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What the label lists and what reports show

Mometasone and olopatadine side effects

Mometasone and olopatadine's FDA label: “The most common adverse reactions (≥1% incidence) are dysgeusia, epistaxis, nasal discomfort, and headache.” FAERS holds 1,989 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device delivery system issue (702 reports).

  • No generic listed

Check it at the source: the mometasone and olopatadine FDA label on DailyMed (effective July 21, 2026, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of RYALTRIS?

RYALTRIS may cause serious side effects, including the following: • nose and throat problems. Symptoms of nose and throat problems may include: o nosebleeds o sores (ulcers) in the nose o hole in the cartilage between your nose (nasal septal perforation). Symptoms of nasal septal perforation may include: ▪ crusting in the nose ▪ nosebleeds ▪ runny nose ▪ whistling sound when you breathe o slow wound healing. You should not use RYALTRIS until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured. o thrush (Candida), a certain fungal infection in your nose and throat. Tell your healthcare provider if you have any redness or white-colored patches in your nose or mouth. • sleepiness or drowsiness. • eye problems, including glaucoma or cataracts. You should have regular eye exams when using RYALTRIS. • allergic reactions. […]

Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective July 21, 2026 (SPL set 406be932-f00e-4c66-9dd1-c142090fe822), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions (≥1% incidence) are dysgeusia, epistaxis, nasal discomfort, and headache.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are described elsewhere in labeling: • Local Nasal Adverse Reactions [see Warnings and Precautions ( 5.1 )] • Somnolence and Impaired Mental Alertness [see Warnings and Precautions ( 5.2 )] • Glaucoma and Cataracts [see Warnings and Precautions ( 5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.5 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.6 ), Use in Specific Populations ( 8.4 )] • Effect on Growth [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (≥1% incidence) are dysgeusia, epistaxis, nasal discomfort, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared with rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective July 21, 2026 (SPL set 406be932-f00e-4c66-9dd1-c142090fe822), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,989 reports list mometasone and olopatadine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 78 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 14 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Device Delivery System Issue702
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)607
  • Drug Dose Omission By Device (a use or a product term, not a reaction)519
  • Product Use Issue (a use or a product term, not a reaction)426
  • Drug Ineffective (a use or a product term, not a reaction)195
  • Device Issue159
  • Wrong Technique In Device Usage Process (a use or a product term, not a reaction)144
  • Device Occlusion133
  • Epistaxis (named in the label)125
  • Product Tampering70
  • Condition Aggravated (a use or a product term, not a reaction)69
  • Device Defective63
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)62
  • Drug Effective For Unapproved Indication (a use or a product term, not a reaction)51
  • Headache (named in the label)48
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)46
  • Product Delivery Mechanism Issue46
  • Somnolence (named in the label)45
  • Fatigue40
  • Dyspnoea39
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)38
  • Product Communication Issue36
  • Product Prescribing Issue (a use or a product term, not a reaction)36
  • Dizziness35
  • Cough32

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Mometasone and olopatadine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions