Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Fraxiparine (Nadroparin). If you are concerned about side effects, discuss the risks and benefits of Fraxiparine (Nadroparin) with your doctor.

The following side effects have been reported by at least 1% of people taking Fraxiparine (Nadroparin). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• discomfort or redness at injection site
• hardening of skin or lump at injection site

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bleeding from the injection site or surgical wound
• prolonged (more than 4 hours) or painful erections, or erections that happen too often
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• skin damage at the injection site

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., swelling of face or throat, Hives, or difficulty breathing or swallowing)
• skin rash
• sudden change or loss of vision
• sudden severe headache; loss of coordination; confusion; difficulty speaking or understanding speech; vision problems in one or both eyes; or weakness or numbness, especially on one side of the body

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Fraxiparine (Nadroparin).

Fraxiparine® Prefilled Syringes

Each mL of aqueous solution contains 9,500 anti-Xa IU of Fraxiparine (Nadroparin) calcium. Single-dose, disposable prefilled glass syringes of 0.2 mL (ungraduated yellow syringes), 1,900 anti-Xa IU; 0.3 mL (ungraduated green syringes), 2,850 anti-Xa IU; 0.4 mL (ungraduated orange syringes), 3,800 anti-Xa IU; 0.6 mL (graduated brown syringes), 5,700 anti-Xa IU; and 1 mL (graduated violet syringes), 9,500 anti-Xa IU. The needle shield of the prefilled syringe may contain latex.

Fraxiparine Forte® Prefilled Syringes

Each mL of aqueous solution contains 19,000 anti-Xa IU of Fraxiparine (Nadroparin) calcium. Single-dose, disposable prefilled glass syringes of 0.6 mL (graduated process blue syringes), 11,400 anti-Xa IU; 0.8 mL (graduated magenta syringes), 15,200 anti-Xa IU; and 1 mL (graduated reflex blue syringes), 19,000 anti-Xa IU. The needle shield of the prefilled syringe may contain latex.

Do not use Fraxiparine (Nadroparin) if you:

• are allergic to Fraxiparine (Nadroparin) or to any of the ingredients of the medication
• are allergic to other low-molecular-weight heparins or Heparin
• currently have or have previously had heparin-induced thrombocytopenia (decrease in the number of platelets), or test positive in a platelet-aggregation test while using Fraxiparine (Nadroparin)
• have a history of bleeding in the brain
• have a severe blood clotting disorder
• have active bleeding, bleeding tendencies, or other conditions that could have an increased risk of bleeding
• have acute infective Endocarditis (bacterial infection of the heart)
• have bleeding due to ulcers (e.g., active stomach or duodenal ulcers)
• have eye problems due to Diabetes or bleeding
• have injuries to and have had operations on the brain, spinal cord, eyes, or ears
• have severe kidney problems (unless you are using Fraxiparine (Nadroparin) to prevent clot formation during dialysis)
• have uncontrolled high blood pressure
• have received spinal anaesthesia and need continued daily treatment

There may be an interaction between Fraxiparine (Nadroparin) and any of the following:

• acetylsalicylic acid (Asa)
• Aliskiren
• angiotensin-converting enzyme inhibitors (ACEIs; Captopril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• Apixaban
• Canagliflozin
• dabigatran
• Dasatinib
• Deferasirox
• Dipyridamole
• Eplerenone
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• heparin
• herbal products that affect blood clotting (e.g., cat's claw, chamomile, fenugreek, evening primrose, feverfew, garlic, ginger, ginseng, turmeric)
• Ibrutinib
• Mesalamine
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• omega-3 fatty acids
• other low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Pentoxifylline
• platelet inhibitors (e.g., Ticlopidine, Clopidogrel, eptifibatide)
• progestins (e.g., Levonorgestrel, medroxyprogesterone, Progesterone)
• potassium-sparing diuretics (e.g., Amiloride, Spironolactone, triamterene)
• potassium supplements (e.g., potassium chloride)
• Prasugrel
• Rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; Desvenlafaxine, Duloxetine, Venlafaxine)
• Sulfasalazine
• Ticagrelor
• thrombolytic agents (e.g., alteplase, streptokinase, urokinase)
• vitamin E
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Fraxiparine (Nadroparin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fraxiparine (Nadroparin).

Bleeding: The most serious risk associated with Fraxiparine (Nadroparin) is bleeding in any tissue or organ. It is extremely important to have regular blood tests (as prescribed by your doctor) to ensure that the correct level of blood thinning is occurring. If you have an increased risk of bleeding (for example, if you are over 65, have liver failure, reduced kidney function, high blood pressure, or a history of ulcers), your doctor should closely monitor your condition while you are taking Fraxiparine (Nadroparin).

Body weight: The safety and efficacy of Fraxiparine (Nadroparin) for very heavy people (e.g., over 120 kg) and very light people (e.g., under 45 kg) have not been fully established. If your weight is very high or low, your doctor will monitor you closely while you are taking Fraxiparine (Nadroparin).

Cardiovascular problems: If you have Coronary Artery Disease or high blood pressure, discuss with your doctor how Fraxiparine (Nadroparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fraxiparine (Nadroparin), and whether any special monitoring is needed.

Kidney function: Kidney Disease or reduced kidney function may cause Fraxiparine (Nadroparin) to build up in the body, causing side effects, including bleeding. If you have reduced kidney function or kidney disease, discuss with your doctor how Fraxiparine (Nadroparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fraxiparine (Nadroparin), and whether any special monitoring is needed.

Platelets: While you are using Fraxiparine (Nadroparin), your doctor will also be monitoring your platelet count. If your platelet level drops very suddenly, you may have to stop Fraxiparine (Nadroparin) and switch to another type of medication. Make sure to tell doctors involved in your care if you have had any problems with low platelets or platelet defects in the past.

Potassium levels: Fraxiparine (Nadroparin) may increase blood potassium levels, especially in people who are at risk for high potassium levels (e.g., people with diabetes or who take certain medications). Your doctor will monitor your potassium levels while you are using Fraxiparine (Nadroparin). If you experience symptoms of high levels of potassium in the blood, such as muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, or nausea, contact your doctor.

Prosthetic heart valves: There have been reports of people with prosthetic heart valves who developed clots in their valves when treated with low-molecular-weight heparin medications such as Fraxiparine (Nadroparin). Your doctor will need to monitor you closely while you are taking Fraxiparine (Nadroparin).

Stomach ulcers: If you have a history of stomach ulcers or bleeding in the digestive system, Fraxiparine (Nadroparin) may cause the condition to reoccur. If you have any symptoms of bleeding in the digestive system, such as bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds, seek medical help immediately.

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Fraxiparine (Nadroparin), contact your doctor immediately.

Breast-feeding: It is not known if Fraxiparine (Nadroparin) passes into breast milk. If you are a breast-feeding mother and are taking Fraxiparine (Nadroparin), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Fraxiparine (Nadroparin) have not been established for children.

Seniors: People over the age of 65 years are more at risk of bleeding from Fraxiparine (Nadroparin).