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Fragmin (Dalteparin) - Liver Injury - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Liver Injury (9)

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

Possible Fragmin side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-16

Patient: 76 year old female

Reactions: Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ferrous SUL Exsiccated TAB
    Dosage: 1 df, 1x/day, oral
    Administration route: Oral
    Indication: Iron Deficiency Anaemia
    Start date: 2012-06-15

Ciprofloxacin HCL
    Dosage: 750 mg, 2x/day, oral
    Administration route: Oral
    Indication: Pseudomonas Infection
    Start date: 2012-06-15
    End date: 2012-06-18

Fragmin
    Dosage: 5000 iu daily, intravenous
    Indication: Thrombosis Prophylaxis
    Start date: 2012-06-15

Tazocilline (Piperacillin, Tazobactam) Injection, Solution
    Dosage: 4 g 3x/day, intravenous
    Indication: Pseudomonas Infection
    Start date: 2012-06-15

Cortancyl (Prednisone) Tablet
    Dosage: 5 mg a day, oral
    Administration route: Oral
    Start date: 2012-06-15

Calcium Carbonate
    Dosage: 2 tablets a day, oral
    Administration route: Oral
    Indication: Vitamin D Deficiency
    Start date: 2012-06-15



Possible Fragmin side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-16

Patient: 76 year old female

Reactions: Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisolone
    Dosage: 5 mg a day, oral
    Administration route: Oral
    Start date: 2012-06-15

Fragmin
    Dosage: 50000 iu daily, intravenous
    Indication: Thrombosis Prophylaxis
    Start date: 2012-06-15

Orocal Vitamin D (Calcium Carbonate, Colecalciferol)
    Dosage: 2 tablets, a day, oral
    Administration route: Oral
    Indication: Vitamin D Deficiency
    Start date: 2012-06-15

Ciprofloxacin
    Dosage: 750 mg, 2x/day, oral
    Administration route: Oral
    Indication: Pseudomonas Infection
    Start date: 2012-06-15
    End date: 2012-06-18

Piperacillin and Tazobactam
    Dosage: 4 g, 3x/day, intravenous
    Indication: Pseudomonas Infection
    Start date: 2012-05-15

Tardyferon B9 (Ferrous Sulfate Exsiccated, Folic Acid)
    Dosage: 1 df, 1x/day, oral
    Administration route: Oral
    Indication: Iron Deficiency Anaemia
    Start date: 2012-06-15



Possible Fragmin side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-13

Patient: 76 year old female

Reactions: Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ferrous Sulfate TAB
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Iron Deficiency Anaemia
    Start date: 2012-06-15

Tazobactam
    Dosage: 4 g, 3x/day
    Indication: Pseudomonas Infection
    Start date: 2012-06-15

Ciprofloxacin Hydrochloride
    Dosage: 750 mg, 2x/day
    Administration route: Oral
    Indication: Pseudomonas Infection
    Start date: 2012-06-15
    End date: 2012-06-18

Prednisone TAB
    Dosage: 5 mg a day
    Administration route: Oral
    Start date: 2012-06-15

Fragmin
    Dosage: 5000 iu daily
    Indication: Thrombosis Prophylaxis
    Start date: 2012-06-15

Calcium Carbonate
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Vitamin D Deficiency
    Start date: 2012-06-15



Possible Fragmin side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-10

Patient: 76 year old female

Reactions: Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin Hydrochloride
    Dosage: 750 mg, 2x/day
    Administration route: Oral
    Indication: Pseudomonas Infection
    Start date: 2012-06-15
    End date: 2012-06-18

Prednisone TAB
    Dosage: 5 mg a day
    Administration route: Oral
    Start date: 2012-06-15

Fragmin
    Dosage: 5000 iu daily
    Indication: Thrombosis Prophylaxis
    Start date: 2012-06-15

Ferrous Sulfate TAB
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Iron Deficiency Anaemia
    Start date: 2012-06-15

Calcium Carbonate
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Vitamin D Deficiency
    Start date: 2012-06-15

Tazobactam
    Dosage: 4 g, 3x/day
    Indication: Pseudomonas Infection
    Start date: 2012-06-15



Possible Fragmin side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-06

Patient: 76 year old female

Reactions: Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fragmin
    Dosage: 5000 iu, qd
    Indication: Thrombosis Prophylaxis
    Start date: 2012-06-15

Prednisone TAB
    Dosage: 5 mg, qd
    Administration route: Oral
    Start date: 2012-06-15

Ciprofloxacin Hydrochloride
    Dosage: 750 mg, bid
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2012-06-15
    End date: 2012-06-18

Tazobactam
    Dosage: 4 g, tid
    Indication: Bronchitis
    Start date: 2012-06-15

Orocal D(3)
    Dosage: 2 df, qd
    Administration route: Oral
    Indication: Vitamin D Deficiency
    Start date: 2012-06-15

Ferrous Sulfate TAB
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Iron Deficiency Anaemia
    Start date: 2012-06-15



Possible Fragmin side effects in 66 year old female

Reported by a physician from Switzerland on 2012-05-09

Patient: 66 year old female

Reactions: Blood Alkaline Phosphatase Increased, Liver Injury, Alanine Aminotransferase Increased, Clostridium Difficile Colitis, Drug Interaction, Pancytopenia, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Sepsis, Enterocolitis, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Novalgin (Metamizole Sodium)
    Dosage: 1 g, 1 per 8 hours, iv bolus
    Indication: Pyrexia
    Start date: 2012-02-29
    End date: 2012-03-03

Amoxicillin Trihydrate
    Dosage: 2 g, 1 per 4 hours, 1 g, 2/day, iv bolus
    Indication: Bacterial Infection
    Start date: 2012-03-05

