This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fragmin (Dalteparin) 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 (105)
Death (29)
Life Threatening Events (10)
Disability (1)
Reports by Reaction Type
Pulmonary Embolism (15),
Pancytopenia (10),
Liver Injury (9),
Cerebral Infarction (9),
Vascular Occlusion (8),
Diarrhoea (8),
Colitis (8),
Drug Interaction (7),
Cerebral Haemorrhage (7),
Neoplasm Malignant (6),
Respiratory Failure (6),
Contusion (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Fragmin (Dalteparin). For a complete list or a specific selection of reports, please use the links above.
Possible Fragmin side effects in 36 year old male
Reported by a physician from France on 2012-08-26
Patient: 36 year old male
Reactions: Haemolytic Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Abilify
Dosage: reduced to 15 mg from 30jun2012
Start date: 2012-06-29
Fragmin
Dosage: 5000 ui anti xa/0.2 ml, solution for injection in prefilled syringe
Lorazepam
Dosage: scored tablet
Tercian
Dosage: 1df: 50 mg/5 ml injectable solution in ampoule
Possible Fragmin side effects in 88 year old male
Reported by a physician from France on 2012-08-17
Patient: 88 year old male
Reactions: Haemorrhagic Stroke
Adverse event resulted in: death
Drug(s) suspected as cause:
Fragmin
Dosage: unk
Torisel
Dosage: unk
Indication: Metastatic Carcinoma of THE Bladder
Start date: 2012-01-03
End date: 2012-03-20
Other drugs received by patient: Amlodipine Besylate; Ramipril; Aspirin; Acetaminophen; Helicidine; Chondrosulf
Possible Fragmin side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: 63 year old female
Reactions: Injection Site Mass, Injection Site Haemorrhage, Injection Site Haematoma, Injection Site Pain
Drug(s) suspected as cause:
Fragmin
Possible Fragmin side effects in 88 year old male
Reported by a physician from France on 2012-08-10
Patient: 88 year old male
Reactions: Cerebrovascular Accident
Adverse event resulted in: death
Drug(s) suspected as cause:
Fragmin
Dosage: unk
Torisel
Dosage: unk
Indication: Metastatic Carcinoma of THE Bladder
Start date: 2012-01-03
End date: 2012-03-20
Other drugs received by patient: Ramipril; Acetaminophen; Aspirin; Amlodipine Besylate; Chondrosulf; Helicidine
Possible Fragmin side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-09
Patient: female
Reactions: Enterocolitis Haemorrhagic, Gastrointestinal Haemorrhage, Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clarithromycin
Dosage: 1000 mg
Administration route: Oral
Indication: Pneumonia
Start date: 2012-03-23
End date: 2012-04-05
Escitalopram
Dosage: 10 mg
Administration route: Oral
Fragmin
Dosage: 5000 iu
Indication: Prophylaxis
Start date: 2012-03-01
End date: 2012-04-04
Ibruprofen
Administration route: Oral
Indication: Back Pain
Start date: 2012-03-01
End date: 2012-04-04
Methotrexate
Administration route: Oral
Indication: Psoriasis
Start date: 2005-08-01
End date: 2012-04-04
Prednisone TAB
Dosage: 10 mg
Administration route: Oral
Indication: Psoriasis
Start date: 2005-08-01
Rocephin
Dosage: 2 g
Indication: Pneumonia
Start date: 2012-03-23
End date: 2012-04-05
Other drugs received by patient: Pantoprazole; Calcimagon D3; Ramipril
Possible Fragmin side effects in 43 year old female
Reported by a pharmacist from United Kingdom on 2012-08-06
Patient: 43 year old female, weighing 78.0 kg (171.6 pounds)
Reactions: Osteoporotic Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fragmin
Other drugs received by patient: Adriamycin (Doxorubicin); Dacarbazine; Bleomycin Sulfate; Vinblastine Sulfate
Possible Fragmin side effects in 72 year old male
