ARGATROBAN

N/A

Manufactured by Accord Healthcare Inc.

2,692 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ARGATROBAN

ARGATROBAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. The most commonly reported adverse reactions for ARGATROBAN include HEPARIN-INDUCED THROMBOCYTOPENIA, DRUG INEFFECTIVE, INTERNATIONAL NORMALISED RATIO INCREASED, OFF LABEL USE, ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ARGATROBAN.

Top Adverse Reactions

HEPARIN INDUCED THROMBOCYTOPENIA185 reports
DRUG INEFFECTIVE153 reports
INTERNATIONAL NORMALISED RATIO INCREASED109 reports
OFF LABEL USE99 reports
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED83 reports
HAEMORRHAGE77 reports
DEEP VEIN THROMBOSIS68 reports
PULMONARY EMBOLISM68 reports
THROMBOCYTOPENIA68 reports
COAGULATION TIME PROLONGED64 reports
THROMBOSIS56 reports
GASTROINTESTINAL HAEMORRHAGE52 reports
CEREBRAL INFARCTION50 reports
PLATELET COUNT DECREASED39 reports
DISSEMINATED INTRAVASCULAR COAGULATION38 reports
RESPIRATORY FAILURE38 reports
ANAEMIA37 reports
CEREBRAL HAEMORRHAGE37 reports
PNEUMONIA36 reports
COAGULOPATHY35 reports
HYPOTENSION35 reports
DEATH32 reports
RENAL FAILURE30 reports
HAEMOGLOBIN DECREASED29 reports
SEPSIS29 reports
DYSPNOEA28 reports
ATRIAL FIBRILLATION27 reports
CARDIAC ARREST27 reports
CONDITION AGGRAVATED26 reports
SUBARACHNOID HAEMORRHAGE23 reports
CARDIOGENIC SHOCK22 reports
NAUSEA22 reports
ASPARTATE AMINOTRANSFERASE INCREASED21 reports
DRUG INTERACTION21 reports
HEPATIC FUNCTION ABNORMAL21 reports
RENAL FAILURE ACUTE21 reports
SEPTIC SHOCK21 reports
ALANINE AMINOTRANSFERASE INCREASED20 reports
ABDOMINAL PAIN19 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME19 reports
PYREXIA19 reports
MULTI ORGAN FAILURE18 reports
RENAL IMPAIRMENT18 reports
VOMITING18 reports
CARDIAC FAILURE17 reports
DIARRHOEA17 reports
EPISTAXIS17 reports
GANGRENE17 reports
ACUTE KIDNEY INJURY16 reports
BLOOD PRESSURE DECREASED16 reports
CEREBROVASCULAR ACCIDENT16 reports
HAEMOPTYSIS16 reports
SKIN DISCOLOURATION16 reports
CARDIAC VENTRICULAR THROMBOSIS15 reports
HAEMATOMA15 reports
PERIPHERAL ISCHAEMIA15 reports
PLEURAL EFFUSION15 reports
RASH15 reports
SKIN NECROSIS15 reports
TREATMENT FAILURE15 reports
ANXIETY14 reports
DRUG RESISTANCE14 reports
GENERAL PHYSICAL HEALTH DETERIORATION14 reports
HAEMATEMESIS14 reports
HAEMORRHAGIC CEREBRAL INFARCTION14 reports
MELAENA14 reports
PAIN14 reports
RHABDOMYOLYSIS14 reports
CARDIAC FAILURE CONGESTIVE13 reports
CARDIO RESPIRATORY ARREST13 reports
HEADACHE13 reports
HYPOXIA13 reports
PROTHROMBIN TIME PROLONGED13 reports
SHOCK HAEMORRHAGIC13 reports
THROMBOSIS IN DEVICE13 reports
CHEST PAIN12 reports
EMBOLISM12 reports
LIVER FUNCTION TEST ABNORMAL12 reports
MYOCARDIAL INFARCTION12 reports
OVERDOSE12 reports
PAIN IN EXTREMITY12 reports
PULMONARY HAEMORRHAGE12 reports
BLISTER11 reports
BLOOD ALKALINE PHOSPHATASE INCREASED11 reports
BLOOD BILIRUBIN INCREASED11 reports
DRY GANGRENE11 reports
HAEMATOCHEZIA11 reports
HAEMORRHAGE INTRACRANIAL11 reports
HEPATIC FAILURE11 reports
ISCHAEMIC STROKE11 reports
LIVER DISORDER11 reports
PRODUCT USE IN UNAPPROVED INDICATION11 reports
PULMONARY ALVEOLAR HAEMORRHAGE11 reports
RECTAL HAEMORRHAGE11 reports
UNRESPONSIVE TO STIMULI11 reports
VENA CAVA THROMBOSIS11 reports
ACTIVATED PARTIAL THROMBOPLASTIN TIME SHORTENED10 reports
ANAPHYLACTIC REACTION10 reports
CARDIAC TAMPONADE10 reports
HYPOFIBRINOGENAEMIA10 reports

Report Outcomes

Out of 1,463 classified reports for ARGATROBAN:

Serious 87.1%Non-Serious 12.9%

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

Male698 (54.0%)
Female585 (45.3%)
Unknown9 (0.7%)

Reports by Age

Age 7545 reports
Age 7041 reports
Age 6339 reports
Age 6136 reports
Age 5933 reports
Age 6433 reports
Age 6833 reports
Age 6532 reports
Age 5031 reports
Age 5730 reports
Age 6729 reports
Age 6026 reports
Age 6926 reports
Age 7826 reports
Age 6625 reports
Age 7123 reports
Age 5322 reports
Age 5622 reports
Age 6222 reports
Age 5819 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 ARGATROBAN?

This profile reflects 2,692 FDA FAERS reports that mention ARGATROBAN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ARGATROBAN?

Frequently reported terms in FAERS include HEPARIN-INDUCED THROMBOCYTOPENIA, DRUG INEFFECTIVE, INTERNATIONAL NORMALISED RATIO INCREASED, OFF LABEL USE, ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED, HAEMORRHAGE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ARGATROBAN?

Labeling and FAERS entries often list Accord Healthcare Inc. in connection with ARGATROBAN. 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.