TOBI: 260 Adverse Event Reports & Safety Profile
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260
Total FAERS Reports
107 (41.2%)
Deaths Reported
101
Hospitalizations
260
As Primary/Secondary Suspect
2
Life-Threatening
6
Disabilities
First Report: 2007 · Latest Report: 20140622
What Are the Most Common TOBI Side Effects?
#1 Most Reported
Death
89 reports (34.2%)
#2 Most Reported
Dyspnoea
29 reports (11.2%)
#3 Most Reported
Cystic fibrosis
25 reports (9.6%)
All TOBI Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 89 | 34.2% | 89 | 7 |
| Dyspnoea | 29 | 11.2% | 4 | 19 |
| Cystic fibrosis | 25 | 9.6% | 6 | 18 |
| Cough | 24 | 9.2% | 2 | 14 |
| Condition aggravated | 23 | 8.9% | 1 | 20 |
| Pneumonia | 20 | 7.7% | 3 | 18 |
| Pseudomonas infection | 19 | 7.3% | 3 | 12 |
| Malaise | 12 | 4.6% | 1 | 7 |
| Drug administered to patient of inappropriate age | 11 | 4.2% | 1 | 3 |
| Chronic obstructive pulmonary disease | 10 | 3.9% | 4 | 7 |
| Pyrexia | 10 | 3.9% | 1 | 7 |
| Chest discomfort | 9 | 3.5% | 0 | 5 |
| Productive cough | 9 | 3.5% | 1 | 6 |
| Bronchiectasis | 8 | 3.1% | 2 | 6 |
| Haemoptysis | 8 | 3.1% | 1 | 5 |
| Lung disorder | 8 | 3.1% | 1 | 4 |
| Dysphonia | 7 | 2.7% | 0 | 1 |
| Fatigue | 7 | 2.7% | 1 | 6 |
| Respiratory disorder | 7 | 2.7% | 1 | 4 |
| Deafness | 6 | 2.3% | 2 | 1 |
Who Reports TOBI Side Effects? Age & Gender Data
Average age: 45.3 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is TOBI Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 0 |
| 2010 | 2 | 0 | 2 |
| 2012 | 8 | 1 | 2 |
| 2013 | 48 | 14 | 26 |
| 2014 | 71 | 27 | 29 |
What Is TOBI Used For?
| Indication | Reports |
|---|---|
| Cystic fibrosis | 97 |
| Bronchiectasis | 52 |
| Pseudomonas infection | 21 |
| Chronic obstructive pulmonary disease | 17 |
| Off label use | 12 |
| Pneumonia pseudomonal | 12 |
| Bronchitis | 5 |
TOBI vs Alternatives: Which Is Safer?
TOBI vs TOBI PODHALER
TOBI vs TOBRAMYCIN
TOBI vs TOBRAMYCIN\TOBRAMYCIN
TOBI vs TOCILIZUMAB
TOBI vs TOCOPHEROL
TOBI vs TOFACITINIB
TOBI vs TOLODODEKIN ALFA
TOBI vs TOLTERODINE
TOBI vs TOLVAPTAN
TOBI vs TOPAMAX
Official FDA Label for TOBI
Official prescribing information from the FDA-approved drug label.