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Orgaran Side Effects

Generic name: danaparoid

Medically reviewed by Last updated on Sep 30, 2023.

Note: This document contains side effect information about danaparoid. Some dosage forms listed on this page may not apply to the brand name Orgaran.

Applies to danaparoid: subcutaneous solution.


There is a risk of bleeding in the spinal or epidural space, possibly resulting in paralysis, when danaparoid is used along with spinal or epidural anesthesia or spinal puncture. This risk may be increased by the use of indwelling epidural catheters or by the concomitant use of drugs that affect blood clotting.

Do not inject this medication intramuscularly (into the muscle) or intravenously (into the vein).

Do not take aspirin, ibuprofen (Motrin, Advil, Nuprin, and others), ketoprofen (Orudis KT, Orudis, Oruvail), naproxen (Aleve, Naprosyn, Anaprox, and others), indomethacin (Indocin), or any other nonsteroidal anti-inflammatory medication without first talking to your doctor. These medicines may lead to bleeding when taken with danaparoid. Ask your pharmacist or doctor before taking any prescription or over-the-counter medication.

If you experience any of the following serious side effects, stop using danaparoid (the active ingredient contained in Orgaran) and seek emergency medical attention or call your doctor immediately:

Other less serious side effects may be more likely to occur. Continue to use danaparoid and notify your doctor if you experience

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to danaparoid: subcutaneous solution.


Patients undergoing spinal/epidural anesthesia or puncture and anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk for long-term or permanent paralysis due to epidural or spinal hematoma. The risk of these events is increased by the use of indwelling epidural catheters or by concomitant use of platelet inhibitors, other anticoagulants, or drugs that affect hemostasis.

Hematologic adverse effects that have been reported include hemorrhage (intraoperative and postoperative blood loss), bruising and wound hematoma. Incidence of bleeding complications appear to be similar to heparin (approximately 10%). Thrombocytopenia has been reported to occur significantly less than with heparin or low molecular weight heparins. Danaparoid is considered a useful substitute for heparin or low molecular weight heparins in thrombocytopenia for the majority of patients who require immediate anticoagulation, although thrombocytopenia has been reported in patients receiving danaparoid (the active ingredient contained in Orgaran) [Ref]

A fatal bleeding episode has been reported in a patient with renal insufficiency. Overall, probable or possible danaparoid-associated mortality due to bleeding, thrombosis, or septic shock occurred in 7 of 230 patients (3.0%).

Danaparoid has shown a much lower in vitro cross-reactivity with heparin-induced antibody than some low molecular weight heparins (6.3% versus 95%, respectively). In fresh patient plasma, 14 of 143 (9.8%) of danaparoid tests showed positive cross-reactivity with heparin-induced antibody.

Patients previously exposed to unfractionated heparin or a low-molecular-weight heparin appear to be more susceptible to developing heparin-induced thrombocytopenia (HIT) and HIT-related thromboembolic complications (e.g., transient ischemic attack, stroke) than those who were never exposed.

Heparin-induced thrombocytopenia (HIT) is an immune-mediated, prothrombotic reaction that occurs in 0.5% to 5% of patients treated with unfractionated heparin and in less than 1% of patients treated with a low molecular weight heparin (LMWH). The decrease in platelet count associated with HIT usually begins 5 to 14 days after starting heparin. However, patients with a previous exposure to heparin may have an abrupt decrease in platelets upon restarting heparin. Patients with LMWH-induced HIT exhibit a longer delay in the onset of symptoms compared with those who develop it from unfractionated heparin. Following discontinuation, platelet counts begin to recover within 4 days, but may take more than 2 weeks in patients with high-titer HIT antibodies. Thrombocytopenia is caused by heparin-dependent IgG antibodies that bind to a specific platelet protein, platelet factor 4 (PF4). The heparin-PF4-IgG immune complex binds to platelets causing platelet activation. The activated platelets cause release of platelet-derived procoagulant microparticles, which accelerate coagulation reactions and generates thrombin. LMWHs have a high cross-reactivity with circulating heparin-PF4-IgG immune complex. Factors associated with a higher risk for developing HIT-associated thrombosis include women, nonwhites, severity of thrombocytopenia, and lower body weight. Complications associated with HIT include exacerbation of venous thromboembolism, arterial or venous thrombosis, limb gangrene, stroke, and skin necrosis. The antibodies that cause HIT will usually disappear after approximately 3 months; therefore, use of unfractionated heparin or LMWH may be considered in a patient with a history of HIT if the antibody test is negative.[Ref]


Local effects may include injection site discomfort and bruising. The incidence of bruising appears to be less with heparin.[Ref]


Hypersensitivity reactions have included a Type IV (IgE) delayed hypersensitivity cutaneous reaction due to subcutaneous injection danaparoid (the active ingredient contained in Orgaran) The reaction was described as a red, itchy, indurated and erythematous.[Ref]


1. de Valk HW, Banga J, Wester JW, et al. Comparing subcutaneous danaparoid and intravenous unfractionated heparin for the treatment of venous thromboembolism: a randomised controlled trial. Ann Intern Med. 1995;123:1-9.

2. de Valk HW, Banga JD, Wester JW, Brouwer CB, van Hessen MW, Meuwissen OJ, Hart HC, Sixma JJ, Nieuwenhuis HK. Comparing subcutaneous danaparoid with intravenous unfractionated heparin for the treatment of venous thromboembolism. A randomized controlled trial. Ann Intern Med. 1995;123:1-9.

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5. Magnani HN. Heparin-induced thrombocytopenia (HIT): an overview of 230 patients treated with orgaran (Org 10172) [published erratum appears in Thromb Haemost 1993 Dec 20;70(6):1072]. Thromb Haemost. 1993;70:554-61.

6. Insler SR, Kraenzler EJ, Bartholomew JR, Kottkemarchant K, Lytle B, Starr NJ. Thrombosis during the use of the heparinoid organon 10172 in a patient with heparin-induced thrombocytopenia. Anesthesiology. 1997;86:495-8.

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13. Bracket E, Burnett B, Larsen J, et al. Health care guideline: deep vein thrombosis (DVT) diagnosis algorithm. 2006.

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22. Gallus A, Cade J, Ockelford P, Hepburn S, Maas M, Magnani H, Bucknall T, Stevens J, Porteous F. Orgaran (Org 10172) or heparin for preventing venous thrombosis after elective surgery for malignant disease? A double-blind, randomised, multicentre comparison. ANZ-Organon Investigators' Group. Thromb Haemost. 1993;70:562-7.

23. Sivakumaran M, Ghosh K, Munks R, Gelsthorpe K, Tan L, Wood JK. Delayed cutaneous reaction to unfractionated heparin, low molecular weight heparin and danaparoid. Br J Haematol. 1994;86:893-4.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.