LORATADINE

Loratadine Adverse Events Reported to the FDA Over Time

How are Loratadine adverse event reports trending over time?

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

Most Common Loratadine Adverse Events Reported to the FDA

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

Drug Ineffective	90 (2.64%)
Dizziness	58 (1.7%)
Convulsion	51 (1.49%)
Dyspnoea	49 (1.44%)
Headache	45 (1.32%)
Nausea	43 (1.26%)
Completed Suicide	41 (1.2%)
Insomnia	40 (1.17%)
Cardiac Arrest	38 (1.11%)
Death	37 (1.08%)
Urticaria	37 (1.08%)
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Vomiting	36 (1.05%)
Loss Of Consciousness	35 (1.03%)
Somnolence	33 (.97%)
Malaise	29 (.85%)
Palpitations	28 (.82%)
Asthenia	26 (.76%)
Hypersensitivity	26 (.76%)
Drug Interaction	25 (.73%)
Heart Rate Increased	25 (.73%)
Syncope	25 (.73%)
Torsade De Pointes	25 (.73%)
Angioedema	24 (.7%)
Blood Pressure Increased	24 (.7%)
Vision Blurred	24 (.7%)
Respiratory Arrest	23 (.67%)
Overdose	22 (.64%)
Drug Exposure During Pregnancy	21 (.62%)
Fall	21 (.62%)
Fatigue	21 (.62%)
Pain	21 (.62%)
Chest Pain	20 (.59%)
Chills	20 (.59%)
Drug Hypersensitivity	20 (.59%)
Dry Mouth	20 (.59%)
Hypokalaemia	20 (.59%)
Dysuria	19 (.56%)
Feeling Abnormal	19 (.56%)
Aggression	18 (.53%)
Dysarthria	18 (.53%)
Hypertension	18 (.53%)
Depression	17 (.5%)
Pruritus	17 (.5%)
Tremor	17 (.5%)
Condition Aggravated	16 (.47%)
Cough	16 (.47%)
Medication Error	16 (.47%)
Muscle Spasms	16 (.47%)
Muscular Weakness	16 (.47%)
Oedema Peripheral	16 (.47%)
Poisoning	16 (.47%)
Alanine Aminotransferase Increased	15 (.44%)
Anxiety	15 (.44%)
Blood Glucose Increased	15 (.44%)
Rash	15 (.44%)
Ventricular Extrasystoles	15 (.44%)
Ventricular Tachycardia	15 (.44%)
Abdominal Pain Upper	14 (.41%)
Arrhythmia	14 (.41%)
Burning Sensation	14 (.41%)
Cholestasis	14 (.41%)
Confusional State	14 (.41%)
Decreased Appetite	14 (.41%)
Intentional Overdose	14 (.41%)
Nervousness	14 (.41%)
Pyrexia	14 (.41%)
Drug Toxicity	13 (.38%)
Abortion Spontaneous	12 (.35%)
Asthma	12 (.35%)
Balance Disorder	12 (.35%)
Diarrhoea	12 (.35%)
Diplopia	12 (.35%)
Electrocardiogram Qt Prolonged	12 (.35%)
Hypotension	12 (.35%)
Myalgia	12 (.35%)
Ventricular Fibrillation	12 (.35%)
Abdominal Pain	11 (.32%)
Cardio-respiratory Arrest	11 (.32%)
Cerebrovascular Accident	11 (.32%)
Grand Mal Convulsion	11 (.32%)
Hallucination	11 (.32%)
Hypoaesthesia	11 (.32%)
Mental Status Changes	11 (.32%)
Nasal Congestion	11 (.32%)
Pain In Extremity	11 (.32%)
Body Temperature Decreased	10 (.29%)
Chest Discomfort	10 (.29%)
Long Qt Syndrome	10 (.29%)
Speech Disorder	10 (.29%)
Swelling Face	10 (.29%)
Tachycardia	10 (.29%)
Urinary Retention	10 (.29%)
Abnormal Behaviour	9 (.26%)
Aspartate Aminotransferase Increase...	9 (.26%)
Atrial Fibrillation	9 (.26%)
Dysphagia	9 (.26%)
Erythema	9 (.26%)
Extrasystoles	9 (.26%)
Incorrect Dose Administered	9 (.26%)
Paraesthesia	9 (.26%)
Psychomotor Hyperactivity	9 (.26%)

