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Fragmin Side Effects

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Common Fragmin Side Effects


The most commonly reported Fragmin side effects (click to view or check a box to report):

Pulmonary Embolism (112)
Deep Vein Thrombosis (52)
Thrombocytopenia (35)
Haemoglobin Decreased (25)
Heparin-induced Thrombocytopenia (24)
Cerebral Haemorrhage (24)
Anaemia (23)
Haemorrhage (19)
Phlebitis (18)
Thrombosis (18)
Oedema Peripheral (18)
Pain (18)
Dyspnoea (18)
Caesarean Section (16)
Haematoma (15)
Post Procedural Complication (15)
Pain In Extremity (14)
Myocardial Infarction (14)
Injection Site Pain (14)
Loss Of Consciousness (13)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Fragmin Side Effects Reported to FDA



Fragmin Side Effect Report#9492248
Pulmonary Embolism, Hepatic Failure, Renal Failure Acute, Thrombocytopenia
This is a report of a 82-year-old female patient (weight: NA) from CH, suffering from the following health symptoms/conditions: prophylaxis,anaesthesia, who was treated with Fragmin (dosage: 2500 Iu, Single, start time:
Aug 06, 2013), combined with:
  • Thiopental (325 Mg, Single)
  • Isofluran ^baxter^ (1 Df (1 Volume % Over 8 At 12l/min Via Respiratory System (intubation))
  • Perfalgan (1 G, Unk)
  • Novalgin (1 G, 1x/day)
  • Fentanyl (0.7 Mg, Single)
  • Methadone (7.5 Mg, Single)
  • Ultiva (50 Ug, Single)
  • Atracurium Besilate (105 Mg, Single)
and developed a serious reaction and side effect(s): Pulmonary Embolism, Hepatic Failure, Renal Failure Acute, Thrombocytopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fragmin treatment in female patients, resulting in Pulmonary Embolism side effect.
Fragmin Side Effect Report#9458237
Blood Creatinine Increased, Glomerular Filtration Rate Decreased, Blood Sodium Decreased, Blood Urea Increased, Lymphocyte Count Decreased, Platelet Count Increased, Renal Failure Acute, Thrombocytopenia, Pulmonary Embolism
This report suggests a potential Fragmine Blood Creatinine Increased side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Fragmine (dosage: NA) starting
Jul 14, 2013. After starting Fragmine the patient began experiencing various side effects, including: Blood Creatinine Increased, Glomerular Filtration Rate Decreased, Blood Sodium Decreased, Blood Urea Increased, Lymphocyte Count Decreased, Platelet Count Increased, Renal Failure Acute, Thrombocytopenia, Pulmonary EmbolismAdditional drugs used concurrently:
  • Xarelto
  • Ciprofloxacin
  • Atacand
  • Pravastatin
  • Imovane
  • Alprazolam
  • Cardensiel
  • Lasilix
Although Fragmine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Creatinine Increased, may still occur.
Fragmin Side Effect Report#9399613
Oedema Peripheral, Pain, Skin Discolouration, Amnesia, Cognitive Disorder, Pain In Extremity, Pain In Extremity, Blister
This Oedema Peripheral problem was reported by a physician from SE. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: deep vein thrombosis. On
Jul 20, 2012 this consumer started treatment with Fragmin (dosage: NA). The following drugs were being taken at the same time:
  • Warfarin (2.5mg, 1 X/day, Oral)
When using Fragmin, the patient experienced the following unwanted symptoms/side effects: Oedema Peripheral, Pain, Skin Discolouration, Amnesia, Cognitive Disorder, Pain In Extremity, Pain In Extremity, BlisterAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oedema Peripheral, may become evident only after a product is in use by the general population.
Fragmin Side Effect Report#9394731
Urticaria, Lip Oedema
This Urticaria side effect was reported by a health professional from FR. A 6-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fragmine (dalteparin Sodium) Solution For Injection (drug dosage: NA), which was initiated on
Feb 29, 2012. Concurrently used drugs:
  • Acetylsalicylic Acid (acetylsalicylic Acid)
.After starting to take Fragmine (dalteparin Sodium) Solution For Injection the consumer reported adverse symptoms, such as: Urticaria, Lip OedemaThese side effects may potentially be related to Fragmine (dalteparin Sodium) Solution For Injection.
Fragmin Side Effect Report#9391197
Renal Failure Acute, Dehydration, Hyperkalaemia, Anaemia
This is a report of a 79-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Fragmine (dalteparin Sodium) Solution For Injection (dosage: 1 Df, 1x/day, Sc, start time:
Apr 09, 2013), combined with:
  • Aprovel (150 Mg, 1x/day, Po)
  • Coaprovel (1 Df, 1x/day, Po)
  • Tranxene (1 Df, 2x/day, Oral)
  • Voltarene (diclofenac Sodium) Gel
  • Sectral (acebutolol Hydrochloride)
  • Paracetamol (paracetamol)
  • Amycor (bifonazole) Cream
  • Smecta (aluminium Magnesium Silicate)
