FONDAPARINUX SODIUM

N/A

Manufactured by Mylan Institutional LLC

13,905 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FONDAPARINUX SODIUM

FONDAPARINUX SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Mylan Institutional LLC. The most commonly reported adverse reactions for FONDAPARINUX SODIUM include ANAEMIA, HAEMATOMA, PULMONARY EMBOLISM, OFF LABEL USE, HAEMORRHAGE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FONDAPARINUX SODIUM.

Top Adverse Reactions

ANAEMIA612 reports
HAEMATOMA559 reports
PULMONARY EMBOLISM443 reports
OFF LABEL USE365 reports
HAEMORRHAGE349 reports
HAEMOGLOBIN DECREASED335 reports
DEATH298 reports
DEEP VEIN THROMBOSIS294 reports
DYSPNOEA270 reports
THROMBOCYTOPENIA260 reports
DRUG INEFFECTIVE258 reports
PYREXIA240 reports
NAUSEA234 reports
THROMBOSIS233 reports
VOMITING231 reports
DRUG INTERACTION228 reports
MUSCLE HAEMORRHAGE215 reports
DIARRHOEA214 reports
CEREBRAL HAEMORRHAGE208 reports
ABDOMINAL PAIN207 reports
PAIN IN EXTREMITY193 reports
INCORRECT DRUG ADMINISTRATION DURATION189 reports
HYPOTENSION183 reports
ASTHENIA176 reports
SHOCK HAEMORRHAGIC175 reports
OEDEMA PERIPHERAL169 reports
PAIN165 reports
MELAENA164 reports
FALL162 reports
HEADACHE160 reports
RENAL FAILURE156 reports
GASTROINTESTINAL HAEMORRHAGE150 reports
MALAISE147 reports
FATIGUE139 reports
GENERAL PHYSICAL HEALTH DETERIORATION133 reports
PLATELET COUNT DECREASED130 reports
RENAL FAILURE ACUTE130 reports
OVERDOSE125 reports
PRURITUS120 reports
HEPARIN INDUCED THROMBOCYTOPENIA119 reports
HAEMATEMESIS118 reports
SEPSIS115 reports
ERYTHEMA114 reports
CONFUSIONAL STATE113 reports
PNEUMONIA111 reports
CHEST PAIN110 reports
PRODUCT QUALITY ISSUE110 reports
POST PROCEDURAL HAEMORRHAGE106 reports
SUBDURAL HAEMATOMA106 reports
DIZZINESS103 reports
DEHYDRATION102 reports
ARTHRALGIA101 reports
EPISTAXIS99 reports
HAEMATURIA99 reports
TACHYCARDIA99 reports
NEUTROPENIA98 reports
HYPERTENSION96 reports
RASH94 reports
CEREBROVASCULAR ACCIDENT93 reports
CONTUSION92 reports
COMA91 reports
WEIGHT DECREASED88 reports
CONDITION AGGRAVATED85 reports
RED BLOOD CELL COUNT DECREASED82 reports
RESPIRATORY FAILURE82 reports
INJECTION SITE PAIN81 reports
BACK PAIN80 reports
PALLOR79 reports
RECTAL HAEMORRHAGE77 reports
RETROPERITONEAL HAEMATOMA74 reports
URTICARIA74 reports
HAEMATOCRIT DECREASED72 reports
INTERNATIONAL NORMALISED RATIO INCREASED72 reports
LOSS OF CONSCIOUSNESS72 reports
PLEURAL EFFUSION72 reports
COUGH71 reports
INJECTION SITE HAEMATOMA71 reports
MYOCARDIAL INFARCTION67 reports
CARDIAC ARREST65 reports
HAEMORRHAGIC ANAEMIA63 reports
INTRA ABDOMINAL HAEMATOMA63 reports
URINARY TRACT INFECTION63 reports
DECREASED APPETITE62 reports
HYPERSENSITIVITY62 reports
ATRIAL FIBRILLATION61 reports
ALTERED STATE OF CONSCIOUSNESS60 reports
ANXIETY60 reports
MALIGNANT NEOPLASM PROGRESSION60 reports
ABDOMINAL WALL HAEMATOMA59 reports
BLOOD CREATININE INCREASED59 reports
POST PROCEDURAL HAEMATOMA59 reports
ACUTE KIDNEY INJURY58 reports
SOMNOLENCE58 reports
ABDOMINAL PAIN UPPER56 reports
DRUG EXPOSURE DURING PREGNANCY56 reports
DYSPHAGIA56 reports
RASH MACULO PAPULAR56 reports
SEPTIC SHOCK55 reports
OEDEMA54 reports
INCORRECT DOSE ADMINISTERED53 reports

Report Outcomes

Out of 7,978 classified reports for FONDAPARINUX SODIUM:

Serious 88.1%Non-Serious 11.9%

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

Female4,133 (56.3%)
Male3,157 (43.0%)
Unknown47 (0.6%)

Reports by Age

Age 70173 reports
Age 74143 reports
Age 75136 reports
Age 71135 reports
Age 72130 reports
Age 80129 reports
Age 73127 reports
Age 68126 reports
Age 69123 reports
Age 77122 reports
Age 65115 reports
Age 60114 reports
Age 83114 reports
Age 67113 reports
Age 62110 reports
Age 79110 reports
Age 78108 reports
Age 81106 reports
Age 66105 reports
Age 64104 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 FONDAPARINUX SODIUM?

This profile reflects 13,905 FDA FAERS reports that mention FONDAPARINUX SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FONDAPARINUX SODIUM?

Frequently reported terms in FAERS include ANAEMIA, HAEMATOMA, PULMONARY EMBOLISM, OFF LABEL USE, HAEMORRHAGE, HAEMOGLOBIN DECREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FONDAPARINUX SODIUM?

Labeling and FAERS entries often list Mylan Institutional LLC in connection with FONDAPARINUX 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.