Arikayce: adverse event reports filed with FDA

6,471

reports as suspect product

0% of all reports · about 801 a year

714

reports, 12 months to June 2026

1,015 in the 12 months before

68.7%

marked serious by the reporter

80.3% across the class

17%

record death among outcomes, as reported

1,100 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 Arikayce reports recording the termmedian drug in aminoglycoside antibacterial

1. Coughcough23.6%1,527
2. Therapy interrupted21.6%1,399
3. Hospitalisationadmission to hospital21.2%1,371
4. Dyspnoeashortness of breath20.6%1,335
5. Off label useused for a purpose or in a way not on the label16.4%1,059
6. Dysphoniaa hoarse voice15.5%1,003
7. Deaththe patient died; cause not stated by this term14.7%953
8. Product dose omission issuea dose was missed11.6%753
9. Fatiguetiredness9.6%624
10. Productive cougha cough with phlegm8.8%567
11. Aphonia7.8%502
12. Drug ineffectivethe medicine did not work as expected7.1%460
13. Haemoptysiscoughing up blood5.9%379
14. Malaisegeneral feeling of being unwell5.7%371
15. Nauseafeeling sick5.4%347
16. Pneumonialung infection5.2%339
17. Astheniaweakness or lack of energy5.2%338
18. Intentional dose omission5.2%337
19. Diarrhoealoose or frequent stools5.1%328
20. Oxygen saturation decreased4.8%313
21. Weight decreasedweight loss4.8%312
22. Device issuea problem with the device4.8%309
23. Oropharyngeal painsore throat4.7%307
24. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine4.6%298
25. Illness4.4%286
26. Headachehead pain3.9%253
27. Drug dose omission by device3.8%243
28. Decreased appetitereduced appetite3.7%240
29. Dizzinesslight-headedness or unsteadiness3.7%240
30. Mycobacterium avium complex infection3.7%240

Top 30 of 692 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. 87.2% 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 6,471 reports.

Drugs most often listed in the same reports

Other products listed in reports where Arikayce is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 Arikayce as a suspect or interacting product; reports listing it only as a concomitant medication (135) 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.