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EXUBERA

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Exubera Adverse Events Reported to the FDA Over Time

How are Exubera adverse event reports trending over time?

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

Most Common Exubera Adverse Events Reported to the FDA

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

Blood Glucose Increased
123 (8.25%)
Dyspnoea
90 (6.04%)
Cough
59 (3.96%)
Hypoglycaemia
46 (3.09%)
Blood Glucose Decreased
42 (2.82%)
Drug Ineffective
35 (2.35%)
Chest Pain
33 (2.21%)
Loss Of Consciousness
24 (1.61%)
Haemoptysis
21 (1.41%)
Cardiac Failure Congestive
20 (1.34%)
Diabetes Mellitus Inadequate Contro...
20 (1.34%)
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Chest Discomfort
19 (1.27%)
Device Malfunction
19 (1.27%)
Wheezing
18 (1.21%)
Dysgeusia
17 (1.14%)
Weight Increased
16 (1.07%)
Fatigue
15 (1.01%)
Hyperglycaemia
15 (1.01%)
Swelling
14 (.94%)
Asthenia
13 (.87%)
Asthma
13 (.87%)
Blood Glucose Fluctuation
13 (.87%)
Death
13 (.87%)
Glycosylated Haemoglobin Increased
13 (.87%)
Malaise
13 (.87%)
Confusional State
11 (.74%)
Dizziness
11 (.74%)
Drug Administration Error
11 (.74%)
Respiratory Disorder
11 (.74%)
Forced Expiratory Volume Decreased
10 (.67%)
Headache
10 (.67%)
Hyperhidrosis
10 (.67%)
Incorrect Dose Administered
10 (.67%)
Productive Cough
10 (.67%)
Tachypnoea
10 (.67%)
Abdominal Pain Upper
9 (.6%)
Blindness
9 (.6%)
Lung Disorder
9 (.6%)
Lung Neoplasm
9 (.6%)
Oedema Peripheral
9 (.6%)
Tremor
9 (.6%)
Disorientation
8 (.54%)
Lung Neoplasm Malignant
8 (.54%)
Myocardial Infarction
8 (.54%)
Pneumonia
8 (.54%)
Rash Erythematous
8 (.54%)
Haemorrhage
7 (.47%)
Lymphadenopathy
7 (.47%)
Nausea
7 (.47%)
Respiratory Distress
7 (.47%)
Visual Acuity Reduced
7 (.47%)
Depressed Mood
6 (.4%)
Diarrhoea
6 (.4%)
Exercise Tolerance Decreased
6 (.4%)
Ill-defined Disorder
6 (.4%)
Medication Error
6 (.4%)
Pain
6 (.4%)
Pain In Jaw
6 (.4%)
Pollakiuria
6 (.4%)
Presyncope
6 (.4%)
Rash
6 (.4%)
Throat Irritation
6 (.4%)
Vomiting
6 (.4%)
Burning Sensation
5 (.34%)
Cardiac Arrest
5 (.34%)
Cardiac Disorder
5 (.34%)
Coma
5 (.34%)
Convulsion
5 (.34%)
Dry Throat
5 (.34%)
Fall
5 (.34%)
Feeling Abnormal
5 (.34%)
Neck Pain
5 (.34%)
Palpitations
5 (.34%)
Respiratory Tract Infection
5 (.34%)
Urticaria
5 (.34%)
Vision Blurred
5 (.34%)
Abortion Spontaneous
4 (.27%)
Anaphylactic Shock
4 (.27%)
Anxiety
4 (.27%)
Blood Potassium Decreased
4 (.27%)
Chest X-ray Abnormal
4 (.27%)
Coronary Artery Disease
4 (.27%)
Coronary Artery Stenosis
4 (.27%)
Feeling Drunk
4 (.27%)
Fluid Retention
4 (.27%)
Hallucination, Auditory
4 (.27%)
Hypersensitivity
4 (.27%)
Hypertension
4 (.27%)
Medical Device Complication
4 (.27%)
Nasopharyngitis
4 (.27%)
Paraesthesia
4 (.27%)
Shock
4 (.27%)
Somnolence
4 (.27%)
Tachycardia
4 (.27%)
Abdominal Symptom
3 (.2%)
Anti-insulin Antibody Increased
3 (.2%)
Cardiac Death
3 (.2%)
Cellulitis
3 (.2%)
Circulatory Collapse
3 (.2%)
Cold Sweat
3 (.2%)
Contusion
3 (.2%)

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

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

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

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

Diabetes Mellitus
166
Type 2 Diabetes Mellitus
67
Diabetes Mellitus Non-insulin-depen...
38
Type 1 Diabetes Mellitus
26
Diabetes Mellitus Insulin-dependent
24
Diabetes Mellitus Inadequate Contro...
4
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Blood Glucose
3
Blood Glucose Abnormal
2
Insulin-requiring Type 2 Diabetes M...
2
Drug Use For Unknown Indication
2
Blood Glucose Increased
2

Exubera Case Reports

What Exubera 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 Exubera. 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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