MOMETASONE

N/A

Manufactured by Amneal Pharmaceuticals LLC

48,940 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MOMETASONE

MOMETASONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. The most commonly reported adverse reactions for MOMETASONE include DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, HEADACHE, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MOMETASONE.

Top Adverse Reactions

DYSPNOEA1,731 reports
ASTHMA1,553 reports
DRUG INEFFECTIVE1,477 reports
HEADACHE1,394 reports
COUGH1,178 reports
FATIGUE1,099 reports
OFF LABEL USE1,035 reports
WHEEZING966 reports
GASTROOESOPHAGEAL REFLUX DISEASE965 reports
PRURITUS905 reports
NAUSEA893 reports
PAIN818 reports
PNEUMONIA804 reports
RASH762 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE740 reports
DIARRHOEA721 reports
DIZZINESS685 reports
ARTHRALGIA675 reports
HYPERSENSITIVITY654 reports
MALAISE654 reports
HYPERTENSION648 reports
PYREXIA637 reports
ANXIETY608 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION577 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES555 reports
CONDITION AGGRAVATED542 reports
NASOPHARYNGITIS528 reports
ERYTHEMA524 reports
INSOMNIA522 reports
CARDIAC DISORDER507 reports
VOMITING507 reports
CHEST DISCOMFORT491 reports
PRODUCT DOSE OMISSION ISSUE483 reports
WEIGHT DECREASED481 reports
ASTHENIA473 reports
DEPRESSION469 reports
PRODUCT USE IN UNAPPROVED INDICATION469 reports
PAIN IN EXTREMITY465 reports
FALL461 reports
SINUSITIS449 reports
SOMNOLENCE438 reports
PRODUCTIVE COUGH432 reports
BURNING SENSATION418 reports
FULL BLOOD COUNT ABNORMAL405 reports
COVID 19393 reports
OBSTRUCTIVE AIRWAYS DISORDER389 reports
SLEEP APNOEA SYNDROME388 reports
DYSPHONIA386 reports
BACK PAIN382 reports
MUSCLE SPASMS368 reports
SWELLING FACE367 reports
BLOOD TEST ABNORMAL360 reports
PSORIASIS359 reports
SKIN EXFOLIATION359 reports
DRUG INTOLERANCE356 reports
HYPOTHYROIDISM353 reports
DRUG HYPERSENSITIVITY346 reports
URTICARIA346 reports
CONSTIPATION341 reports
ABDOMINAL PAIN334 reports
CHEST PAIN332 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION330 reports
MYALGIA326 reports
RHINITIS ALLERGIC321 reports
DYSPNOEA EXERTIONAL316 reports
NASAL CONGESTION314 reports
WEIGHT INCREASED311 reports
FIBROMYALGIA307 reports
OROPHARYNGEAL PAIN301 reports
PARAESTHESIA298 reports
CARPAL TUNNEL SYNDROME294 reports
SWOLLEN TONGUE291 reports
ANGIOEDEMA290 reports
DEATH288 reports
FEELING ABNORMAL287 reports
BLOOD PRESSURE INCREASED286 reports
INFLUENZA284 reports
ATRIAL FIBRILLATION282 reports
PERIPHERAL SWELLING279 reports
UPPER RESPIRATORY TRACT INFECTION279 reports
ABDOMINAL PAIN UPPER278 reports
ECZEMA277 reports
DRY SKIN276 reports
SLEEP DISORDER275 reports
TREMOR274 reports
POLYCYSTIC OVARIES273 reports
BRONCHITIS272 reports
DECREASED APPETITE270 reports
SENSITISATION270 reports
PNEUMONIA ASPIRATION269 reports
GAIT DISTURBANCE263 reports
INJECTION SITE PAIN263 reports
URINARY TRACT INFECTION262 reports
ALOPECIA261 reports
RENAL DISORDER261 reports
RHINORRHOEA258 reports
CHILLS252 reports
HOSPITALISATION249 reports
HYPOAESTHESIA248 reports
ILLNESS248 reports

Report Outcomes

Out of 17,178 classified reports for MOMETASONE:

Serious 74.6%Non-Serious 25.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female9,621 (62.3%)
Male5,819 (37.7%)
Unknown13 (0.1%)

Reports by Age

Age 64416 reports
Age 54414 reports
Age 76349 reports
Age 61328 reports
Age 41300 reports
Age 72284 reports
Age 60264 reports
Age 71261 reports
Age 78257 reports
Age 67246 reports
Age 66245 reports
Age 68244 reports
Age 70243 reports
Age 57238 reports
Age 52236 reports
Age 77233 reports
Age 59229 reports
Age 65225 reports
Age 75224 reports
Age 69221 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with MOMETASONE?

This profile reflects 48,940 FDA FAERS reports that mention MOMETASONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MOMETASONE?

Frequently reported terms in FAERS include DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, HEADACHE, COUGH, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MOMETASONE?

Labeling and FAERS entries often list Amneal Pharmaceuticals LLC in connection with MOMETASONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.