Brand name · Olopatadine hydrochloride and mometasone furoate
Ryaltris: adverse event reports filed with FDA
1,735 reports list it as a suspect or interacting product, 2023–2026. Class: Corticosteroid.
- 1,735
- reports as suspect product
- 0% of all reports · about 509 a year
- 741
- reports, 12 months to June 2026
- 574 in the 12 months before
- 6.6%
- marked serious by the reporter
- 77.7% across the class
- 0.2%
- record death among outcomes, as reported
- 4 reports · not verified by FDA
Between February 2023 and June 2026, 1,735 adverse event reports received by FDA list the brand name Ryaltris (olopatadine hydrochloride and mometasone furoate) as a suspect or interacting product. Reports that mention it only as a concomitant medication (253) are left out of every figure here.
In the 12 months to June 2026, 741 reports listed it, up 29% from 574 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 509 reports a year and 0% of the 20,646,523 reports in the database, and 0.2% of the reports for the corticosteroid class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are device delivery system issue (40.4%), product use in unapproved indication (34.7%) and drug dose omission by device (29.8%). A report can list several reactions, so shares add to more than 100%; 183 different terms appear across these reports. Device delivery system issue is recorded in 40.4% of these reports, with no counterpart in the median corticosteroid drug (0%).
6.6% of the reports are marked serious by the reporter (77.7% across the class); 0.2% record death among the outcomes and 1.4% record hospitalisation, as reported. 48.5% of the reports came from consumers, and the largest patient age group is 18 to 44 (1.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Ryaltris reports recording the termmedian drug in corticosteroid
- Device delivery system issuea problem with the delivery system40.4%701
- Product use in unapproved indicationused for a purpose not on the label34.7%602
- Drug dose omission by device29.8%517
- Product use issuea problem in how the product was used24.3%421
- Drug ineffectivethe medicine did not work as expected10.1%176
- Device issuea problem with the device9%157
- Device occlusionthe device blocked7.7%133
- Epistaxisnosebleed7.1%124
- Product tampering4%70
- Condition aggravatedthe condition being treated got worse3.6%63
- Device defective3.5%60
- Wrong technique in product usage processthe product was used in the wrong way3.5%60
- Product delivery mechanism issue2.7%46
- Somnolencedrowsiness2.5%43
- Headachehead pain2.1%36
- Incorrect dose administered by devicethe device gave the wrong dose1.7%30
- Device failurethe device failed1.7%29
- Fatiguetiredness1.7%29
- Inappropriate schedule of product administrationthe product was taken at the wrong times1.5%26
- Nasal dryness1.5%26
- Dizzinesslight-headedness or unsteadiness1.4%24
- Nasal discomfort1.4%24
- Incorrect dose administeredthe wrong dose was given1.3%23
- Device breakagethe device broke1.3%22
- Coughcough1.2%21
Top 30 of 183 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 96.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypersensitivity | 364 | 21% |
| Rhinitis allergic | 139 | 8% |
| Seasonal allergy | 132 | 7.6% |
| Nasal congestion | 59 | 3.4% |
| Rhinitis | 48 | 2.8% |
| Sinus disorder | 42 | 2.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,735 reports.
In context
| Measure | Ryaltris | Corticosteroid | All reports |
|---|---|---|---|
| Reports as suspect product | 1,735 | 808,789 | 20,646,523 |
| Share of that pool | — | 0.2% | 0% |
| Reports, latest 12 months | 741 | — | 1,332,454 |
| Marked serious | 6.6% | 77.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 2 | 146 | 91 |
| Hospitalisation recorded, per 1,000 reports | 14 | 336 | 213 |
| Consumer-filed share | 48.5% | 29.1% | 45.8% |
| Top term, share of reports | Device delivery system issue 40.4% | median 0% | 0.1% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Prednisone | generic | 183,867 | 15,614 | 91.4% |
| Dexamethasone | generic | 129,677 | 9,216 | 95.1% |
| Prednisolone | generic | 87,806 | 6,624 | 97.6% |
| Methylprednisolone | generic | 49,537 | 4,430 | 95.2% |
| Symbicort | brand | 39,119 | 1,177 | 50.6% |
| Breo Ellipta | brand | 22,220 | 628 | 31.7% |
| Hydrocortisone | generic | 21,263 | 2,386 | 89.5% |
| Advair Diskus | brand | 20,518 | 120 | 29% |
| Advair Hfa | brand | 19,622 | 589 | 54.9% |
| Budesonide | generic | 14,714 | 1,083 | 82.2% |
| Desoximetasone | generic | 12,209 | 1,525 | 99.2% |
| Flovent | brand | 10,772 | 171 | 42.1% |
| Methylprednisolone sodium succinate | generic | 10,772 | 1,630 | 97.8% |
| Solu-medrol | generic | 10,288 | 432 | 88.8% |
| Cipro | brand | 9,791 | 108 | 57.3% |
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.
Questions about Ryaltris reports
How many adverse event reports has FDA received for Ryaltris?
1,735 reports list Ryaltris as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 741 of them arrived in the latest 12 months. Another 253 list it only as a concomitant medication.
What reactions are recorded in Ryaltris reports?
device delivery system issue (40.4%), product use in unapproved indication (34.7%), drug dose omission by device (29.8%), product use issue (24.3%) and drug ineffective (10.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Ryaltris was responsible.
How serious are the reports?
6.6% are marked serious by the reporter. Among the outcomes recorded, 0.2% of reports include death and 1.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (48.5%), pharmacist (37.2%) and other health professional (12.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Ryaltris rising?
741 reports in the 12 months to June 2026, up 29% from 574 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Ryaltris was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Ryaltris?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Ryaltris as a suspect or interacting product; reports listing it only as a concomitant medication (253) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.