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Pulmicort Adverse Events Reported to the FDA Over Time

How are Pulmicort adverse event reports trending over time?

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

Most Common Pulmicort Adverse Events Reported to the FDA

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

Age 1-9 Years

Asthma
107 (.72%)
Cough
83 (.56%)
Drug Ineffective
54 (.36%)
Dyspnoea
44 (.3%)
Psychomotor Hyperactivity
41 (.28%)
Aggression
31 (.21%)
Nasopharyngitis
27 (.18%)
Abnormal Behaviour
25 (.17%)
Pneumonia
25 (.17%)
Wheezing
25 (.17%)
Pyrexia
23 (.15%)
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Insomnia
22 (.15%)
Drug Dose Omission
19 (.13%)
Irritability
19 (.13%)
Crying
18 (.12%)
Medication Error
18 (.12%)
Vomiting
17 (.11%)
Agitation
16 (.11%)
Respiratory Distress
16 (.11%)
Urticaria
16 (.11%)
Anger
15 (.1%)
Rhinorrhoea
15 (.1%)
Tremor
15 (.1%)
Hypersensitivity
14 (.09%)
Overdose
14 (.09%)
Malaise
13 (.09%)
Oxygen Saturation Decreased
13 (.09%)
Croup Infectious
12 (.08%)
Heart Rate Increased
12 (.08%)
Mood Altered
12 (.08%)
Weight Increased
12 (.08%)
Anxiety
11 (.07%)
Chest Discomfort
11 (.07%)
Diarrhoea
11 (.07%)
Drug Ineffective For Unapproved Ind...
11 (.07%)
Rash
11 (.07%)
Tachycardia
11 (.07%)
Dysphonia
10 (.07%)
Ear Infection
10 (.07%)
Hyperhidrosis
10 (.07%)
Ill-defined Disorder
10 (.07%)
Increased Appetite
10 (.07%)
Lethargy
10 (.07%)
Pain In Extremity
10 (.07%)
Dental Caries
9 (.06%)
Erythema
9 (.06%)
Fatigue
9 (.06%)
Off Label Use
9 (.06%)
Abdominal Pain Upper
8 (.05%)
Anaphylactic Reaction
8 (.05%)
Bone Density Decreased
8 (.05%)
Drooling
8 (.05%)
Flushing
8 (.05%)
Growth Retardation
8 (.05%)
Lip Swelling
8 (.05%)
Pruritus Generalised
8 (.05%)
Respiratory Rate Increased
8 (.05%)
Tooth Discolouration
8 (.05%)
Bronchitis
7 (.05%)
Condition Aggravated
7 (.05%)
Drug Administration Error
7 (.05%)
Glycosuria
7 (.05%)
Hyperglycaemia
7 (.05%)
Nasal Congestion
7 (.05%)
Throat Irritation
7 (.05%)
Weight Gain Poor
7 (.05%)
Convulsion
6 (.04%)
Cyanosis
6 (.04%)
Disturbance In Attention
6 (.04%)
Hallucination
6 (.04%)
Headache
6 (.04%)
Ketonuria
6 (.04%)
Nightmare
6 (.04%)
Osteonecrosis
6 (.04%)
Pruritus
6 (.04%)
Pulmonary Congestion
6 (.04%)
Respiratory Tract Infection
6 (.04%)
Restlessness
6 (.04%)
Retching
6 (.04%)
Sleep Terror
6 (.04%)
Swelling Face
6 (.04%)
Alopecia
5 (.03%)
Bronchospasm
5 (.03%)
Chest Pain
5 (.03%)
Dehydration
5 (.03%)
Energy Increased
5 (.03%)
Epistaxis
5 (.03%)
Generalised Erythema
5 (.03%)
Lymphadenopathy
5 (.03%)
Mood Swings
5 (.03%)
Oral Mucosa Erosion
5 (.03%)
Pain
5 (.03%)
Pallor
5 (.03%)
Sinusitis
5 (.03%)
Skin Irritation
5 (.03%)
Sleep Disorder
5 (.03%)
Unresponsive To Stimuli
5 (.03%)
Abdominal Pain
4 (.03%)
Acne
4 (.03%)
Adverse Event
4 (.03%)
Arthralgia
4 (.03%)

