Recommended Topic Related To:

Fragmin

"How long a young adult is obese may affect that person's heart disease risk in middle age, according to new research. The finding suggests that not only preventing but also delaying the onset of obesity can help reduce heart disease later in life"...

Fragmin

Fragmin

Fragmin Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Fragmin (dalteparin) is an anticoagulant (blood thinner) medication. Specifically, it is a low molecular weight heparin indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy. It is also used for the prevention of deep vein thrombosis in certain patients. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. Fragmin is administered by subcutaneous injection.

Side effects can include easy bruising or bleeding. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether dalteparin passes into breast milk or if it could harm a nursing baby.

Our Fragmin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Fragmin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dalteparin and call your doctor at once if you have a serious side effect such as:

  • unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
  • easy bruising, purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • black or bloody stools, coughing up blood or vomit that looks like coffee grounds;
  • numbness, tingling, or muscle weakness (especially in your legs and feet);
  • loss of movement in any part of your body;
  • sudden weakness, severe headache, confusion, or problems with speech, vision, or balance; or
  • trouble breathing.

Less serious side effects include pain, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fragmin (Dalteparin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Fragmin Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Irritation, bruising, or pain at the injection site may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause bleeding if its effect on your blood clotting proteins is too strong. Tell your doctor immediately if any of these unlikely but serious signs of bleeding occur: unusual pain/swelling/discomfort, unusual or prolonged bleeding, unusual or easy bruising.

Tell your doctor immediately if any of these rare but very serious signs of bleeding occur: dark urine, black stools, severe headache, confusion, vision changes, unusual dizziness, fainting, seizures, weakness, numbness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Fragmin (Dalteparin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Fragmin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not accurately reflect the rates observed in practice.

Hemorrhage

The incidence of hemorrhagic complications during treatment with FRAGMIN (dalteparin) Injection has been low. The most commonly reported side effect is hematoma at the injection site. The risk for bleeding varies with the indication and may increase with higher doses.

Unstable Angina and Non-Q-Wave Myocardial Infarction

Table 5 summarizes major bleeding reactions that occurred with FRAGMIN (dalteparin) , heparin, and placebo in clinical trials of unstable angina and non-Q-wave myocardial infarction.

Table 5 : Major Bleeding Reactions in Unstable Angina and Non-Q-Wave Myocardial Infarction

Indication Dosing Regimen
Unstable Angina and Non-Q-Wave MI FRAGMIN (dalteparin) 120 IU/kg/12 hr subcutaneous1
n (%)
Heparin2 intravenous and subcutaneous2
n (%)
Placebo every 12 hr subcutaneous
n (%)
Major Bleeding Reactions3,4 15/1497 (1.0) 7/731 (1.0) 4/760 (0.5)
1 Treatment was administered for 5 to 8 days.
2 Heparin intravenous infusion for at least 48 hours, APTT 1.5 to 2 times control, then 12,500 U subcutaneously every 12 hours for 5 to 8 days
3 Aspirin (75 to 165 mg per day) and beta blocker therapies were administered concurrently.
4 Bleeding reactions were considered major if: 1) accompanied by a decrease in hemoglobin of ≥ 2 g/dL in connection with clinical symptoms; 2) a transfusion was required; 3) bleeding led to interruption of treatment or death; or 4) intracranial bleeding

Hip Replacement Surgery

Table 6 summarizes: 1) all major bleeding reactions and, 2) other bleeding reactions possibly or probably related to treatment with FRAGMIN (dalteparin) (preoperative dosing regimen), warfarin sodium, or heparin in two hip replacement surgery clinical trials.

Table 6 : Bleeding Reactions Following Hip Replacement Surgery

Indication FRAGMIN vs Warfarin Sodium FRAGMIN vs Heparin
Dosing Regimen Dosing Regimen
Hip Replacement Surgery FRAGMIN2 5000 IU once daily subcutaneous n (%) Warfarin Sodium1 oral n (%) FRAGMIN4 5000 IU once daily subcutaneous n (%) Heparin 5000 U three times a day subcutaneous n (%)
Major Bleeding Reactions3 7/274 (2.6) 1/279 (0.4) 0 3/69 (4.3)
Other Bleeding Reactions5Hematuria 8/274 (2.9) 5/279 (1.8) 0 0
Wound Hematoma 6/274 (2.2) 0 0 0
Injection Site Hematoma 3/274 (1.1) NA 2/69 (2.9) 7/69 (10.1)
1 Warfarin sodium dosage was adjusted to maintain a prothrombin time index of 1.4 to 1.5, corresponding to an International Normalized Ratio (INR) of approximately 2.5.
2 Includes three treated patients who did not undergo a surgical procedure.
3 A bleeding event was considered major if: 1) hemorrhage caused a significant clinical event, 2) it was associated with a hemoglobin decrease of ≥ 2 g/dL or transfusion of 2 or more units of blood products, 3) it resulted in reoperation due to bleeding, or 4) it involved retroperitoneal or intracranial hemorrhage.
4 Includes two treated patients who did not undergo a surgical procedure.
5 Occurred at a rate of at least 2% in the group treated with FRAGMIN (dalteparin) 5000 IU once daily.

