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Mometasone Furoate and Formoterol side effects: what 15,500 FDA adverse event reports show

Mometasone Furoate And Formoterol Fumarate Dihydrate · 1,032 reaction terms · 54,786 drug–reaction co-reports · data 2026-09-14
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Drug class

Corticosteroid

FDA label, Indications wording of the closest related product

Label matched

Mometasone Furoate (Asmanex)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

15,500 reports · 31% serious · 438 with death outcome · 68% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ASMANEX ® TWISTHALER ® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. Limitations of Use ASMANEX TWISTHALER is not indicated for the relief of acute bronchospasm. ASMANEX TWISTHALER is not indicated in children less than 4 years of age.

FDA label, Indications and Usage

What it is

Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 3Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 10Lab value / disease marker 1Not in label — unassessed 20
What the badges mean

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 992 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Poor quality device used1,095192.8
181.3–205.0ROR 207.4 · χ² 182,465 / p <1e-300
168.1 EB05 159.9 · IC025 +7.2
3/3 methods agree
Not in label — unassessedserious n=69not reported in cached trials
Product container issue41770.4
63.9–77.6ROR 72.3 · χ² 27,042 / p <1e-300
66.7 EB05 61.5 · IC025 +5.8
3/3 methods agree
Reporting / coding artifactserious n=13not reported in cached trials
Product quality issue3,22533.1
32.1–34.2ROR 41.6 · χ² 98,686 / p <1e-300
32.4 EB05 31.4 · IC025 +5.0
3/3 methods agree
Reporting / coding artifactserious PRR 13.5not reported in cached trials
Infective pulmonary exacerbation of cystic fibrosis9824.6
20.2–30.0ROR 24.7 · χ² 2,155 / p <1e-300
24.1 EB05 20.3 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=86not reported in cached trials
No adverse event2,78621.6
20.9–22.3ROR 26.1 · χ² 54,233 / p <1e-300
21.2 EB05 20.6 · IC025 +4.3
3/3 methods agree
Reporting / coding artifactserious PRR 1.2NCT01471340: 1/5,861 (0.0%) on Mometasone Furoate and Formoterol
Adrenal suppression1321.1
12.2–36.6ROR 21.2 · χ² 226 / p 2e-51
20.1 EB05 12.1 · IC025 +2.6
3/3 methods agree
Labeled adverse reaction
exact term
serious n=10not reported in cached trials
Drug dose omission2,13517.4
16.8–18.1ROR 20.1 · χ² 32,896 / p <1e-300
17.2 EB05 16.6 · IC025 +4.0
3/3 methods agree
Reporting / coding artifactserious PRR 8.9not reported in cached trials
Device malfunction75615.4
14.3–16.5ROR 16.1 · χ² 10,068 / p <1e-300
15.2 EB05 14.3 · IC025 +3.8
3/3 methods agree
Reporting / coding artifactserious PRR 12.5not reported in cached trials
Incorrect dose administered by product1715.3
9.5–24.7ROR 15.3 · χ² 211 / p 5e-48
14.4 EB05 9.0 · IC025 +2.6
3/3 methods agree
Reporting / coding artifact–not reported in cached trials
Cystic fibrosis6014.7
11.4–19.0ROR 14.8 · χ² 746 / p 1e-164
14.5 EB05 11.6 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=59 · ♀ 47% (drug 68%) · 78% consumernot reported in cached trials
Infusion site discharge1713.6
8.4–21.9ROR 13.6 · χ² 184 / p 4e-42
12.6 EB05 7.7 · IC025 +2.5
3/3 methods agree
Not in label — unassessedserious n=16not reported in cached trials
Essential hypertension2412.6
8.5–18.9ROR 12.7 · χ² 244 / p 3e-55
11.9 EB05 8.0 · IC025 +2.7
3/3 methods agree
Not in label — unassessedserious n=22not reported in cached trials
Bronchial secretion retention1111.9
6.6–21.5ROR 11.9 · χ² 98 / p 2e-23
9.9 EB05 5.3 · IC025 +2.0
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=9not reported in cached trials
Total lung capacity decreased1311.1
6.4–19.1ROR 11.1 · χ² 108 / p 1e-25
9.4 EB05 5.4 · IC025 +2.1
3/3 methods agree
Not in label — unassessedserious n=7not reported in cached trials
Infusion site bruising1710.9
6.8–17.5ROR 10.9 · χ² 142 / p 5e-33
9.6 EB05 6.0 · IC025 +2.3
