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Venofer Side Effects

Generic Name: iron sucrose

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

Side Effects of Venofer - for the Consumer

Venofer

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Venofer:

Diarrhea; dizziness; headache; muscle cramps; nausea; taste changes; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Venofer:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning or pain at the injection site; burning, numbness, or tingling; chest pain; fainting; loss of consciousness; severe or persistent dizziness, headache, or light-headedness; seizures; shortness of breath; swelling of the hands, ankles, or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Venofer Side Effects - for the Professional

Venofer

Venofer injection may cause serious hypersensitivity reactions and hypotension. [See Warnings and Precautions (5.1; 5.2)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice.

Adverse Reactions in Clinical Studies

The frequency of adverse reactions associated with the use of Venofer has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD.  Treatment-emergent adverse events reported by ≥ 2% of treated patients in the six clinical trials for which the rate for Venofer exceeds the rate for comparator are listed by indication in Table 1.  Patients with HDD-CKD received 100 mg doses at 10 consecutive dialysis sessions until a cumulative dose of 1000 mg was administered.  Patients with NDD-CKD received either 5 doses of 200 mg over 2 weeks or 2 doses of 500 mg separated by fourteen days, and patients with PDD-CKD received 2 doses of 300 mg followed by a dose of 400 mg over a period of 4 weeks.

Table 1.  Treatment-Emergent Adverse Reactions Reported in ≥ 2% of Study Populations and for which the Rate for Venofer Exceeds the Rate for Comparator
HDD-CKD NDD-CKD PDD-CKD
Adverse Reaction
(Preferred Term)		 Venofer
(N=231)
%		 Venofer
(N=139)
%		 Oral Iron
(N=139)
%		 Venofer
(N=75)
%		 EPO* Only
(N=46)
%
*  EPO=Erythropoietin
Subjects with any adverse reaction 78.8 76.3 73.4 72.0 65.2
Ear and Labyrinth Disorders
   Ear Pain
0
2.2
0.7
0
0
Eye Disorders
  Conjunctivitis
0.4
0
0
2.7
0
Gastrointestinal Disorders
   Abdominal pain
   Diarrhea
   Dysgeusia
   Nausea
   Vomiting
3.5
5.2
0.9
14.7
9.1
1.4
7.2
7.9
8.6
5.0
2.9
10.1
0
12.2
8.6
4.0
8.0
0
5.3
8.0
6.5
4.3
0
4.3
2.2
General Disorders and Administration
Site Conditions
   Asthenia
   Chest pain
   Feeling abnormal
   Infusion site pain or burning
   Injection site extravasation
   Peripheral edema
   Pyrexia

2.2
6.1
3.0
0
0
2.6
3.0

0.7
1.4
0
5.8
2.2
7.2
0.7

2.2
0
0
0
0
5.0
0.7

2.7
2.7
0
0
0
5.3
1.3

0
0
0
0
0
10.9
0
Infections and Infestations
    Nasopharyngitis, Sinusitis, Upper
respiratory tract infections,
Pharyngitis


2.6


2.2


4.3


16.0


4.3
Injury, Poisoning and Procedural
Complications
   Graft complication

9.5

1.4

0

0

0
Metabolism and Nutrition Disorders
   Fluid overload
   Gout
   Hyperglycemia
   Hypoglycemia
3.0
0
0
0.4
1.4
2.9
2.9
0.7
0.7
1.4
0
0.7
1.3
0
0
4.0
0
0
2.2
0
Musculoskeletal and Connective
Tissue Disorders
   Arthralgia
   Back pain
   Muscle cramp
   Myalgia
   Pain in extremity

3.5
2.2
29.4
0
5.6

1.4
2.2
0.7
3.6
4.3

2.2
3.6
0.7
0
0

4.0
1.3
2.7
1.3
2.7

4.3
4.3
0
0
6.5
Nervous System Disorders
  Dizziness
  Headache
6.5
12.6
6.5
2.9
1.4
0.7
1.3
4.0
4.3
0
Respiratory, Thoracic and
Mediastinal Disorders
   Cough
   Dyspnea
   Nasal congestion

3.0
3.5
0

2.2
5.8
1.4

0.7
1.4
2.2

1.3
1.3
1.3

0
2.2
0
Skin and Subcutaneous
Tissue Disorders
   Pruritus

3.9

2.2

4.3

2.7

0
Vascular Disorders
   Hypertension
   Hypotension
6.5
39.4
6.5
2.2
4.3
0.7
8.0
2.7
6.5
2.2

One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials in HDD-CKD patients (studies A, B and the two post marketing studies) had prior other intravenous iron therapy and were reported to be intolerant (defined as precluding further use of that iron product). When these patients were treated with Venofer there were no occurrences of adverse reactions that precluded further use of Venofer.  [See Warning and Precautions (5)]

Adverse Reactions from Post-Marketing Spontaneous Reports

In the post-marketing safety studies in 1,051 treated patients with HDD-CKD, the adverse reactions reported by > 1% were: cardiac failure congestive, sepsis and dysgeusia.

The following additional adverse reactions have been identified with the use of Venofer from postmarketing spontaneous reports: Anaphylactic-type reactions, shock, loss of consciousness, collapse, bronchospasm, dyspnea, convulsions, light-headedness, confusion, angioedema, swelling of the joints, hyperhidrosis, back pain, bradycardia, and chromaturia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Venofer injection.  Reactions have occurred following the first dose or subsequent doses of Venofer.  Symptoms may respond to IV fluids, hydrocortisone, and/or antihistamines. Slowing the infusion rate may alleviate symptoms.

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Side Effects by Body System - for Healthcare Professionals

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 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 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 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 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 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 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 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 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 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 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 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 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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