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SALBUTAMOL

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Salbutamol Adverse Events Reported to the FDA Over Time

How are Salbutamol adverse event reports trending over time?

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

Most Common Salbutamol Adverse Events Reported to the FDA

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

Drug Ineffective
274 (7.18%)
Dyspnoea
118 (3.09%)
Asthma
114 (2.99%)
Drug Exposure During Pregnancy
87 (2.28%)
Chronic Obstructive Pulmonary Disea...
71 (1.86%)
Tachycardia
59 (1.55%)
Cough
53 (1.39%)
Wheezing
45 (1.18%)
Condition Aggravated
41 (1.07%)
Metabolic Acidosis
41 (1.07%)
Lactic Acidosis
36 (.94%)
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Emphysema
34 (.89%)
Chest Pain
33 (.86%)
Caesarean Section
32 (.84%)
Drug Effect Decreased
32 (.84%)
Hyperglycaemia
30 (.79%)
Pneumonia
29 (.76%)
Lower Respiratory Tract Infection
27 (.71%)
Lung Neoplasm Malignant
26 (.68%)
Mesothelioma
25 (.65%)
Respiratory Failure
25 (.65%)
Convulsion
24 (.63%)
Foetal Distress Syndrome
24 (.63%)
Nausea
24 (.63%)
Chest Discomfort
23 (.6%)
Tachypnoea
23 (.6%)
Cardiac Failure
22 (.58%)
Heart Rate Increased
22 (.58%)
Vomiting
22 (.58%)
Tachycardia Foetal
21 (.55%)
Hyperventilation
20 (.52%)
Drug Interaction
19 (.5%)
Fatigue
19 (.5%)
Bronchopneumonia
18 (.47%)
Dizziness
18 (.47%)
Hypokalaemia
18 (.47%)
Infective Exacerbation Of Chronic O...
18 (.47%)
Overdose
18 (.47%)
Oxygen Saturation Decreased
18 (.47%)
Diabetic Ketoacidosis
17 (.45%)
Respiratory Acidosis
17 (.45%)
Anxiety
16 (.42%)
Hypersensitivity
16 (.42%)
Product Quality Issue
16 (.42%)
Respiratory Distress
16 (.42%)
Throat Irritation
16 (.42%)
Tremor
16 (.42%)
Acute Myocardial Infarction
15 (.39%)
Bronchospasm
15 (.39%)
Premature Baby
15 (.39%)
Somnolence
15 (.39%)
Atrial Fibrillation
14 (.37%)
Hypotension
14 (.37%)
Drug Toxicity
13 (.34%)
General Physical Health Deteriorati...
13 (.34%)
Headache
13 (.34%)
Mitral Valve Incompetence
13 (.34%)
Oedema Peripheral
13 (.34%)
Palpitations
13 (.34%)
Toxic Epidermal Necrolysis
13 (.34%)
Blood Glucose Increased
12 (.31%)
Cyanosis
12 (.31%)
Death
12 (.31%)
Dysgeusia
12 (.31%)
Maternal Drugs Affecting Foetus
12 (.31%)
Myalgia
12 (.31%)
Pain In Extremity
12 (.31%)
Pulmonary Oedema
12 (.31%)
Blood Pressure Increased
11 (.29%)
Myocardial Infarction
11 (.29%)
Weight Increased
11 (.29%)
Acute Pulmonary Oedema
10 (.26%)
Agitation
10 (.26%)
Blood Pressure Decreased
10 (.26%)
Ejection Fraction Decreased
10 (.26%)
Hypercapnia
10 (.26%)
Increased Upper Airway Secretion
10 (.26%)
Intra-uterine Death
10 (.26%)
Myocardial Ischaemia
10 (.26%)
Pulmonary Hypertension
10 (.26%)
Blood Ph Decreased
9 (.24%)
Dyskinesia
9 (.24%)
Foreign Body Aspiration
9 (.24%)
Glycosuria
9 (.24%)
Intentional Drug Misuse
9 (.24%)
Loss Of Consciousness
9 (.24%)
Premature Labour
9 (.24%)
Pulmonary Embolism
9 (.24%)
Pyrexia
9 (.24%)
Rash
9 (.24%)
Tricuspid Valve Incompetence
9 (.24%)
Cardiac Arrest
8 (.21%)
Cardiomegaly
8 (.21%)
Choking
8 (.21%)
Cholestasis Of Pregnancy
8 (.21%)
Confusional State
8 (.21%)
Diarrhoea
8 (.21%)
Dysphonia
8 (.21%)
Emotional Distress
8 (.21%)
Hellp Syndrome
8 (.21%)
Hyperhidrosis
8 (.21%)

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

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

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This graph shows the top categories of adverse events submitted to the FDA for Salbutamol, 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 Salbutamol 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 Salbutamol According to Those Reporting Adverse Events

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

Asthma
797
Drug Use For Unknown Indication
534
Chronic Obstructive Pulmonary Disea...
265
Product Used For Unknown Indication
123
Dyspnoea
87
Wheezing
44
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Ill-defined Disorder
35
Bronchospasm
24
Emphysema
23
Cough
22
Bronchitis
16
Respiratory Disorder
11
Chronic Obstructive Airways Disease
10
Premature Labour
10
Inhalation Therapy
7
Status Asthmaticus
7
Tocolysis
7
Asthma Exercise Induced
6
Hyperkalaemia
5
Lower Respiratory Tract Infection
5
Cystic Fibrosis
4
Prophylaxis
4
Bronchopulmonary Dysplasia
4
Pneumonia
4
Allergic Bronchitis
4
Asthmatic Crisis
4
Condition Aggravated
4
Influenza
3
Uterine Contractions Abnormal
3
Hypersensitivity
3
Respiratory Distress
3
Nasopharyngitis
3
Infection
3
Respiratory Failure
3
Obstructive Airways Disorder
3
Respiratory Tract Infection
3
Infective Exacerbation Of Chronic O...
3
Bronchiectasis
3
Seasonal Allergy
3
Subcutaneous Abscess
2
Respiratory Therapy
2
Non-small Cell Lung Cancer
2
Drug Exposure During Pregnancy
2
Infection Prophylaxis
2
Bronchitis Chronic
2
Asbestosis
2
Lung Disorder
2
Upper Respiratory Tract Infection
2
Hypertension
2
Exposure To Toxic Agent
2
Poisoning
2

Salbutamol Case Reports

What Salbutamol 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 Salbutamol. 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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