Fondaparinux Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 12, 2024.

Applies to fondaparinux: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

Subcutaneous route (solution)

Epidural or spinal hematomas, which may result in long-term or permanent paralysis, can occur in patients who are anticoagulated with low molecular weight heparins, heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture.

Use of indwelling epidural catheters, concomitant use of drugs affecting hemostasis (eg, NSAIDs, platelet inhibitors, or other anticoagulants), history of traumatic or repeated epidural or spinal puncture, spinal deformity, or spinal surgery may increase the risk of developing these hematomas.

Monitor patients frequently for neurological impairment.

If neurological compromise is noted, urgent treatment is necessary.

Serious side effects of fondaparinux

Along with its needed effects, fondaparinux 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 fondaparinux:

More common side effects

• pale skin
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common side effects

• black, tarry stools
• bladder pain
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain
• chills
• collection of blood under the skin
• confusion
• convulsions
• cough
• decreased or cloudy urine
• deep, dark purple bruise
• difficult, burning, or painful urination
• dizziness
• dry mouth
• fainting or lightheadedness when getting up from a lying or sitting position
• fever
• frequent urge to urinate
• increased thirst
• irregular heartbeat
• itching, pain, redness, or swelling at the injection site
• loss of appetite
• lower back or side pain
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• pinpoint red spots on the skin
• red, tender, or oozing skin at incision
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sudden sweating

Incidence not known

• back pain
• bowel or bladder dysfunction
• difficulty with swallowing
• fast heartbeat
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• leg weakness
• numbness
• paralysis
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest

Get emergency help immediately if any of the following symptoms of overdose occur while taking fondaparinux:

Symptoms of overdose

• abdominal or stomach pain or swelling
• bruising or purple areas on the skin
• coughing up blood
• decreased alertness
• headache
• joint pain or swelling
• nosebleeds

Other side effects of fondaparinux

Some side effects of fondaparinux 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:

More common side effects

• difficulty having a bowel movement
• swelling
• trouble sleeping

Less common side effects

• acid or sour stomach
• belching
• diarrhea
• heartburn
• indigestion
• pain
• skin blisters
• stomach discomfort, upset, or pain
• tightness in the chest
• unusual changes to site of surgery
• wound drainage, increased

For healthcare professionals

Applies to fondaparinux: subcutaneous solution.

General adverse events

The most common adverse events were bleeding events.

The most serious adverse events were bleeding complications and thrombocytopenia.^[Ref]

Hematologic

• Very common (10% or more): Anemia (19.6%)
• Common (1% to 10%): Post-operative hemorrhage, major bleeding, minor bleeding, moderate thrombocytopenia, non-fatal major bleeding at surgical site, overt bleeding associated with a bleeding index of 2 or greater, prothrombin decreased, other clinically overt bleeding, bleeding
• Uncommon (0.1% to 1%): Reoperation due to bleeding, non-fatal major bleeding at non-surgical site, severe thrombocytopenia, fatal bleeding, intracranial bleeding, thrombocythemia, abnormal platelets, coagulation disorder
• Very rare (less than 0.01%): Hypertensive encephalopathy with intracranial bleeding, minor gastrointestinal bleeding
• Postmarketing reports: Thrombocytopenia with thrombosis, aPTT elevation, intracerebral bleeding, retroperitoneal bleeding^[Ref]

The majority of major bleeding events occurred during the first 4 days after surgery. Major bleeding incidence increased in patients weighing less than 50 kg and in patients with impaired renal function.^[Ref]

Other

• Very common (10% or more): Fever (13.6%)
• Common (1% to 10%): Edema, post-operative wound infection, wound drainage increased, surgical site reaction, pain, chest pain
• Uncommon (0.1% to 1%): Edema peripheral, wound secretion
• Rare (less than 0.1%): Hot flushes^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (11.3%)
• Common (1% to 10%): Constipation, vomiting, diarrhea, dyspepsia, abdominal pain
• Rare (less than 0.1%): Gastritis^[Ref]

Local

• Common (1% to 10%): Hematoma, bruising
• Rare (less than 0.1%): Injection site reaction
• Frequency not reported: Local irritation (injection site bleeding, rash, pruritus)^[Ref]

Hepatic

• Common (1% to 10%): Increases in ALT, increases in AST
• Uncommon (0.1% to 1%): Hepatic function abnormal, hepatic enzymes increased
• Rare (less than 0.1%): Bilirubinemia
• Frequency not reported: Increases in bilirubin^[Ref]

Cardiovascular

• Common (1% to 10%): Hypotension, hypertension^[Ref]

Dermatologic

• Common (1% to 10%): Rash, purpura, bullous eruption (includes localized blister)
• Uncommon (0.1% to 1%): Pruritus
• Rare (less than 0.1%): Flushing^[Ref]

Nervous system

• Common (1% to 10%): Headache, dizziness
• Rare (less than 0.1%): Somnolence, vertigo, fatigue, syncope
• Postmarketing reports: Spinal or epidural hematoma^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection, urinary retention
• Rare (less than 0.1%): Edema genital^[Ref]

Metabolic

• Common (1% to 10%): Hypokalemia^[Ref]

Musculoskeletal

• Common (1% to 10%): Leg pain, back pain^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, confusion
• Uncommon (0.1% to 1%): Anxiety^[Ref]

Respiratory

• Common (1% to 10%): Pneumonia, coughing, epistaxis
• Rare (less than 0.1%): Dyspnea^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Allergic reaction
• Very rare (less than 0.01%): Angioedema, anaphylactoid/anaphylactic reaction
• Postmarketing reports: Serious allergic reactions^[Ref]

Further information

Fondaparinux 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.

Medical Disclaimer