and developed a serious reaction and side effect(s): Renal Failure Acute, Dehydration, Hyperkalaemia, Anaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fragmine (dalteparin Sodium) Solution For Injection treatment in female patients, resulting in Renal Failure Acute side effect.
Fragmin Side Effect Report#9387747
Peripheral Artery Thrombosis, Leg Amputation
This report suggests a potential Fragmin (dalteparin Sodium) Solution For Injection Peripheral Artery Thrombosis side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from DK was diagnosed with the following symptoms/conditions: NA and used Fragmin (dalteparin Sodium) Solution For Injection (dosage: NA) starting NS. After starting Fragmin (dalteparin Sodium) Solution For Injection the patient began experiencing various side effects, including: Peripheral Artery Thrombosis, Leg AmputationAdditional drugs used concurrently: NA. Although Fragmin (dalteparin Sodium) Solution For Injection demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Peripheral Artery Thrombosis, may still occur.
Fragmin Side Effect Report#9387744
Thrombocytopenia, Cerebrovascular Accident
This Thrombocytopenia problem was reported by a consumer or non-health professional from CH. A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 10, 2013 this consumer started treatment with Fragmin (dalteparin Sodium) Solution For Injection (dosage: NA). The following drugs were being taken at the same time:
  • Micardis
  • Torem
  • Lasix
When using Fragmin (dalteparin Sodium) Solution For Injection, the patient experienced the following unwanted symptoms/side effects: Thrombocytopenia, Cerebrovascular AccidentThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombocytopenia, may become evident only after a product is in use by the general population.
Fragmin Side Effect Report#9387692
Multi-organ Failure, Acute Respiratory Distress Syndrome, Hepatocellular Injury, Renal Failure Acute, Pancytopenia
This Multi-organ Failure side effect was reported by a health professional from FR. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fragmine (drug dosage: NA), which was initiated on
Apr 27, 2013. Concurrently used drugs: NA..After starting to take Fragmine the consumer reported adverse symptoms, such as: Multi-organ Failure, Acute Respiratory Distress Syndrome, Hepatocellular Injury, Renal Failure Acute, PancytopeniaThese side effects may potentially be related to Fragmine.
Fragmin Side Effect Report#9346627
Renal Failure Acute, Hypotension, Haemoglobin Decreased, Peritoneal Haemorrhage, Muscle Haemorrhage
This is a report of a 69-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: prophylaxis,pulmonary embolism, who was treated with Fragmin (dosage: 18000 Iu, Unk, start time:
May 03, 2013), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure Acute, Hypotension, Haemoglobin Decreased, Peritoneal Haemorrhage, Muscle Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fragmin treatment in male patients, resulting in Renal Failure Acute side effect.
Fragmin Side Effect Report#9332605
Irritability, Tremor, Restlessness, Formication, Insomnia
This report suggests a potential Fragmin (dalteparin Sodium) Solution For Injection Irritability side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: thrombosis and used Fragmin (dalteparin Sodium) Solution For Injection (dosage: 1x/day) starting
Mar 14, 2013. After starting Fragmin (dalteparin Sodium) Solution For Injection the patient began experiencing various side effects, including: Irritability, Tremor, Restlessness, Formication, InsomniaAdditional drugs used concurrently:
  • Byetta (exenatide)
  • Lantus (insulin Glargine)
  • Ramipril (ramipril)
  • Metformin (metformin)
  • Glimepiride (glimepiride)
  • Tramadol (tramadol)
  • Paracetamol (paracetamol)
  • Ezetimibe (ezetimibe) (tablet)
Although Fragmin (dalteparin Sodium) Solution For Injection demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Irritability, may still occur.
Fragmin Side Effect Report#9318720
Deep Vein Thrombosis, Pulmonary Embolism, Atrial Thrombosis, Deep Vein Thrombosis
This Deep Vein Thrombosis problem was reported by a health professional from PL. A 80-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hip arthroplasty. On
Aug 01, 2012 this consumer started treatment with Fragmin (dosage: NA). The following drugs were being taken at the same time:
  • Poltram
When using Fragmin, the patient experienced the following unwanted symptoms/side effects: Deep Vein Thrombosis, Pulmonary Embolism, Atrial Thrombosis, Deep Vein ThrombosisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Deep Vein Thrombosis, may become evident only after a product is in use by the general population.
Fragmin Side Effect Report#9318705
Injection Site Injury, Needle Issue, Foreign Body, Product Quality Issue
