FORMOTEROL FUMARATE

N/A

Manufactured by Alembic Pharmaceuticals Inc.

18,067 FDA adverse event reports analyzed

Last updated: 2026-04-15

About FORMOTEROL FUMARATE

FORMOTEROL FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. The most commonly reported adverse reactions for FORMOTEROL FUMARATE include DYSPNOEA, ASTHMA, COUGH, WHEEZING, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FORMOTEROL FUMARATE.

Top Adverse Reactions

DYSPNOEA1,075 reports
ASTHMA1,032 reports
COUGH604 reports
WHEEZING543 reports
PNEUMONIA415 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE410 reports
OBSTRUCTIVE AIRWAYS DISORDER404 reports
DRUG INEFFECTIVE377 reports
GASTROOESOPHAGEAL REFLUX DISEASE373 reports
HEADACHE330 reports
FATIGUE320 reports
HYPERTENSION301 reports
FULL BLOOD COUNT ABNORMAL294 reports
PRODUCTIVE COUGH244 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES241 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION234 reports
CHEST DISCOMFORT209 reports
PYREXIA206 reports
HYPOTHYROIDISM203 reports
SLEEP APNOEA SYNDROME201 reports
MALAISE200 reports
CONDITION AGGRAVATED197 reports
ANXIETY195 reports
BLOOD TEST ABNORMAL194 reports
PAIN190 reports
PAIN IN EXTREMITY190 reports
OEDEMA PERIPHERAL183 reports
BRONCHIECTASIS179 reports
ASTHENIA177 reports
HAEMOPTYSIS177 reports
SPUTUM DISCOLOURED176 reports
FALL164 reports
LOWER RESPIRATORY TRACT INFECTION162 reports
DIZZINESS161 reports
PULMONARY EMBOLISM161 reports
NAUSEA160 reports
WEIGHT DECREASED156 reports
HYPOXIA151 reports
DEATH147 reports
DEPRESSION146 reports
WEIGHT INCREASED146 reports
MYOCARDIAL INFARCTION140 reports
SINUSITIS140 reports
PULMONARY FIBROSIS139 reports
CARDIAC DISORDER136 reports
BACK PAIN135 reports
BURNING SENSATION135 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE135 reports
POLYCYSTIC OVARIES135 reports
PRURITUS135 reports
EMPHYSEMA134 reports
BLOOD PRESSURE INCREASED133 reports
PULMONARY MASS132 reports
DIARRHOEA130 reports
ARTHRALGIA125 reports
BRONCHITIS124 reports
OROPHARYNGEAL PAIN124 reports
CHEST PAIN121 reports
RESPIRATORY SYMPTOM120 reports
INFLUENZA116 reports
LUNG DISORDER116 reports
ECZEMA115 reports
NASAL POLYPS114 reports
NASOPHARYNGITIS114 reports
DRUG HYPERSENSITIVITY113 reports
HOSPITALISATION113 reports
UPPER RESPIRATORY TRACT INFECTION113 reports
NASAL CONGESTION112 reports
GAIT DISTURBANCE107 reports
RALES105 reports
RHINITIS ALLERGIC104 reports
BRONCHOPULMONARY ASPERGILLOSIS ALLERGIC103 reports
EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS103 reports
THROMBOSIS103 reports
VASCULITIS103 reports
OFF LABEL USE101 reports
HYPERSENSITIVITY99 reports
OEDEMA99 reports
DYSPNOEA EXERTIONAL98 reports
MYALGIA98 reports
DUST ALLERGY97 reports
ANAEMIA96 reports
FIBROMYALGIA95 reports
PRODUCT DOSE OMISSION ISSUE95 reports
HEART RATE INCREASED93 reports
CARPAL TUNNEL SYNDROME91 reports
FORCED EXPIRATORY VOLUME DECREASED91 reports
PARAESTHESIA91 reports
RENAL DISORDER91 reports
SENSITISATION91 reports
CONSTIPATION90 reports
EOSINOPHIL COUNT INCREASED90 reports
OSTEOPOROSIS90 reports
RASH90 reports
VOMITING90 reports
MYCOTIC ALLERGY88 reports
SPIROMETRY ABNORMAL88 reports
NODULE87 reports
RESPIRATORY DISORDER87 reports
TYPE 2 DIABETES MELLITUS86 reports

Report Outcomes

Out of 3,238 classified reports for FORMOTEROL FUMARATE:

Serious 93.7%Non-Serious 6.3%

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

Female1,768 (58.7%)
Male1,245 (41.3%)
Unknown1 (0.0%)

Reports by Age

Age 65136 reports
Age 54103 reports
Age 60103 reports
Age 7894 reports
Age 7484 reports
Age 7275 reports
Age 7670 reports
Age 4060 reports
Age 6354 reports
Age 7552 reports
Age 6648 reports
Age 7948 reports
Age 5243 reports
Age 7743 reports
Age 7340 reports
Age 4839 reports
Age 6738 reports
Age 8338 reports
Age 6937 reports
Age 8137 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 FORMOTEROL FUMARATE?

This profile reflects 18,067 FDA FAERS reports that mention FORMOTEROL FUMARATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FORMOTEROL FUMARATE?

Frequently reported terms in FAERS include DYSPNOEA, ASTHMA, COUGH, WHEEZING, PNEUMONIA, THERAPEUTIC PRODUCT EFFECT INCOMPLETE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FORMOTEROL FUMARATE?

Labeling and FAERS entries often list Alembic Pharmaceuticals Inc. in connection with FORMOTEROL FUMARATE. 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.