3/3 methods agree
Not in label — unassessedserious n=14not reported in cached trials
Hyperparathyroidism secondary1910.2
6.5–16.0ROR 10.2 · χ² 148 / p 3e-34
9.1 EB05 5.8 · IC025 +2.3
3/3 methods agree
Not in label — unassessedserious n=19not reported in cached trials
Pulmonary function test decreased3310.2
7.3–14.4ROR 10.2 · χ² 263 / p 2e-59
9.5 EB05 6.9 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=19not reported in cached trials
Blood immunoglobulin e increased1810.1
6.3–16.0ROR 10.1 · χ² 137 / p 6e-32
8.8 EB05 5.6 · IC025 +2.2
3/3 methods agree
Lab value / disease markerserious n=12not reported in cached trials
Asthma82610.0
9.4–10.7ROR 10.5 · χ² 6,695 / p <1e-300
9.9 EB05 9.4 · IC025 +3.2
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 12.1NCT01471340: 32/5,868 (0.5%) on Mometasone Furoate and Formoterol (serious AE)
Impaired quality of life1039.7
8.0–11.8ROR 9.8 · χ² 794 / p 5e-175
9.5 EB05 8.0 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious PRR 4.9not reported in cached trials
Pulmonary function test abnormal119.6
5.3–17.3ROR 9.6 · χ² 76 / p 2e-18
7.7 EB05 4.3 · IC025 +1.8
3/3 methods agree
Reporting / coding artifactserious n=8not reported in cached trials
Respiration abnormal489.6
7.2–12.7ROR 9.6 · χ² 357 / p 6e-80
9.1 EB05 7.0 · IC025 +2.6
3/3 methods agree
Not in label — unassessedserious n=15not reported in cached trials
Poor quality drug administered469.5
7.1–12.7ROR 9.6 · χ² 341 / p 2e-76
9.0 EB05 6.9 · IC025 +2.6
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Product taste abnormal919.2
7.5–11.3ROR 9.3 · χ² 654 / p 2e-144
8.9 EB05 7.4 · IC025 +2.8
3/3 methods agree
Reporting / coding artifactserious n=13not reported in cached trials
Wheezing3848.8
8.0–9.8ROR 9.0 · χ² 2,649 / p <1e-300
8.7 EB05 8.0 · IC025 +3.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 7.7NCT01471340: 3/5,861 (0.1%) on Mometasone Furoate and Formoterol
Infusion site haemorrhage208.4
5.4–13.0ROR 8.4 · χ² 122 / p 1e-28
7.3 EB05 4.9 · IC025 +2.1
3/3 methods agree
Not in label — unassessedserious n=12 · ♀ 100% (drug 68%) · 85% consumerNCT01471340: 1/5,868 (0.0%) on Mometasone Furoate and Formoterol (serious AE)
Pulmonary pain178.0
5.0–13.0ROR 8.1 · χ² 97 / p 3e-23
6.9 EB05 4.4 · IC025 +1.9
3/3 methods agree
Not in label — unassessedserious n=4not reported in cached trials
Sinus operation148.0
4.7–13.5ROR 8.0 · χ² 79 / p 4e-19
6.6 EB05 4.1 · IC025 +1.8
3/3 methods agree
Reporting / coding artifactserious n=11not reported in cached trials
Infusion site swelling357.7
5.5–10.8ROR 7.7 · χ² 197 / p 4e-45
7.1 EB05 5.3 · IC025 +2.2
3/3 methods agree
Not in label — unassessedserious n=18 · ♀ 91% (drug 68%)NCT01471340: 1/5,861 (0.0%) on Mometasone Furoate and Formoterol
Multiple allergies447.6
5.7–10.2ROR 7.6 · χ² 245 / p 1e-55
7.1 EB05 5.5 · IC025 +2.3
3/3 methods agree
Not in label — unassessedserious n=34 · 79% consumernot reported in cached trials
Nephrogenic anaemia267.6
5.1–11.1ROR 7.6 · χ² 141 / p 9e-33
6.8 EB05 4.8 · IC025 +2.1
3/3 methods agree
Not in label — unassessedserious n=26not reported in cached trials
Rebound acid hypersecretion177.5
4.7–12.1ROR 7.5 · χ² 89 / p 2e-21
6.4 EB05 4.2 · IC025 +1.8
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Product dose omission3657.5
6.8–8.3ROR 7.6 · χ² 2,042 / p <1e-300
7.4 EB05 6.8 · IC025 +2.7
3/3 methods agree
Reporting / coding artifactserious PRR 8.7not reported in cached trials
Pre-existing condition improved337.1
5.0–10.0ROR 7.1 · χ² 166 / p 2e-38
6.5 EB05 4.8 · IC025 +2.1
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Dysphonia2796.5
5.8–7.3ROR 6.6 · χ² 1,287 / p 5e-282
6.4 EB05 5.8 · IC025 +2.5
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 6.1NCT01471340: 4/5,868 (0.1%) on Mometasone Furoate and Formoterol
Aphonia666.4
5.0–8.2ROR 6.4 · χ² 296 / p 1e-66
6.2 EB05 5.0 · IC025 +2.2
3/3 methods agree
Not in label — unassessedserious PRR 15.0NCT01471340: 2/5,861 (0.0%) on Mometasone Furoate and Formoterol

