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PULMICORT FLEXHALER

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Pulmicort Flexhaler Adverse Events Reported to the FDA Over Time

How are Pulmicort Flexhaler adverse event reports trending over time?

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

Most Common Pulmicort Flexhaler Adverse Events Reported to the FDA

What are the most common Pulmicort Flexhaler adverse events reported to the FDA?

Dyspnoea
362 (7.06%)
Asthma
267 (5.2%)
Drug Ineffective
242 (4.72%)
Cough
185 (3.61%)
Drug Dose Omission
183 (3.57%)
Malaise
135 (2.63%)
Off Label Use
116 (2.26%)
Chest Discomfort
83 (1.62%)
Dysphonia
73 (1.42%)
Wheezing
70 (1.36%)
Incorrect Dose Administered
63 (1.23%)
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Chest Pain
61 (1.19%)
Dizziness
55 (1.07%)
Throat Irritation
52 (1.01%)
Chronic Obstructive Pulmonary Disea...
50 (.97%)
Dysgeusia
48 (.94%)
Headache
44 (.86%)
Circumstance Or Information Capable...
39 (.76%)
Gastrooesophageal Reflux Disease
39 (.76%)
Pneumonia
38 (.74%)
Increased Upper Airway Secretion
37 (.72%)
Intentional Drug Misuse
37 (.72%)
Bronchitis
35 (.68%)
Nasopharyngitis
35 (.68%)
Oropharyngeal Pain
35 (.68%)
Tremor
35 (.68%)
Insomnia
31 (.6%)
Nasal Congestion
30 (.58%)
Feeling Abnormal
29 (.57%)
Condition Aggravated
28 (.55%)
Fatigue
27 (.53%)
Anxiety
26 (.51%)
Ill-defined Disorder
25 (.49%)
Lung Disorder
25 (.49%)
Nervousness
25 (.49%)
Heart Rate Increased
24 (.47%)
Nausea
24 (.47%)
Abdominal Pain Upper
21 (.41%)
Blood Pressure Increased
21 (.41%)
Pain
21 (.41%)
Asthenia
20 (.39%)
Glaucoma
20 (.39%)
Inappropriate Schedule Of Drug Admi...
20 (.39%)
Rhinorrhoea
20 (.39%)
Vomiting
20 (.39%)
Dry Mouth
19 (.37%)
Fall
19 (.37%)
Oral Candidiasis
19 (.37%)
Adverse Event
18 (.35%)
Cataract
18 (.35%)
Diarrhoea
18 (.35%)
Dyspepsia
18 (.35%)
Emphysema
18 (.35%)
Palpitations
18 (.35%)
Respiratory Disorder
18 (.35%)
Weight Decreased
18 (.35%)
Abdominal Discomfort
17 (.33%)
Drug Exposure During Pregnancy
17 (.33%)
Diabetes Mellitus
16 (.31%)
Drug Effect Decreased
16 (.31%)
Medication Error
16 (.31%)
Neoplasm Malignant
16 (.31%)
Weight Increased
16 (.31%)
Back Pain
15 (.29%)
Drug Hypersensitivity
15 (.29%)
Drug Ineffective For Unapproved Ind...
15 (.29%)
Product Quality Issue
15 (.29%)
Pyrexia
15 (.29%)
Sinusitis
15 (.29%)
Cardiac Disorder
14 (.27%)
Retching
14 (.27%)
Visual Impairment
14 (.27%)
Wrong Technique In Drug Usage Proce...
14 (.27%)
Glossodynia
13 (.25%)
Hypersensitivity
13 (.25%)
Pruritus
13 (.25%)
Activities Of Daily Living Impaired
12 (.23%)
Arthritis
12 (.23%)
Dry Throat
12 (.23%)
Gait Disturbance
12 (.23%)
Gastric Disorder
12 (.23%)
Productive Cough
12 (.23%)
Rash
12 (.23%)
Agitation
11 (.21%)
Blood Glucose Increased
11 (.21%)
Drug Administration Error
11 (.21%)
Dyspnoea Exertional
11 (.21%)
Flatulence
11 (.21%)
Lip Swelling
11 (.21%)
Neck Pain
11 (.21%)
Overdose
11 (.21%)
Oxygen Saturation Decreased
11 (.21%)
Product Taste Abnormal
11 (.21%)
Stomatitis
11 (.21%)
Adverse Drug Reaction
10 (.19%)
Depression
10 (.19%)
Multiple Allergies
10 (.19%)
Myocardial Infarction
10 (.19%)
Road Traffic Accident
10 (.19%)
Therapeutic Response Unexpected
10 (.19%)
Tongue Discolouration
10 (.19%)

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

What are the most common Pulmicort Flexhaler adverse events reported to the FDA?

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

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

Asthma
649
Chronic Obstructive Pulmonary Disea...
110
Emphysema
32
Cough
29
Bronchitis
26
Dyspnoea
23
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Hypersensitivity
11
Wheezing
8
Sarcoidosis
7
Respiratory Disorder
6
Multiple Allergies
6
Drug Use For Unknown Indication
5
Bronchitis Chronic
5
Bronchiectasis
5
Obstructive Airways Disorder
4
Pneumonia
4
Ill-defined Disorder
3
Bronchial Hyperreactivity
3
Respiratory Tract Infection
3
Nasopharyngitis
3
Asthma Exercise Induced
3
Restrictive Pulmonary Disease
2
Gastrooesophageal Reflux Disease
2
Oesophageal Spasm
2
Pulmonary Congestion
2
Pulmonary Fibrosis
2
Pulmonary Function Test Decreased
2
Upper Respiratory Tract Inflammatio...
2
Lung Infection
2
Lung Disorder
2
Sick Building Syndrome
1
Nasal Congestion
1
Rales
1
Lung Operation
1
Parosmia
1
Respiratory Tract Irritation
1
Rhinorrhoea
1
Lung Neoplasm Malignant
1
Condition Aggravated
1
Feeling Cold
1
Sinusitis
1
Inflammation
1
Bronchiolitis
1
Cystic Fibrosis
1
Respiratory Failure
1
Bronchial Disorder
1
Croup Infectious
1
Mesothelioma
1
Laryngitis
1
Chest Discomfort
1
Infection
1

Drug Labels

LabelLabelerEffective
PulmicortflexhalerAstraZeneca LP10-JUL-10
PulmicortflexhalerRebel Distributors Corp06-SEP-11
PulmicortflexhalerPhysicians Total Care, Inc.04-JUN-12

Pulmicort Flexhaler Case Reports

What Pulmicort Flexhaler 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 Pulmicort Flexhaler. 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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