What the label lists and what reports show
Formoterol and mometasone side effects
Formoterol and mometasone's FDA label: “Most common adverse reactions (reported in ≥3% in any treatment arm and greater than placebo) included: Nasopharyngitis, sinusitis and headache.” FAERS holds 15,502 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 dyspnoea (1,726 reports).
- No generic listed
Check it at the source: the formoterol and mometasone FDA label on DailyMed (effective July 10, 2026); 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 DULERA?DULERA may cause serious side effects, including: Thrush in the mouth and throat. You may develop thrush, a yeast infection (Candida albicans), in your mouth or throat. After each dose of DULERA (2 puffs), rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat. Immune system effects and a higher chance for infections. Signs of infection may include: fever nausea chills feeling tired body aches pain vomiting Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines. Increased wheezing right after taking DULERA. Always have a rescue inhaler with you to treat sudden wheezing. Serious allergic reactions. […]
Source: FDA drug label, Organon LLC, effective July 10, 2026 (SPL set 8f399784-f257-4f31-b3dc-368bf2a1864d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (reported in ≥3% in any treatment arm and greater than placebo) included: Nasopharyngitis, sinusitis and headache.
Table 2: Treatment-Emergent Adverse Events in DULERA Groups Occurring at an Incidence of ≥3% and More Commonly than Placebo
| Reaction | 100 mcg/5 mcg n=424 n (%) | 200 mcg/5 mcg n=255 n (%) | 100 mcg n=192 n (%) | 200 mcg n=240 n (%) | 5 mcg n=202 n (%) | n=196 n (%) |
|---|---|---|---|---|---|---|
| Nasopharyngitis | 20 (4.7) | 12 (4.7) | 15 (7.8) | 13 (5.4) | 13 (6.4) | 7 (3.6) |
| Sinusitis | 14 (3.3) | 5 (2.0) | 6 (3.1) | 4 (1.7) | 7 (3.5) | 2 (1.0) |
| Headache | 19 (4.5) | 5 (2.0) | 10 (5.2) | 8 (3.3) | 6 (3.0) | 7 (3.6) |
| Average Duration of Exposure (days) | 116 | 81 | 165 | 79 | 131 | 138 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedLABA use may result in the following: Serious asthma-related events – hospitalizations, intubations, and death [see Warnings and Precautions (5.1) ]. Cardiovascular and central nervous system effects [see Warnings and Precautions (5.11) ]. Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.4) ] Immunosuppression [see Warnings and Precautions (5.5) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7) ] Growth effects in pediatrics [see Warnings and Precautions (5.13) ] Glaucoma and cataracts [see Warnings and Precautions (5.14) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (reported in ≥3% in any treatment arm and greater than placebo) included: Nasopharyngitis, sinusitis and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Organon LLC, effective July 10, 2026 (SPL set 8f399784-f257-4f31-b3dc-368bf2a1864d), via openFDA; the full label on DailyMed
What do FAERS reports show?
15,502 reports list formoterol and mometasone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 438 are coded as a death and 2,478 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, 8 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Formoterol and mometasone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions