Index of reports
> Cases with Off Label Use (36)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arixtra (Fondaparinux Injection) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 36 Next >>
Possible Arixtra side effects in female
Reported by a physician from France on 2012-06-29
Patient: female, weighing 49.9 kg (109.8 pounds)
Reactions: Off Label Use, Subdural Haematoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Omeprazole; Tercian; Plavix; Anafranil
Possible Arixtra side effects in female
Reported by a lawyer from France on 2012-06-27
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Gastrointestinal Haemorrhage, Disseminated Intravascular Coagulation, Laryngeal Oedema, Lactic Acidosis, Pallor, Haematemesis, Haemodynamic Instability, Off Label Use, Cardio-Respiratory Arrest, Cyanosis, Hepatocellular Injury, Blood Pressure Immeasurable, Mydriasis, General Physical Health Deterioration, Arrhythmia, Pigmentation Disorder, Bradycardia, Cardiac Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Arixtra
Dosage: 7.5mg per day
Indication: Atrial Fibrillation
Start date: 2011-01-17
End date: 2011-01-27
Prednisolone
Dosage: 3tab in the morning
Administration route: Oral
Indication: Cough
Start date: 2011-01-18
End date: 2011-01-22
Other drugs received by patient: Xanax; Acetaminophen; Calcium Carbonate; Boniva; Paroxetine; Acamprosate Calcium; Cefazolin; Dressing; Levothyroxine Sodium; Lasix; Biseptine; Pentoxifylline; Propranolol; Digoxin; Lovenox; Zolpidem; Compresses; Vastarel; Arimidex
Possible Arixtra side effects in female
Reported by a physician from France on 2012-06-22
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Mydriasis, Gastrointestinal Haemorrhage, Disseminated Intravascular Coagulation, Lactic Acidosis, Pallor, Haemodynamic Instability, Haematemesis, Off Label Use, Cardio-Respiratory Arrest, Cyanosis, Hepatocellular Injury, Pigmentation Disorder, Bradycardia, Blood Pressure Immeasurable, Cardiac Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Arixtra
Dosage: 7.5mg per day
Indication: Atrial Fibrillation
Start date: 2011-01-17
End date: 2011-01-27
Prednisolone
Dosage: 3tab in the morning
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-18
Other drugs received by patient: Calcium Carbonate; Propranolol; Lasix; Boniva; Paroxetine; Dressing; Levothyroxine Sodium; Pentoxifylline; Lovenox; Digoxin; Acetaminophen; Acamprosate Calcium; Zolpidem; Arimidex; Cefazolin; Vastarel; Arimidex; Xanax; Biseptine; Compresses
Possible Arixtra side effects in male
Reported by a consumer/non-health professional from France on 2012-06-08
Patient: male
Reactions: Off Label Use, Mydriasis, Subdural Haematoma, Coma, Hemiparesis, Headache, Cerebral Haemorrhage
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Lovenox
Dosage: .4ml per day
Indication: Thrombosis Prophylaxis
Start date: 2009-07-18
End date: 2009-07-20
Arixtra
Dosage: 2.5mg per day
Indication: Thrombosis Prophylaxis
Start date: 2009-07-21
End date: 2009-07-22
Possible Arixtra side effects in 83 year old female
Reported by a physician from France on 2012-06-06
Patient: 83 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: Agitation, Confusional State, Encephalomalacia, Dilatation Ventricular, Disorientation, Somnolence, Convulsion, Off Label Use, Cerebellar Haematoma, Nervous System Disorder, Disturbance in Attention, Memory Impairment
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Dosage: 7.5mg per day
Indication: Atrial Fibrillation
End date: 2012-04-12
Pentoxifylline
Dosage: 10mg per day
Administration route: Oral
Indication: Atrial Fibrillation
End date: 2012-04-12
Other drugs received by patient: Irbesartan and Hydrochlorothiazide; Bisoprolol Fumarate; Vitamin D; Fenofibrate; Rhinocort; Cordarone; Nexium; Lercanidipine
Possible Arixtra side effects in 83 year old female
Reported by a physician from France on 2012-05-25
Patient: 83 year old female
Reactions: Agitation, Confusional State, Encephalomalacia, Dilatation Ventricular, Disorientation, Somnolence, Convulsion, Off Label Use, Cerebellar Haematoma, Nervous System Disorder, Disturbance in Attention, Memory Impairment
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Dosage: 7.5mg per day
Indication: Atrial Fibrillation
End date: 2012-04-12
Pentoxifylline
Dosage: 10mg per day
Administration route: Oral
Indication: Atrial Fibrillation
End date: 2012-04-12
Other drugs received by patient: Rhinocort; Cordarone; Lercanidipine; Nexium; Irbesartan; Bisoprolol Fumarate; Vitamin D; Fenofibrate
