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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

FORMOTEROL\MOMETASONE FUROATE: 8,185 Adverse Event Reports & Safety Profile

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8,185
Total FAERS Reports
104 (1.3%)
Deaths Reported
1,722
Hospitalizations
8,185
As Primary/Secondary Suspect
215
Life-Threatening
79
Disabilities

Active Ingredient: FORMOTEROL FUMARATE DIHYDRATE\MOMETASONE FUROATE ·

First Report: 19790101 · Latest Report: 20250701

What Are the Most Common FORMOTEROL\MOMETASONE FUROATE Side Effects?

#1 Most Reported
Dyspnoea
2,560 reports (31.3%)
#2 Most Reported
Asthma
2,482 reports (30.3%)
#3 Most Reported
Product quality issue
2,458 reports (30.0%)

All FORMOTEROL\MOMETASONE FUROATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 2,560 31.3% 53 1,142
Asthma 2,482 30.3% 52 1,290
Product quality issue 2,458 30.0% 1 58
No adverse event 2,315 28.3% 0 0
Wheezing 1,912 23.4% 47 1,104
Drug dose omission 1,474 18.0% 1 30
Therapeutic product effect incomplete 1,394 17.0% 42 804
Cough 1,188 14.5% 0 445
Loss of personal independence in daily activities 1,148 14.0% 35 695
Poor quality device used 1,091 13.3% 1 30
Sleep disorder due to a general medical condition 902 11.0% 37 559
Obstructive airways disorder 743 9.1% 38 441
Device malfunction 655 8.0% 0 20
Drug ineffective 645 7.9% 7 254
Full blood count abnormal 632 7.7% 38 409
Productive cough 631 7.7% 38 430
Pneumonia 518 6.3% 1 304
Condition aggravated 507 6.2% 38 356
Blood count abnormal 496 6.1% 0 265
Gastrooesophageal reflux disease 463 5.7% 0 261

Who Reports FORMOTEROL\MOMETASONE FUROATE Side Effects? Age & Gender Data

Gender: 59.7% female, 40.3% male. Average age: 61.3 years. Most reports from: US. View detailed demographics →

Is FORMOTEROL\MOMETASONE FUROATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2002 2 0 1
2003 1 0 0
2005 4 0 3
2006 1 0 0
2007 2 0 0
2008 1 0 1
2009 5 0 2
2010 8 0 2
2011 10 1 5
2012 21 1 2
2013 51 0 13
2014 324 6 34
2015 315 5 32
2016 250 2 28
2017 271 3 37
2018 351 2 41
2019 420 0 29
2020 364 3 35
2021 328 1 16
2022 183 2 9
2023 17 0 6
2024 21 0 6
2025 7 0 2

View full timeline →

What Is FORMOTEROL\MOMETASONE FUROATE Used For?

IndicationReports
Product used for unknown indication 2,354
Asthma 1,852
Chronic obstructive pulmonary disease 469
Dyspnoea 65
Emphysema 53
Productive cough 34
Bronchitis 33
Respiratory disorder 27
Cough 26
Hypersensitivity 24

FORMOTEROL\MOMETASONE FUROATE vs Alternatives: Which Is Safer?

FORMOTEROL\MOMETASONE FUROATE vs FORTEO FORMOTEROL\MOMETASONE FUROATE vs FOSAMAX FORMOTEROL\MOMETASONE FUROATE vs FOSAMPRENAVIR FORMOTEROL\MOMETASONE FUROATE vs FOSAPREPITANT FORMOTEROL\MOMETASONE FUROATE vs FOSAPREPITANT DIMEGLUMINE FORMOTEROL\MOMETASONE FUROATE vs FOSCARBIDOPA\FOSLEVODOPA FORMOTEROL\MOMETASONE FUROATE vs FOSCARNET FORMOTEROL\MOMETASONE FUROATE vs FOSFOMYCIN FORMOTEROL\MOMETASONE FUROATE vs FOSFOMYCIN TROMETHAMINE FORMOTEROL\MOMETASONE FUROATE vs FOSINOPRIL

Official FDA Label for FORMOTEROL\MOMETASONE FUROATE

Official prescribing information from the FDA-approved drug label.