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Drug side effects

mometasone Side Effects

The reactions most often reported to the FDA for mometasone (also sold as Asmanex), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

17,186
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of mometasone come from 17,186 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 17,186 reports to the FDA Adverse Event Reporting System (FAERS) for mometasone (Asmanex): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

17,186

Reports Mentioning Death

814

4.7% of reports — not proof the medicine caused the death

Hospitalizations

5,350

31.1% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DYSPNOEA
1,730
ASTHMA
1,553
HEADACHE
1,393
COUGH
1,178
FATIGUE
1,098
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
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
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
NAUSEA 327
CARDIAC DISORDER 311
PAIN 308
DIARRHOEA 302
ASTHENIA 297

Compare mometasone vs aclidinium →

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 headache.

How to read these numbers

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.