This Injection Site Injury side effect was reported by a health professional from CA. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fragmin (drug dosage: NA), which was initiated on
Apr 15, 2013. Concurrently used drugs: NA..After starting to take Fragmin the consumer reported adverse symptoms, such as: Injection Site Injury, Needle Issue, Foreign Body, Product Quality IssueThese side effects may potentially be related to Fragmin.
Fragmin Side Effect Report#9318685
Ischaemic Stroke, Cerebral Artery Embolism
This is a report of a male patient (weight: NA) from PL, suffering from the following health symptoms/conditions: hypoplastic left heart syndrome, who was treated with Fragmin (dalteparin Sodium) Solution For Injection (dosage: 750 Iu, Twice Daily Subcutaneous, start time:
Sep 12, 2012), combined with: NA. and developed a serious reaction and side effect(s): Ischaemic Stroke, Cerebral Artery Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fragmin (dalteparin Sodium) Solution For Injection treatment in male patients, resulting in Ischaemic Stroke side effect. The patient was hospitalized and became disabled.
Fragmin Side Effect Report#9312485
Renal Failure Acute, Haemorrhage, Hypotension, Haemoglobin Decreased, Peritoneal Haemorrhage, Muscle Haemorrhage
This report suggests a potential Fragmin Renal Failure Acute side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: prophylaxis and used Fragmin (dosage: NA) starting
May 03, 2013. After starting Fragmin the patient began experiencing various side effects, including: Renal Failure Acute, Haemorrhage, Hypotension, Haemoglobin Decreased, Peritoneal Haemorrhage, Muscle HaemorrhageAdditional drugs used concurrently: NA. Although Fragmin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure Acute, may still occur.
Fragmin Side Effect Report#9305526
Pulmonary Embolism
This Pulmonary Embolism problem was reported by a physician from DE. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: thrombosis prophylaxis. On NS this consumer started treatment with Fragmin P Forte (dalteparin Sodium) Solution For Injection (dosage: 1 Df, 1x/day, Subcutaneous). The following drugs were being taken at the same time: NA. When using Fragmin P Forte (dalteparin Sodium) Solution For Injection, the patient experienced the following unwanted symptoms/side effects: Pulmonary EmbolismAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Embolism, may become evident only after a product is in use by the general population.
Fragmin Side Effect Report#9298846
Thrombocytosis
This Thrombocytosis side effect was reported by a health professional from FR. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fragmine (dalteparin Sodium) Solution For Injection (drug dosage: NA), which was initiated on
Jan 25, 2013. Concurrently used drugs: NA..After starting to take Fragmine (dalteparin Sodium) Solution For Injection the consumer reported adverse symptoms, such as: ThrombocytosisThese side effects may potentially be related to Fragmine (dalteparin Sodium) Solution For Injection.
Fragmin Side Effect Report#9290644
Pulmonary Embolism
This is a report of a 63-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: thrombosis prophylaxis, who was treated with Fragmin P Forte (dalteparin Sodium) Solution For Injection (dosage: NA, start time:
Apr 02, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pulmonary Embolism after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fragmin P Forte (dalteparin Sodium) Solution For Injection treatment in female patients, resulting in Pulmonary Embolism side effect. The patient was hospitalized.
Fragmin Side Effect Report#9277023
Cerebrovascular Accident
This report suggests a potential Fragmin (dalteparin Sodium) Solution For Injection Cerebrovascular Accident side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from SE was diagnosed with the following symptoms/conditions: NA and used Fragmin (dalteparin Sodium) Solution For Injection (dosage: NA) starting NS. After starting Fragmin (dalteparin Sodium) Solution For Injection the patient began experiencing various side effects, including: Cerebrovascular AccidentAdditional drugs used concurrently: NA. Although Fragmin (dalteparin Sodium) Solution For Injection demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Fragmin Side Effect Report#9277018
Laryngeal Oedema, Hypoxia
This Laryngeal Oedema problem was reported by a health professional from FR. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: deep vein thrombosis,oedema. On
Apr 02, 2013 this consumer started treatment with Fragmine (dalteparin Sodium) Solution For Injection (dosage: NA). The following drugs were being taken at the same time:
  • Voltarene
  • Inexium
  • Zolpidem (zolpidem)
