ALBUTEROL SULFATE

Albuterol Sulfate Adverse Events Reported to the FDA Over Time

How are Albuterol Sulfate adverse event reports trending over time?

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

Most Common Albuterol Sulfate Adverse Events Reported to the FDA

What are the most common Albuterol Sulfate adverse events reported to the FDA?

Drug Ineffective	2451 (7.33%)
Dyspnoea	1816 (5.43%)
Asthma	1096 (3.28%)
Product Quality Issue	765 (2.29%)
Cough	657 (1.96%)
Pneumonia	472 (1.41%)
Dysgeusia	430 (1.29%)
Wheezing	327 (.98%)
Condition Aggravated	301 (.9%)
Dizziness	293 (.88%)
Drug Effect Decreased	292 (.87%)
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Chest Discomfort	276 (.82%)
Chronic Obstructive Pulmonary Disea...	270 (.81%)
Malaise	265 (.79%)
Tremor	256 (.77%)
Chest Pain	255 (.76%)
Headache	249 (.74%)
Death	244 (.73%)
Throat Irritation	238 (.71%)
Heart Rate Increased	229 (.68%)
Nausea	225 (.67%)
Tachycardia	219 (.65%)
Overdose	205 (.61%)
Dysphonia	168 (.5%)
Bronchitis	161 (.48%)
Vomiting	160 (.48%)
Drug Exposure During Pregnancy	158 (.47%)
Hypersensitivity	154 (.46%)
Loss Of Consciousness	152 (.45%)
Medication Error	151 (.45%)
Palpitations	151 (.45%)
Asthenia	148 (.44%)
Feeling Abnormal	144 (.43%)
Anxiety	137 (.41%)
Drug Administration Error	137 (.41%)
Insomnia	135 (.4%)
Respiratory Failure	130 (.39%)
Atrial Fibrillation	124 (.37%)
Fatigue	123 (.37%)
Lung Disorder	123 (.37%)
Pyrexia	123 (.37%)
Blood Pressure Increased	120 (.36%)
Lactic Acidosis	119 (.36%)
Lower Respiratory Tract Infection	119 (.36%)
Dry Mouth	118 (.35%)
Pain	118 (.35%)
Hallucination	115 (.34%)
Burning Sensation	114 (.34%)
Rash	114 (.34%)
Oropharyngeal Pain	113 (.34%)
Therapeutic Response Decreased	108 (.32%)
Myocardial Infarction	104 (.31%)
Oedema Peripheral	102 (.3%)
Increased Upper Airway Secretion	100 (.3%)
Nasopharyngitis	98 (.29%)
Bronchospasm	96 (.29%)
Fall	96 (.29%)
Urticaria	95 (.28%)
Hypokalaemia	94 (.28%)
Metabolic Acidosis	94 (.28%)
Cerebrovascular Accident	90 (.27%)
Lung Neoplasm Malignant	88 (.26%)
Respiratory Distress	88 (.26%)
Choking	87 (.26%)
Hyperhidrosis	87 (.26%)
Cardiac Disorder	85 (.25%)
Drug Interaction	85 (.25%)
Nervousness	85 (.25%)
Convulsion	84 (.25%)
Cardiac Failure Congestive	83 (.25%)
Lung Infection	82 (.25%)
Cardiac Arrest	80 (.24%)
Oxygen Saturation Decreased	80 (.24%)
Blood Glucose Increased	79 (.24%)
Cyanosis	79 (.24%)
Hypertension	78 (.23%)
Pruritus	78 (.23%)
Productive Cough	77 (.23%)
Confusional State	76 (.23%)
Cardiac Failure	75 (.22%)
Pulmonary Congestion	75 (.22%)
Drug Hypersensitivity	74 (.22%)
Expired Drug Administered	74 (.22%)
Throat Tightness	74 (.22%)
Muscle Spasms	73 (.22%)
Ill-defined Disorder	71 (.21%)
Memory Impairment	71 (.21%)
Weight Increased	71 (.21%)
Hypotension	70 (.21%)
Respiratory Arrest	69 (.21%)
Oral Discomfort	68 (.2%)
Dehydration	67 (.2%)
Device Failure	67 (.2%)
Vision Blurred	67 (.2%)
Constipation	65 (.19%)
Hypoaesthesia	65 (.19%)
Incorrect Dose Administered	65 (.19%)
Respiratory Disorder	65 (.19%)
Adverse Event	62 (.19%)
Gait Disturbance	62 (.19%)
Back Pain	61 (.18%)

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

What are the most common Albuterol Sulfate adverse events reported to the FDA?

