EPOPROSTENOL SODIUM

N/A

Manufactured by GlaxoSmithKline LLC

22,890 FDA adverse event reports analyzed

Last updated: 2026-04-14

About EPOPROSTENOL SODIUM

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

Top Adverse Reactions

DYSPNOEA1,092 reports
HEADACHE801 reports
DEATH781 reports
DIARRHOEA760 reports
NAUSEA660 reports
HOSPITALISATION584 reports
PAIN IN JAW501 reports
DEVICE RELATED INFECTION485 reports
PNEUMONIA465 reports
FLUSHING413 reports
FATIGUE403 reports
PULMONARY ARTERIAL HYPERTENSION403 reports
VOMITING403 reports
MALAISE402 reports
HYPOTENSION373 reports
DIZZINESS353 reports
PULMONARY HYPERTENSION346 reports
FLUID RETENTION343 reports
RIGHT VENTRICULAR FAILURE338 reports
PYREXIA318 reports
PAIN IN EXTREMITY313 reports
COUGH297 reports
CENTRAL VENOUS CATHETERISATION290 reports
DEVICE OCCLUSION289 reports
CONDITION AGGRAVATED282 reports
WEIGHT DECREASED274 reports
PAIN270 reports
CHEST PAIN266 reports
CARDIAC FAILURE260 reports
RASH246 reports
COMPLICATION ASSOCIATED WITH DEVICE234 reports
OEDEMA PERIPHERAL228 reports
OFF LABEL USE224 reports
NASOPHARYNGITIS222 reports
OXYGEN SATURATION DECREASED214 reports
ASTHENIA206 reports
CATHETER SITE ERYTHEMA206 reports
ANAEMIA196 reports
OEDEMA195 reports
UNDERDOSE194 reports
HYPOXIA192 reports
SYNCOPE191 reports
FLUID OVERLOAD181 reports
EPISTAXIS176 reports
CATHETER SITE INFECTION174 reports
HAEMOPTYSIS174 reports
PALPITATIONS174 reports
SEPSIS173 reports
DYSPNOEA EXERTIONAL172 reports
DECREASED APPETITE170 reports
ABDOMINAL PAIN166 reports
FALL164 reports
LUNG TRANSPLANT157 reports
ABDOMINAL DISTENSION156 reports
ASCITES155 reports
BACK PAIN155 reports
DISEASE PROGRESSION150 reports
INFECTION150 reports
PLATELET COUNT DECREASED149 reports
DEVICE LEAKAGE147 reports
WEIGHT INCREASED147 reports
PRODUCT ADMINISTRATION INTERRUPTED146 reports
ARTHRALGIA142 reports
CATHETER SITE PAIN140 reports
DRUG INEFFECTIVE136 reports
THROMBOCYTOPENIA136 reports
ERYTHEMA132 reports
RESPIRATORY FAILURE132 reports
MEDICAL DEVICE COMPLICATION128 reports
PRURITUS125 reports
PERIPHERAL SWELLING123 reports
HEART RATE INCREASED120 reports
ABDOMINAL PAIN UPPER113 reports
CATHETERISATION CARDIAC113 reports
VASCULAR DEVICE INFECTION113 reports
CATHETER SITE HAEMORRHAGE112 reports
PULMONARY OEDEMA112 reports
TACHYCARDIA111 reports
DEHYDRATION110 reports
INFLUENZA108 reports
FEELING ABNORMAL106 reports
NASAL CONGESTION103 reports
CATHETER SITE DISCHARGE102 reports
DEVICE ALARM ISSUE101 reports
HAEMORRHAGE99 reports
HYPERTHYROIDISM99 reports
RENAL FAILURE99 reports
SINUSITIS99 reports
BLOOD PRESSURE DECREASED98 reports
CARDIAC FAILURE CONGESTIVE96 reports
DEVICE DISLOCATION96 reports
URINARY TRACT INFECTION96 reports
ANXIETY95 reports
HAEMOGLOBIN DECREASED95 reports
GASTROINTESTINAL HAEMORRHAGE94 reports
ABDOMINAL DISCOMFORT93 reports
CHEST DISCOMFORT93 reports
PLEURAL EFFUSION92 reports
MYALGIA90 reports
ALANINE AMINOTRANSFERASE INCREASED89 reports

Report Outcomes

Out of 7,990 classified reports for EPOPROSTENOL SODIUM:

Serious 80.1%Non-Serious 19.9%

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

Female5,343 (77.8%)
Male1,510 (22.0%)
Unknown15 (0.2%)

Reports by Age

Age 50137 reports
Age 55136 reports
Age 53134 reports
Age 52125 reports
Age 56117 reports
Age 47115 reports
Age 54114 reports
Age 40112 reports
Age 44112 reports
Age 48112 reports
Age 57106 reports
Age 60104 reports
Age 39103 reports
Age 61101 reports
Age 65100 reports
Age 5899 reports
Age 4998 reports
Age 5198 reports
Age 4196 reports
Age 4394 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 EPOPROSTENOL SODIUM?

This profile reflects 22,890 FDA FAERS reports that mention EPOPROSTENOL SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EPOPROSTENOL SODIUM?

Frequently reported terms in FAERS include DYSPNOEA, HEADACHE, DEATH, DIARRHOEA, NAUSEA, HOSPITALISATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EPOPROSTENOL SODIUM?

Labeling and FAERS entries often list GlaxoSmithKline LLC in connection with EPOPROSTENOL SODIUM. 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.