TOBI for Off label use: Side Effects & Safety Data

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There are 12 adverse event reports in the FDA FAERS database where TOBI was used for Off label use.

Most Reported Side Effects for TOBI

Side Effect	Reports	%	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