Tobi: adverse event reports filed with FDA

3,702

reports as suspect product

0% of all reports · about 166 a year

12

reports, 12 months to June 2026

34 in the 12 months before

82.7%

marked serious by the reporter

80.3% across the class

28.5%

record death among outcomes, as reported

1,054 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Tobi reports recording the termmedian drug in aminoglycoside antibacterial

1. Deaththe patient died; cause not stated by this term22.2%823
2. Coughcough8.1%300
3. Dyspnoeashortness of breath8.1%300
4. Cystic fibrosis6.8%253
5. Pneumonialung infection6.6%244
6. Off label useused for a purpose or in a way not on the label6.5%241
7. Infective pulmonary exacerbation of cystic fibrosis5.7%211
8. Malaisegeneral feeling of being unwell4.7%175
9. Condition aggravatedthe condition being treated got worse4.6%169
10. Pseudomonas infection4.3%160
11. Product use issuea problem in how the product was used3.3%121
12. Pyrexiafever3.1%115
13. Haemoptysiscoughing up blood3.1%114
14. Lung infection3.1%113
15. Lung disordera lung problem, type not specified2.8%105
16. Upper respiratory tract infectiona cold or similar infection2.8%103
17. Drug administered to patient of inappropriate age2.7%99
18. Pulmonary function test decreased2.6%97
19. Dysphoniaa hoarse voice2.6%96
20. Infectionan infection, type not specified2.6%96
21. Bronchiectasis2.5%94
22. Fatiguetiredness2.1%79
23. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease2%74
24. Productive cougha cough with phlegm1.8%67
25. Drug ineffectivethe medicine did not work as expected1.8%66
26. Asthmaasthma1.6%61
27. Respiratory failurethe lungs could not supply enough oxygen1.6%59
28. Weight decreasedweight loss1.6%59
29. Chest discomfortchest discomfort1.5%55
30. Wheezingwheezing1.4%53

Top 30 of 482 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 15 drugs in the aminoglycoside antibacterial class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 37,840 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 80.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,702 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the aminoglycoside antibacterial class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Tobi as a suspect or interacting product; reports listing it only as a concomitant medication (1,884) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.