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Albuterol Adverse Events Reported to the FDA Over Time

How are Albuterol adverse event reports trending over time?

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

Most Common Albuterol Adverse Events Reported to the FDA

What are the most common Albuterol 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, 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 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

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

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

Common Uses of Albuterol According to Those Reporting Adverse Events

Why are people taking Albuterol, according to those reporting adverse events to the FDA?

Asthma
10407
Chronic Obstructive Pulmonary Disea...
4991
Drug Use For Unknown Indication
3203
Product Used For Unknown Indication
3066
Dyspnoea
1458
Emphysema
755
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Wheezing
436
Bronchitis
435
Cough
251
Bronchospasm
168
Respiratory Disorder
155
Lung Disorder
139
Hypersensitivity
129
Pneumonia
126
Bronchitis Chronic
123
Chronic Obstructive Airways Disease
112
Ill-defined Disorder
84
Multiple Allergies
69
Asthma Exercise Induced
66
Prophylaxis
63
Bronchial Hyperreactivity
56
Seasonal Allergy
43
Bronchiectasis
37
Inhalation Therapy
36
Upper Respiratory Tract Infection
35
Premedication
35
Status Asthmaticus
32
Pulmonary Congestion
28
Bronchiolitis
26
Cystic Fibrosis
24
Lower Respiratory Tract Infection
24
Pulmonary Fibrosis
23
Bronchial Disorder
23
Asthmatic Crisis
23
Respiratory Failure
22
Respiratory Distress
21
Drug Exposure During Pregnancy
20
Influenza
19
Obstructive Airways Disorder
19
Foetal Exposure During Pregnancy
18
Off Label Use
17
Unevaluable Event
15
Oxygen Saturation Decreased
15
Nasopharyngitis
15
Respiratory Tract Congestion
15
Chest Discomfort
13
Sinusitis
12
Antasthmatic Drug Level
12
Lung Neoplasm Malignant
12
Cardiac Failure Congestive
11
Pulmonary Function Test
11

