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Urso 250 (Ursodiol) - Sudden Cardiac Death - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Sudden Cardiac Death (4)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Urso 250 (Ursodiol) where reactions include sudden cardiac death. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Urso 250 side effects in male

Reported by a physician from Japan on 2012-05-18

Patient: male, weighing 163.0 kg (358.6 pounds)

Reactions: Sudden Cardiac Death

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aliskiren
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-10-05

Lasix
    Dosage: 80 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2002-03-06

Motilium
    Dosage: 30 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-03-25

Lendormin
    Dosage: 0.25 mg, unk
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-04-10
    End date: 2012-05-02

Xalatan
    Dosage: 1 gtt, unk
    Indication: Glaucoma
    Start date: 2004-01-30

Diart
    Dosage: 40 mg, unk
    Indication: Cardiac Failure Chronic
    Start date: 2012-04-16

Felbinac
    Dosage: unk
    Indication: Lumbar Spinal Stenosis
    Start date: 2011-09-09

Lasix
    Dosage: 60 mg, unk
    Administration route: Oral
    Start date: 2008-08-25

Hyalein
    Dosage: 2 gtt, unk
    Indication: DRY Eye
    Start date: 2011-10-28

Enalapril Maleate
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-10-05

Warfarin Sodium
    Dosage: 3 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2009-11-03

Warfarin Sodium
    Dosage: 3 mg, daily (alternate day therapy)
    Administration route: Oral
    Start date: 2009-12-01
    End date: 2009-12-28

Aldactone
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2004-01-28

Feltase
    Dosage: 1080 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-03-25

Allopurinol
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Hyperuricaemia
    Start date: 2007-06-19

Gascon
    Dosage: 320 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-06-22

Gascon
    Dosage: 240 mg, unk
    Administration route: Oral
    Start date: 2009-06-22

Azopt
    Dosage: 1 gtt, unk
    Start date: 2004-01-30

Warfarin Sodium
    Dosage: 3.25 mg, daily (alternate day therapy)
    Administration route: Oral
    Start date: 2009-12-02
    End date: 2009-12-28

Lasix
    Dosage: 20 mg, qd
    Administration route: Oral

Xalatan
    Dosage: 2 gtt, unk
    Start date: 2004-01-30
    End date: 2012-05-02

Trinosin
    Dosage: 3 g, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Pletal
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Sermion
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Bufferin
    Dosage: 81 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2002-03-06

Azopt
    Dosage: 2 gtt, unk
    Indication: Glaucoma
    Start date: 2004-01-30

Warfarin Sodium
    Dosage: 2.25 mg, unk
    Administration route: Oral
    Start date: 2012-04-16

Pletal
    Dosage: 50 mg, unk
    Administration route: Oral
    Start date: 2007-10-01

LAC B
    Dosage: 3 g, unk
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2009-09-14
    End date: 2009-12-28

Urso 250
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Hepatic Function Abnormal
    Start date: 2011-08-29

Limaprost
    Dosage: 15 ug, unk
    Administration route: Oral
    Indication: Lumbar Spinal Stenosis
    Start date: 2002-03-06

Mecobalamin
    Dosage: 0.5 mg, unk
    Administration route: Oral
    Indication: Lumbar Spinal Stenosis
    Start date: 2011-09-09

Other drugs received by patient: Gasmotin; Adenosine



Possible Urso 250 side effects in male

Reported by a physician from Japan on 2012-05-16

Patient: male, weighing 163.0 kg (358.6 pounds)

Reactions: Sudden Cardiac Death

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Warfarin Sodium
    Dosage: 3 mg, daily (alternate day therapy)
    Administration route: Oral
    Start date: 2009-12-01
    End date: 2009-12-28

Azopt
    Dosage: 2 gtt, unk
    Indication: Glaucoma
    Start date: 2004-01-30

Bufferin
    Dosage: 81 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2002-03-06

Xalatan
    Dosage: 2 gtt, unk
    Start date: 2004-01-30
    End date: 2012-05-02

Azopt
    Dosage: 1 gtt, unk
    Start date: 2004-01-30

Hyalein
    Dosage: 2 gtt, unk
    Indication: DRY Eye
    Start date: 2011-10-28

Felbinac
    Dosage: unk
    Indication: Lumbar Spinal Stenosis
    Start date: 2011-09-09

