LABETALOL

Labetalol Adverse Events Reported to the FDA Over Time

How are Labetalol adverse event reports trending over time?

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

Most Common Labetalol Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	77 (3.17%)
Hypotension	65 (2.68%)
Caesarean Section	44 (1.81%)
Premature Baby	42 (1.73%)
Blood Pressure Increased	40 (1.65%)
Bradycardia	34 (1.4%)
Hypertension	34 (1.4%)
Nausea	34 (1.4%)
Cardiac Arrest	31 (1.28%)
Drug Ineffective	30 (1.24%)
Dyspnoea	25 (1.03%)
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Completed Suicide	24 (.99%)
Headache	23 (.95%)
Medication Error	23 (.95%)
Maternal Drugs Affecting Foetus	22 (.91%)
Asthenia	21 (.87%)
Blood Pressure Decreased	21 (.87%)
Drug Interaction	21 (.87%)
Dizziness	20 (.82%)
Vomiting	20 (.82%)
Overdose	19 (.78%)
Loss Of Consciousness	18 (.74%)
Abdominal Pain	17 (.7%)
Bone Marrow Failure	16 (.66%)
Hypertensive Crisis	16 (.66%)
Foetal Growth Retardation	14 (.58%)
Hypoglycaemia	14 (.58%)
Premature Labour	14 (.58%)
Confusional State	13 (.54%)
Fatigue	13 (.54%)
Thrombocytopenia	13 (.54%)
Blood Potassium Increased	12 (.49%)
Depressed Level Of Consciousness	12 (.49%)
Malaise	12 (.49%)
Blood Pressure Inadequately Control...	11 (.45%)
Death	11 (.45%)
Hyperhidrosis	11 (.45%)
Oedema Peripheral	11 (.45%)
Pre-eclampsia	11 (.45%)
Atrioventricular Block First Degree	10 (.41%)
Blood Glucose Increased	10 (.41%)
Bronchitis	10 (.41%)
Coma	10 (.41%)
Cough	10 (.41%)
Phaeochromocytoma	10 (.41%)
Renal Failure	10 (.41%)
Tachycardia	10 (.41%)
Constipation	9 (.37%)
Hip Fracture	9 (.37%)
Intra-uterine Death	9 (.37%)
No Therapeutic Response	9 (.37%)
Orthostatic Hypotension	9 (.37%)
Osteoarthritis	9 (.37%)
Pregnancy	9 (.37%)
Respiratory Distress	9 (.37%)
Anuria	8 (.33%)
Chest Pain	8 (.33%)
Fall	8 (.33%)
Hypoglycaemia Neonatal	8 (.33%)
Rash	8 (.33%)
Small For Dates Baby	8 (.33%)
Unresponsive To Stimuli	8 (.33%)
Blood Ph Decreased	7 (.29%)
Cardiogenic Shock	7 (.29%)
Cerebrovascular Accident	7 (.29%)
Condition Aggravated	7 (.29%)
Haemodialysis	7 (.29%)
Heart Rate Decreased	7 (.29%)
Incorrect Dose Administered	7 (.29%)
Labile Hypertension	7 (.29%)
Palpitations	7 (.29%)
Proteinuria	7 (.29%)
Pulmonary Oedema	7 (.29%)
Pyrexia	7 (.29%)
Renal Failure Acute	7 (.29%)
Urinary Incontinence	7 (.29%)
Cardio-respiratory Arrest	6 (.25%)
Circulatory Collapse	6 (.25%)
Congenital Hand Malformation	6 (.25%)
Convulsion	6 (.25%)
Coronary Artery Disease	6 (.25%)
Drug Effect Decreased	6 (.25%)
Drug Exposure Via Breast Milk	6 (.25%)
Drug Toxicity	6 (.25%)
Heart Rate Increased	6 (.25%)
Lymphopenia	6 (.25%)
Pallor	6 (.25%)
Pruritus	6 (.25%)
Renal Impairment	6 (.25%)
Septic Shock	6 (.25%)
Sinus Bradycardia	6 (.25%)
Somnolence	6 (.25%)
Abdominal Pain Upper	5 (.21%)
Anaemia	5 (.21%)
Anal Atresia	5 (.21%)
Anxiety	5 (.21%)
Apgar Score Low	5 (.21%)
Blood Lactic Acid Increased	5 (.21%)
Blood Potassium Decreased	5 (.21%)
Bone Marrow Toxicity	5 (.21%)
Bradycardia Foetal	5 (.21%)