Reported by a consumer/non-health professional from Sweden on 2012-07-30
Patient: 72 year old male
Reactions: Angina Pectoris
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fragmin
Possible Fragmin side effects in female
Reported by a consumer/non-health professional from Netherlands on 2012-07-20
Patient: female
Reactions: Maternal Drugs Affecting Foetus, Foetal Death
Drug(s) suspected as cause:
Fragmin
Possible Fragmin side effects in 43 year old male
Reported by a physician from Switzerland on 2012-07-16
Patient: 43 year old male, weighing 72.0 kg (158.4 pounds)
Reactions: Stomatitis, Agranulocytosis, Sepsis, Chills, Pyrexia, Necrotising Fasciitis, Injection Site Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fluoxetine Hydrochloride
Dosage: 1 df, unk, oral
Administration route: Oral
Indication: Burnout Syndrome
Start date: 2012-03-01
End date: 2012-04-19
Fragmin
Dosage: 1 df, 1x/day, intramuscular
Start date: 2012-03-03
Ibuprofen
Dosage: 400 mg, 1x/day, oral
Administration route: Oral
Indication: Multiple Fractures
Start date: 2012-03-03
End date: 2012-04-19
Novalgin (Metamizole Sodium)
Dosage: 500 mg, 2x/day, oral
Administration route: Oral
Indication: Multiple Fractures
Start date: 2012-03-03
End date: 2012-04-19
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:
Ciprofloxacin
Dosage: 750 mg, 2x/day, oral
Administration route: Oral
Indication: Pseudomonas Infection
Start date: 2012-06-15
End date: 2012-06-18
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
Piperacillin and Tazobactam
Dosage: 4 g, 3x/day, intravenous
Indication: Pseudomonas Infection
Start date: 2012-05-15
Prednisolone
Dosage: 5 mg a day, oral
Administration route: Oral
Start date: 2012-06-15
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 2012-07-16
Patient: 76 year old female
Reactions: Liver Injury
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Calcium Carbonate
Dosage: 2 tablets a day, oral
Administration route: Oral
Indication: Vitamin D Deficiency
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
Cortancyl (Prednisone) Tablet
Dosage: 5 mg a day, oral
Administration route: Oral
Start date: 2012-06-15
Ferrous SUL Exsiccated TAB
Dosage: 1 df, 1x/day, oral
Administration route: Oral
Indication: Iron Deficiency Anaemia
Start date: 2012-06-15
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
Possible Fragmin side effects in 58 year old male
Reported by a pharmacist from United Kingdom on 2012-07-16
Patient: 58 year old male
Reactions: Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fragmin
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:
Calcium Carbonate
Dosage: 2 tablets a day
Administration route: Oral
Indication: Vitamin D Deficiency
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
Ferrous Sulfate TAB
Dosage: 1 df, 1x/day
Administration route: Oral
Indication: Iron Deficiency Anaemia
Start date: 2012-06-15
Fragmin
Dosage: 5000 iu daily
Indication: Thrombosis Prophylaxis
Start date: 2012-06-15
Prednisone TAB
Dosage: 5 mg a day
Administration route: Oral
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 2012-07-10
Patient: 76 year old female
Reactions: Liver Injury
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Calcium Carbonate
Dosage: 2 tablets a day
Administration route: Oral
Indication: Vitamin D Deficiency
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
Ferrous Sulfate TAB
Dosage: 1 df, 1x/day
Administration route: Oral
Indication: Iron Deficiency Anaemia
Start date: 2012-06-15
Fragmin
Dosage: 5000 iu daily
Indication: Thrombosis Prophylaxis
Start date: 2012-06-15
Prednisone TAB
