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Fragmin (Dalteparin) - Colitis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Colitis (8)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fragmin (Dalteparin) where reactions include colitis. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Fragmin side effects in 59 year old female

Reported by a consumer/non-health professional from Germany on 2012-02-20

Patient: 59 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Vascular Occlusion, Diarrhoea, Neoplasm Malignant, Respiratory Failure, Colitis, Pancytopenia, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fragmin
    Dosage: 5000 ie
    Start date: 2011-09-09
    End date: 2011-09-27

Aspirin
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 1996-07-01
    End date: 2011-10-06

Ipilimumab
    Dosage: interrupted:10aug11. also took 162mg 02-02sep11.
    Indication: Malignant Melanoma
    Start date: 2011-07-19
    End date: 2011-09-02

Prednisolone
    Dosage: 14sep-26sep-150mg,60 mg 26sep11 to 29sep11 150 mg iv 30sep11 to 11oct11, 7.5mg 20ju-9sep11,
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2011-09-14
    End date: 2011-10-11

Other drugs received by patient: Mesalamine; Arixtra; Methylprednisolone; Zopiclon; Pantoprazole; Lactobacillus; Arixtra



Possible Fragmin side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: 59 year old female

Reactions: Vomiting, Paresis, Vascular Occlusion, Unresponsive To Stimuli, Pancytopenia, Sensory Loss, Disease Progression, Cerebral Haemorrhage, Diarrhoea, Respiratory Failure, Neoplasm Malignant, Colitis, Large Intestinal Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 171 mg, unk
    Indication: Malignant Melanoma
    Start date: 2011-07-19

Fragmin
    Dosage: unk ukn, unk
    Start date: 2011-09-09
    End date: 2011-09-27

Prednisolone
    Dosage: 60 mg, unk
    Administration route: Oral
    Start date: 2011-09-27

Acetylsalicylic Acid SRT
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 1996-07-01
    End date: 2011-10-06

Prednisolone
    Dosage: 150 mg, unk
    Administration route: Oral
    Indication: Colitis
    Start date: 2011-09-14

Ipilimumab
    Dosage: 162 mg, unk
    Start date: 2011-09-02

Other drugs received by patient: Methylprednisolone; Metronidazole; Lactobacillus; Nadroparin; Ciprofloxacin; Infliximab; Fluconazole; Loperamide HCL; Nadroparin; Filgrastim; Arixtra; Arixtra; Alprostadil; Arixtra; Heparin; Pantoprazole; Blood Cells, Packed Human; Nadroparin; Ciprofloxacin; Arixtra; Pantoprazole; Mesalamine; Blood Cells, Packed Human; Blood Cells, Packed Human; Platelets; Methylprednisolone; Zopiclon; Salofalk ^aventis^; Blood Cells, Packed Human; Clindamycin



Possible Fragmin side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-02-08

Patient: 59 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Vascular Occlusion, Neoplasm Malignant, Diarrhoea, Respiratory Failure, Colitis, Pancytopenia, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prednisolone
    Dosage: 14sep-26sep-150mg,60 mg 26sep11 to 29sep11 150 mg iv 30sep11 to 11oct11, 7.5mg 20ju-9sep11,
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2011-09-14
    End date: 2011-10-11

Ipilimumab
    Dosage: interrupted:10aug11. also took 162mg 02-02sep11.
    Indication: Malignant Melanoma
    Start date: 2011-07-19
    End date: 2011-09-02

Aspirin
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 1996-07-01
    End date: 2011-10-06

Fragmin
    Start date: 2011-09-09
    End date: 2011-09-27

Other drugs received by patient: Mesalamine; Arixtra; Zopiclon; Lactobacillus; Pantoprazole



Possible Fragmin side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-12-16

Patient: 59 year old female, weighing 52.0 kg (114.4 pounds)

Reactions: Vascular Occlusion, Respiratory Failure, Diarrhoea, Neoplasm Malignant, Pancytopenia, Colitis, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: interrupted:10aug11. also took 162mg 02-02sep11.
    Indication: Malignant Melanoma
    Start date: 2011-07-19
    End date: 2011-09-02

Prednisolone
    Dosage: 14sep-26sep-150mg,60 mg 26sep11 to 29sep11 150 mg iv 30sep11 to 11oct11, 7.5mg 20ju-9sep11,
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2011-09-14
    End date: 2011-10-11

