CARVEDILOL

Carvedilol Adverse Events Reported to the FDA Over Time

How are Carvedilol adverse event reports trending over time?

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

Most Common Carvedilol Adverse Events Reported to the FDA

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

Dizziness	990 (3.89%)
Fatigue	775 (3.05%)
Dyspnoea	620 (2.44%)
Drug Ineffective	501 (1.97%)
Hypotension	500 (1.97%)
Asthenia	412 (1.62%)
Nausea	368 (1.45%)
Blood Pressure Increased	348 (1.37%)
Headache	288 (1.13%)
Bradycardia	273 (1.07%)
Syncope	259 (1.02%)
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Weight Increased	252 (.99%)
Drug Interaction	239 (.94%)
Diarrhoea	223 (.88%)
Blood Pressure Decreased	222 (.87%)
Malaise	220 (.87%)
Chest Pain	217 (.85%)
Oedema Peripheral	216 (.85%)
Death	206 (.81%)
Heart Rate Decreased	191 (.75%)
Hypertension	182 (.72%)
Rash	181 (.71%)
Somnolence	179 (.7%)
Insomnia	175 (.69%)
Blood Glucose Increased	173 (.68%)
Feeling Abnormal	169 (.66%)
Palpitations	165 (.65%)
Atrial Fibrillation	164 (.65%)
Cardiac Failure	156 (.61%)
Cough	154 (.61%)
Loss Of Consciousness	153 (.6%)
Vomiting	152 (.6%)
Vision Blurred	151 (.59%)
Heart Rate Increased	144 (.57%)
Pain In Extremity	142 (.56%)
Fall	140 (.55%)
Alopecia	138 (.54%)
Pruritus	132 (.52%)
Completed Suicide	127 (.5%)
Cardiac Failure Congestive	121 (.48%)
Overdose	121 (.48%)
Weight Decreased	113 (.44%)
Myalgia	110 (.43%)
Pain	107 (.42%)
Cardiac Arrest	103 (.41%)
Hypoglycaemia	102 (.4%)
Pneumonia	101 (.4%)
Myocardial Infarction	99 (.39%)
Renal Failure Acute	99 (.39%)
Adverse Event	98 (.39%)
Abdominal Pain Upper	97 (.38%)
Hyperhidrosis	97 (.38%)
Chest Discomfort	94 (.37%)
Hyperkalaemia	92 (.36%)
Depression	91 (.36%)
Dehydration	89 (.35%)
Anxiety	88 (.35%)
Cardiac Disorder	83 (.33%)
Abdominal Pain	82 (.32%)
Paraesthesia	81 (.32%)
Blood Pressure Fluctuation	79 (.31%)
Heart Rate Irregular	79 (.31%)
Hypoaesthesia	79 (.31%)
Arthralgia	78 (.31%)
Blood Creatinine Increased	78 (.31%)
Muscle Spasms	77 (.3%)
Renal Failure	77 (.3%)
Confusional State	75 (.3%)
Muscular Weakness	75 (.3%)
Orthostatic Hypotension	74 (.29%)
Back Pain	72 (.28%)
Medication Error	72 (.28%)
Cerebrovascular Accident	71 (.28%)
Constipation	71 (.28%)
Condition Aggravated	70 (.28%)
Tachycardia	70 (.28%)
Fluid Retention	69 (.27%)
Arrhythmia	68 (.27%)
Hyponatraemia	67 (.26%)
Oedema	66 (.26%)
Vertigo	66 (.26%)
Anaemia	65 (.26%)
Lethargy	64 (.25%)
Gait Disturbance	63 (.25%)
Hypersensitivity	63 (.25%)
Dry Mouth	62 (.24%)
Pyrexia	62 (.24%)
Asthma	61 (.24%)
Dry Eye	59 (.23%)
Wheezing	59 (.23%)
Anorexia	58 (.23%)
Abdominal Discomfort	55 (.22%)
Convulsion	55 (.22%)
Haemoglobin Decreased	55 (.22%)
Joint Swelling	55 (.22%)
Product Quality Issue	54 (.21%)
Abasia	53 (.21%)
Balance Disorder	53 (.21%)
Peripheral Coldness	53 (.21%)
Blood Pressure Inadequately Control...	52 (.2%)
Abdominal Distension	49 (.19%)