Dosage: 5 mg a day
Administration route: Oral
Start date: 2012-06-15
Tazobactam
Dosage: 4 g, 3x/day
Indication: Pseudomonas Infection
Start date: 2012-06-15
Possible Fragmin side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-10
Patient: female
Reactions: Enterocolitis Haemorrhagic, Gastrointestinal Haemorrhage, Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clarithromycin
Dosage: 1000 mg
Administration route: Oral
Indication: Pneumonia
Start date: 2012-03-23
End date: 2012-04-05
Escitalopram
Dosage: 10 mg
Administration route: Oral
Fragmin
Dosage: 5000 iu
Indication: Prophylaxis
Start date: 2012-03-01
End date: 2012-04-04
Ibruprofen
Administration route: Oral
Indication: Back Pain
Start date: 2012-03-01
End date: 2012-04-04
Methotrexate
Administration route: Oral
Indication: Psoriasis
Start date: 2005-08-01
End date: 2012-04-04
Prednisone
Dosage: 10 mg
Administration route: Oral
Indication: Psoriasis
Start date: 2005-08-01
Rocephin
Dosage: 2000 mg
Indication: Pneumonia
Start date: 2012-03-23
End date: 2012-04-05
Other drugs received by patient: Pantoprazole; Ramipril; Calcimagon D3
Possible Fragmin side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-09
Patient: female
Reactions: Blood Pressure Increased, Abdominal Pain, Nasopharyngitis, Pain in Extremity, Haemorrhage, Pain, Pulmonary Embolism, Abdominal Pain Upper, Vaginal Haemorrhage, Fatigue, Arthralgia, Swelling, Menorrhagia, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fragmin
Sandostatin LAR
Dosage: 30 mg,every 4 weeks
Sandostatin LAR
Dosage: 30 mg, qmo
Indication: Carcinoid Tumour
Start date: 2005-03-07
Sandostatin LAR
Dosage: 30 mg, every 3 weeks
Start date: 2005-07-03
Other drugs received by patient: Coumadin; Lovenox
Possible Fragmin side effects in 67 year old female
Reported by a physician from Switzerland on 2012-07-06
Patient: 67 year old female
Reactions: Pneumonia Bacterial
Drug(s) suspected as cause:
Escitalopram Oxalate
Dosage: 10 mg, 1x/day, oral
Administration route: Oral
Fragmin
Dosage: 5000 iu, 1x/day, subcutaneous
Indication: Prophylaxis
Start date: 2012-03-01
End date: 2012-04-04
Ibuprofen
Dosage: 1 df per day, oral
Administration route: Oral
Indication: Back Pain
Start date: 2012-03-20
End date: 2012-04-04
Methotrexate
Dosage: 1 df, 1x/day, oral
Administration route: Oral
Indication: Psoriatic Arthropathy
Start date: 2005-08-01
End date: 2012-04-04
Prednisone TAB
Dosage: 10 mg, 1x/day, oral
Administration route: Oral
Indication: Psoriatic Arthropathy
Start date: 2005-08-01
Other drugs received by patient: Pantoprazole Sodium; Calcimagon-D3 (Calcium Carbonate, Colecalciferol); Ramipril
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:
Ciprofloxacin Hydrochloride
Dosage: 750 mg, bid
Administration route: Oral
Indication: Bronchitis
Start date: 2012-06-15
End date: 2012-06-18
Ferrous Sulfate TAB
Dosage: 1 df, qd
Administration route: Oral
Indication: Iron Deficiency Anaemia
Start date: 2012-06-15
Fragmin
Dosage: 5000 iu, qd
Indication: Thrombosis Prophylaxis
Start date: 2012-06-15
Orocal D(3)
Dosage: 2 df, qd
Administration route: Oral
Indication: Vitamin D Deficiency
Start date: 2012-06-15
Prednisone TAB
Dosage: 5 mg, qd
Administration route: Oral
Start date: 2012-06-15
Tazobactam
Dosage: 4 g, tid
Indication: Bronchitis
Start date: 2012-06-15
Possible Fragmin side effects in 67 year old female
Reported by a physician from Switzerland on 2012-07-05
Patient: 67 year old female
Reactions: Fractured Sacrum, Enterocolitis Haemorrhagic, Cytomegalovirus Test Positive, Haemorrhoids, Drug Interaction, Haemorrhagic Anaemia, Diverticulum, Pneumonia Bacterial, Stress Fracture, Lower Gastrointestinal Haemorrhage, Back Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clarithromycin
