Fragmin Side Effects
Generic name: dalteparin
Medically reviewed by Drugs.com. Last updated on Jul 15, 2024.
Note: This document provides detailed information about Fragmin Side Effects associated with dalteparin. Some dosage forms listed on this page may not apply specifically to the brand name Fragmin.
Applies to dalteparin: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that the medicine is working properly. Blood tests may be needed to check for unwanted effects. Be sure to keep all appointments.
This medicine may increase your risk of bleeding or bruising. This risk is higher if you have poorly controlled high blood pressure, a heart infection, stomach ulcers, or other bleeding problems. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.
This medicine may increase your risk of serious bleeding or nerve problems in your spine. This risk is higher if you have a catheter in your back for pain medicine or anesthetics, or have an injection into your spine (sometimes called an "epidural" or "spinal"). Other factors include traumatic or repeated epidural or spinal punctures in the past, spinal deformity, previous spinal surgery, or use of other medications that increase the risk of bleeding. Check with your doctor right away if you develop weakness or numbness in your legs or feet, or loss of urine or bowel control.
Call your doctor right away if you start having pains in the chest, groin, or legs, especially the calves, difficulty with breathing, severe, sudden headache, slurred speech, sudden, sudden loss of coordination, sudden, severe weakness or numbness in the arm or leg, or vision changes. These may be symptoms of thromboembolism.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.
This medicine contains benzyl alcohol which may cause serious unwanted effects to newborn or premature infants. Talk to your doctor if you have concerns about this.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 side effects
- bruise
- deep, dark purple bruise, pain, or swelling at the injection site
- nosebleed
Less common side effects
- 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 side effects
- 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 adverse events
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
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]
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References
1. (2001) "Product Information. Fragmin (dalteparin)." Pharmacia and Upjohn
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Fragmin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.