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

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

Neurological	274 (8.03%)
Cardiac Arrhythmias	192 (5.63%)
Therapeutic And Nontherapeutic Effe...	145 (4.25%)
Gastrointestinal Signs	136 (3.98%)
Respiratory	126 (3.69%)
Epidermal And Dermal Conditions	116 (3.4%)
Cardiac And Vascular Investigations	99 (2.9%)
Medication Errors	97 (2.84%)
Seizures	67 (1.96%)
Allergic Conditions	65 (1.9%)
Angiedema And Urticaria	64 (1.88%)
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Chemical Injury And Poisoning	64 (1.88%)
Suicidal And Self-injurious Behavio...	64 (1.88%)
Urinary Tract Signs	63 (1.85%)
Sleep Disorders	56 (1.64%)
Hepatic And Hepatobiliary	52 (1.52%)
Headaches	51 (1.49%)
Anxiety Disorders	47 (1.38%)
Vision	47 (1.38%)
Muscle	46 (1.35%)
Infections - Pathogen Unspecified	45 (1.32%)
Fatal Outcomes	40 (1.17%)
Upper Respiratory Tract Disorders	39 (1.14%)
Cardiac Disorder Signs	36 (1.05%)
Movement Disorders	35 (1.03%)
Physical Examination Topics	33 (.97%)
Hematology Investigations	32 (.94%)
Hepatobiliary	32 (.94%)
Musculoskeletal And Connective Tiss...	31 (.91%)
Metabolic, Nutritional And Blood Ga...	30 (.88%)
Injuries	27 (.79%)
Psychiatric	27 (.79%)
Electrolyte And Fluid Balance Condi...	26 (.76%)
Appetite And General Nutritional	22 (.64%)
Bronchial Disorders	22 (.64%)
Gastrointestinal Motility And Defec...	21 (.62%)
Personality Disorders	21 (.62%)
Salivary Gland Conditions	21 (.62%)
Vascular Hypertensive	21 (.62%)
Body Temperature Conditions	19 (.56%)
Decreased And Nonspecific Blood Pre...	19 (.56%)
Depressed Mood Disorders	19 (.56%)
Therapeutic Procedures And Supporti...	19 (.56%)
Deliria	18 (.53%)
Oral Soft Tissue Conditions	18 (.53%)
Eye	17 (.5%)
Mental Impairment	17 (.5%)
Disturbances In Thinking	16 (.47%)
Abortions And Stillbirth	15 (.44%)
Central Nervous System Vascular	15 (.44%)
Mood Disorders	15 (.44%)
Pregnancy, Labour, Delivery And Pos...	15 (.44%)
Coronary Artery	14 (.41%)
Joint	14 (.41%)
Ocular Infections, Irritations And ...	14 (.41%)
Product Quality Issues	14 (.41%)
Tongue Conditions	13 (.38%)
Water, Electrolyte And Mineral	13 (.38%)
Inner Ear And Viiith Cranial Nerve	12 (.35%)
Lifestyle Issues	12 (.35%)
Ocular Neuromuscular	12 (.35%)
Renal Disorders	12 (.35%)
Skin Appendage Conditions	12 (.35%)
Peripheral Neuropathies	11 (.32%)
Bacterial Infectious	10 (.29%)
Lower Respiratory Tract Disorders	10 (.29%)
Myocardial	10 (.29%)
Psychiatric And Behavioural Symptom...	9 (.26%)
Viral Infectious	9 (.26%)
Changes In Physical Activity	8 (.23%)
Embolism And Thrombosis	8 (.23%)
Gastrointestinal Conditions	8 (.23%)
Nephropathies	8 (.23%)
Skin Vascular Abnormalities	8 (.23%)
Toxicology And Therapeutic Drug Mon...	8 (.23%)
Communication Disorders	7 (.21%)
White Blood Cell	7 (.21%)
Bladder And Bladder Neck Disorders	6 (.18%)
Gastrointestinal Hemorrhages	6 (.18%)
Glucose Metabolism Disorders	6 (.18%)
Heart Failures	6 (.18%)
Obstetric And Gynecological Therape...	6 (.18%)
Vascular	6 (.18%)
Dental And Gingival Conditions	5 (.15%)
Fungal Infectious	5 (.15%)
Musculoskeletal And Connective Tiss...	5 (.15%)
Procedural And Device Related Injur...	5 (.15%)
Renal And Urinary Tract Investigati...	5 (.15%)
Synovial And Bursal	5 (.15%)
Vascular Inflammations	5 (.15%)
Administration Site Reactions	4 (.12%)
Arteriosclerosis, Stenosis, Vascula...	4 (.12%)
Aural	4 (.12%)
Neurological, Special Senses And Ps...	4 (.12%)
Neuromuscular	4 (.12%)
Ocular Structural Change, Deposit A...	4 (.12%)
Prostatic Disorders	4 (.12%)
Sleep Disturbances	4 (.12%)
Adjustment Disorders	3 (.09%)
Bone, Calcium, Magnesium And Phosph...	3 (.09%)
Breast	3 (.09%)

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