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Cyklokapron (Tranexamic Acid) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cyklokapron (Tranexamic Acid) 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 (10)
Death (2)

Reports by Reaction Type

Pulmonary Embolism (4)Hypersensitivity (1)Accidental Overdose (1)Cerebral Ischaemia (1)Encephalocele (1)Death (1)LOW SET Ears (1)Drug Administration Error (1)Dizziness (1)External Auditory Canal Atresia (1)Myocardial Infarction (1)Umbilical Hernia (1)

Possible Cyklokapron side effects in 70 year old male

Reported by a physician from Switzerland on 2012-06-26

Patient: 70 year old male, weighing 69.0 kg (151.8 pounds)

Reactions: Cerebral Ischaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cyklokapron
    Dosage: 2.5 g, qd
    Administration route: Oral
    Start date: 2012-05-27

Cyklokapron
    Dosage: 1.5 g, qd
    Administration route: Oral
    Start date: 2012-05-28
    End date: 2012-06-01

Cyklokapron
    Dosage: 1 g, tid
    Administration route: Oral
    Indication: Haemorrhage
    Start date: 2012-05-22
    End date: 2012-05-26

Novoseven
    Dosage: 31 mg, qd
    Indication: Factor Viii Deficiency
    Start date: 2012-05-23

Novoseven
    Dosage: 40 mg, qd
    Start date: 2012-05-24

Novoseven
    Dosage: 19 mg, qd
    Indication: Gastrointestinal Haemorrhage
    Start date: 2012-05-22

Novoseven
    Dosage: 21 mg, qd
    Start date: 2012-05-25



Possible Cyklokapron side effects in

Reported by a pharmacist from United States on 2012-04-18

Patient:

Reactions: Pulmonary Embolism

Drug(s) suspected as cause:
Cyklokapron
    Dosage: 1000 mg, unk
    Indication: Procoagulant Therapy
    Start date: 2012-03-01
    End date: 2012-03-01

Lovenox
    Dosage: unk
    Indication: Thrombosis Prophylaxis
    Start date: 2012-03-01



Possible Cyklokapron side effects in 60 year old male

Reported by a pharmacist from United States on 2012-04-18

Patient: 60 year old male

Reactions: Pulmonary Embolism

Drug(s) suspected as cause:
Cyklokapron
    Dosage: 1000 mg, unk
    Indication: Procoagulant Therapy
    Start date: 2012-03-01
    End date: 2012-03-01

Lovenox
    Dosage: unk
    Indication: Deep Vein Thrombosis
    Start date: 2012-03-01



Possible Cyklokapron side effects in

Reported by a pharmacist from United States on 2012-04-18

Patient:

Reactions: Pulmonary Embolism

Drug(s) suspected as cause:
Cyklokapron
    Dosage: 1000 mg, unk
    Indication: Procoagulant Therapy
    Start date: 2012-03-01
    End date: 2012-03-01

Lovenox
    Dosage: unk
    Indication: Thrombosis Prophylaxis
    Start date: 2012-03-01



Possible Cyklokapron side effects in

Reported by a pharmacist from United States on 2012-04-18

Patient:

Reactions: Pulmonary Embolism

Drug(s) suspected as cause:
Cyklokapron
    Dosage: 1000 mg, unk
    Indication: Procoagulant Therapy
    Start date: 2012-03-01
    End date: 2012-03-01

Lovenox
    Dosage: unk
    Indication: Thrombosis Prophylaxis
    Start date: 2012-03-01



Possible Cyklokapron side effects in 71 year old male

Reported by a pharmacist from Australia on 2012-04-17

Patient: 71 year old male

Reactions: Death, Drug Administration Error, Accidental Overdose

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyklokapron
    Dosage: 1 g, every 4 hrs

Cyklokapron
    Dosage: 5 g given instead of 1g



Possible Cyklokapron side effects in 55 year old male

Reported by a physician from Austria on 2012-04-04

Patient: 55 year old male

Reactions: Cardiomyopathy

Drug(s) suspected as cause:
Cyklokapron



Possible Cyklokapron side effects in male

Reported by a physician from Germany on 2012-04-04

Patient: male, weighing 3.1 kg (6.8 pounds)

Reactions: LOW SET Ears, External Auditory Canal Atresia, Umbilical Hernia, Maternal Exposure Timing Unspecified, Encephalocele, Facial Asymmetry

Drug(s) suspected as cause:
Cyklokapron

Other drugs received by patient: Folic Acid



Possible Cyklokapron side effects in female

Reported by a pharmacist from United States on 2012-04-04

Patient: female, weighing 96.1 kg (211.5 pounds)

Reactions: Rash Generalised, Hypotension, Renal Failure Acute

Drug(s) suspected as cause:
Cyklokapron

Other drugs received by patient: Diovan



Possible Cyklokapron side effects in female

Reported by a consumer/non-health professional from Australia on 2011-11-09

Patient: female

Reactions: Hypersensitivity, Dizziness, Hypoaesthesia, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyklokapron

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