Dosage: 500 mg, 2x/day, oral
Administration route: Oral
Indication: Pneumonia Bacterial
Start date: 2012-03-23
End date: 2012-04-05
Escitalopram Oxalate
Dosage: 10 mg, 1x/day,
Fragmin
Dosage: 5000 iu, 1x/day, subcutaneous
Indication: Prophylaxis
Start date: 2012-03-01
End date: 2012-04-04
Ibuprofen
Dosage: 1 df per day, oral
Administration route: Oral
Indication: Back Disorder
Start date: 2012-03-01
End date: 2012-04-04
Methotrexate
Dosage: 1 df, 1x/day, oral
Administration route: Oral
Indication: Psoriatic Arthropathy
Start date: 2005-08-01
End date: 2012-04-04
Prednisone
Dosage: 10 mg, 1x/day, oral
Administration route: Oral
Indication: Psoriatic Arthropathy
Start date: 2005-08-01
Rocephin
Dosage: 2 g, 1x/day, intravenous
Indication: Pneumonia Bacterial
Start date: 2012-03-23
End date: 2012-04-05
Other drugs received by patient: Calcimagon-D3 (Calcium Carbonate, Colecalciferol); Ramipril; Pantoprazole Sodium
Possible Fragmin side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-29
Patient: female
Reactions: Abdominal Pain, Blood Pressure Increased, Nasopharyngitis, Haemorrhage, Pain in Extremity, Pain, Pulmonary Embolism, Vaginal Haemorrhage, Abdominal Pain Upper, Fatigue, Arthralgia, Swelling, Menorrhagia, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fragmin
Sandostatin LAR
Dosage: 30 mg, qmo
Indication: Carcinoid Tumour
Start date: 2005-03-07
Sandostatin LAR
Dosage: 30 mg, every 3 weeks
Start date: 2005-07-03
Sandostatin LAR
Dosage: 30 mg,every 4 weeks
Other drugs received by patient: Lovenox
Possible Fragmin side effects in 90 year old
Reported by a physician from Sweden on 2012-06-25
Patient: 90 year old , weighing 50.0 kg (110.0 pounds)
Reactions: Cerebral Infarction
Drug(s) suspected as cause:
Fragmin
Other drugs received by patient: Warfarin Sodium
Possible Fragmin side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-06-13
Patient: female
Reactions: Blood Pressure Increased, Abdominal Pain, Nasopharyngitis, Haemorrhage, Pain in Extremity, Pain, Pulmonary Embolism, Abdominal Pain Upper, Vaginal Haemorrhage, Fatigue, Arthralgia, Swelling, Asthenia, Menorrhagia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fragmin
Dosage: unk ukn, daily
Sandostatin LAR
Dosage: 30 mg, qmo
Indication: Carcinoid Tumour
Start date: 2005-03-07
Sandostatin LAR
Dosage: 30 mg, once in every 3 weeks
Sandostatin LAR
Dosage: 30 mg,every 4 weeks
Other drugs received by patient: Lovenox
Possible Fragmin side effects in 69 year old female
Reported by a physician from Slovakia (Slovak Republic) on 2012-06-12
Patient: 69 year old female
Reactions: Multi-Organ Failure, Pulmonary Embolism
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Fragmin
Other drugs received by patient: Prestarium A (Perindopril); Vitamin B12; Agen (Amlodipine Besilate) (Amlodipine Besilate); Concor COR (Bisoprolol); Prothazin (Promethazine Hydrochloride); Helicid (Omeprazole); Perindopril Arginine; Ciprofloxacin
Possible Fragmin side effects in 32 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-12
Patient: 32 year old male
Reactions: Platelet Count Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fragmin
Other drugs received by patient: Ramipril; Crestor (Rosuvastatin) Film-Coated Tablet; Topalgic (Tramadol Hydrochloride) Prolonged-Release Tablet; Plavix; Levemir
Possible Fragmin side effects in 68 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-08
Patient: 68 year old male, weighing 73.0 kg (160.6 pounds)
