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Pulmozyme Adverse Events Reported to the FDA Over Time

How are Pulmozyme adverse event reports trending over time?

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

Most Common Pulmozyme Adverse Events Reported to the FDA

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

Pneumonia
86 (14.63%)
Death
60 (10.2%)
Cough
29 (4.93%)
Pyrexia
26 (4.42%)
Haemoptysis
25 (4.25%)
Dyspnoea
19 (3.23%)
Weight Decreased
12 (2.04%)
Vomiting
10 (1.7%)
Abdominal Pain
9 (1.53%)
Cystic Fibrosis
9 (1.53%)
Lung Infection
7 (1.19%)
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Diabetes Mellitus
6 (1.02%)
Drug Exposure During Pregnancy
6 (1.02%)
Headache
6 (1.02%)
Infection
6 (1.02%)
Insulin Resistance
6 (1.02%)
Bronchitis
5 (.85%)
Bronchospasm
5 (.85%)
Cardiopulmonary Failure
5 (.85%)
Chest Discomfort
5 (.85%)
Disease Progression
5 (.85%)
Pseudomonas Infection
5 (.85%)
Pulmonary Function Test Decreased
5 (.85%)
Pulmonary Haemorrhage
5 (.85%)
Tonsillitis
5 (.85%)
Urticaria
5 (.85%)
Chest Pain
4 (.68%)
Diarrhoea
4 (.68%)
Drug Administration Error
4 (.68%)
Rash
4 (.68%)
Sinusitis
4 (.68%)
Asthma
3 (.51%)
Bacterial Infection
3 (.51%)
Caesarean Section
3 (.51%)
Cellulitis
3 (.51%)
Cleft Palate
3 (.51%)
Conjunctivitis
3 (.51%)
Incorrect Storage Of Drug
3 (.51%)
Malaise
3 (.51%)
Medication Error
3 (.51%)
Nausea
3 (.51%)
Oxygen Saturation Decreased
3 (.51%)
Pregnancy
3 (.51%)
Premature Baby
3 (.51%)
Sepsis
3 (.51%)
Blood Fibrinogen Increased
2 (.34%)
Bronchial Wall Thickening
2 (.34%)
Cardiac Murmur
2 (.34%)
Cerebral Haemorrhage
2 (.34%)
Drug Hypersensitivity
2 (.34%)
Drug Ineffective
2 (.34%)
Empyema
2 (.34%)
Eosinophil Count Decreased
2 (.34%)
Gastric Ulcer
2 (.34%)
Hepatic Function Abnormal
2 (.34%)
Ill-defined Disorder
2 (.34%)
Increased Upper Airway Secretion
2 (.34%)
Influenza
2 (.34%)
Leukocytosis
2 (.34%)
Lung Disorder
2 (.34%)
Lung Infection Pseudomonal
2 (.34%)
Meconium Ileus
2 (.34%)
Meningitis
2 (.34%)
Nasal Congestion
2 (.34%)
Neoplasm Malignant
2 (.34%)
Oesophageal Ulcer
2 (.34%)
Pancreatic Insufficiency
2 (.34%)
Pathogen Resistance
2 (.34%)
Pneumonia Staphylococcal
2 (.34%)
Premature Labour
2 (.34%)
Pulmonary Hypertension
2 (.34%)
Red Blood Cell Sedimentation Rate I...
2 (.34%)
Respiratory Disorder
2 (.34%)
Respiratory Failure
2 (.34%)
Respiratory Tract Infection
2 (.34%)
Rubella
2 (.34%)
Sinus Disorder
2 (.34%)
Staphylococcal Infection
2 (.34%)
Tracheostomy
2 (.34%)
Tracheostomy Infection
2 (.34%)
Urinary Tract Infection
2 (.34%)
Viral Infection
2 (.34%)
Adrenal Insufficiency
1 (.17%)
Aggression
1 (.17%)
Anxiety
1 (.17%)
Appendicitis
1 (.17%)
Arthralgia
1 (.17%)
Aspiration
1 (.17%)
Asthenia
1 (.17%)
Blood Creatine Phosphokinase Increa...
1 (.17%)
Body Temperature Increased
1 (.17%)
Bradycardia
1 (.17%)
Bronchial Obstruction
1 (.17%)
Bronchopneumonia
1 (.17%)
Cardiac Arrest
1 (.17%)
Cervical Dysplasia
1 (.17%)
Chills
1 (.17%)
Chronic Obstructive Pulmonary Disea...
1 (.17%)
Convulsion
1 (.17%)
Crying
1 (.17%)
Cystic Fibrosis Related Diabetes
1 (.17%)

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

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

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

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

Cystic Fibrosis
265
Product Used For Unknown Indication
54
Drug Use For Unknown Indication
41
Cystic Fibrosis Lung
19
Pleural Infection
10
Cystic Fibrosis Pancreatic
8
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Lung Disorder
6
Asthma
6
Respiratory Tract Infection
5
Increased Bronchial Secretion
3
Chronic Obstructive Pulmonary Disea...
2
Lung Infection
2
Atelectasis
2
Secretion Discharge
1
Endotracheal Intubation
1
Sputum Abnormal
1
Pneumonia
1
Immotile Cilia Syndrome
1
Respiratory Failure
1
Bronchopneumonia
1
Fibrinous Bronchitis
1

Drug Labels

LabelLabelerEffective
PulmozymeGenentech, Inc.14-OCT-10

Pulmozyme Case Reports

What Pulmozyme 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 Pulmozyme. 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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