Drug Labels

LabelLabelerEffective
Albuterol SulfateBryant Ranch Prepack05-DEC-89
VospireerDAVA Pharmaceuticals, Inc.12-AUG-06
Albuterol SulfateMylan Pharmaceuticals Inc.28-NOV-06
AlbuterolUDL Laboratories, Inc.08-DEC-06
Albuterol SulfateerDAVA Pharmaceuticals, Inc.07-FEB-07
Ventolinhfa HfaRebel Distributors Corp.01-SEP-09
Albuterol SulfateNephron Pharmaceuticals Corporation09-NOV-09
Albuterol SulfateNephron Pharmaceuticals Corporation09-NOV-09
Albuterol SulfatePhysicians Total Care, Inc.09-NOV-09
Albuterol SulfateMutual Pharmaceutical Company, Inc.19-NOV-09
AlbuterolMylan Pharmaceuticals Inc.04-JAN-10
AlbuterolPD-Rx Pharmaceuticals, Inc.04-JAN-10
Albuterol SulfateHi-Tech Pharmacal Co., Inc.12-JAN-10
Albuterol SulfatePhysicians Total Care, Inc.12-JAN-10
VentolinhfaDispensing Solutions Inc.02-MAR-10
Albuterol SulfatePreferred Pharmaceuticals, inc16-JUN-10
Albuterol SulfateHi-Tech Pharmacal Co., Inc.16-JUN-10
Albuterol SulfatePhysicians Total Care, Inc.19-JUL-10
VentolinhfaSTAT RX USA LLC27-JUL-10
ProairhfaTeva Respiratory, LLC20-AUG-10
Albuterol SulfateRebel Distributors Corp.31-AUG-10
Albuterol SulfateRebel Distributors Corp.02-SEP-10
CombiventPhysicians Total Care, Inc.21-SEP-10
Ipratropium Bromide And Albuterol SulfatePhysicians Total Care, Inc.05-NOV-10
ProairhfaRebel Distributors Corp11-NOV-10
Albuterol SulfateRebel Distributors Corp03-JAN-11
Proventil HfaLake Erie Medical DBA Quality Care Products LLC17-JAN-11
Albuterol SulfateLake Erie Medical DBA Quality Care Products LLC04-FEB-11
Albuterol SulfateMylan Pharmaceuticals Inc.23-MAR-11
Albuterol SulfatePreferred Pharmaceuticals, Inc29-MAR-11
AlbuterolRebel Distributors Corp20-JUL-11
Albuterol SulfateNephron Pharmaceuticals Corporation27-SEP-11
Albuterol SulfateDispensing Solutions, Inc.03-OCT-11
Proventil HfaRebel Distributors Corp.04-OCT-11
Proairhfa HfaH.J. Harkins Company, Inc.04-NOV-11
Albuterol SulfateMylan Pharmaceuticals Inc.01-JAN-12
Albuterol SulfatePreferred Pharmaceuticals, Inc10-JAN-12
VentolinhfaPhysicians Total Care, Inc.13-JAN-12
VentolinhfaH.J. Harkins Company, Inc.20-JAN-12
ProairhfaPreferred Pharmaceuticals, Inc13-FEB-12
ProairhfaLake Erie Medical & Surgical Supply DBA Quality Care Products LLC21-MAR-12
Albuterol SulfateCardinal Health27-MAR-12
Albuterol SulfateCardinal Health27-MAR-12
Albuterol SulfatePhysicians Total Care, Inc.05-APR-12
Ipratropium Bromide And Albuterol SulfateCardinal Health15-MAY-12
ProairhfaTeva Respiratory, LLC23-MAY-12
VentolinhfaLake Erie Medical & Surgical Supply DBA Quality Care Products LLC13-JUN-12
Proventil HfaMerck Sharp & Dohme Corp.02-JUL-12
Ipratropium Bromide And Albuterol SulfateCobalt Laboratories17-JUL-12
Albuterol SulfatePreferred Pharmaceuticals, Inc.27-JUL-12
Combivent RespimatBoehringer Ingelheim Pharmaceuticals Inc.24-AUG-12
Ipratropium Bromide And Albuterol SulfateMylan Pharmaceuticals Inc.31-AUG-12
Ipratropium Bromide And Albuterol SulfateEon Labs, Inc.31-AUG-12
Ipratropium Bromide And Albuterol SulfateNephron Pharmaceuticals Corporation04-SEP-12
CombiventBoehringer Ingelheim Pharmaceuticals, Inc.20-SEP-12
Albuterol SulfateRitedose Pharmaceuticals, LLC28-SEP-12
Albuterol SulfatePreferred Pharmaceuticals, Inc03-OCT-12
Albuterol SulfateMylan Pharmaceuticals, Inc.03-OCT-12
VentolinhfaGlaxoSmithKline LLC03-OCT-12
Albuterol SulfateSandoz Inc.18-OCT-12
Albuterol SulfateTeva Pharmaceuticals USA Inc23-OCT-12
Albuterol SulfatePhysicians Total Care, Inc.24-OCT-12
Albuterol SulfateWatson Laboratories, Inc.12-NOV-12
Ipratropium Bromide And Albuterol SulfateRitedose Pharmaceuticals, LLC13-DEC-12
Albuterol SulfateWatson Laboratories, Inc.17-DEC-12
Ipratropium Bromide And Albuterol SulfateTeva Pharmaceuticals USA Inc18-DEC-12
Ipratropium Bromide And Albuterol SulfateWatson Laboratories, Inc.08-FEB-13
Albuterol SulfateBryant Ranch Prepack13-FEB-13
Ipratropium Bromide And Albuterol SulfateMylan Pharmaceuticals, Inc.25-FEB-13
Albuterol SulfateREMEDYREPACK INC. 06-MAR-13
Albuterol SulfateQualitest Pharmaceuticals09-APR-13
Albuterol SulfateBausch & Lomb Incorporated10-APR-13
Albuterol SulfateCardinal Health19-APR-13
Albuterol SulfatePreferred Pharmaceuticals, Inc30-APR-13
Albuterol SulfatePreferred Pharmaceuticals, inc30-APR-13

Albuterol Case Reports

What Albuterol safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Albuterol. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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