All Ages and Genders

Dyspnoea
812 (5.46%)
Asthma
603 (4.06%)
Drug Ineffective
509 (3.43%)
Cough
445 (2.99%)
Drug Dose Omission
328 (2.21%)
Malaise
296 (1.99%)
Off Label Use
249 (1.68%)
Dysphonia
213 (1.43%)
Wheezing
187 (1.26%)
Chest Discomfort
165 (1.11%)
Pneumonia
165 (1.11%)
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Dizziness
137 (.92%)
Chronic Obstructive Pulmonary Disea...
127 (.85%)
Insomnia
113 (.76%)
Medication Error
111 (.75%)
Headache
108 (.73%)
Chest Pain
106 (.71%)
Nasopharyngitis
105 (.71%)
Throat Irritation
104 (.7%)
Fatigue
98 (.66%)
Dysgeusia
95 (.64%)
Rhinorrhoea
95 (.64%)
Bronchitis
94 (.63%)
Incorrect Dose Administered
91 (.61%)
Tremor
88 (.59%)
Nausea
85 (.57%)
Anxiety
77 (.52%)
Condition Aggravated
77 (.52%)
Increased Upper Airway Secretion
77 (.52%)
Vomiting
77 (.52%)
Weight Decreased
75 (.5%)
Intentional Drug Misuse
73 (.49%)
Diarrhoea
72 (.48%)
Oropharyngeal Pain
71 (.48%)
Dry Mouth
70 (.47%)
Cataract
69 (.46%)
Psychomotor Hyperactivity
69 (.46%)
Pyrexia
69 (.46%)
Pruritus
68 (.46%)
Gastrooesophageal Reflux Disease
66 (.44%)
Heart Rate Increased
66 (.44%)
Rash
66 (.44%)
Feeling Abnormal
64 (.43%)
Fall
60 (.4%)
Weight Increased
60 (.4%)
Blood Pressure Increased
59 (.4%)
Nasal Congestion
59 (.4%)
Circumstance Or Information Capable...
58 (.39%)
Sinusitis
57 (.38%)
Blood Glucose Increased
56 (.38%)
Asthenia
54 (.36%)
Ill-defined Disorder
54 (.36%)
Lung Disorder
53 (.36%)
Pain
53 (.36%)
Glaucoma
51 (.34%)
Nervousness
51 (.34%)
Hypersensitivity
49 (.33%)
Palpitations
48 (.32%)
Dyspepsia
46 (.31%)
Urticaria
46 (.31%)
Muscle Spasms
45 (.3%)
Oedema Peripheral
44 (.3%)
Wrong Technique In Drug Usage Proce...
44 (.3%)
Diabetes Mellitus
43 (.29%)
Aggression
42 (.28%)
Hypertension
42 (.28%)
Overdose
41 (.28%)
Respiratory Disorder
41 (.28%)
Abdominal Pain Upper
39 (.26%)
Candidiasis
38 (.26%)
Depression
38 (.26%)
Drug Administration Error
38 (.26%)
Abnormal Behaviour
37 (.25%)
Drug Effect Decreased
37 (.25%)
Oxygen Saturation Decreased
37 (.25%)
Abdominal Distension
36 (.24%)
Adverse Event
36 (.24%)
Arthralgia
36 (.24%)
Pain In Extremity
36 (.24%)
Drug Exposure During Pregnancy
35 (.24%)
Epistaxis
35 (.24%)
Muscular Weakness
35 (.24%)
Back Pain
34 (.23%)
Choking
34 (.23%)
Irritability
33 (.22%)
Stomatitis
33 (.22%)
Vision Blurred
33 (.22%)
Erythema
32 (.22%)
Gait Disturbance
32 (.22%)
Throat Tightness
32 (.22%)
Agitation
30 (.2%)
Alopecia
30 (.2%)
Contusion
30 (.2%)
Drug Hypersensitivity
30 (.2%)
Glossodynia
30 (.2%)
Oral Candidiasis
30 (.2%)
Tachycardia
30 (.2%)
Activities Of Daily Living Impaired
29 (.2%)
Arthritis
29 (.2%)
Flatulence
29 (.2%)
Loss Of Consciousness
29 (.2%)

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

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

Age 1-9 Years

Show More Show More

All Ages and Genders

Show More Show More

ExportShare/Embed Graph Export Export Data

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

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

Asthma
2245
Chronic Obstructive Pulmonary Disea...
622
Drug Use For Unknown Indication
335
Product Used For Unknown Indication
247
Emphysema
149
Dyspnoea
107
Show More Show More
Bronchitis
87
Cough
83
Wheezing
43
Lung Disorder
36
Hypersensitivity
35
Pneumonia
31
Bronchitis Chronic
31
Respiratory Disorder
26
Multiple Allergies
21
Bronchial Hyperreactivity
19
Sarcoidosis
16
Bronchiectasis
15
Bronchospasm
15
Pulmonary Fibrosis
11
Obstructive Airways Disorder
11
Nasopharyngitis
11
Prophylaxis
11
Chronic Obstructive Airways Disease
10
Sinusitis
10
Sinus Disorder
9
Lung Infection
8
Ill-defined Disorder
8
Nasal Polyps
7
Respiratory Tract Infection
7
Seasonal Allergy
7
Chest Discomfort
7
Eosinophilic Oesophagitis
6
Respiration Abnormal
6
Chronic Sinusitis
6
Bronchiolitis
5
Croup Infectious
5
Bronchitis Acute
5
Respiratory Failure
5
Asthma Prophylaxis
5
Upper Respiratory Tract Infection
4
Inflammation
4
Respiratory Distress
4
Asthma Exercise Induced
4
Cystic Fibrosis
4
Rhinitis
3
Gastrooesophageal Reflux Disease
3
Rhinorrhoea
3
Fatigue
3
Influenza
3
Pulmonary Hypertension
3

Child Safety Precautions


Drug Labels

LabelLabelerEffective
Pulmicort RespulesAstraZeneca LP02-JUL-10
PulmicortflexhalerAstraZeneca LP10-JUL-10
PulmicortflexhalerRebel Distributors Corp06-SEP-11
PulmicortflexhalerPhysicians Total Care, Inc.04-JUN-12
Pulmicort RespulesPhysicians Total Care, Inc.04-JUN-12
Pulmicort RespulesCardinal Health20-JUN-12

Pulmicort Case Reports

What Pulmicort 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. 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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