What are the possible side effects of TOBI Podhaler?

Most common side effects1

TOBI Podhaler (n=308)

TOBI (n=209)

Cough

48.4%

31.1%

Worsening of lung problems or CF

33.8%

30.1%

Productive cough

18.2%

19.6%

Shortness of breath

15.6%

12.4%

Fever

15.6%

12.4%

Sore throat

14.0%

10.5%

Voice alteration*

13.6%

3.8%

Coughing up blood

13.0%

12.4%

Headache

11.4%

12.0%

Altered taste

3.9%

0.5%

*Majority of voice alterations recorded as hoarseness.

  • In a clinical study, stopping of treatment due to side effects was 14% for TOBI Podhaler vs 8% for TOBI 300 mg/5 mL

TOBI Podhaler can cause serious side effects, including1

  • Hearing loss or ringing in the ears (ototoxicity): Tell your health care provider right away if you have hearing loss or you hear noises in your ears, such as ringing or hissing. Tell your health care provider if you develop vertigo, difficulty with balance, or dizziness

  • Worsening kidney problems (nephrotoxicity): TOBI Podhaler is in a class of drugs that may cause worsening kidney problems, especially in people with known or suspected kidney problems. Your health care provider may do a blood test to check how your kidneys are working while you are taking TOBI Podhaler

  • Worsening muscle weakness: TOBI Podhaler is in a class of drugs that can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson's disease)

  • Severe breathing problems (bronchospasm): Tell your health care provider right away if you get any of these symptoms of bronchospasm while you are taking TOBI Podhaler

  • Shortness of breath with wheezing

  • Coughing and chest tightness

  • Fetal harm: TOBI Podhaler is in a class of drugs that may cause harm to an unborn baby

Most common side effects1

  • The most common side effects of TOBI Podhaler include cough, worsening of lung problems or cystic fibrosis (CF), productive cough, shortness of breath, fever, sore throat, changes in your voice (hoarseness), coughing up blood, headache, and altered taste.

What should you know about cough when starting TOBI Podhaler?

Cough is a common symptom of CF.1

Cough may develop while using TOBI Podhaler, especially during the first week of treatment.

In a clinical trial evaluating the safety of TOBI Podhaler vs TOBI® nebulizer solution

Patients using TOBI Podhaler, the dry-powder inhalation, experienced cough more frequently than patients using TOBI nebulizer solution (48% vs 31%).1

After the first week of treatment, the time to first cough was similar for patients using TOBI Podhaler and TOBI nebulizer solution.1

Five percent of patients using TOBI Podhaler discontinued due to cough compared with 1% of patients using TOBI nebulizer solution.1

Reference: 1. TOBI Podhaler [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016.