Jublia: adverse event reports filed with FDA

1,271

reports as suspect product

0% of all reports · about 107 a year

79

reports, 12 months to June 2026

62 in the 12 months before

18%

marked serious by the reporter

79% across the class

3.1%

record death among outcomes, as reported

40 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 Jublia reports recording the termmedian drug in azole antifungal

1. Drug ineffectivethe medicine did not work as expected26%330
2. Painpain, site not specified10.1%128
3. Headachehead pain9%115
4. Fatiguetiredness9%114
5. Drug hypersensitivityan allergic-type reaction to a medicine8.9%113
6. Oedema peripheralswelling of the legs, ankles or hands8.9%113
7. Asthmaasthma8.7%111
8. Bronchopulmonary aspergillosis allergic8.7%111
9. Musculoskeletal stiffnessstiffness in muscles or joints8.7%111
10. Anaemialow red blood cells8.7%110
11. Aspirationbreathing material into the lungs8.7%110
12. Astheniaweakness or lack of energy8.6%109
13. Upper respiratory tract infectiona cold or similar infection8.6%109
14. Blood calcium increased8.5%108
15. Blood creatinine increasedraised creatinine, a kidney test8.5%108
16. Blood test abnormal8.5%108
17. Lower respiratory tract infectiona chest infection8.5%108
18. Pyrexiafever8.4%107
19. Transaminases increased8.4%107
20. Tremorshaking8.3%106
21. Nail discolouration8.2%104
22. Product dose omission issuea dose was missed7.4%94
23. Dyspnoeashortness of breath7%89
24. Constipationconstipation6.9%88
25. Pneumonialung infection6.9%88
26. Bronchiectasis6.8%87
27. Gastrooesophageal reflux diseaseacid reflux6.8%87
28. Haemoptysiscoughing up blood6.8%87
29. Obstructive airways disorder6.8%87
30. Pulmonary fibrosis6.8%87

Top 30 of 253 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 16 drugs in the azole antifungal 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 69,035 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. 87.3% 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 1,271 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 azole antifungal 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 Jublia as a suspect or interacting product; reports listing it only as a concomitant medication (468) 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.