2%)
Fetal Complications	34 (.19%)
Tissue	33 (.19%)
Viral Infectious	33 (.19%)
Neurological, Special Senses And Ps...	32 (.18%)
Hemolyses And Related Conditions	31 (.18%)
Endocrine Investigations	28 (.16%)

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