Respiratory	4638 (13.86%)
Therapeutic And Nontherapeutic Effe...	3242 (9.69%)
Bronchial Disorders	1932 (5.77%)
Neurological	1670 (4.99%)
Infections - Pathogen Unspecified	1324 (3.96%)
Medication Errors	976 (2.92%)
Product Quality Issues	886 (2.65%)
Cardiac Arrhythmias	790 (2.36%)
Gastrointestinal Signs	747 (2.23%)
Cardiac And Vascular Investigations	631 (1.89%)
Epidermal And Dermal Conditions	589 (1.76%)
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Anxiety Disorders	419 (1.25%)
Movement Disorders	389 (1.16%)
Oral Soft Tissue Conditions	339 (1.01%)
Allergic Conditions	337 (1.01%)
Cardiac Disorder Signs	333 (1%)
Lower Respiratory Tract Disorders	322 (.96%)
Metabolic, Nutritional And Blood Ga...	292 (.87%)
Injuries	290 (.87%)
Fatal Outcomes	282 (.84%)
Headaches	281 (.84%)
Upper Respiratory Tract Disorders	280 (.84%)
Chemical Injury And Poisoning	263 (.79%)
Coronary Artery	239 (.71%)
Acid-base	230 (.69%)
Musculoskeletal And Connective Tiss...	226 (.68%)
Sleep Disorders	223 (.67%)
Procedural And Device Related Injur...	215 (.64%)
Electrolyte And Fluid Balance Condi...	210 (.63%)
Heart Failures	197 (.59%)
Muscle	197 (.59%)
Physical Examination Topics	183 (.55%)
Gastrointestinal Motility And Defec...	180 (.54%)
Tongue Conditions	169 (.51%)
Therapeutic Procedures And Supporti...	167 (.5%)
Central Nervous System Vascular	149 (.45%)
Mental Impairment	145 (.43%)
Fungal Infectious	144 (.43%)
Urinary Tract Signs	144 (.43%)
Body Temperature Conditions	141 (.42%)
Disturbances In Thinking	141 (.42%)
Vision	141 (.42%)
Hematology Investigations	140 (.42%)
Renal Disorders	137 (.41%)
Salivary Gland Conditions	135 (.4%)
Respiratory And Mediastinal Neoplas...	133 (.4%)
Psychiatric	132 (.39%)
Skin Appendage Conditions	131 (.39%)
Angiedema And Urticaria	126 (.38%)
Glucose Metabolism Disorders	122 (.36%)
Decreased And Nonspecific Blood Pre...	119 (.36%)
Deliria	119 (.36%)
Joint	118 (.35%)
Lifestyle Issues	114 (.34%)
Dental And Gingival Conditions	108 (.32%)
Seizures	108 (.32%)
Bacterial Infectious	107 (.32%)
Bone And Joint Injuries	107 (.32%)
Toxicology And Therapeutic Drug Mon...	106 (.32%)
Viral Infectious	103 (.31%)
Water, Electrolyte And Mineral	100 (.3%)
Vascular	99 (.3%)
Eye	98 (.29%)
Musculoskeletal And Connective Tiss...	93 (.28%)
Respiratory And Pulmonary Investiga...	89 (.27%)
Appetite And General Nutritional	84 (.25%)
Pulmonary Vascular	81 (.24%)
Vascular Hypertensive	81 (.24%)
Cardiac Valve	78 (.23%)
Hepatobiliary	76 (.23%)
Ocular Infections, Irritations And ...	76 (.23%)
Myocardial	75 (.22%)
Suicidal And Self-injurious Behavio...	72 (.22%)
Mood Disorders	70 (.21%)
Hepatic And Hepatobiliary	69 (.21%)
Depressed Mood Disorders	65 (.19%)
Injuries By Physical Agents	65 (.19%)
Personality Disorders	62 (.19%)
Cranial Nerve Disorders	60 (.18%)
Anterior Eye Structural Change, Dep...	59 (.18%)
Ocular Neuromuscular	52 (.16%)
Renal And Urinary Tract Investigati...	52 (.16%)
Gastrointestinal Hemorrhages	50 (.15%)
Mesotheliomas	50 (.15%)
Enzyme	44 (.13%)
Pleural	43 (.13%)
Exocrine Pancreas Conditions	42 (.13%)
Neonatal And Perinatal Conditions	42 (.13%)
Neuromuscular	42 (.13%)
Anemias Nonhemolytic And Marrow Dep...	41 (.12%)
Arteriosclerosis, Stenosis, Vascula...	40 (.12%)
Obstetric And Gynecological Therape...	40 (.12%)
Changes In Physical Activity	39 (.12%)
White Blood Cell	39 (.12%)
Lipid Analyses	38 (.11%)
Spinal Cord And Nerve Root	38 (.11%)
Bone Disorders	37 (.11%)
Aneurysms And Artery Dissections	36 (.11%)
Investigations, Imaging And Histopa...	35 (.1%)
Vascular Hemorrhagic	35 (.1%)
Gastrointestinal Conditions	34 (.1%)

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