This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Refludan (Lepirudin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (8)
Death (2)
Reports by Reaction Type
Haemorrhage (2),
Injection Site Extravasation (2),
Embolism (2),
Hypersensitivity (1),
Respiratory Disorder (1),
Myocardial Ischaemia (1),
Hyperaemia (1),
Wound Haemorrhage (1),
Activated Partial Thromboplastin Time Prolonged (1),
Death (1),
Skin Discolouration (1),
Hydrocephalus (1)
Possible Refludan side effects in
Reported by a consumer/non-health professional from United States on 2012-04-10
Patient:
Reactions: Injection Site Extravasation
Drug(s) suspected as cause:
Refludan
Possible Refludan side effects in
Reported by a pharmacist from United States on 2012-04-10
Patient:
Reactions: Injection Site Extravasation
Drug(s) suspected as cause:
Refludan
Possible Refludan side effects in 32 year old female
Reported by a physician from United Kingdom on 2012-04-05
Patient: 32 year old female
Reactions: Death, Subdural Haematoma, Brain Herniation, Cerebral Infarction, Hydrocephalus, Intracranial Venous Sinus Thrombosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Refludan
Other drugs received by patient: Alteplase; Plasma; Warfarin Sodium
Possible Refludan side effects in
Reported by a physician from United States on 2012-02-24
Patient:
Reactions: Limb Amputation, Hypersensitivity, Respiratory Disorder, Pneumonia, Haemorrhage, Haemorrhage Intracranial, Myocardial Ischaemia, Cerebrovascular Accident, Multi-Organ Failure, Renal Failure, Cardiac Failure, Embolism, Sepsis, Ventricular Fibrillation, Septic Shock, Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Refludan
Other drugs received by patient: Phenprocoumon; Ticlopidin; Aspirin
Possible Refludan side effects in male
Reported by a physician from United Kingdom on 2012-02-10
Patient: male
Reactions: Renal Impairment
Drug(s) suspected as cause:
Refludan
Possible Refludan side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-03
Patient: male
Reactions: Activated Partial Thromboplastin Time Prolonged, Skin Discolouration, Hyperaemia
Drug(s) suspected as cause:
Refludan
Other drugs received by patient: Norvasc; Sildenafil
Possible Refludan side effects in
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2011-10-27
Patient:
Reactions: Haemorrhage, Embolism, Thrombocytopenia
Drug(s) suspected as cause:
Refludan
Possible Refludan side effects in 48 year old female
Reported by a individual with unspecified qualification from United States on 2011-10-14
Patient: 48 year old female
Reactions: Pain, Hypoaesthesia, Asthenia, Wound Haemorrhage
Drug(s) suspected as cause:
Activase
Indication: Aortic Thrombosis
Aspirin
Indication: Aortic Thrombosis
Refludan
Indication: Aortic Thrombosis
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