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Refludan

More information: STITCH, PubChem and possibly Wikipedia

ATC Code: B01AE02

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4
Anaemia Anaemia 1.1% - 13.1% x x x x
Haemoglobin decreased Haemoglobin decreased 1.1% - 13.1% x x x
Haematoma Haematoma 4.4% - 11.1% x x x x
Wound Wound 4.4% - 14.1% x x x
Haemorrhage Haemorrhage 0.7% - 21.5% x x x x
Haemoglobin Haemorrhage 0.7% - 21.5% x x x x
Rectal haemorrhage Rectal haemorrhage 5.1% - 6.6% x x x x
Pneumonia Pneumonia 5% x x x
Multi-organ failure Multi-organ failure 4% x x x
Aspartate aminotransferase increased Aspartate aminotransferase increased 3% x
Sepsis Sepsis 3% x x x
Body temperature increased Body temperature increased 2.5% - 3% x x x
Fever chills x
Haematuria Haematuria 0% - 6.6% x x x x
Injection site haemorrhage Injection site haemorrhage 1.9% - 2.1% x
Prothrombin level increased Prothrombin level increased 1.5% x
Vaginal haemorrhage Vaginal haemorrhage 0% - 1.8% x x x x
Epistaxis Epistaxis 0.6% - 4.4% x x x x
Haemothorax Haemothorax 0% - 3% x x x x
Shock Shock postmarketing, 2% x x x x
Eczema Eczema 1% x
Dermatitis Rash 1% x x x x
Rash Rash 1% x x x x
Gastrointestinal haemorrhage Gastrointestinal haemorrhage 0.7% - 1.3% x x
Hypersensitivity Hypersensitivity 1% x x x
Anaphylactic shock Anaphylactic shock postmarketing x x x
Haemorrhage intracranial Haemorrhage intracranial postmarketing, 0% - 2.2% x x x x
Abscess Abscess x
Angioedema Angioedema x x x x
Bronchospasm Bronchospasm x x x
Infection Infection x x
Confusional state Confusional state x
Feeling abnormal Confusional state x
Coronary artery thrombosis Coronary artery thrombosis x
Cough Cough x x x x
Diarrhoea Diarrhoea x
Dyspepsia Dyspepsia x
Dyspnoea Dyspnoea x x x x
Oedema Oedema x x x
Flushing Flushing x x x
Gastritis Gastritis x
Gingival bleeding Gingival bleeding x
Headache Headache x
Cardiac arrest Cardiac arrest x
Cardiac failure Cardiac failure x x
Haematemesis Haematemesis x
Pericardial haemorrhage Pericardial haemorrhage x
Peritoneal haemorrhage Peritoneal haemorrhage x x x
Haemoptysis Haemoptysis x x x
Hypotension Hypotension x
Immune system disorder Immune system disorder x
Laryngeal oedema Laryngeal oedema x x x x
Mediastinal disorder Mediastinal disorder x
Nausea Nausea x
Mouth haemorrhage Mouth haemorrhage x x x
Pain Pain x x
Pericardial effusion Pericardial effusion x x x
Pruritus Pruritus x x x x
Pulmonary embolism Pulmonary embolism x
Convulsion Convulsion x
Stridor Stridor x x x x
Superinfection Superinfection x
Thrombophlebitis Thrombophlebitis x
Urticaria Urticaria x x x x
Angiopathy Angiopathy x
Vasodilation procedure Vasodilation x
Ventricular fibrillation Ventricular fibrillation x x x
Ventricular tachycardia Ventricular tachycardia x
Vomiting Vomiting x
Chills Chills x x x
Agitation Agitation x
Hepatic function abnormal Hepatic function abnormal x x
Antinuclear antibody positive Antinuclear antibody positive x
Tongue disorder Tongue oedema x x x x
Tongue oedema Tongue oedema x x x x
Pulmonary haemorrhage Pulmonary haemorrhage x x
Retroperitoneal haemorrhage Retroperitoneal haemorrhage x x x
Injection site reaction Injection site reaction x x
Renal impairment Kidney function abnormal x x
Liver function test abnormal Liver function test abnormal x
Skin necrosis Skin necrosis x
Skin exfoliation Skin necrosis x
Injection site pain Injection site pain x
Arterial thrombosis Arterial thrombosis x
Acute myocardial infarction Acute myocardial infarction x x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x
Bradycardia Bradycardia x
Subcutaneous haematoma Subcutaneous haematoma x
Face oedema Face oedema x x x x
Hypovolaemia Hypovolaemia x
Surgery Surgical intervention x
Menopausal symptoms Hot flush x
Hot flush Hot flush x
Blood creatinine increased Serum creatinine increased x
Hyperhidrosis Sweating increased x
Skin haemorrhage Skin haemorrhage x
Insomnia Insomnia x
Gastritis haemorrhagic Gastritis haemorrhagic x

Indications

Information about indications was extracted from the indications and usage sections of the labels.

lepirudin / lepirudin

Side effects:31
Source:EMA

LEPIRUDIN

Side effects:43
Source:FDA Structured Product Label

LEPIRUDIN RECOMBINANT / REFLUDAN

Side effects:43
Source:FDA

LEPIRUDIN / REFLUDAN

Side effects:80
Source:Health Canada

Color scheme:

standard – alternative

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    infrequent (0.1% to 1%)
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    postmarketing
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    no frequency information
    not found on label