Motilium
    Dosage: 30 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-03-25

Lendormin
    Dosage: 0.25 mg, unk
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-04-10
    End date: 2012-05-02

Xalatan
    Dosage: 1 gtt, unk
    Indication: Glaucoma
    Start date: 2004-01-30

Lasix
    Dosage: 20 mg, qd
    Administration route: Oral

Mecobalamin
    Dosage: 0.5 mg, unk
    Administration route: Oral
    Indication: Lumbar Spinal Stenosis
    Start date: 2011-09-09

Aliskiren
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-10-05

Warfarin Sodium
    Dosage: 3 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2009-11-03

Lasix
    Dosage: 80 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2002-03-06

Sermion
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Trinosin
    Dosage: 3 g, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Limaprost
    Dosage: 15 ug, unk
    Administration route: Oral
    Indication: Lumbar Spinal Stenosis
    Start date: 2002-03-06

Enalapril Maleate
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-10-05

Warfarin Sodium
    Dosage: 3.25 mg, daily (alternate day therapy)
    Administration route: Oral
    Start date: 2009-12-02
    End date: 2009-12-28

Warfarin Sodium
    Dosage: 2.25 mg, unk
    Administration route: Oral
    Start date: 2012-04-16

Gascon
    Dosage: 320 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-06-22

Pletal
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Pletal
    Dosage: 50 mg, unk
    Administration route: Oral
    Start date: 2007-10-01

Allopurinol
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Hyperuricaemia
    Start date: 2007-06-19

LAC B
    Dosage: 3 g, unk
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2009-09-14
    End date: 2009-12-28

Diart
    Dosage: 40 mg, unk
    Indication: Cardiac Failure Chronic
    Start date: 2012-04-16

Lasix
    Dosage: 60 mg, unk
    Administration route: Oral
    Start date: 2008-08-25

Aldactone
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2004-01-28

Gascon
    Dosage: 240 mg, unk
    Administration route: Oral
    Start date: 2009-06-22

Feltase
    Dosage: 1080 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-03-25

Urso 250
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Hepatic Function Abnormal
    Start date: 2011-08-29

Other drugs received by patient: Adenosine; Gasmotin



Possible Urso 250 side effects in male

Reported by a physician from Japan on 2012-05-08

Patient: male, weighing 163.0 kg (358.6 pounds)

Reactions: Sudden Cardiac Death

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Warfarin Sodium
    Dosage: 2.25 mg, unk
    Administration route: Oral
    Start date: 2012-04-16

Diart
    Dosage: 40 mg, unk
    Indication: Cardiac Failure Chronic
    Start date: 2012-04-16

Enalapril Maleate
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-10-05

Warfarin Sodium
    Dosage: 3 mg, daily (alternate day therapy)
    Administration route: Oral
    Start date: 2009-12-01
    End date: 2009-12-28

Azopt
    Dosage: 1 gtt, unk
    Start date: 2004-01-30

Bufferin
    Dosage: 81 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2002-03-06

Pletal
    Dosage: 50 mg, unk
    Administration route: Oral
    Start date: 2007-10-01

Xalatan
    Dosage: 1 gtt, unk
    Indication: Glaucoma
    Start date: 2004-01-30

Urso 250
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Hepatic Function Abnormal
    Start date: 2011-08-29

Felbinac
    Dosage: unk
    Indication: Lumbar Spinal Stenosis
    Start date: 2011-09-09

Warfarin Sodium
    Dosage: 3.25 mg, daily (alternate day therapy)
    Administration route: Oral
    Start date: 2009-12-02
    End date: 2009-12-28

Lasix
    Dosage: 80 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2002-03-06

Lasix
    Dosage: 60 mg, unk
    Administration route: Oral
    Start date: 2008-08-25

Motilium
    Dosage: 30 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-03-25

Sermion
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Xalatan
    Dosage: 2 gtt, unk
    Start date: 2004-01-30

Aliskiren
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-11-02

Warfarin Sodium
    Dosage: 3 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2009-11-03

Aldactone
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2004-01-28

Gascon
    Dosage: 240 mg, unk
    Administration route: Oral
    Start date: 2009-06-22

Lendormin
    Dosage: 0.25 mg, unk
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-04-10