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

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

Neurological	2261 (8.89%)
Cardiac And Vascular Investigations	1246 (4.9%)
Cardiac Arrhythmias	1193 (4.69%)
Respiratory	1165 (4.58%)
Therapeutic And Nontherapeutic Effe...	1027 (4.04%)
Gastrointestinal Signs	991 (3.9%)
Decreased And Nonspecific Blood Pre...	779 (3.06%)
Epidermal And Dermal Conditions	760 (2.99%)
Physical Examination Topics	413 (1.62%)
Electrolyte And Fluid Balance Condi...	407 (1.6%)
Medication Errors	397 (1.56%)
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Muscle	354 (1.39%)
Gastrointestinal Motility And Defec...	347 (1.37%)
Musculoskeletal And Connective Tiss...	346 (1.36%)
Heart Failures	331 (1.3%)
Infections - Pathogen Unspecified	331 (1.3%)
Injuries	307 (1.21%)
Headaches	304 (1.2%)
Metabolic, Nutritional And Blood Ga...	301 (1.18%)
Skin Appendage Conditions	294 (1.16%)
Hematology Investigations	290 (1.14%)
Sleep Disorders	288 (1.13%)
Vision	288 (1.13%)
Cardiac Disorder Signs	285 (1.12%)
Renal Disorders	279 (1.1%)
Fatal Outcomes	222 (.87%)
Hepatobiliary	220 (.87%)
Coronary Artery	217 (.85%)
Anxiety Disorders	204 (.8%)
Vascular Hypertensive	194 (.76%)
Glucose Metabolism Disorders	187 (.74%)
Hepatic And Hepatobiliary	185 (.73%)
Renal And Urinary Tract Investigati...	177 (.7%)
Joint	174 (.68%)
Appetite And General Nutritional	172 (.68%)
Urinary Tract Signs	170 (.67%)
Suicidal And Self-injurious Behavio...	163 (.64%)
Bronchial Disorders	161 (.63%)
Water, Electrolyte And Mineral	141 (.55%)
Central Nervous System Vascular	135 (.53%)
Lifestyle Issues	134 (.53%)
Mental Impairment	134 (.53%)
Allergic Conditions	129 (.51%)
Deliria	115 (.45%)
Vascular	114 (.45%)
Arteriosclerosis, Stenosis, Vascula...	112 (.44%)
Inner Ear And Viiith Cranial Nerve	111 (.44%)
Eye	103 (.41%)
Lower Respiratory Tract Disorders	102 (.4%)
Depressed Mood Disorders	101 (.4%)
Product Quality Issues	94 (.37%)
Movement Disorders	93 (.37%)
Chemical Injury And Poisoning	90 (.35%)
Body Temperature Conditions	88 (.35%)
Lipid Analyses	87 (.34%)
Myocardial	85 (.33%)
Anemias Nonhemolytic And Marrow Dep...	81 (.32%)
Bone And Joint Injuries	79 (.31%)
Enzyme	78 (.31%)
Angiedema And Urticaria	72 (.28%)
Oral Soft Tissue Conditions	70 (.28%)
Seizures	70 (.28%)
Toxicology And Therapeutic Drug Mon...	69 (.27%)
Mood Disorders	67 (.26%)
Salivary Gland Conditions	63 (.25%)
Sexual Function And Fertility	62 (.24%)
Upper Respiratory Tract Disorders	58 (.23%)
Psychiatric	57 (.22%)
Cardiac Valve	55 (.22%)
Ocular Infections, Irritations And ...	54 (.21%)
White Blood Cell	54 (.21%)
Gastrointestinal Conditions	50 (.2%)
Procedural And Device Related Injur...	49 (.19%)
Tongue Conditions	49 (.19%)
Disturbances In Thinking	48 (.19%)
Therapeutic Procedures And Supporti...	46 (.18%)
Neuromuscular	41 (.16%)
Bacterial Infectious	40 (.16%)
Platelet	40 (.16%)
Gastrointestinal Hemorrhages	39 (.15%)
Cardiac Therapeutic Procedures	38 (.15%)
Vascular Hemorrhagic	38 (.15%)
Pleural	37 (.15%)
Endocrine Investigations	36 (.14%)
Viral Infectious	36 (.14%)
Bone, Calcium, Magnesium And Phosph...	35 (.14%)
Gallbladder	34 (.13%)
Sleep Disturbances	34 (.13%)
Anterior Eye Structural Change, Dep...	32 (.13%)
Bone Disorders	32 (.13%)
Dental And Gingival Conditions	30 (.12%)
Hematological And Lymphoid Tissue T...	29 (.11%)
Skin Vascular Abnormalities	29 (.11%)
Ocular Neuromuscular	28 (.11%)
Vascular Therapeutic Procedures	27 (.11%)
Breast	26 (.1%)
Bone And Joint Therapeutic Procedur...	24 (.09%)
Changes In Physical Activity	24 (.09%)
Gastrointestinal Neoplasms Malignan...	24 (.09%)
Miscellaneous And Site Unspecified ...	24 (.09%)
Ocular Hemorrhages And Vascular	23 (.09%)

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