Note: This document contains side effect information about dalteparin. Some dosage forms listed on this page may not apply to the brand name Fragmin.
Summary
Common side effects of Fragmin include: pain at injection site. Other side effects include: hematoma at injection site and increased serum alanine aminotransferase. Continue reading for a comprehensive list of adverse effects.
Applies to dalteparin: subcutaneous solution.
Warning
Subcutaneous route (Solution)
Patients anticoagulated with low molecular weight heparins or heparinoids who receive neuraxial anesthesia or undergo a spinal puncture are at risk for epidural or spinal hematomas, which may result in long-term or permanent paralysis. The use of indwelling epidural catheters, concomitant drugs that also affect hemostasis (eg, NSAIDs, platelet inhibitors, or other anticoagulants), history of traumatic or repeated epidural or spinal punctures, or history of spinal deformity or spinal surgery further increase this risk. The optimal timing of dalteparin administration and a neuraxial procedure is unknown. Frequent monitoring for signs and symptoms of neurological impairment is recommended. Seek urgent treatment if neurological compromise occurs.
Serious side effects of Fragmin
Along with its needed effects, dalteparin (the active ingredient contained in Fragmin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking dalteparin:
More common
- Bruise
- deep, dark purple bruise, pain, or swelling at the injection site
- nosebleed
Less common
- Bleeding of the gums
- constipation
- coughing up blood
- difficulty with breathing or swallowing
- dizziness
- headache
- increased menstrual flow or vaginal bleeding
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- severe stomach pain
- unexplained pain, swelling, or discomfort, especially in the chest, abdomen or stomach, joints, or muscles
- unusual bleeding or bruising
- vomiting of blood or material that looks like coffee grounds
- weakness
Rare
- Back pain
- bleeding from mucous membranes
- bluish or black discoloration, flushing, or redness of the skin
- burning, pricking, tickling, or tingling sensation
- cough
- feeling faint
- fever
- leg weakness
- numbness
- problems with bowel or bladder function
- skin rash (which may consist of pinpoint, purple-red spots), hives, or itching
- sloughing of the skin at the injection site
- swelling of the eyelids, face, or lips
- tightness in the chest
Incidence not known
- Blue-green to black skin discoloration
- decrease in height
- pain in the ribs, arms, or legs
Other side effects of Fragmin
Some side effects of dalteparin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Hair loss or thinning of hair
For Healthcare Professionals
Applies to dalteparin: subcutaneous solution.
General
The most common side effects were any bleeding, postoperative transfusion, transaminase increases, and injection site pain.[Ref]
Cardiovascular
Very common (10% or more): Any bleeding (up to 18.5%)
Common (1% to 10%): Major bleeding reactions
Postmarketing reports: Prosthetic cardiac valve thrombosis[Ref]
A bleeding reaction was considered major if accompanied by a decrease in hemoglobin of 2 g/dL or greater in connection with clinical symptoms, a transfusion was required, bleeding led to interruption of treatment or death, bleeding caused a significant clinical event, bleeding resulted in reoperation, or retroperitoneal or intracranial bleeding occurred.[Ref]
Other
Very common (10% or more): Postoperative transfusion (up to 15.9%)
Common (1% to 10%): Wound hematoma, reoperation due to bleeding[Ref]
Hepatic
Very common (10% or more): Grades 2 through 4 increases in AST and ALT (up to 14%)
Common (1% to 10%): Asymptomatic increases in transaminase levels (serum glutamic oxaloacetic transaminase/AST and Serum glutamic pyruvic transaminase/ALT) greater than 3 times the upper limit of normal, grades 3 and 4 increases in AST and ALT[Ref]
Nervous system
Postmarketing reports: Epidural/spinal hematoma, intracranial bleed[Ref]
Local
Very common (10% or more): Injection site pain (up to 12%)
Common (1% to 10%): Injection site hematoma[Ref]
Hematologic
Common (1% to 10%): Reversible non-immunologically-mediated thrombocytopenia (type I)
Rare (less than 0.1%): Immunologically-mediated heparin-induced thrombocytopenia (type II, with or without associated thrombotic complications)[Ref]
Genitourinary
Common (1% to 10%): Hematuria[Ref]
Immunologic
Uncommon (0.1% to 1%): Allergic reaction
Rare (less than 0.1%): Fever
Frequency not reported: Anaphylactoid reaction[Ref]
Dermatologic
Uncommon (0.1% to 1%): Rash, urticaria, pruritus
Rare (less than 0.1%): Bullous eruptions, skin necrosis, alopecia[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity[Ref]
Metabolic
Uncommon (0.1% to 1%): Hyperkalemia[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Osteoporosis[Ref]
Endocrine
Postmarketing reports: Hypoaldosteronism[Ref]
Gastrointestinal
Frequency not reported: Gastrointestinal bleeding
Postmarketing reports: Retroperitoneal bleed[Ref]
Renal
Frequency not reported: Serum creatinine increased[Ref]
