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SYMBICORT

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Symbicort Adverse Events Reported to the FDA Over Time

How are Symbicort adverse event reports trending over time?

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

Most Common Symbicort Adverse Events Reported to the FDA

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

Dyspnoea
2924 (7.29%)
Drug Dose Omission
1650 (4.11%)
Asthma
1046 (2.61%)
Malaise
899 (2.24%)
Drug Ineffective
833 (2.08%)
Cough
792 (1.97%)
Chronic Obstructive Pulmonary Disea...
788 (1.96%)
Pneumonia
683 (1.7%)
Dysphonia
455 (1.13%)
Intentional Drug Misuse
450 (1.12%)
Off Label Use
429 (1.07%)
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Wheezing
425 (1.06%)
Incorrect Dose Administered
411 (1.02%)
Headache
356 (.89%)
Chest Discomfort
337 (.84%)
Chest Pain
314 (.78%)
Fatigue
301 (.75%)
Bronchitis
300 (.75%)
Tremor
289 (.72%)
Oropharyngeal Pain
285 (.71%)
Hypertension
280 (.7%)
Dizziness
279 (.7%)
Death
261 (.65%)
Fall
257 (.64%)
Insomnia
257 (.64%)
Nasopharyngitis
256 (.64%)
Weight Increased
252 (.63%)
Pain
230 (.57%)
Throat Irritation
224 (.56%)
Nausea
208 (.52%)
Emphysema
202 (.5%)
Gastrooesophageal Reflux Disease
200 (.5%)
Nervousness
198 (.49%)
Diabetes Mellitus
195 (.49%)
Muscle Spasms
185 (.46%)
Oedema Peripheral
179 (.45%)
Condition Aggravated
178 (.44%)
Back Pain
177 (.44%)
Feeling Abnormal
175 (.44%)
Cerebrovascular Accident
170 (.42%)
Palpitations
169 (.42%)
Dry Mouth
167 (.42%)
Anxiety
165 (.41%)
Blood Pressure Increased
158 (.39%)
Myocardial Infarction
155 (.39%)
Asthenia
154 (.38%)
Lung Neoplasm Malignant
153 (.38%)
Pyrexia
152 (.38%)
Vomiting
152 (.38%)
Cataract
149 (.37%)
Lung Disorder
147 (.37%)
Cardiac Disorder
146 (.36%)
Respiratory Disorder
146 (.36%)
Aphonia
139 (.35%)
Adverse Event
137 (.34%)
Weight Decreased
134 (.33%)
Increased Upper Airway Secretion
133 (.33%)
Heart Rate Increased
130 (.32%)
Tachycardia
125 (.31%)
Pain In Extremity
122 (.3%)
Feeling Jittery
119 (.3%)
Sinusitis
119 (.3%)
Dysgeusia
117 (.29%)
Influenza
116 (.29%)
Hypersensitivity
114 (.28%)
Circumstance Or Information Capable...
113 (.28%)
Depression
111 (.28%)
Rash
109 (.27%)
Abdominal Pain Upper
108 (.27%)
Neoplasm Malignant
108 (.27%)
Syncope
108 (.27%)
Inappropriate Schedule Of Drug Admi...
106 (.26%)
Diarrhoea
105 (.26%)
Memory Impairment
104 (.26%)
Gait Disturbance
102 (.25%)
Vision Blurred
102 (.25%)
Nasal Congestion
101 (.25%)
Arthralgia
100 (.25%)
Drug Effect Decreased
97 (.24%)
Oral Candidiasis
97 (.24%)
Candidiasis
96 (.24%)
Hallucination
94 (.23%)
Pruritus
93 (.23%)
Visual Impairment
90 (.22%)
Dyspepsia
89 (.22%)
Pulmonary Congestion
89 (.22%)
Laryngitis
88 (.22%)
Wrong Technique In Drug Usage Proce...
85 (.21%)
Hypoaesthesia
83 (.21%)
Cardiac Failure Congestive
81 (.2%)
Rhinorrhoea
81 (.2%)
Dyspnoea Exertional
78 (.19%)
Respiratory Failure
78 (.19%)
Ill-defined Disorder
77 (.19%)
Somnolence
76 (.19%)
Bronchospasm
74 (.18%)
Loss Of Consciousness
74 (.18%)
Arthritis
72 (.18%)
Stomatitis
72 (.18%)
Cardiac Failure
71 (.18%)
Swelling Face
71 (.18%)

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

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

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

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

Asthma
3947
Chronic Obstructive Pulmonary Disea...
2652
Product Used For Unknown Indication
832
Drug Use For Unknown Indication
676
Emphysema
412
Dyspnoea
305
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Bronchitis
288
Cough
128
Bronchitis Chronic
80
Lung Disorder
73
Wheezing
55
Respiratory Disorder
50
Pneumonia
39
Hypersensitivity
34
Bronchiectasis
32
Pulmonary Fibrosis
25
Obstructive Airways Disorder
20
Multiple Allergies
19
Bronchospasm
19
Ill-defined Disorder
18
Asthma Exercise Induced
17
Nasopharyngitis
16
Bronchial Hyperreactivity
15
Bronchopneumopathy
13
Bronchial Disorder
10
Interstitial Lung Disease
9
Foetal Exposure During Pregnancy
8
Lung Neoplasm Malignant
8
Sarcoidosis
8
Fatigue
7
Pulmonary Congestion
7
Respiratory Failure
7
Upper Respiratory Tract Infection
7
Cystic Fibrosis
7
Asbestosis
7
Respiratory Tract Infection
7
Pulmonary Oedema
6
Dyspnoea Exertional
6
Pulmonary Hypertension
6
Lung Carcinoma Cell Type Unspecifie...
5
Lung Infection
5
Total Lung Capacity Decreased
5
Rheumatoid Arthritis
5
Seasonal Allergy
5
Sleep Apnoea Syndrome
5
Chronic Obstructive Airways Disease
4
Pleurisy
4
Blood Cholesterol Increased
4
Fibrosis
4
Fungal Infection
4
Respiratory Tract Congestion
4

Drug Labels

LabelLabelerEffective
SymbicortAstraZeneca LP17-JUN-10

Symbicort Case Reports

What Symbicort 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 Symbicort. 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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