Six of the patients treated with FRAGMIN (dalteparin) experienced seven major bleeding reactions. Two of the reactions were wound hematoma (one requiring reoperation), three were bleeding from the operative site, one was intraoperative bleeding due to vessel damage, and one was gastrointestinal bleeding. None of the patients experienced retroperitoneal or intracranial hemorrhage or died of bleeding complications.

In the third hip replacement surgery clinical trial, the incidence of major bleeding reactions was similar in all three treatment groups: 3.6% (18/496) for patients who started FRAGMIN (dalteparin) before surgery; 2.5% (12/487) for patients who started FRAGMIN (dalteparin) after surgery; and 3.1% (15/489) for patients treated with warfarin sodium.

Abdominal Surgery

Table 7 summarizes bleeding reactions that occurred in clinical trials which studied FRAGMIN (dalteparin) 2500 and 5000 IU administered once daily to abdominal surgery patients.

Table 7 : Bleeding Reactions Following Abdominal Surgery

Indication FRAGMIN vs Placebo FRAGMIN vs FRAGMIN
Dosing Regimen Dosing Regimen
Abdominal Surgery FRAGMIN (dalteparin) 2500 IU
once daily subcutaneous
n (%)
Placebo once daily subcutaneous
n (%)
FRAGMIN (dalteparin) 2500 IU once daily subcutaneous
n (%)
FRAGMIN (dalteparin) 5000 IU
once daily subcutaneous
n (%)
Postoperative 14/182 13/182 89/1025 125/1033
Transfusions (7.7) (7.1) (8.7) (12.1)
Wound 2/79 2/77 1/1030 4/1039
Hematoma (2.5) (2.6) (0.1) (0.4)
Reoperation 1/79 1/78 2/1030 13/1038
Due to Bleeding (1.3) (1.3) (0.2) (1.3)
Injection Site 8/172 2/174 36/1026 57/1035
Hematoma (4.7) (1.1) (3.5) (5.5)
Postoperative 26/459 36/454 81/508 63/498
Transfusions (5.7) (7.9) (15.9) (12.7)
Wound 16/467 18/467 12/508 6/498
Hematoma (3.4) (3.9) (2.4) (1.2)
Reoperation 2/392 3/392 4/508 2/498
Due to Bleeding (0.5) (0.8) (0.8) (0.4)
Injection Site 1/466 5/464 36/506 47/493
Hematoma (0.2) (1.1) (7.1) (9.5)

In a trial comparing FRAGMIN (dalteparin) 5000 IU once daily to FRAGMIN (dalteparin) 2500 IU once daily in patients undergoing surgery for malignancy, the incidence of bleeding reactions was 4.6% and 3.6%, respectively (n.s.). In a trial comparing FRAGMIN (dalteparin) 5000 IU once daily to heparin 5000 U twice daily, in the malignancy subgroup the incidence of bleeding reactions was 3.2% and 2.7%, respectively for FRAGMIN (dalteparin) and Heparin (n.s.).

Medical Patients with Severely Restricted Mobility During Acute Illness

Table 8 summarizes major bleeding reactions that occurred in a clinical trial of medical patients with severely restricted mobility during acute illness.

Table 8 : Bleeding Reactions in Medical Patients with Severely Restricted Mobility During Acute Illness

Indication Dosing Regimen
Medical Patients with Severely Restricted Mobility FRAGMIN (dalteparin) 5000 IU once daily subcutaneous
n (%)
Placebo once daily subcutaneous
n (%)
Major Bleeding Reactions1 at Day 14 8/1848 (0.4) 0/1833 (0)
Major Bleeding Reactions1 at Day 21 9/1848 (0.5) 3/1833 (0.2)
1 A bleeding event was considered major if: 1) it was accompanied by a decrease in hemoglobin of ≥ 2 g/dL in connection with clinical symptoms; 2) intraocular, spinal/epidural, intracranial, or retroperitoneal bleeding; 3) required transfusion of ≥ 2 units of blood products; 4) required significant medical or surgical intervention; or 5) led to death.

Three of the major bleeding reactions that occurred by Day 21 were fatal, all due to gastrointestinal hemorrhage (two patients in the group treated with FRAGMIN (dalteparin) and one in the group receiving placebo).