  • Dexeryl Cream
  • Gardenal (phenobarbital)
When using Fragmine (dalteparin Sodium) Solution For Injection, the patient experienced the following unwanted symptoms/side effects: Laryngeal Oedema, HypoxiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Laryngeal Oedema, may become evident only after a product is in use by the general population.
Fragmin Side Effect Report#9216379
Polymyalgia Rheumatica, Musculoskeletal Pain, Neck Pain, Pain In Extremity, Hypoaesthesia, Paraesthesia, Dyspnoea, Alanine Aminotransferase Increased, Musculoskeletal Stiffness
This Polymyalgia Rheumatica side effect was reported by a physician from SE. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: thrombophlebitis,venous thrombosis limb.The patient was prescribed Fragmin (drug dosage: NA), which was initiated on
Jan 04, 2013. Concurrently used drugs: NA..After starting to take Fragmin the consumer reported adverse symptoms, such as: Polymyalgia Rheumatica, Musculoskeletal Pain, Neck Pain, Pain In Extremity, Hypoaesthesia, Paraesthesia, Dyspnoea, Alanine Aminotransferase Increased, Musculoskeletal StiffnessThese side effects may potentially be related to Fragmin.
Fragmin Side Effect Report#9206360
Platelet Count Increased, Foot Fracture
This is a report of a 30-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Fragmine (dalteparin Sodium) Solution For Injection (dosage: NA, start time:
Mar 05, 2013), combined with:
  • Adalate (nifedipine)
and developed a serious reaction and side effect(s): Platelet Count Increased, Foot Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fragmine (dalteparin Sodium) Solution For Injection treatment in male patients, resulting in Platelet Count Increased side effect.
Fragmin Side Effect Report#9206349
Cardiac Valve Replacement Complication, Cerebral Infarction
This report suggests a potential Fragmin Cardiac Valve Replacement Complication side effect(s) that can have serious consequences. A 46-year-old female patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: thrombosis prophylaxis and used Fragmin (dosage: 7500 Iu, 2x/day, Subcutaneous) starting
Oct 31, 2012. After starting Fragmin the patient began experiencing various side effects, including: Cardiac Valve Replacement Complication, Cerebral InfarctionAdditional drugs used concurrently:
  • Marcoumar (phenprocoumon)
  • Triatec (ramipril)
The patient was hospitalized. Although Fragmin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Valve Replacement Complication, may still occur.
Fragmin Side Effect Report#9171756
Pulmonary Embolism, Coronary Artery Thrombosis, Off Label Use
This Pulmonary Embolism problem was reported by a health professional from GB. A 36-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fragmin (dosage: NA). The following drugs were being taken at the same time: NA. When using Fragmin, the patient experienced the following unwanted symptoms/side effects: Pulmonary Embolism, Coronary Artery Thrombosis, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Embolism, may become evident only after a product is in use by the general population.
Fragmin Side Effect Report#9171756
Pulmonary Embolism, Coronary Artery Thrombosis, Off Label Use
This Pulmonary Embolism side effect was reported by a health professional from GB. A 36-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fragmin (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fragmin the consumer reported adverse symptoms, such as: Pulmonary Embolism, Coronary Artery Thrombosis, Off Label UseThese side effects may potentially be related to Fragmin.
Fragmin Side Effect Report#9164382
Pulmonary Embolism, Embolism, Blood Creatine Abnormal, Glomerular Filtration Rate Abnormal, Renal Cell Carcinoma, Disease Recurrence
This is a report of a 75-year-old female patient (weight: NA) from CO, suffering from the following health symptoms/conditions: NA, who was treated with Fragmin (dalteparin Sodium) Solution For Injection (dosage: NA, start time:
Sep 19, 2012), combined with: NA. and developed a serious reaction and side effect(s): Pulmonary Embolism, Embolism, Blood Creatine Abnormal, Glomerular Filtration Rate Abnormal, Renal Cell Carcinoma, Disease Recurrence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fragmin (dalteparin Sodium) Solution For Injection treatment in female patients, resulting in Pulmonary Embolism side effect.


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The appearance of Fragmin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Fragmin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    More About Fragmin

    Side Effects reported to FDA: 738

    Fragmin safety alerts: No

    Reported deaths: 232

    Reported hospitalizations: 297

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