CETIRIZINE

Cetirizine Adverse Events Reported to the FDA Over Time

How are Cetirizine adverse event reports trending over time?

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

Most Common Cetirizine Adverse Events Reported to the FDA

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

Product Quality Issue	662 (3.56%)
Pruritus	269 (1.44%)
Urticaria	262 (1.41%)
Drug Ineffective	257 (1.38%)
Wrong Drug Administered	247 (1.33%)
Drug Exposure During Pregnancy	233 (1.25%)
Dizziness	220 (1.18%)
Dyspnoea	219 (1.18%)
Somnolence	218 (1.17%)
Convulsion	216 (1.16%)
Rash	208 (1.12%)
	Show More
Off Label Use	189 (1.02%)
Pyrexia	184 (.99%)
Vomiting	165 (.89%)
Condition Aggravated	163 (.88%)
Fatigue	157 (.84%)
Hypersensitivity	154 (.83%)
Headache	153 (.82%)
Malaise	146 (.78%)
Insomnia	139 (.75%)
Diarrhoea	126 (.68%)
Nausea	122 (.66%)
Withdrawal Syndrome	118 (.63%)
Depression	116 (.62%)
Overdose	112 (.6%)
Abnormal Behaviour	110 (.59%)
Medication Error	110 (.59%)
Fall	109 (.59%)
Feeling Abnormal	109 (.59%)
Pain	107 (.57%)
Abdominal Pain Upper	100 (.54%)
Loss Of Consciousness	96 (.52%)
Asthma	91 (.49%)
Pruritus Generalised	88 (.47%)
Aggression	87 (.47%)
Anxiety	86 (.46%)
Abortion Spontaneous	84 (.45%)
Cough	80 (.43%)
Hallucination	80 (.43%)
Drug Withdrawal Syndrome	77 (.41%)
Drug Interaction	76 (.41%)
Arthralgia	74 (.4%)
Suicide Attempt	74 (.4%)
Palpitations	73 (.39%)
Oedema Peripheral	70 (.38%)
Erythema	69 (.37%)
Weight Decreased	68 (.37%)
Irritability	67 (.36%)
Pain In Extremity	67 (.36%)
Weight Increased	67 (.36%)
Suicidal Ideation	64 (.34%)
Epilepsy	61 (.33%)
Rash Generalised	61 (.33%)
Syncope	61 (.33%)
Asthenia	60 (.32%)
Dry Mouth	58 (.31%)
Liver Disorder	58 (.31%)
Muscle Spasms	58 (.31%)
Hypertension	55 (.3%)
Crying	54 (.29%)
Tremor	54 (.29%)
Eye Swelling	51 (.27%)
Drug Dependence	50 (.27%)
Vision Blurred	50 (.27%)
Drug Dispensing Error	49 (.26%)
Sinusitis	49 (.26%)
Blood Pressure Increased	48 (.26%)
Hepatitis	48 (.26%)
Blood Glucose Increased	47 (.25%)
Memory Impairment	47 (.25%)
Accidental Overdose	46 (.25%)
Angioedema	46 (.25%)
Dyskinesia	46 (.25%)
Hypoaesthesia	46 (.25%)
Lethargy	46 (.25%)
Abdominal Pain	44 (.24%)
Agitation	44 (.24%)
Electrocardiogram Qt Prolonged	44 (.24%)
Chest Discomfort	43 (.23%)
Disturbance In Attention	43 (.23%)
Drug Hypersensitivity	43 (.23%)
Alanine Aminotransferase Increased	42 (.23%)
Anger	42 (.23%)
Aspartate Aminotransferase Increase...	42 (.23%)
Maternal Drugs Affecting Foetus	42 (.23%)
Chest Pain	41 (.22%)
Confusional State	41 (.22%)
Contusion	41 (.22%)
Premature Baby	41 (.22%)
Ear Infection	40 (.21%)
Heart Rate Increased	40 (.21%)
Stevens-johnson Syndrome	40 (.21%)
Paraesthesia	39 (.21%)
Dependence	38 (.2%)
Fibromyalgia	38 (.2%)
Anaphylactic Shock	37 (.2%)
Cardiac Arrest	37 (.2%)
Gait Disturbance	37 (.2%)
Swelling	37 (.2%)
Arthritis	36 (.19%)
Drug Effect Decreased	36 (.19%)

