Safety

TOBI Podhaler (tobramycin inhalation powder) for oral inhalation, 28 mg

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

October 2015

Summary View

ADVERSE REACTIONS

Postmarketing Experience

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

  • Malaise

 

April 2014

Summary View

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

Patient Information

Tell your healthcare provider about ...

  • “water pills” (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or intravenous mannitol 

 

Page Last Updated: 11/13/2015
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