Patients with Cancer and Acute Symptomatic Venous Thromboembolism

Table 9 summarizes the number of patients with bleeding reactions that occurred in the clinical trial of patients with cancer and acute symptomatic venous thromboembolism. A bleeding event was considered major if it: 1) was accompanied by a decrease in hemoglobin of ≥ 2 g/dL in connection with clinical symptoms; 2) occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding); 3) required transfusion of ≥ 2 units of blood products; or 4) led to death. Minor bleeding was classified as clinically overt bleeding that did not meet criteria for major bleeding.

At the end of the six-month study, a total of 46 (13.6%) patients in the FRAGMIN (dalteparin) arm and 62 (18.5%) patients in the OAC arm experienced any bleeding event. One bleeding event (hemoptysis in a patient in the FRAGMIN (dalteparin) arm at Day 71) was fatal.

Table 9 : Bleeding Reactions (Major and Any) (As treated population)1

Study period FRAGMIN 200 IU/kg (max. 18,000 IU) subcutaneous once daily x 1 month, then 150 IU/kg (max. 18,000 IU) subcutaneous once daily x 5 months OAC FRAGMIN 200 IU/kg (max 18,000 IU) subcutaneous once daily x 5-7 days and OAC for 6 months (target INR 2-3)
Number
at risk
Patients with Major Bleeding
n (%)
Patients with Any
Bleeding
n (%)
Number at risk Patients with Major Bleeding
n (%)
Patients with Any Bleeding
n (%)
Total during study 338 19 (5.6) 46 (13.6) 335 12 (3.6) 62 (18.5)
Week1 338 4 (1.2) 15 (4.4) 335 4 (1.2) 12 (3.6)
Weeks 2-4 332 9 (2.7) 17 (5.1) 321 1 (0.3) 12 (3.7)
Weeks 5-28 297 9 (3.0) 26 (8.8) 267 8 (3.0) 40 (15.0)
1 Patients with multiple bleeding episodes within any time interval were counted only once in that interval. However, patients with multiple bleeding episodes that occurred at different time intervals were counted once in each interval in which the event occurred.

Thrombocytopenia

[See WARNINGS AND PRECAUTIONS]

Elevations of Serum Transaminases

In FRAGMIN (dalteparin) clinical trials supporting non-cancer indications, where hepatic transaminases were measured, asymptomatic increases in transaminase levels (SGOT/AST and SGPT/ALT) greater than three times the upper limit of normal of the laboratory reference range were seen in 4.7% and 4.2%, respectively, of patients during treatment with FRAGMIN (dalteparin) .

In the FRAGMIN (dalteparin) clinical trial of patients with cancer and acute symptomatic venous thromboembolism treated with FRAGMIN (dalteparin) for up to 6 months, asymptomatic increases in transaminase levels, AST and ALT, greater than three times the upper limit of normal of the laboratory reference range were reported in 8.9% and 9.5% of patients, respectively. The frequencies of Grades 3 and 4 increases in AST and ALT, as classified by the National Cancer Institute, Common Toxicity Criteria (NCICTC) Scoring System, were 3% and 3.8%, respectively. Grades 2, 3 & 4 combined have been reported in 12% and 14% of patients, respectively.

Other

Allergic Reactions: Allergic reactions (i.e., pruritus, rash, fever, injection site reaction, bullous eruption) have occurred. Cases of anaphylactoid reactions have been reported.

Local Reactions: Pain at the injection site, the only non-bleeding event determined to be possibly or probably related to treatment with FRAGMIN (dalteparin) and reported at a rate of at least 2% in the group treated with FRAGMIN (dalteparin) , was reported in 4.5% of patients treated with FRAGMIN (dalteparin) 5000 IU once daily vs 11.8% of patients treated with heparin 5000 U twice daily in the abdominal surgery trials. In the hip replacement trials, pain at injection site was reported in 12% of patients treated with FRAGMIN (dalteparin) 5000 IU once daily vs 13% of patients treated with heparin 5000 U three times a day.

Post-Marketing Experience

The following adverse reactions have been identified during postapproval use of FRAGMIN (dalteparin) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Since first international market introduction in 1985, there have been more than 15 reports of epidural or spinal hematoma formation with concurrent use of dalteparin sodium and spinal/epidural anesthesia or spinal puncture. The majority of patients had postoperative indwelling epidural catheters placed for analgesia or received additional drugs affecting hemostasis. In some cases the hematoma resulted in long-term or permanent paralysis (partial or complete). [see BOXED WARNING]

Skin necrosis has occurred. There have been cases of alopecia reported that improved on drug discontinuation.

Read the entire FDA prescribing information for Fragmin (Dalteparin) »

A A A

Fragmin - User Reviews

Fragmin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Fragmin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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.


Heart Health

Get the latest treatment options.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations