Sodium Ferric Gluconate Complex Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 4, 2024.

Applies to sodium ferric gluconate complex: intravenous solution.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious types of allergic reactions, including anaphylaxis and Kounis syndrome, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, chest pain or discomfort, pain or discomfort in arms, jaw, back or neck, nausea, sweating, or vomiting after you receive the medicine.

This medicine may cause hypotension (low blood pressure). Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.

This medicine contains benzyl alcohol which may cause serious reactions (eg, gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.

Serious side effects

Along with its needed effects, sodium ferric gluconate complex 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 or nurse immediately if any of the following side effects occur while taking sodium ferric gluconate complex:

Other side effects

Some side effects of sodium ferric gluconate complex 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:

For healthcare professionals

Applies to sodium ferric gluconate complex: intravenous solution.

General adverse events

The most common adverse events were nausea, vomiting, diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, abnormal erythrocytes (changes in morphology, color, or number of red blood cells), dyspnea, chest pain, leg cramps, pain, headache, and tachycardia.^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (35%), hypertension (23%), tachycardia (17%)
• Common (1% to 10%): Thrombosis
• Frequency not reported: Bradycardia, vasodilatation, angina pectoris, myocardial infarction
• Postmarketing reports: Hemorrhage, shock, phlebitis^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea/vomiting and/or diarrhea (35%)
• Common (1% to 10%): Abdominal pain
• Frequency not reported: Rectal disorder, dyspepsia, eructation, flatulence, gastrointestinal disorder, melena
• Postmarketing reports: Dry mouth^[Ref]

Local

• Very common (10% or more): Injection site reaction (33%)^[Ref]

Hypersensitivity

• Postmarketing reports: Allergic reaction, anaphylactic-type reactions^[Ref]

Nervous system

• Very common (10% or more): Headache (24%), dizziness (13%)
• Common (1% to 10%): Headache, paresthesias, syncope
• Frequency not reported: Lightheadedness, somnolence, decreased level of consciousness
• Postmarketing reports: Hypertonia, loss of consciousness, convulsion, dysgeusia, hypoesthesia^[Ref]

Musculoskeletal

• Very common (10% or more): Cramps (25%), leg cramps (10%)
• Frequency not reported: Myalgia, arthralgia, back pain, arm pain^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (11%)
• Common (1% to 10%): Coughing, upper respiratory infections, pharyngitis, rhinitis
• Frequency not reported: Pneumonia, pulmonary edema^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus
• Frequency not reported: Rash, increased sweating
• Postmarketing reports: Skin discoloration^[Ref]

Hematologic

• Very common (10% or more): Abnormal erythrocytes (changes in morphology, color, or number of red blood cells) (11%)
• Frequency not reported: Anemia, leukocytosis, lymphadenopathy^[Ref]

Other

• Very common (10% or more): Chest pain (10%), pain (10%)
• Common (1% to 10%): Asthenia, fatigue, fever, malaise, infection, generalized edema
• Frequency not reported: Infection, abscess, chills, rigors, flu-like syndrome, weakness, deafness, leg edema, peripheral edema, edema^[Ref]

Metabolic

• Common (1% to 10%): Hyperkalemia
• Frequency not reported: Anorexia, hypoglycemia, hypervolemia, hypokalemia^[Ref]

Immunologic

• Common (1% to 10%): Infection
• Frequency not reported: Sepsis^[Ref]

Genitourinary

• Frequency not reported: Urinary tract infection, menorrhagia^[Ref]

Psychiatric

• Frequency not reported: Agitation
• Postmarketing reports: Nervousness^[Ref]

Oncologic

• Frequency not reported: Carcinoma^[Ref]

Ocular

• Frequency not reported: Conjunctivitis, rolling of the eyes, watery eyes, puffy eye lids, arcus senilis, diplopia^[Ref]

See also:

Further information

Sodium ferric gluconate complex 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.

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