Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
The following adverse reactions have been identified during postapproval use of TOBI Podhaler. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Respiratory, thoracic, and mediastinal disorders
- Aphonia, Sputum discolored
General disorders and administration site conditions
6 ADVERSE REACTIONS
6.2 Post-Marketing Experience
- added ... aphonia to nervous system disorders.
7 DRUG INTERACTIONS
- TOBI Podhaler should not be administered concomitantly with intravenous mannitol
Tell your healthcare provider about ...
- “water pills” (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or intravenous mannitol