Share/Embed Graph Export Data

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

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

Epidermal And Dermal Conditions	1187 (6.38%)
Neurological	1180 (6.34%)
Medication Errors	797 (4.28%)
Product Quality Issues	748 (4.02%)
Respiratory	662 (3.56%)
Therapeutic And Nontherapeutic Effe...	584 (3.14%)
Gastrointestinal Signs	575 (3.09%)
Seizures	342 (1.84%)
Hepatic And Hepatobiliary	333 (1.79%)
Allergic Conditions	330 (1.77%)
Angiedema And Urticaria	322 (1.73%)
	Show More
Chemical Injury And Poisoning	321 (1.72%)
Infections - Pathogen Unspecified	319 (1.71%)
Injuries	291 (1.56%)
Cardiac Arrhythmias	286 (1.54%)
Sleep Disorders	246 (1.32%)
Psychiatric	243 (1.31%)
Cardiac And Vascular Investigations	240 (1.29%)
Anxiety Disorders	239 (1.28%)
Therapeutic Procedures And Supporti...	228 (1.22%)
Gastrointestinal Motility And Defec...	212 (1.14%)
Movement Disorders	202 (1.08%)
Hematology Investigations	191 (1.03%)
Upper Respiratory Tract Disorders	189 (1.02%)
Muscle	187 (1%)
Body Temperature Conditions	186 (1%)
Suicidal And Self-injurious Behavio...	183 (.98%)
Headaches	182 (.98%)
Physical Examination Topics	170 (.91%)
Musculoskeletal And Connective Tiss...	164 (.88%)
Hepatobiliary	160 (.86%)
Bronchial Disorders	159 (.85%)
Joint	151 (.81%)
Depressed Mood Disorders	150 (.81%)
Mental Impairment	146 (.78%)
Personality Disorders	144 (.77%)
Mood Disorders	141 (.76%)
Lifestyle Issues	137 (.74%)
Eye	130 (.7%)
Vision	128 (.69%)
Disturbances In Thinking	124 (.67%)
Oral Soft Tissue Conditions	116 (.62%)
Urinary Tract Signs	116 (.62%)
Cardiac Disorder Signs	114 (.61%)
Psychiatric And Behavioural Symptom...	114 (.61%)
Skin Appendage Conditions	106 (.57%)
Bacterial Infectious	102 (.55%)
Abortions And Stillbirth	97 (.52%)
Deliria	82 (.44%)
Metabolic, Nutritional And Blood Ga...	77 (.41%)
Vascular	76 (.41%)
Central Nervous System Vascular	67 (.36%)
Electrolyte And Fluid Balance Condi...	67 (.36%)
Changes In Physical Activity	65 (.35%)
Ocular Infections, Irritations And ...	65 (.35%)
Salivary Gland Conditions	65 (.35%)
Obstetric And Gynecological Therape...	64 (.34%)
Hearing	63 (.34%)
Pregnancy, Labour, Delivery And Pos...	61 (.33%)
Renal Disorders	60 (.32%)
Viral Infectious	57 (.31%)
Appetite And General Nutritional	55 (.3%)
Bone And Joint Injuries	55 (.3%)
Vascular Hypertensive	55 (.3%)
Water, Electrolyte And Mineral	55 (.3%)
Enzyme	54 (.29%)
Inner Ear And Viiith Cranial Nerve	54 (.29%)
Neuromuscular	54 (.29%)
Ocular Neuromuscular	53 (.28%)
Cranial Nerve Disorders	52 (.28%)
Glucose Metabolism Disorders	50 (.27%)
Lipid Analyses	49 (.26%)
Decreased And Nonspecific Blood Pre...	48 (.26%)
Tongue Conditions	48 (.26%)
Exocrine Pancreas Conditions	47 (.25%)
Neonatal And Perinatal Conditions	47 (.25%)
Neurological Disorders Congenital	41 (.22%)
White Blood Cell	41 (.22%)
Anemias Nonhemolytic And Marrow Dep...	40 (.21%)
Bone Disorders	40 (.21%)
Renal And Urinary Tract Investigati...	40 (.21%)
Skin Vascular Abnormalities	38 (.2%)
Procedural And Device Related Injur...	37 (.2%)
Coronary Artery	35 (.19%)
Lower Respiratory Tract Disorders	35 (.19%)
Immunology And Allergy	34 (.18%)
Toxicology And Therapeutic Drug Mon...	32 (.17%)
Fatal Outcomes	31 (.17%)
Musculoskeletal And Connective Tiss...	30 (.16%)
Sleep Disturbances	30 (.16%)
Thyroid Gland	30 (.16%)
Gastrointestinal Hemorrhages	29 (.16%)
Gastrointestinal Inflammatory Condi...	29 (.16%)
Peripheral Neuropathies	29 (.16%)
Platelet	29 (.16%)
Dental And Gingival Conditions	28 (.15%)
Eating Disorders	28 (.15%)
Cardiac And Vascular Disorders Cong...	27 (.15%)
Communication Disorders	27 (.15%)
Gastrointestinal Conditions	27 (.15%)
Gastrointestinal Tract Disorders Co...	27 (.15%)

Share/Embed Graph Export Data

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