SALMETEROL XINAFOATE

N/A

Manufactured by GlaxoSmithKline LLC

19,705 FDA adverse event reports analyzed

Last updated: 2026-04-14

About SALMETEROL XINAFOATE

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

Top Adverse Reactions

DYSPNOEA1,247 reports
DRUG INEFFECTIVE1,220 reports
ASTHMA901 reports
COUGH585 reports
HEADACHE452 reports
PNEUMONIA402 reports
NAUSEA392 reports
WHEEZING368 reports
DIZZINESS365 reports
CHEST DISCOMFORT355 reports
FATIGUE347 reports
PHARMACEUTICAL PRODUCT COMPLAINT318 reports
CHEST PAIN294 reports
MALAISE293 reports
DIARRHOEA272 reports
PAIN271 reports
PRODUCT QUALITY ISSUE265 reports
DEATH259 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE246 reports
VOMITING243 reports
ANXIETY242 reports
DYSPHONIA242 reports
PYREXIA235 reports
ASTHENIA233 reports
HYPERTENSION229 reports
CONDITION AGGRAVATED223 reports
OFF LABEL USE213 reports
INSOMNIA203 reports
WEIGHT DECREASED195 reports
MUSCLE SPASMS190 reports
DRUG HYPERSENSITIVITY188 reports
TREMOR180 reports
PALPITATIONS178 reports
BACK PAIN175 reports
PRODUCTIVE COUGH175 reports
RASH169 reports
CARDIAC FAILURE CONGESTIVE167 reports
DRY MOUTH165 reports
BRONCHITIS164 reports
CONSTIPATION162 reports
ARTHRALGIA161 reports
DEPRESSION160 reports
MYALGIA158 reports
FALL157 reports
PAIN IN EXTREMITY150 reports
PRURITUS149 reports
ABDOMINAL PAIN UPPER148 reports
ANAEMIA146 reports
OEDEMA PERIPHERAL145 reports
MYOCARDIAL INFARCTION143 reports
RESPIRATORY FAILURE143 reports
CEREBROVASCULAR ACCIDENT139 reports
ABDOMINAL PAIN135 reports
HEART RATE INCREASED134 reports
HYPERSENSITIVITY133 reports
OBSTRUCTIVE AIRWAYS DISORDER130 reports
ATRIAL FIBRILLATION129 reports
SINUSITIS127 reports
NASOPHARYNGITIS124 reports
OVERDOSE119 reports
SOMNOLENCE117 reports
DRUG INTERACTION115 reports
DYSPNOEA EXERTIONAL113 reports
BLOOD PRESSURE INCREASED112 reports
LUNG DISORDER112 reports
WEIGHT INCREASED112 reports
FEELING ABNORMAL111 reports
THROAT IRRITATION107 reports
ARTHRITIS106 reports
BLOOD GLUCOSE INCREASED106 reports
HYPERHIDROSIS106 reports
ERYTHEMA105 reports
TACHYCARDIA104 reports
CORONARY ARTERY DISEASE101 reports
PRODUCT USE ISSUE98 reports
DRUG DOSE OMISSION97 reports
CARDIAC DISORDER96 reports
HYPOXIA96 reports
URINARY TRACT INFECTION96 reports
LOSS OF CONSCIOUSNESS95 reports
PULMONARY EMBOLISM95 reports
DIABETES MELLITUS94 reports
HYPOTENSION94 reports
PULMONARY OEDEMA94 reports
VISION BLURRED92 reports
BRONCHOSPASM89 reports
ABDOMINAL DISTENSION88 reports
NEUROPATHY PERIPHERAL88 reports
RENAL FAILURE88 reports
SLEEP DISORDER88 reports
PARAESTHESIA86 reports
PHARYNGOLARYNGEAL PAIN86 reports
UPPER RESPIRATORY TRACT INFECTION85 reports
URTICARIA85 reports
HAEMOPTYSIS84 reports
HYPOAESTHESIA84 reports
ADVERSE EVENT83 reports
GAIT DISTURBANCE82 reports
PRODUCT DOSE OMISSION ISSUE82 reports
CONFUSIONAL STATE80 reports

Report Outcomes

Out of 8,521 classified reports for SALMETEROL XINAFOATE:

Serious 58.7%Non-Serious 41.3%

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

Female5,178 (63.6%)
Male2,956 (36.3%)
Unknown11 (0.1%)

Reports by Age

Age 75218 reports
Age 71184 reports
Age 72150 reports
Age 73147 reports
Age 67144 reports
Age 74144 reports
Age 77144 reports
Age 70142 reports
Age 68140 reports
Age 54139 reports
Age 76138 reports
Age 65136 reports
Age 80134 reports
Age 69129 reports
Age 63127 reports
Age 64127 reports
Age 66126 reports
Age 61114 reports
Age 60113 reports
Age 78112 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 SALMETEROL XINAFOATE?

This profile reflects 19,705 FDA FAERS reports that mention SALMETEROL XINAFOATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SALMETEROL XINAFOATE?

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

Who manufactures SALMETEROL XINAFOATE?

Labeling and FAERS entries often list GlaxoSmithKline LLC in connection with SALMETEROL XINAFOATE. 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.