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

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

Cardiac Arrhythmias	141 (5.81%)
Cardiac And Vascular Investigations	125 (5.15%)
Chemical Injury And Poisoning	112 (4.61%)
Neurological	112 (4.61%)
Decreased And Nonspecific Blood Pre...	95 (3.91%)
Gastrointestinal Signs	93 (3.83%)
Respiratory	89 (3.67%)
Medication Errors	82 (3.38%)
Therapeutic And Nontherapeutic Effe...	76 (3.13%)
Vascular Hypertensive	60 (2.47%)
Neonatal And Perinatal Conditions	57 (2.35%)
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Obstetric And Gynecological Therape...	45 (1.85%)
Metabolic, Nutritional And Blood Ga...	39 (1.61%)
Renal Disorders	39 (1.61%)
Epidermal And Dermal Conditions	34 (1.4%)
Infections - Pathogen Unspecified	33 (1.36%)
Anemias Nonhemolytic And Marrow Dep...	29 (1.19%)
Hepatic And Hepatobiliary	27 (1.11%)
Fetal Complications	25 (1.03%)
Glucose Metabolism Disorders	25 (1.03%)
Headaches	25 (1.03%)
Suicidal And Self-injurious Behavio...	25 (1.03%)
Coronary Artery	24 (.99%)
Maternal Complications Of Pregnancy	24 (.99%)
Water, Electrolyte And Mineral	24 (.99%)
Maternal Complications Of Labour An...	22 (.91%)
Central Nervous System Vascular	21 (.87%)
Physical Examination Topics	21 (.87%)
Deliria	19 (.78%)
Hepatobiliary	19 (.78%)
Myocardial	19 (.78%)
Urinary Tract Signs	19 (.78%)
Injuries	18 (.74%)
Lower Respiratory Tract Disorders	18 (.74%)
Muscle	18 (.74%)
Fatal Outcomes	17 (.7%)
Hematology Investigations	17 (.7%)
Musculoskeletal And Connective Tiss...	17 (.7%)
Pregnancy, Labour, Delivery And Pos...	17 (.7%)
Bone And Joint Injuries	16 (.66%)
Gastrointestinal Motility And Defec...	16 (.66%)
Skin Appendage Conditions	16 (.66%)
Heart Failures	15 (.62%)
Electrolyte And Fluid Balance Condi...	14 (.58%)
Endocrine Neoplasms Malignant And U...	14 (.58%)
Platelet	14 (.58%)
Seizures	14 (.58%)
Body Temperature Conditions	13 (.54%)
Cardiac Disorder Signs	13 (.54%)
White Blood Cell	13 (.54%)
Abortions And Stillbirth	12 (.49%)
Anxiety Disorders	12 (.49%)
Joint	12 (.49%)
Renal And Urinary Tract Investigati...	12 (.49%)
Hematological And Lymphoid Tissue T...	11 (.45%)
Musculoskeletal And Connective Tiss...	11 (.45%)
Ocular Neuromuscular	11 (.45%)
Vision	11 (.45%)
Enzyme	10 (.41%)
Gastrointestinal Tract Disorders Co...	10 (.41%)
Procedural And Device Related Injur...	10 (.41%)
Psychiatric	10 (.41%)
Vascular	10 (.41%)
Product Quality Issues	9 (.37%)
Cardiac Valve	8 (.33%)
Mental Impairment	8 (.33%)
Skin Vascular Abnormalities	8 (.33%)
Upper Respiratory Tract Disorders	8 (.33%)
Acid-base	7 (.29%)
Appetite And General Nutritional	7 (.29%)
Lifestyle Issues	7 (.29%)
Movement Disorders	7 (.29%)
Neuromuscular	7 (.29%)
Allergic Conditions	6 (.25%)
Bacterial Infectious	6 (.25%)
Coagulopathies And Bleeding Diathes...	6 (.25%)
Metastases	6 (.25%)
Neonatal Respiratory	6 (.25%)
Nephropathies	6 (.25%)
Toxicology And Therapeutic Drug Mon...	6 (.25%)
Arteriosclerosis, Stenosis, Vascula...	5 (.21%)
Cardiac And Vascular Disorders Cong...	5 (.21%)
Encephalopathies	5 (.21%)
Fetal And Neonatal	5 (.21%)
Fungal Infectious	5 (.21%)
Placental, Amniotic And Cavity Diso...	5 (.21%)
Vascular Hemorrhagic	5 (.21%)
Bronchial Disorders	4 (.16%)
Ear And Labyrinthine Disorders Cong...	4 (.16%)
Embolism And Thrombosis	4 (.16%)
Hematopoietic Neoplasms	4 (.16%)
Inner Ear And Viiith Cranial Nerve	4 (.16%)
Mood Disorders	4 (.16%)
Therapeutic Procedures And Supporti...	4 (.16%)
Angiedema And Urticaria	3 (.12%)
Bone Disorders	3 (.12%)
Breast	3 (.12%)
Cranial Nerve Disorders	3 (.12%)
Endocrine Investigations	3 (.12%)
Eye	3 (.12%)
Gastrointestinal Conditions	3 (.12%)

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