Amoxicillin Trihydrate
    Dosage: 2 g, 1 per 4 hours, 1 g, 2/day, iv bolus
    Indication: Bacterial Infection
    Start date: 2012-02-29
    End date: 2012-03-04

Zovirax
    Dosage: 750 mg, 1 per 8 hours, iv bolus
    Indication: Encephalitis Viral
    Start date: 2012-02-29
    End date: 2012-03-04

Esomeprazole Magnesium
    Dosage: 40 mg, 1xday, iv bolus
    Start date: 2012-02-29

Fragmin
    Dosage: 5000 iu, 1x/day, subcutaneous
    Indication: Thrombosis Prophylaxis
    Start date: 2012-02-29
    End date: 2012-03-04

Methotrexate Sodium
    Dosage: 5500 mg, during 4 hours, iv drip
    Indication: Peripheral T-Cell Lymphoma Unspecified
    Start date: 2012-03-03
    End date: 2012-03-03

Rocephin
    Dosage: 2 g, 1x/day, iv bolus
    Indication: Bacterial Infection
    Start date: 2012-02-29
    End date: 2012-03-03

Other drugs received by patient: Spiricort (Prednisolone); Escitalopram Oxalate; Pantoprazole Sodium; Leucovorin (Folinic Acid)



Possible Fragmin side effects in 66 year old female

Reported by a physician from Switzerland on 2012-04-11

Patient: 66 year old female

Reactions: Liver Injury, Drug Level Increased, Sepsis, Drug Interaction, Clostridium Difficile Colitis, Pancytopenia, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Esomeprazole Magnesium
    Dosage: 40mg per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-29

Dipyrone TAB
    Indication: Pyrexia
    Start date: 2012-02-29
    End date: 2012-03-03

Methotrexate
    Dosage: 5500mg per day
    Indication: Peripheral T-Cell Lymphoma Unspecified
    Start date: 2012-03-03
    End date: 2012-03-03

Fragmin
    Dosage: 5000u per day
    Indication: Prophylaxis
    Start date: 2012-02-29
    End date: 2012-03-04

Zovirax
    Indication: Encephalitis Viral
    Start date: 2012-02-29
    End date: 2012-03-04

Rocephin
    Dosage: 2g per day
    Indication: Bacterial Infection
    Start date: 2012-02-29
    End date: 2012-03-03

Amoxicillin Trihydrate
    Indication: Bacterial Infection
    Start date: 2012-02-29

Other drugs received by patient: Escitalopram; Prednisolone; Carboxypeptidase G2; Pantoprazole; Leucovorin Calcium



Possible Fragmin side effects in 66 year old female

Reported by a physician from Switzerland on 2012-04-09

Patient: 66 year old female

Reactions: Liver Injury, Drug Level Increased, Sepsis, Clostridium Difficile Colitis, Drug Interaction, Pancytopenia, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Zovirax
    Indication: Encephalitis Viral
    Start date: 2012-02-29
    End date: 2012-03-04

Fragmin
    Indication: Neoplasm Prophylaxis
    Start date: 2012-02-29
    End date: 2012-03-04

Rocephin
    Indication: Bacterial Infection
    Start date: 2012-02-29
    End date: 2012-03-03

Dipyrone TAB
    Indication: Pyrexia
    Start date: 2012-02-29
    End date: 2012-03-03

Other drugs received by patient possibly interacting with the suspect drug:
Esomeprazole Sodium
    Start date: 2012-02-29

Methotrexate
    Indication: Peripheral T-Cell Lymphoma Unspecified
    Start date: 2012-03-03
    End date: 2012-03-03

Amoxicillin Trihydrate
    Indication: Bacterial Infection
    Start date: 2012-02-29

Amoxicillin Trihydrate
    Start date: 2012-03-05

Other drugs received by patient: Pantoprazole; Leucovorin Calcium; Prednisolone; Escitalopram; Carboxypeptidase G2



Possible Fragmin side effects in 66 year old female

Reported by a physician from Switzerland on 2012-04-09

Patient: 66 year old female

Reactions: Enterocolitis Bacterial, Liver Injury, Drug Level Increased, Disseminated Intravascular Coagulation, Drug Interaction, Febrile Neutropenia, Clostridium Difficile Colitis, Pancytopenia, Somnolence, Sepsis, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Methotrexate Sodium
    Dosage: 5500 mg, during 4 hours, iv drip
    Indication: Peripheral T-Cell Lymphoma Unspecified
    Start date: 2012-03-03
    End date: 2012-03-03

Amoxicillin Trihydrate
    Dosage: 2 g, 1 per 4 hours, iv bolus
    Indication: Bacterial Infection
    Start date: 2012-02-29
    End date: 2012-03-04

Esomeprazole Magnesium
    Dosage: 40 mg, 1x/day, iv bolus
    Start date: 2012-02-29

Zovirax
    Dosage: 750 mg, 1 per 8 hours, iv bolus
    Indication: Encephalitis Viral
    Start date: 2012-02-29
    End date: 2012-03-04

Rocephin
    Dosage: 2 g, 1x/day, iv bolus
    Indication: Bacterial Infection
    Start date: 2012-02-29
    End date: 2012-03-03

Novalgin (Metamizole Sodium)
    Dosage: 1g, 1 per 8 hours, iv bolus
    Indication: Pyrexia
    Start date: 2012-02-29
    End date: 2012-03-03

Fragmin
    Dosage: 5000 iu, 1x/day, subcutaneous
    Indication: Thrombosis Prophylaxis
    Start date: 2012-02-29
    End date: 2012-03-04

Other drugs received by patient: Escitalopram Oxalate; Leucovorin (Folinic Acid); Spiricort (Prednisolone); Pantoprazole Sodium

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