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Mometasone Furoate and Formoterol as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (9 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Product quality issue3,22533.1
32.1–34.2ROR 41.6 · χ² 98,686 / p <1e-300
32.4 EB05 31.4 · IC025 +5.0
3/3 methods agree
Reporting / coding artifactserious PRR 13.5not reported in cached trials
No adverse event2,78621.6
20.9–22.3ROR 26.1 · χ² 54,233 / p <1e-300
21.2 EB05 20.6 · IC025 +4.3
3/3 methods agree
Reporting / coding artifactserious PRR 1.2NCT01471340: 1/5,861 (0.0%) on Mometasone Furoate and Formoterol
Drug dose omission2,13517.4
16.8–18.1ROR 20.1 · χ² 32,896 / p <1e-300
17.2 EB05 16.6 · IC025 +4.0
3/3 methods agree
Reporting / coding artifactserious PRR 8.9not reported in cached trials
Dyspnoea (shortness of breath)1,7264.1
4.0–4.3ROR 4.5 · χ² 4,204 / p <1e-300
4.1 EB05 4.0 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.6NCT01471340: 4/5,868 (0.1%) on Mometasone Furoate and Formoterol
Poor quality device used1,095192.8
181.3–205.0ROR 207.4 · χ² 182,465 / p <1e-300
168.1 EB05 159.9 · IC025 +7.2
3/3 methods agree
Not in label — unassessedserious n=69not reported in cached trials
Cough8804.3
4.0–4.5ROR 4.5 · χ² 2,219 / p <1e-300
4.2 EB05 4.0 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.4NCT01471340: 2/5,868 (0.0%) on Mometasone Furoate and Formoterol
Drug ineffective (drug did not work)8610.9
0.8–0.9ROR 0.9 · χ² 14 / p 1e-4
0.9 EB05 0.8 · IC025 -0.3
PRR-only: not supported by EBGM or IC
Reporting / coding artifactserious PRR 1.1not reported in cached trials
Asthma82610.0
9.4–10.7ROR 10.5 · χ² 6,695 / p <1e-300
9.9 EB05 9.4 · IC025 +3.2
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 12.1NCT01471340: 32/5,868 (0.5%) on Mometasone Furoate and Formoterol (serious AE)
Device malfunction75615.4
14.3–16.5ROR 16.1 · χ² 10,068 / p <1e-300
15.2 EB05 14.3 · IC025 +3.8
3/3 methods agree
Reporting / coding artifactserious PRR 12.5not reported in cached trials
Product dose omission issue6613.1
2.9–3.4ROR 3.2 · χ² 976 / p 1e-214
3.1 EB05 2.9 · IC025 +1.5
3/3 methods agree
Reporting / coding artifactserious PRR 5.8not reported in cached trials
Fatigue (tiredness)6461.1
1.0–1.2ROR 1.1 · χ² 9 / p 0.001
1.1 EB05 1.1 · IC025 +0.0Labeled adverse reaction
exact term
serious PRR 1.9not reported in cached trials
Headache6131.3
1.2–1.4ROR 1.3 · χ² 50 / p 8e-13
1.3 EB05 1.2 · IC025 +0.3Labeled adverse reaction
exact term
serious PRR 2.2NCT01471340: 1/5,868 (0.0%) on Mometasone Furoate and Formoterol (serious AE)
Incorrect dose administered5803.5
3.2–3.8ROR 3.6 · χ² 1,039 / p 3e-228
3.5 EB05 3.2 · IC025 +1.7
3/3 methods agree
Reporting / coding artifactserious PRR 2.4not reported in cached trials
Product use issue5443.9
3.6–4.3ROR 4.1 · χ² 1,200 / p 3e-263
3.9 EB05 3.7 · IC025 +1.8
3/3 methods agree
Reporting / coding artifactserious PRR 2.8not reported in cached trials

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Mometasone Furoate and Formoterol?

In FDA FAERS, the most frequently co-reported reaction terms for Mometasone Furoate and Formoterol are dyspnoea, poor quality device used, cough, asthma, fatigue, headache. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Mometasone Furoate and Formoterol have an FDA boxed warning?

No. The FDA label retrieved for Mometasone Furoate and Formoterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Mometasone Furoate and Formoterol causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.