Azopt
    Dosage: 2 gtt, unk
    Indication: Glaucoma
    Start date: 2004-01-30

Pletal
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Allopurinol
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Hyperuricaemia
    Start date: 2007-06-19

Limaprost
    Dosage: 15 ug, unk
    Administration route: Oral
    Indication: Lumbar Spinal Stenosis
    Start date: 2002-03-06

Feltase
    Dosage: 1080 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-03-25

Mecobalamin
    Dosage: 0.5 mg, unk
    Administration route: Oral
    Indication: Lumbar Spinal Stenosis
    Start date: 2011-09-09

Gascon
    Dosage: 320 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-06-22

LAC B
    Dosage: 3 g, unk
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2009-09-14
    End date: 2009-12-28

Trinosin
    Dosage: 3 g, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Hyalein
    Dosage: 2 gtt, unk
    Indication: DRY Eye
    Start date: 2011-10-28

Other drugs received by patient: Gasmotin; Adenosine



Possible Urso 250 side effects in male

Reported by a physician from Japan on 2012-05-08

Patient: male, weighing 163.0 kg (358.6 pounds)

Reactions: Sudden Cardiac Death

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Warfarin Sodium
    Dosage: 3 mg, daily (alternate day therapy)
    Administration route: Oral
    Start date: 2009-12-01
    End date: 2009-12-28

Warfarin Sodium
    Dosage: 2.25 mg, unk
    Administration route: Oral
    Start date: 2012-04-16

Aldactone
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2004-01-28

Gascon
    Dosage: 320 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-06-22

Allopurinol
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Hyperuricaemia
    Start date: 2007-06-19

Xalatan
    Dosage: 1 gtt, unk
    Indication: Glaucoma
    Start date: 2004-01-30

Xalatan
    Dosage: 2 gtt, unk
    Start date: 2004-01-30

Hyalein
    Dosage: 2 gtt, unk
    Indication: DRY Eye
    Start date: 2011-10-28

Gascon
    Dosage: 240 mg, unk
    Administration route: Oral
    Start date: 2009-06-22

Pletal
    Dosage: 200 mg, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Trinosin
    Dosage: 3 g, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

Aliskiren
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-11-02

Warfarin Sodium
    Dosage: 3.25 mg, daily (alternate day therapy)
    Administration route: Oral
    Start date: 2009-12-02
    End date: 2009-12-28

Azopt
    Dosage: 1 gtt, unk
    Start date: 2004-01-30

Mecobalamin
    Dosage: 0.5 mg, unk
    Administration route: Oral
    Indication: Lumbar Spinal Stenosis
    Start date: 2011-09-09

Feltase
    Dosage: 1080 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-03-25

Lendormin
    Dosage: 0.25 mg, unk
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-04-10

Urso 250
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Hepatic Function Abnormal
    Start date: 2011-08-29

Warfarin Sodium
    Dosage: 3 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2009-11-03

Bufferin
    Dosage: 81 mg, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2002-03-06

Sermion
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2007-10-01

LAC B
    Dosage: 3 g, unk
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2009-09-14
    End date: 2009-12-28

Diart
    Dosage: 40 mg, unk
    Indication: Cardiac Failure Chronic
    Start date: 2012-04-16

Felbinac
    Dosage: unk
    Indication: Lumbar Spinal Stenosis
    Start date: 2011-09-09

Enalapril Maleate
    Dosage: unk
    Administration route: Oral
    Indication: Cardiac Failure
    Start date: 2009-10-05

Lasix
    Dosage: 60 mg, unk
    Administration route: Oral
    Start date: 2008-08-25

Motilium
    Dosage: 30 mg, unk
    Administration route: Oral
    Indication: Gastritis
    Start date: 2009-03-25

Azopt
    Dosage: 2 gtt, unk
    Indication: Glaucoma
    Start date: 2004-01-30

Limaprost
    Dosage: 15 ug, unk
    Administration route: Oral
    Indication: Lumbar Spinal Stenosis
    Start date: 2002-03-06

Lasix
    Dosage: 80 mg, unk
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2002-03-06

Pletal
    Dosage: 50 mg, unk
    Administration route: Oral
    Start date: 2007-10-01

Other drugs received by patient: Adenosine; Gasmotin

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