MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE

N/A

Manufactured by Organon LLC

35,067 FDA adverse event reports analyzed

Last updated: 2026-04-14

About MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE

MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. The most commonly reported adverse reactions for MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE include PRODUCT QUALITY ISSUE, NO ADVERSE EVENT, DRUG DOSE OMISSION, DYSPNOEA, POOR QUALITY DEVICE USED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE.

Top Adverse Reactions

PRODUCT QUALITY ISSUE3,225 reports
NO ADVERSE EVENT2,782 reports
DRUG DOSE OMISSION2,136 reports
DYSPNOEA1,700 reports
POOR QUALITY DEVICE USED1,094 reports
COUGH865 reports
DRUG INEFFECTIVE844 reports
ASTHMA810 reports
DEVICE MALFUNCTION755 reports
PRODUCT DOSE OMISSION ISSUE631 reports
FATIGUE629 reports
HEADACHE596 reports
INCORRECT DOSE ADMINISTERED575 reports
PRODUCT USE ISSUE542 reports
PNEUMONIA502 reports
NAUSEA477 reports
DIZZINESS433 reports
PRODUCT CONTAINER ISSUE417 reports
OFF LABEL USE414 reports
PAIN411 reports
MALAISE396 reports
WHEEZING379 reports
PRODUCT DOSE OMISSION367 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR363 reports
DIARRHOEA330 reports
SINUSITIS330 reports
RASH329 reports
ARTHRALGIA305 reports
PRODUCT USE IN UNAPPROVED INDICATION303 reports
ANXIETY290 reports
UNDERDOSE287 reports
CHEST DISCOMFORT281 reports
DYSPHONIA278 reports
PRURITUS274 reports
CHEST PAIN273 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS251 reports
NASOPHARYNGITIS249 reports
FALL245 reports
BRONCHITIS244 reports
PAIN IN EXTREMITY235 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE232 reports
VOMITING231 reports
INSOMNIA230 reports
FEELING ABNORMAL224 reports
DEATH220 reports
CONDITION AGGRAVATED218 reports
COVID 19214 reports
ASTHENIA211 reports
DEPRESSION210 reports
MUSCLE SPASMS205 reports
OROPHARYNGEAL PAIN202 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS202 reports
BACK PAIN191 reports
HYPERSENSITIVITY191 reports
WEIGHT DECREASED191 reports
PYREXIA181 reports
TREMOR181 reports
WEIGHT INCREASED180 reports
INFLUENZA178 reports
INJECTION SITE PAIN175 reports
CHRONIC KIDNEY DISEASE172 reports
URTICARIA169 reports
PERIPHERAL SWELLING167 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION163 reports
URINARY TRACT INFECTION154 reports
DRUG HYPERSENSITIVITY153 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION152 reports
NASAL CONGESTION152 reports
HYPERTENSION150 reports
PRODUCTIVE COUGH148 reports
ABDOMINAL PAIN UPPER142 reports
CONSTIPATION140 reports
ACUTE KIDNEY INJURY139 reports
BLOOD PRESSURE INCREASED138 reports
INFECTION136 reports
ADVERSE EVENT130 reports
RENAL FAILURE129 reports
PALPITATIONS127 reports
ALOPECIA126 reports
MIGRAINE126 reports
HOSPITALISATION125 reports
GAIT DISTURBANCE124 reports
HEART RATE INCREASED122 reports
INTENTIONAL PRODUCT MISUSE122 reports
UPPER RESPIRATORY TRACT INFECTION122 reports
MYALGIA119 reports
MEMORY IMPAIRMENT118 reports
ILLNESS117 reports
GASTROOESOPHAGEAL REFLUX DISEASE116 reports
SOMNOLENCE115 reports
CANDIDA INFECTION114 reports
ABDOMINAL PAIN108 reports
EXPIRED PRODUCT ADMINISTERED107 reports
RHINORRHOEA106 reports
IMPAIRED QUALITY OF LIFE102 reports
DECREASED APPETITE101 reports
ERYTHEMA101 reports
HYPOAESTHESIA101 reports
DRY MOUTH100 reports
PARAESTHESIA100 reports

Report Outcomes

Out of 15,238 classified reports for MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE:

Serious 31.2%Non-Serious 68.8%

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

Female9,308 (66.7%)
Male4,408 (31.6%)
Unknown242 (1.7%)

Reports by Age

Age 63214 reports
Age 60203 reports
Age 61198 reports
Age 65193 reports
Age 67191 reports
Age 62188 reports
Age 71188 reports
Age 72188 reports
Age 64185 reports
Age 68184 reports
Age 69183 reports
Age 57179 reports
Age 66178 reports
Age 70177 reports
Age 59175 reports
Age 58163 reports
Age 56160 reports
Age 74145 reports
Age 55142 reports
Age 73140 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 FUROATE AND FORMOTEROL FUMARATE DIHYDRATE?

This profile reflects 35,067 FDA FAERS reports that mention MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE?

Frequently reported terms in FAERS include PRODUCT QUALITY ISSUE, NO ADVERSE EVENT, DRUG DOSE OMISSION, DYSPNOEA, POOR QUALITY DEVICE USED, COUGH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE?

Labeling and FAERS entries often list Organon LLC in connection with MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE. 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.