Possible Arixtra side effects in 76 year old male
Reported by a physician from France on 2012-05-16
Patient: 76 year old male
Reactions: Off Label Use, Coma, Cerebral Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Novolog; Baclofen; Amaryl; Acetaminophen; Folic Acid; Toco 500
Possible Arixtra side effects in female
Reported by a physician from France on 2012-05-11
Patient: female, weighing 115.0 kg (253.0 pounds)
Reactions: Off Label Use, Injection Site Haematoma, Oedema Peripheral, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aspirin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-02-05
Arixtra
Dosage: 7.5mg per day
Indication: Deep Vein Thrombosis
Start date: 2012-02-01
End date: 2012-02-05
Other drugs received by patient: Paroxetine; Atarax; Diamicron; Acetaminophen; Piascledine; Acetaminophen; Beclomethasone Dipropionate + Formoterol; Fenofibrate; Metformin HCL; Bromazepam; Moviprep; Zopiclone; Nexium; Levemir; Indapamide; Oxygen Therapy
Possible Arixtra side effects in 69 year old female
Reported by a physician from France on 2012-05-07
Patient: 69 year old female
Reactions: Off Label Use, Hyperthermia, Purpura, Toxic Skin Eruption, Eosinophilia, Prurigo
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Augmentin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-08-09
Pyostacine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-08-07
End date: 2010-08-09
Arixtra
Indication: Product Used FOR Unknown Indication
Start date: 2010-08-07
End date: 2010-08-09
Possible Arixtra side effects in female
Reported by a physician from France on 2012-04-23
Patient: female
Reactions: Off Label Use, Injection Site Haematoma, Oedema Peripheral, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aspirin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-02-04
Arixtra
Dosage: 7.5mg per day
Indication: Deep Vein Thrombosis
Start date: 2012-02-01
End date: 2012-02-05
Other drugs received by patient: Bromazepam; Beclomethasone Dipropionate + Formoterol; Levemir; Metformin HCL; Acetaminophen; Paroxetine; Atarax; Indapamide; Piascledine; Nexium; Fenofibrate; Zopiclone; Oxygen Therapy; Diamicron; Moviprep; Acetaminophen
Possible Arixtra side effects in female
Reported by a physician from France on 2012-04-19
Patient: female
Reactions: Muscle Haemorrhage, Off Label Use, Skin Lesion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Depakote; Oxazepam; Zolpidem Tartrate; Sulfarlem; Paroxetine Hydrochloride; Zoloft; Aspirin; Risperdal; Polyethylene Glycol
Possible Arixtra side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-16
Patient: female
Reactions: Off Label Use, Heparin-Induced Thrombocytopenia, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Possible Arixtra side effects in male
Reported by a physician from France on 2012-04-16
Patient: male
Reactions: Pain in Extremity, Anaemia, Groin Pain, Muscle Haemorrhage, Off Label Use, Arthropathy, Overdose, Arthralgia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Kerlone; Olmesartan Medoxomil; Mediatensyl; Aspirin; Esidrix; Zolpidem Tartrate; Lercanidipine
Possible Arixtra side effects in 75 year old female
Reported by a physician from France on 2012-04-12
Patient: 75 year old female, weighing 55.0 kg (121.0 pounds)
Reactions: Off Label Use, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Lercanidipine; Atenolol
Possible Arixtra side effects in male
Reported by a physician from France on 2012-04-12
Patient: male
Reactions: Off Label Use, Dermatitis Allergic, Pruritus Generalised, Rash Erythematous
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Cordarone
Possible Arixtra side effects in 74 year old male
Reported by a physician from France on 2012-04-09
Patient: 74 year old male, weighing 79.0 kg (173.8 pounds)
Reactions: Off Label Use, Incorrect Drug Administration Duration, Haematoma
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Atorvastatin; Furosemide; Acetaminophen and Tramadol HCL; Omeprazole; Bisoprolol Fumarate; Acetaminophen and Codeine Phosphate
Possible Arixtra side effects in 51 year old female
Reported by a physician from France on 2012-04-05
Patient: 51 year old female
Reactions: Muscle Haemorrhage, Off Label Use
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Dosage: 7.5mg per day
Indication: Deep Vein Thrombosis
Start date: 2012-03-04
End date: 2012-03-10
Aspirin
Dosage: 75mg per day
Administration route: Oral
Indication: Prophylaxis
Other drugs received by patient: Paroxetine Hydrochloride; Zoloft; Depakote; Risperdal; Oxazepam; Sulfarlem; Zolpidem Tartrate
