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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ONBREZ: 156 Adverse Event Reports & Safety Profile

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156
Total FAERS Reports
35 (22.4%)
Deaths Reported
59
Hospitalizations
156
As Primary/Secondary Suspect
4
Life-Threatening
4
Disabilities

First Report: 20010530 · Latest Report: 20140525

What Are the Most Common ONBREZ Side Effects?

#1 Most Reported
Dyspnoea
26 reports (16.7%)
#2 Most Reported
Cough
14 reports (9.0%)
#3 Most Reported
Pneumonia
13 reports (8.3%)

All ONBREZ Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 26 16.7% 4 11
Cough 14 9.0% 1 4
Pneumonia 13 8.3% 6 7
Fatigue 12 7.7% 1 6
Malaise 11 7.1% 0 6
Chronic obstructive pulmonary disease 10 6.4% 6 4
Dizziness 8 5.1% 0 6
General physical health deterioration 8 5.1% 1 3
Asthma 7 4.5% 1 4
Death 7 4.5% 7 0
Agitation 6 3.9% 0 2
Fall 6 3.9% 2 2
Incorrect route of drug administration 6 3.9% 1 3
Influenza 6 3.9% 0 3
Pulmonary oedema 6 3.9% 1 4
Emphysema 5 3.2% 3 2
Hypertension 5 3.2% 0 3
Peripheral swelling 5 3.2% 0 4
Secretion discharge 5 3.2% 1 2
Syncope 5 3.2% 0 3

Who Reports ONBREZ Side Effects? Age & Gender Data

Average age: 70.5 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →

Is ONBREZ Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2007 1 0 1
2011 7 1 2
2012 5 2 3
2013 44 11 23
2014 31 8 11

View full timeline →

What Is ONBREZ Used For?

IndicationReports
Chronic obstructive pulmonary disease 72
Off label use 35
Emphysema 19
Asthma 16
Dyspnoea 7
Lung disorder 6

ONBREZ vs Alternatives: Which Is Safer?

ONBREZ vs ONDANSETRON ONBREZ vs ONFI ONBREZ vs OPANA ONBREZ vs OPICAPONE ONBREZ vs OPIPRAMOL ONBREZ vs OPIUM ONBREZ vs OPSUMIT ONBREZ vs OPTIMARK ONBREZ vs OPTIRAY ONBREZ vs ORELABRUTINIB

Official FDA Label for ONBREZ

Official prescribing information from the FDA-approved drug label.