What are the most common side effects of DALTEPARIN SODIUM?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for DALTEPARIN SODIUM. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is DALTEPARIN SODIUM the same as Fragmin?

Fragmin is a brand name for DALTEPARIN SODIUM. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

DALTEPARIN SODIUM

Q: What is DALTEPARIN SODIUM used for?

DALTEPARIN SODIUM (brand name Fragmin) is a Anticoagulant indicated for when concurrently administered with aspirin therapy [see Clinical Studies (14.1) ] . 1.2 Prophylaxis of Deep Vein Thrombosis FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): • In patients undergoing hip replacement surgery [see Clinical Studies (14.2) ], • In patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.3) ].

Q: How does DALTEPARIN SODIUM work?

DALTEPARIN SODIUM works through the following mechanism: 12.1 Mechanism of Action Dalteparin is a low molecular weight heparin with antithrombotic properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT)..

Anticoagulant

Brand names: Fragmin

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action Dalteparin is a low molecular weight heparin with antithrombotic properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT).

Indications

when concurrently administered with aspirin therapy [see Clinical Studies (14.1) ] . 1.2 Prophylaxis of Deep Vein Thrombosis FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT)

which may lead to pulmonary embolism (PE): • In patients undergoing hip replacement surgery [see Clinical Studies (14.2) ]

• In patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.3) ]

to reduce the recurrence of VTE in adult patients with cancer. In these patients

Contraindications

• pruritis
• rash
• anaphylactic reactions) [see Adverse Reactions (6.1) ] . • Patients undergoing Epidural/Neuraxial anesthesia
• do not administer FRAGMIN [see Boxed Warning and Warnings and Precautions (5.1) ]
• 6.1 ) • In patients undergoing Epidural/Neuraxial anesthesia

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Hemorrhage: Use caution in conditions with increased risk of hemorrhage ( 5
1 Risk of Hemorrhage including Spinal/Epidural Hematomas Spinal or epidural hemorrhage and subsequent hematomas can occur with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture
The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [see Boxed Warning , Adverse Reactions (6
To reduce the potential risk of bleeding associated with the concurrent use of FRAGMIN and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of FRAGMIN [see Clinical Pharmacology (12

Known Side Effects

8 documented side effects by frequency

Nausea

1-10%

Shortness of Breath

1-10%

Vomiting

1-10%

Abdominal Pain

1-10%

Fever

1-10%

Diarrhea

1-10%

Fatigue

1-10%

Constipation

1-10%

Community Discussions

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Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → DALTEPARIN SODIUM openFDA label JSON → DALTEPARIN SODIUM FAERS adverse-event reports → DALTEPARIN SODIUM ClinicalTrials.gov → completed Phase 2+ trials of DALTEPARIN SODIUM

Compare With

4 available comparisons

Formulations

Dosage Forms

Tablet

Route

Subcutaneous