Possible Arixtra side effects in female
Reported by a consumer/non-health professional from France on 2012-04-02
Patient: female
Reactions: Off Label Use, Heparin-Induced Thrombocytopenia, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Possible Arixtra side effects in female
Reported by a physician from France on 2012-03-30
Patient: female, weighing 49.9 kg (109.8 pounds)
Reactions: Off Label Use, Subdural Haematoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Anafranil; Tercian; Plavix; Omeprazole
Possible Arixtra side effects in female
Reported by a physician from France on 2012-03-29
Patient: female
Reactions: Agitation, Gastrointestinal Haemorrhage, Vomiting, Hypotension, Anaemia, Muscular Weakness, Fall, Haematemesis, Off Label Use, Blood Creatinine, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Previscan
Dosage: 10mg per day
Administration route: Oral
Indication: Atrial Flutter
Start date: 2011-02-21
Arixtra
Dosage: 7.5mg per day
Indication: Atrial Flutter
Start date: 2011-02-21
End date: 2011-02-24
Other drugs received by patient: Citalopram Hydrobromide; Levothyroxine Sodium; Flecainide Acetate; Pravastatin; Bisoprolol Fumarate; Lorazepam; Digoxin; Cordarone; Omeprazole
Possible Arixtra side effects in 75 year old female
Reported by a physician from France on 2012-03-26
Patient: 75 year old female
Reactions: Off Label Use, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Atenolol; Lercanidipine
Possible Arixtra side effects in female
Reported by a physician from France on 2012-03-09
Patient: female
Reactions: Muscle Haemorrhage, Off Label Use, Incorrect Drug Administration Duration, Anaemia, Walking Disability
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Bisoprolol Fumarate; Pantoprazole; Furosemide; Zolpidem
Possible Arixtra side effects in female
Reported by a physician from France on 2012-03-09
Patient: female, weighing 49.9 kg (109.8 pounds)
Reactions: Off Label Use, Subdural Haematoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Plavix; Omeprazole; Anafranil; Tercian
Possible Arixtra side effects in male
Reported by a physician from Germany on 2012-03-08
Patient: male, weighing 75.0 kg (165.0 pounds)
Reactions: Off Label Use, Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Metoprolol Tartrate; Clopidogrel
Possible Arixtra side effects in male
Reported by a physician from Germany on 2012-03-05
Patient: male
Reactions: Off Label Use, Haemorrhage
Drug(s) suspected as cause:
Arixtra
Possible Arixtra side effects in male
Reported by a physician from France on 2012-03-02
Patient: male
Reactions: Off Label Use, Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Previscan
Dosage: 20mg see dosage text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2011-01-01
Arixtra
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
End date: 2011-09-06
Other drugs received by patient: Corvasal; Atenolol; Omeprazole; Nitroderm; Aldactone; Depakene; Amlodipine Besylate; Prozac; Enalapril Maleate and Hydrochlorothiazide
Possible Arixtra side effects in female
Reported by a physician from France on 2012-02-27
Patient: female
Reactions: Off Label Use, Subdural Haematoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Omeprazole; Plavix; Anafranil; Tercian
Possible Arixtra side effects in 48 year old male
Reported by a physician from France on 2012-02-24
Patient: 48 year old male
Reactions: Off Label Use, Anaemia, Asthenia, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Other drugs received by patient: Daflon; UN-Alpha; Potassium Chloride; Polyethylene Glycol; Lasix; Omeprazole; Loxen; Atorvastatin
Possible Arixtra side effects in 57 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-16
Patient: 57 year old male, weighing 187.0 kg (411.4 pounds)
Reactions: Off Label Use, Haemorrhage, Superinfection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arixtra
Possible Arixtra side effects in 84 year old female
Reported by a pharmacist from France on 2012-01-20
Patient: 84 year old female, weighing 67.0 kg (147.4 pounds)
Reactions: Off Label Use, Injection Site Haematoma, Anaemia, Haematoma
Drug(s) suspected as cause:
Aspirin
Administration route: Oral
Indication: Venous Stent Insertion
Start date: 2011-01-01
Arixtra
Dosage: 7.5mg per day
Indication: Arrhythmia
Start date: 2011-12-19
Plavix
Administration route: Oral
Indication: Venous Stent Insertion
Start date: 2011-01-01
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