Reactions: Chest Discomfort, Urticaria, Throat Tightness
Drug(s) suspected as cause:
Fragmin
Other drugs received by patient: Perindopril Erbumine; Beconase
Possible Fragmin side effects in 83 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-08
Patient: 83 year old male
Reactions: Confusional State, Hypotension, Lung Infection, Haemorrhagic Anaemia, Respiratory Distress, Blood Lactic Acid Increased, Lung Disorder, Hyperaesthesia, Nervous System Disorder, Altered State of Consciousness, Apnoea, Haematoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Fragmin
Other drugs received by patient: Lasix; Morphine; Nexium; Acetaminophen; Tramadol HCL; Prednisone TAB
Possible Fragmin side effects in 40 year old male
Reported by a physician from Sweden on 2012-06-08
Patient: 40 year old male
Reactions: Gingival Bleeding, Intentional Overdose, Haemorrhage, Compartment Syndrome, Fall, Haematemesis, Stab Wound, Activated Partial Thromboplastin Time Prolonged, RED Blood Cell Count Decreased, Oedema Peripheral, Platelet Count Decreased, Traumatic Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fragmin
Dosage: see image, intravenous
Start date: 2011-08-01
Fragmin
Dosage: see image, intravenous
Start date: 2011-04-01
Fragmin
Dosage: see image, intravenous
Start date: 2010-12-01
Fragmin
Dosage: see image, intravenous
Start date: 2009-10-01
Fragmin
Dosage: see image, intravenous
Start date: 2010-03-01
Possible Fragmin side effects in 65 year old male
Reported by a pharmacist from Canada on 2012-06-06
Patient: 65 year old male
Reactions: International Normalised Ratio Decreased, Pulmonary Embolism, Treatment Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Fragmin
Dosage: 5,000 iu; qd; sc
Indication: Thrombosis Prophylaxis
Start date: 2011-12-20
End date: 2011-12-24
Warfarin Sodium
Dosage: 2.5 mg; qd, 5 mg; qd
Indication: Thrombosis Prophylaxis
Start date: 2011-12-20
End date: 2011-12-24
Warfarin Sodium
Dosage: 2.5 mg; qd, 5 mg; qd
Indication: Thrombosis Prophylaxis
Start date: 2011-12-20
End date: 2011-12-24
Other drugs received by patient: Dimenhydrinate; Paracetamol (Atasol); Codeine Phosphate; Bacitracin; Docusate Sodium; Acetaminophen; Ferrous Fumarate; Caffeine Citrate; Cefazolin; Morphine
Possible Fragmin side effects in 75 year old male
Reported by a pharmacist from Canada on 2012-06-06
Patient: 75 year old male
Reactions: Pulmonary Embolism
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Fragmin
Dosage: 5,000 iu; qd; sc
Indication: Thrombosis Prophylaxis
Start date: 2012-01-11
End date: 2012-01-14
Warfarin Sodium
Indication: Thrombosis Prophylaxis
Other drugs received by patient: Mometasone Furoate; Clindamycin; Copper; Clonazepam; Ergocalciferol; Meloxicam; Ascorbic Acid; Betacarotene; Amlodipine Besylate; Atorvastatin Calcium; Perindopril Erbumine; Riboflavin
Possible Fragmin side effects in 43 year old male
Reported by a physician from Switzerland on 2012-05-29
Patient: 43 year old male, weighing 72.0 kg (158.4 pounds)
Reactions: Agranulocytosis, Chills, Neutropenia, Pyrexia, Necrotising Fasciitis, Thrombocytopenia, Injection Site Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fragmin
Dosage: intramuscular
Start date: 2012-03-03
Ibuprofen
Dosage: 400 mg, 1x/day, oral
Administration route: Oral
Indication: Multiple Fractures
Start date: 2012-03-03
End date: 2012-04-19
Novalgin (Metamizole Sodium)
Dosage: 500 mg, 2x/day, oral
Administration route: Oral
Indication: Multiple Fractures
Start date: 2012-03-03
End date: 2012-04-19
Other drugs received by patient: Fluoxetine HCL
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