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mometasone Side Effects

Also known as: Asmanex

Analysis of 17,186 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

17,186

Death-Related

814

4.7% of reports

Hospitalizations

5,350

31.1% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DYSPNOEA
1,730
ASTHMA
1,553
DRUG INEFFECTIVE
1,477
HEADACHE
1,393
COUGH
1,178
FATIGUE
1,098
OFF LABEL USE
1,035
WHEEZING
966
GASTROOESOPHAGEAL REFLUX DISEASE
965
PRURITUS
905
NAUSEA
892
PAIN
818
PNEUMONIA
804
RASH
761
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
740
DIARRHOEA
720
DIZZINESS
685
ARTHRALGIA
675
HYPERSENSITIVITY
654
MALAISE
654

Who Reports Side Effects

Gender Distribution

Female 9,620 (62%)
Male 5,818 (38%)
Unknown 13

Age Distribution

0-17 893 (8%)
18-44 2,275 (19%)
45-64 4,126 (35%)
65-74 2,383 (20%)
75+ 2,102 (18%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 814 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 287
PNEUMONIA 83
DYSPNOEA 80
OFF LABEL USE 63
HYPERSENSITIVITY 58
GENERAL PHYSICAL HEALTH DETERIORATION 54
CARDIAC DISORDER 53
FATIGUE 52
PLEURAL EFFUSION 51
WEIGHT DECREASED 50
ASTHENIA 48
FALL 45
RESPIRATORY FAILURE 41
DIARRHOEA 40
ANAEMIA 38
OEDEMA PERIPHERAL 36
SEPSIS 36
DRUG INEFFECTIVE 35
COUGH 34
ERYTHEMA 34

Reactions in Hospitalization Reports

Top reactions in 5,350 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 921
ASTHMA 767
PNEUMONIA 581
GASTROOESOPHAGEAL REFLUX DISEASE 557
HEADACHE 539
WHEEZING 536
COUGH 461
FATIGUE 420
PYREXIA 409
HYPERTENSION 399
THERAPEUTIC PRODUCT EFFECT INCOMPLETE 392
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 369
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES 364
DRUG INEFFECTIVE 354
NAUSEA 327
CARDIAC DISORDER 311
PAIN 308
DIARRHOEA 302
ASTHENIA 297
OFF LABEL USE 297

Nearby — Related Medications

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What the FAERS Data Reveals About mometasone Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 17,186 voluntary reports linked to mometasone and its brand equivalents (Asmanex), spanning 2004 through 2025. Of those, 814 (4.7%) listed death as an outcome and 5,350 (31.1%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 62% were female and 38% male; age distribution skews toward 45-64, with 4,126 reports in that bracket. The single most reported reaction is dyspnoea with 1,730 submissions, followed by asthma and drug ineffective.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.