Aspirin
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 1996-07-01
    End date: 2011-10-06

Fragmin
    Start date: 2011-09-09
    End date: 2011-09-27

Other drugs received by patient: Zopiclon; Mesalamine; Pantoprazole Sodium; Lactobacillus; Arixtra



Possible Fragmin side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2011-10-31

Patient: 59 year old female

Reactions: Vascular Occlusion, Vomiting, Paresis, Unresponsive To Stimuli, Pancytopenia, Sensory Loss, Disease Progression, Neoplasm Malignant, Diarrhoea, Colitis, Large Intestinal Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prednisolone
    Dosage: 60 mg, unk
    Administration route: Oral
    Start date: 2011-09-27

Ipilimumab
    Dosage: 162 mg, unk
    Start date: 2011-09-02

Aspirin
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 1996-07-01

Prednisolone
    Dosage: 150 mg, unk
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2011-09-14

Fragmin
    Dosage: unk ukn, unk

Ipilimumab
    Dosage: 171 mg, unk
    Indication: Malignant Melanoma
    Start date: 2011-08-10

Other drugs received by patient: Zopiclon; Pantoprazole Sodium; Mesalamine; Arixtra; Methylprednisolone; Arixtra; Nadroparin; Methylprednisolone; Arixtra; Salofalk ^aventis^; Nadroparin; Arixtra; Loperamide HCL; Lactobacillus



Possible Fragmin side effects in 59 year old female

Reported by a consumer/non-health professional from Germany on 2011-10-24

Patient: 59 year old female, weighing 52.0 kg (114.4 pounds)

Reactions: Vascular Occlusion, Respiratory Failure, Diarrhoea, Neoplasm Malignant, Pancytopenia, Colitis, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: interrupted:10aug11. also took 162mg 02-02sep11.
    Indication: Malignant Melanoma
    Start date: 2011-07-19
    End date: 2011-09-02

Prednisolone
    Dosage: 14sep-26sep-150mg,60 mg 26sep11 to 29sep11 150 mg iv 30sep11 to 11oct11, 7.5mg 20ju-9sep11,
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2011-09-14
    End date: 2011-10-11

Fragmin
    Start date: 2011-09-09
    End date: 2011-09-27

Aspirin
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 1996-07-01
    End date: 2011-10-06

Other drugs received by patient: Arixtra; Lactobacillus; Zopiclon; Pantoprazole Sodium; Mesalamine



Possible Fragmin side effects in 59 year old female

Reported by a physician from United States on 2011-10-20

Patient: 59 year old female

Reactions: Vascular Occlusion, Diarrhoea, Colitis, Sensory Loss, Large Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisolone
    Dosage: 60 mg, unk
    Administration route: Oral
    Start date: 2011-09-27

Fragmin
    Dosage: unk ukn, unk

Ipilimumab
    Dosage: 162 mg, unk
    Start date: 2011-09-02

Aspirin
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 1996-07-01

Ipilimumab
    Dosage: 171 mg, unk
    Indication: Malignant Melanoma
    Start date: 2011-08-10

Prednisolone
    Dosage: 150 mg, unk
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2011-09-14

Other drugs received by patient: Arixtra; Arixtra; Salofalk ^aventis^; Methylprednisolone; Zopiclon; Pantoprazole Sodium; Loperamide HCL; Lactobacillus; Nadroparin; Nadroparin; Methylprednisolone; Arixtra; Arixtra; Mesalamine



Possible Fragmin side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: 59 year old female

Reactions: Vascular Occlusion, Diarrhoea, Colitis, Sensory Loss, Large Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 171 mg, unk
    Indication: Malignant Melanoma
    Start date: 2011-08-10

Ipilimumab
    Dosage: 162 mg, unk
    Start date: 2011-09-02

Prednisolone
    Dosage: 150 mg, unk
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2011-09-14

Aspirin
    Dosage: 100 mg, unk
    Administration route: Oral
    Indication: Peripheral Arterial Occlusive Disease
    Start date: 1996-07-01

Fragmin
    Dosage: unk ukn, unk

Other drugs received by patient: Arixtra; Methylprednisolone; Salofalk ^aventis^; Arixtra; Loperamide HCL; Lactobacillus; Arixtra; Arixtra; Zopiclon; Pantoprazole Sodium

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