Mometasone Furoate and Formoterol side effects: what 15,500 FDA adverse event reports show
Drug class
Corticosteroid
Label matched
Mometasone Furoate (Asmanex)
Who reports
15,500 reports · 31% serious · 438 with death outcome · 68% female
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.
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.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Poor quality device used | 1,095 | 192.8 181.3–205.0ROR 207.4 · χ² 182,465 / p <1e-300 | 168.1 EB05 159.9 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=69 | not reported in cached trials |
| Product container issue | 417 | 70.4 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 artifact | serious n=13 | not reported in cached trials |
| Product quality issue | 3,225 | 33.1 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 artifact | serious PRR 13.5 | not reported in cached trials |
| Infective pulmonary exacerbation of cystic fibrosis | 98 | 24.6 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 — unassessed | serious n=86 | not reported in cached trials |
| No adverse event | 2,786 | 21.6 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 artifact | serious PRR 1.2 | NCT01471340: 1/5,861 (0.0%) on Mometasone Furoate and Formoterol |
| Adrenal suppression | 13 | 21.1 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=10 | not reported in cached trials |
| Drug dose omission | 2,135 | 17.4 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 artifact | serious PRR 8.9 | not reported in cached trials |
| Drug administered to patient of inappropriate age | 86 | 16.2 13.1–20.0ROR 16.3 · χ² 1,196 / p 2e-262 | 15.9 EB05 13.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=4 · ♀ 41% (drug 68%) | not reported in cached trials |
| Device malfunction | 756 | 15.4 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 artifact | serious PRR 12.5 | not reported in cached trials |
| Incorrect dose administered by product | 17 | 15.3 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 |
| Circumstance or information capable of leading to medication error | 363 | 14.8 13.3–16.4ROR 15.1 · χ² 4,608 / p <1e-300 | 14.6 EB05 13.4 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | not reported in cached trials |
| Cystic fibrosis | 60 | 14.7 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 — unassessed | serious n=59 · ♀ 47% (drug 68%) · 78% consumer | not reported in cached trials |
| Infusion site discharge | 17 | 13.6 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 — unassessed | serious n=16 | not reported in cached trials |
| Infusion site pruritus | 29 | 12.7 8.8–18.3ROR 12.7 · χ² 298 / p 5e-67 | 12.1 EB05 8.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=14 · ♀ 90% (drug 68%) | NCT01471340: 1/5,868 (0.0%) on Mometasone Furoate and Formoterol |
| Essential hypertension | 24 | 12.6 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 — unassessed | serious n=22 | not reported in cached trials |
| Bronchial secretion retention | 11 | 11.9 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=9 | not reported in cached trials |
| Total lung capacity decreased | 13 | 11.1 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 — unassessed | serious n=7 | not reported in cached trials |
| Infusion site bruising | 17 | 10.9 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 — unassessed | serious n=14 | not reported in cached trials |
| Hyperparathyroidism secondary | 19 | 10.2 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 — unassessed | serious n=19 | not reported in cached trials |
| Pulmonary function test decreased | 33 | 10.2 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 — unassessed | serious n=19 | not reported in cached trials |
| Blood immunoglobulin e increased | 18 | 10.1 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 marker | serious n=12 | not reported in cached trials |
| Asthma | 826 | 10.0 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 12.1 | NCT01471340: 32/5,868 (0.5%) on Mometasone Furoate and Formoterol (serious AE) |
| Impaired quality of life | 103 | 9.7 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 — unassessed | serious PRR 4.9 | not reported in cached trials |
| Pulmonary function test abnormal | 11 | 9.6 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 artifact | serious n=8 | not reported in cached trials |
| Respiration abnormal | 48 | 9.6 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 — unassessed | serious n=15 | not reported in cached trials |
| Poor quality drug administered | 46 | 9.5 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 |
| Candida infection (yeast infection) | 116 | 9.5 7.9–11.4ROR 9.5 · χ² 864 / p 3e-190 | 9.2 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 | NCT01471340: 1/5,868 (0.0%) on Mometasone Furoate and Formoterol |
| Product taste abnormal | 91 | 9.2 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 artifact | serious n=13 | not reported in cached trials |
| Wheezing | 384 | 8.8 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 7.7 | NCT01471340: 3/5,861 (0.1%) on Mometasone Furoate and Formoterol |
| Infusion site haemorrhage | 20 | 8.4 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 — unassessed | serious n=12 · ♀ 100% (drug 68%) · 85% consumer | NCT01471340: 1/5,868 (0.0%) on Mometasone Furoate and Formoterol (serious AE) |
| Pulmonary pain | 17 | 8.0 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 — unassessed | serious n=4 | not reported in cached trials |
| Sinus operation | 14 | 8.0 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 artifact | serious n=11 | not reported in cached trials |
| Infusion site swelling | 35 | 7.7 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 — unassessed | serious n=18 · ♀ 91% (drug 68%) | NCT01471340: 1/5,861 (0.0%) on Mometasone Furoate and Formoterol |
| Multiple allergies | 44 | 7.6 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 — unassessed | serious n=34 · 79% consumer | not reported in cached trials |
| Nephrogenic anaemia | 26 | 7.6 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 — unassessed | serious n=26 | not reported in cached trials |
| Rebound acid hypersecretion | 17 | 7.5 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 — unassessed | serious n=17 | not reported in cached trials |
| Product dose omission | 365 | 7.5 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 artifact | serious PRR 8.7 | not reported in cached trials |
| Pre-existing condition improved | 33 | 7.1 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 — unassessed | serious n=17 | not reported in cached trials |
| Dysphonia | 279 | 6.5 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 6.1 | NCT01471340: 4/5,868 (0.1%) on Mometasone Furoate and Formoterol |
| Aphonia | 66 | 6.4 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 — unassessed | serious PRR 15.0 | NCT01471340: 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).
