FDA Adverse Events Reports (FAERS) Summary for RYALTRIS

These tables and charts are based on 2,001 total reports for RYALTRIS (MOMETASONE FUROATE MONOHYDRATE\OLOPATADINE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 1,984 pharmaceutical company-submitted and non-U.S. FAERS reports and 17 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 17 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch RYALTRIS summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with RYALTRIS (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DEVICE DELIVERY SYSTEM ISSUE	702
2	PRODUCT USE IN UNAPPROVED INDICATION	607
3	DRUG DOSE OMISSION BY DEVICE	519
4	PRODUCT USE ISSUE	426
5	DRUG INEFFECTIVE	196
6	DEVICE ISSUE	159
7	WRONG TECHNIQUE IN DEVICE USAGE PROCESS	144
8	DEVICE OCCLUSION	133
9	NOSEBLEED	125
10	PRODUCT TAMPERING	70
11	CONDITION AGGRAVATED	69
12	DEVICE DEFECTIVE	63
13	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	62
14	DRUG EFFECTIVE FOR UNAPPROVED INDICATION	51
15	HEADACHE	48
16	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	46
17	PRODUCT DELIVERY MECHANISM ISSUE	46
18	DROWSINESS	45
19	SHORTNESS OF BREATH	41
20	FATIGUE	40
21	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	38
22	DIZZINESS	36
23	PRODUCT COMMUNICATION ISSUE	36
24	PRODUCT PRESCRIBING ISSUE	36
25	COUGH	33
26	PRODUCT DOSE OMISSION ISSUE	33
27	INCORRECT DOSE ADMINISTERED BY DEVICE	31
28	ASTHMA	30
29	NAUSEA	30
30	DEVICE FAILURE	29
31	NASAL DRYNESS	26
32	INCORRECT DOSE ADMINISTERED	25
33	RASH	25
34	NASAL CONGESTION	24
35	NASAL DISCOMFORT	24
36	DEVICE BREAKAGE	23
37	HYPERSENSITIVITY	23
38	THROAT PAIN	23
39	DEVICE MALFUNCTION	22
40	INSOMNIA	22
41	PRODUCT ODOUR ABNORMAL	21
42	SINUSITIS	21
43	DEVICE MECHANICAL ISSUE	20
44	ILLNESS	20
45	ITCHING	20
46	PAIN	19
47	THROAT IRRITATION	19
48	PRODUCT TASTE ABNORMAL	17
49	RUNNY NOSE	17
50	ADVERSE DRUG REACTION	16
51	DIARRHEA	16
52	METALLIC OR ALTERED TASTE	16
53	MALAISE	16
54	PNEUMONIA	16
55	INTENTIONAL PRODUCT USE ISSUE	15
56	UPPER-AIRWAY COUGH SYNDROME	15
57	VISION BLURRED	15
58	ANXIETY	14
59	DRUG HYPERSENSITIVITY	14
60	DRY EYE	14
61	PRODUCT QUALITY ISSUE	14
62	HIVES	14
63	FALL	13
64	PRODUCT AFTER TASTE	13
65	JOINT PAIN	12
66	COVID-19	12
67	DEVICE PHYSICAL PROPERTY ISSUE	12
68	DRY MOUTH	12
69	OFF LABEL USE	12
70	THERAPY INTERRUPTED	12
71	FEELING ABNORMAL	11
72	PRODUCT ADMINISTRATION INTERRUPTED	11
73	PRODUCT CONTAINER SEAL ISSUE	11
74	PRODUCT DEPOSIT	11
75	RHINITIS ALLERGIC	11
76	PRODUCT PACKAGING QUANTITY ISSUE	10
77	RHINALGIA	10
78	RINGING IN THE EARS	10
79	VOMITING	10
80	WEIGHT INCREASED	10
81	CHEST DISCOMFORT	9
82	DEATH	9
83	DEPRESSION	9
84	DEVICE DIFFICULT TO USE	9
85	DRY THROAT	9
86	HOARSE VOICE	9
87	ILL-DEFINED DISORDER	9
88	MIGRAINE	9
89	PRODUCT STORAGE ERROR	9
90	FEVER	9
91	SEASONAL ALLERGY	9
92	ABDOMINAL DISCOMFORT	8
93	ACCIDENTAL EXPOSURE TO PRODUCT	8
94	ADVERSE EVENT	8
95	LOSS OF TASTE	8
96	LOSS OF SMELL	8
97	DEVICE LEAKAGE	8
98	DRUG EFFECT DECREASED	8
99	INDIGESTION	8
100	ITCHY EYES	8

Latest Known Outcomes for Reactions Reported for RYALTRIS

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1843
2	Patient recovered	183
3	Patient has not recovered/symtoms have not resolved	94
4	Patient is recovering/symptoms resolving	66
5	Patient died	11
6	Patient has recovered but has consequent health issues	2

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2017	1
2020	5
2022	3
2023	259
2024	660
2025	289
2026	784

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	2
11-20	16
21-30	18
31-40	36
41-50	32
51-60	36
61-70	51
71-80	25
81-90	10
91+	4

Based on 230 reports that included a patient age.

RYALTRIS Total Reports

Male	Female	Unknown	Total
95	212		2,001

Top Countries Reporting

	Country	Number of Reports
1	United States	1843
2	EU	49
3	Canada	40
4	France	14
5	South Africa	11
6	Australia	5
7	Spain	5
8	Finland	5
9	United Kingdom	5
10	Russia	4

Outcomes for Reports

Serious: 276
Not Serious: 1723
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Product used for unknown indication
Hypersensitivity
Rhinitis allergic
Rhinitis
Asthma

Top Companies Reporting

GLENMARK

Safety-Related FDA Updates

RYALTRIS (MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE) Rx Drug:
Added trials results for expanded approval for age 6 and up; may cause reduction in growth velocity when administered to pediatric patients. Safety-related Labeling Changes

Have experience (good or bad) with RYALTRIS? Rate RYALTRIS at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for RYALTRIS reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.