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AERIUS

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Aerius Adverse Events Reported to the FDA Over Time

How are Aerius adverse event reports trending over time?

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

Most Common Aerius Adverse Events Reported to the FDA

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

Dyspnoea
27 (1.41%)
Cytolytic Hepatitis
25 (1.3%)
Drug Exposure During Pregnancy
24 (1.25%)
Vomiting
22 (1.15%)
Nausea
21 (1.09%)
Condition Aggravated
20 (1.04%)
Anaemia
19 (.99%)
Suicide Attempt
19 (.99%)
Cardiac Arrest
17 (.89%)
Pyrexia
17 (.89%)
Toxic Skin Eruption
17 (.89%)
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Hypotension
15 (.78%)
Cyanosis
14 (.73%)
Tachycardia
14 (.73%)
Diarrhoea
13 (.68%)
Dry Mouth
13 (.68%)
Face Oedema
13 (.68%)
Pruritus
13 (.68%)
Septic Shock
13 (.68%)
Somnolence
13 (.68%)
Agranulocytosis
12 (.63%)
Aspartate Aminotransferase Increase...
12 (.63%)
Confusional State
12 (.63%)
Fatigue
12 (.63%)
Feeling Abnormal
12 (.63%)
Palpitations
12 (.63%)
Alanine Aminotransferase Increased
11 (.57%)
Aplasia Pure Red Cell
11 (.57%)
Rash
11 (.57%)
Abdominal Pain
10 (.52%)
Cholestasis
10 (.52%)
Drug Rash With Eosinophilia And Sys...
10 (.52%)
Headache
10 (.52%)
Hepatitis Cholestatic
10 (.52%)
Prurigo
10 (.52%)
Rash Maculo-papular
10 (.52%)
Shock
10 (.52%)
Agitation
9 (.47%)
Anxiety
9 (.47%)
Blood Creatine Phosphokinase Increa...
9 (.47%)
Chest Pain
9 (.47%)
Dizziness
9 (.47%)
Drug Ineffective
9 (.47%)
Hepatitis
9 (.47%)
Hyperventilation
9 (.47%)
Insomnia
9 (.47%)
Loss Of Consciousness
9 (.47%)
Myalgia
9 (.47%)
Purpura
9 (.47%)
Aggression
8 (.42%)
Asthenia
8 (.42%)
Coarctation Of The Aorta
8 (.42%)
Coma
8 (.42%)
Dyspnoea Exertional
8 (.42%)
Fall
8 (.42%)
Gastrointestinal Malformation
8 (.42%)
Inflammation
8 (.42%)
Lichenoid Keratosis
8 (.42%)
Lung Disorder
8 (.42%)
Metabolic Acidosis
8 (.42%)
Oesophageal Atresia
8 (.42%)
Psychomotor Hyperactivity
8 (.42%)
Renal Failure
8 (.42%)
Respiratory Failure
8 (.42%)
Arrhythmia
7 (.36%)
Asthma
7 (.36%)
Blood Pressure Increased
7 (.36%)
Bradycardia
7 (.36%)
Cerebral Ischaemia
7 (.36%)
Drug Interaction
7 (.36%)
Erythema Infectiosum
7 (.36%)
Eyelid Oedema
7 (.36%)
Feeding Disorder Neonatal
7 (.36%)
Gastrointestinal Disorder
7 (.36%)
General Physical Health Deteriorati...
7 (.36%)
Haemodynamic Instability
7 (.36%)
Heart Disease Congenital
7 (.36%)
Hypersensitivity
7 (.36%)
Malaise
7 (.36%)
Multi-organ Failure
7 (.36%)
Pain In Extremity
7 (.36%)
Rhabdomyolysis
7 (.36%)
Sepsis
7 (.36%)
Thrombocytopenia
7 (.36%)
Tongue Oedema
7 (.36%)
Anuria
6 (.31%)
Bronchitis
6 (.31%)
C-reactive Protein Increased
6 (.31%)
Cell Death
6 (.31%)
Cognitive Disorder
6 (.31%)
Convulsion
6 (.31%)
Disseminated Intravascular Coagulat...
6 (.31%)
Drug Exposure Via Breast Milk
6 (.31%)
Drug Hypersensitivity
6 (.31%)
Dysphagia
6 (.31%)
Hepatitis Toxic
6 (.31%)
Hepatocellular Injury
6 (.31%)
Hyperkinesia
6 (.31%)
Hypovolaemia
6 (.31%)
Hypoxia
6 (.31%)
Jaundice
6 (.31%)

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

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

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

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

Drug Use For Unknown Indication
126
Hypersensitivity
101
Product Used For Unknown Indication
78
Rhinitis Allergic
60
Premedication
48
Asthma
35
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Pruritus
31
Urticaria
28
Rash
27
Seasonal Allergy
25
Rhinitis Seasonal
9
Rhinitis
9
Nasal Congestion
7
Sinusitis
7
Eczema
6
Suicide Attempt
6
Urticaria Chronic
6
Allergic Cough
5
Nasopharyngitis
5
Erythema
5
Respiration Abnormal
4
Dermatitis Allergic
4
Prophylaxis
4
Dermatitis
4
Ill-defined Disorder
4
Cough
3
Respiratory Disorder
3
Multiple Allergies
3
Photosensitivity Reaction
2
Bronchiectasis
2
Eye Swelling
2
Senile Pruritus
2
Pyrexia
2
Pruritus Generalised
2
Rash Pruritic
2
Conjunctivitis
2
Urticaria Generalised
2
House Dust Allergy
2
Solar Urticaria
2
Allergic Respiratory Disease
2
Nasal Polyps
1
Lacrimation Increased
1
Psychotic Disorder
1
Throat Irritation
1
Ear Congestion
1
Eyelid Oedema
1
Respiratory Tract Infection
1
Dermatitis Contact
1
Oropharyngeal Pain
1
Crying
1
Tracheitis
1

Aerius Case Reports

What Aerius 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 Aerius. 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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