- NCT01471340 — A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Y (N=11744, PHASE4; 249 AE terms posted; arms: MF/F MDI BID; MF MDI BID)
- NCT00941798 — Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma (N=2283, PHASE2; 101 AE terms posted; arms: QMF149 Twisthaler® 500/400; Mometasone Twisthaler®)
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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Product quality issue | 3,225 | 33.1 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 artifact | serious PRR 13.5 | not reported in cached trials |
| No adverse event | 2,786 | 21.6 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 artifact | serious PRR 1.2 | NCT01471340: 1/5,861 (0.0%) on Mometasone Furoate and Formoterol |
| Drug dose omission | 2,135 | 17.4 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 artifact | serious PRR 8.9 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,726 | 4.1 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 3.6 | NCT01471340: 4/5,868 (0.1%) on Mometasone Furoate and Formoterol |
| Poor quality device used | 1,095 | 192.8 181.3–205.0ROR 207.4 · χ² 182,465 / p <1e-300 | 168.1 EB05 159.9 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=69 | not reported in cached trials |
| Cough | 880 | 4.3 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 4.4 | NCT01471340: 2/5,868 (0.0%) on Mometasone Furoate and Formoterol |
| Drug ineffective (drug did not work) | 861 | 0.9 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 artifact | serious PRR 1.1 | not reported in cached trials |
| Asthma | 826 | 10.0 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 12.1 | NCT01471340: 32/5,868 (0.5%) on Mometasone Furoate and Formoterol (serious AE) |
| Device malfunction | 756 | 15.4 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 artifact | serious PRR 12.5 | not reported in cached trials |
| Product dose omission issue | 661 | 3.1 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 artifact | serious PRR 5.8 | not reported in cached trials |
| Fatigue (tiredness) | 646 | 1.1 1.0–1.2ROR 1.1 · χ² 9 / p 0.001 | 1.1 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
| Headache | 613 | 1.3 1.2–1.4ROR 1.3 · χ² 50 / p 8e-13 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 2.2 | NCT01471340: 1/5,868 (0.0%) on Mometasone Furoate and Formoterol (serious AE) |
| Incorrect dose administered | 580 | 3.5 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 artifact | serious PRR 2.4 | not reported in cached trials |
| Product use issue | 544 | 3.9 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 artifact | serious PRR 2.8 | not reported in cached trials |
| Pneumonia (lung infection) | 509 | 2.1 2.0–2.3ROR 2.2 · χ² 309 / p 2e-69 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 3.9 | NCT01471340: 10/5,868 (0.2%) on Mometasone Furoate and Formoterol (serious AE) |
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.
- Poor quality device used — n=1,095, PRR 192.8
- Infective pulmonary exacerbation of cystic fibrosis — n=98, PRR 24.6
- Cystic fibrosis — n=60, PRR 14.7
- Essential hypertension — n=24, PRR 12.6
- Pulmonary function test decreased — n=33, PRR 10.2
- Impaired quality of life — n=103, PRR 9.7
- Respiration abnormal — n=48, PRR 9.6
- Poor quality drug administered — n=46, PRR 9.5
- Infusion site haemorrhage — n=20, PRR 8.4 (also seen in trial arm)
- Infusion site swelling — n=35, PRR 7.7 (also seen in trial arm)
✓ 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
- FDA label via openFDA (set ID 10b36fb2-6b0d-4f20-b197-3564d6f594b9, effective 20260707; matched on
openfda.generic_name.exact:"MOMETASONE FUROATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,032 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
MOMETASONE FUROATE, results-bearing studies sorted by enrollment)
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.