Mometasone: adverse event reports filed with FDA

1,766

reports as suspect product

0% of all reports · about 89 a year

183

reports, 12 months to June 2026

127 in the 12 months before

82.6%

marked serious by the reporter

77.7% across the class

1.5%

record death among outcomes, as reported

27 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 Mometasone reports recording the termmedian drug in corticosteroid

1. Asthmaasthma31.4%554
2. Dyspnoeashortness of breath30.4%537
3. Wheezingwheezing27.5%486
4. Therapeutic product effect incomplete24.4%431
5. Gastrooesophageal reflux diseaseacid reflux23.8%421
6. Drug ineffectivethe medicine did not work as expected19.7%348
7. Sleep disorder due to a general medical condition19%335
8. Coughcough18.2%322
9. Cardiac disorder18%318
10. Headachehead pain18%318
11. Loss of personal independence in daily activities18%318
12. Hypertensionhigh blood pressure15.1%267
13. Blood test abnormal14.2%251
14. Rhinitis allergic13.1%232
15. Sleep apnoea syndromepauses in breathing during sleep13%230
16. Hypothyroidismunderactive thyroid13%229
17. Burning sensationa burning feeling12.9%228
18. Fibromyalgia12.5%220
19. Sensitisation12.5%220
20. Carpal tunnel syndrome12.4%219
21. Polycystic ovaries12.3%218
22. Full blood count abnormal11.5%203
23. Chest discomfortchest discomfort11.3%200
24. Renal disorder10.5%186
25. Ejection fraction10.2%181
26. Obstructive airways disorder9.2%163
27. Nasopharyngitisa cold8.9%157
28. Productive cougha cough with phlegm8.4%149
29. Dyspnoea exertional8.2%145
30. Dysphoniaa hoarse voice7.4%130

Top 30 of 579 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 74 drugs in the corticosteroid 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 808,789 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. 24.6% 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 1,766 reports.

Drugs most often listed in the same reports

Other products listed in reports where Mometasone 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 corticosteroid 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 Mometasone as a suspect or interacting product; reports listing it only as a concomitant medication (6,841) 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.