Venofer Side Effects

Generic name: iron sucrose

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

Some side effects of Venofer may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to iron sucrose: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking iron sucrose (the active ingredient contained in Venofer) hives, itching; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have a serious side effect such as:

• chest pain;

• feeling like you might pass out;

• swelling in your hands, ankles, or feet;

• trouble breathing; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of iron sucrose may include:

• muscle cramps;

• weakness, tired feeling;

• dizziness, anxiety, headache;

• nausea, vomiting, stomach pain;

• diarrhea, constipation;

• ear pain;

• sore throat, sinus pain or congestion;

• decreased sense of taste;

• joint pain; or

• pain, swelling, burning, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to iron sucrose: intravenous solution

Cardiovascular

Hypotension has been reported in all patients receiving intravenous iron with the highest incidence reported in HDD-CKD patients. Hypotension following administration of iron sucrose (the active ingredient contained in Venofer) may be related to both the rate of administration and total dose administered; therefore, caution should be taken to ensure administration of iron sucrose according to the manufacturer recommended guidelines.

Cardiovascular side effects associated with the use of iron sucrose in the treatment of HDD-CKD have included chest pain (6.1%), cardiac murmur (0.4%), hypertension (6.5%), hypotension (39.4%), and fluid overload (3.0%).

Cardiovascular side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included chest pain (1.4%), cardiac murmur (2.2%), hypertension (6.5%), hypotension (2.2%), and fluid overload (1.4%).

Cardiovascular side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included chest pain (2.7%), hypertension (8.0%), hypotension (2.7%), and fluid overload (1.3%).

Musculoskeletal

Musculoskeletal side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included arthralgia (3.5%), back pain (2.2%), muscle cramp (29.4%), and pain in extremity (5.6%).

Musculoskeletal side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included arthralgia (1.4%), back pain (2.2%), muscle cramp (0.7%), myalgia (3.6%), and pain in extremity (4.3%).

Musculoskeletal side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included arthralgia (4.0%), back pain (1.3%), muscle cramp (2.7%), myalgia (1.3%), and pain in extremity (2.7%).

Gastrointestinal

Gastrointestinal side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included abdominal pain (3.5%), constipation (1.3%), diarrhea (5.2%), dysgeusia (0.9%), nausea (14.7%), and vomiting (9.1%).

Gastrointestinal side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included abdominal pain (1.4%), constipation (4.3%), diarrhea (7.2%), dysgeusia (7.9%), nausea (8.6%), and vomiting (5%).

Gastrointestinal side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included abdominal pain (4.0%), constipation (4.0%), diarrhea (8.0%), nausea (5.3%), and vomiting (8.0%).

Dry mouth has also been reported.

Nervous system

Nervous system side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included dizziness (6.5%), headache (12.6%), and asthenia (2.2%).

Nervous system side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included dizziness (6.5%), headache (2.9%), hypoesthesia (0.7%), and asthenia (0.7%).

Nervous system side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included dizziness (1.3%), headache (4.0%), and asthenia (2.7%).

Respiratory

Respiratory side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included cough (3.0%), dyspnea (3.5%), upper respiratory infection (1.3%), pharyngitis (0.4%), and nasopharyngitis (0.9%).

Respiratory side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included cough (2.2%), dyspnea (3.6%), exacerbated dyspnea (2.2%), nasal congestion (1.4%), sinusitis (0.7%), upper respiratory infection (0.7%), allergic rhinitis (0.7%), and nasopharyngitis (0.7%).

Respiratory side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included nasopharyngitis (2.7%), sinusitis (4.0%), upper respiratory tract infection (2.7%), cough (1.3%), dyspnea (1.3%), nasal congestion (1.3%), and pharyngitis (6.7%).

Pneumonia and cough have also been reported.

Local

Local side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of NDD-CKD have included burning (3.6%), extravasation (2.2%), and pain (2.2%) at the injection site.

Dermatologic

Dermatologic side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included pruritus (3.9%) and rash (0.4%).

Dermatologic side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included pruritus (2.2%) and rash (1.4%).

Dermatologic side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included pruritus (2.7%).

Hepatic

Hepatic side effects have included elevated liver enzymes (1% to 5%).

Immunologic

Immunologic side effects have included a possible increase in susceptibility to infections.

Endocrine

Endocrine side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included hypoglycemia (0.4%).

Endocrine side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included gout (2.9%), hyperglycemia (2.9%), and hypoglycemia (0.7%).

Endocrine side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included hypoglycemia (4.0%).

Other

Other side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included edema (0.4%), fatigue (1.7%), feeling abnormal (3.0%), peripheral edema (2.6%), pyrexia (3.0%), and graft complication (9.5%).

Other side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included ear pain (2.2%), edema (6.5%), fatigue (3.6%), peripheral edema (7.2%), pyrexia (0.7%), and graft complication (1.4%).

Other side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included peripheral edema (5.3%), pyrexia (1.3%), catheter site infection (4.0%), and peritoneal infection (8.0%).

Accidental injury and fever have also been reported.

Genitourinary

Genitourinary side effects associated with the use of iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included urinary tract infection (0.4%).

Genitourinary side effects associated with the use of iron sucrose in the treatment of NDD-CKD have included urinary tract infection (0.7%) and proteinuria.

Genitourinary side effects associated with the use of iron sucrose in the treatment of PDD-CKD have included urinary tract infection (1.3%).

Hypersensitivity

Hypersensitivity side effects have included wheezing, dyspnea, hypotension, rashes, and pruritus. Hypersensitivity reactions to iron sucrose (the active ingredient contained in Venofer) are reported to occur in less than 0.1% of patients. Anaphylactic reactions consisting of anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, and/or convulsion have also been reported.

Serious hypotensive episodes have been reported in two patients following administration of iron sucrose at a dosage of 500 mg.

Between 1992 and February 2005, a total of 104 reports of anaphylactoid reactions including serious or life-threatening reactions have been collected in postmarketing spontaneous reporting worldwide based on estimated use in over 3.8 million patients.

Four U.S. trials involving the administration of iron sucrose to patients with HDD-CKD (n=1,151) included 130 (11%) patients who reportedly had a previous history of intravenous iron therapy and were reported to be intolerant, that is, precluded from further use of that iron product. Following administration of iron sucrose, it was reported that none of these patients had an adverse reaction that would preclude them from further use of iron sucrose.

Ocular

Ocular side effects associated with the use iron sucrose (the active ingredient contained in Venofer) in the treatment of HDD-CKD have included conjunctivitis (0.4%).

Ocular side effects associated with the use iron sucrose in the treatment of PDD-CKD have included conjunctivitis (2.7%).

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