Ferric Carboxymaltose Side Effects
Medically reviewed by Drugs.com. Last updated on Jan 9, 2025.
Applies to ferric carboxymaltose: intravenous solution.
Precautions
It is very important that your doctor check you closely while you are receiving this medicine. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.
Check with your doctor right away if you have bone, joint, or muscle pain, fractures, loss of appetite, trouble breathing, seizures, or unusual tiredness or weakness. These may be symptoms of hypophosphatemia (low phosphate in the blood).
This medicine may cause high blood pressure. Tell your doctor or nurse right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat after receiving the injection.
Make sure your doctor knows if you are also using other iron supplements. Also, tell your doctor if you have had an allergic reaction to injectable iron products.
Other side effects
Some side effects of ferric carboxymaltose 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
- nausea
Less common side effects
- change in taste
- discoloration at the injection site
- loss of taste
- vomiting
Rare side effects
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- constipation
- diarrhea
- pain or irritation at the injection site
- sneezing
- stomach pain
Incidence not known
- back pain
- difficulty with moving
- muscle pain or stiffness
- pain in the joints
- redness of the skin
Serious side effects
Along with its needed effects, ferric carboxymaltose 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 ferric carboxymaltose:
Less common side effects
- blurred vision
- bone pain
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- headache
- loss of appetite
- nervousness
- pounding in the ears
- redness of the face, neck, arms, and occasionally, upper chest
- seizures
- slow or fast heartbeat
- sweating
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- chest discomfort or tightness
- chills
- cough
- difficult or labored breathing
- difficulty swallowing
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
For healthcare professionals
Applies to ferric carboxymaltose: intravenous solution.
Cardiovascular adverse events
- Common (1% to 10%): Flushing/hot flush, hypertension, hypotension
- Uncommon (0.1% to 1%): Chest pain, peripheral edema, tachycardia
- Rare (less than 0.1%): Phlebitis
- Postmarketing reports: Chest discomfort, pallor[Ref]
Dermatologic
- Uncommon (0.1% to 1%): Erythema, rash, pruritus, urticaria
- Postmarketing reports: Angioedema, dermatitis[Ref]
Gastrointestinal
- Common (1% to 10%): Nausea, vomiting
- Uncommon (0.1% to 1%): Abdominal pain, constipation, diarrhea, dyspepsia
- Rare (less than 0.1%): Flatulence[Ref]
Hepatic
- Common (1% to 10%): Alanine aminotransferase increase
- Uncommon (0.1% to 1%): Aspartate aminotransferase increase, gamma glutamyl transferase increase[Ref]
Hypersensitivity
- Common (1% to 10%): Pruritus, rash, urticaria, wheezing, and hypertension associated with hypersensitivity reactions
- Rare (less than 0.1%): Serious anaphylactic/anaphylactoid reactions[Ref]
Local
- Common (1% to 10%): Injection site reactions[Ref]
Injection site reactions include infusion site burning, -pain, -bruising, -discoloration, -extravasation, -irritation, and -paresthesia.[Ref]
Metabolic
- Common (1% to 10%): Blood phosphorus decrease, hypophosphatemia
- Uncommon (0.1% to 1%): Blood alkaline phosphatase increase, blood lactate dehydrogenase increase[Ref]
Musculoskeletal
- Postmarketing reports: Arthralgia, back pain, hypophosphatemic osteomalacia, muscle spasms, myalgia[Ref]
Nervous system
- Common (1% to 10%): Dizziness, dysgeusia, headache
- Uncommon (0.1% to 1%): Paraesthesia
- Rare (less than 0.1%): Syncope, presyncope
- Postmarketing reports: Loss of consciousness[Ref]
Other
- Uncommon (0.1% to 1%): Chills, fatigue, pain, pyrexia
- Rare (less than 0.1%): Malaise, rigors
- Frequency not reported: Overestimate of serum iron and transferrin bound iron laboratory assays
- Postmarketing reports: Face edema, vertigo[Ref]
Respiratory
- Uncommon (0.1% to 1%): Sneezing
- Rare (less than 0.1%): Bronchospasm
- Postmarketing reports: Dyspnea[Ref]
Psychiatric
- Rare (less than 0.1%): Anxiety[Ref]
See also:
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2013) "Product Information. Injectafer (ferric carboxymaltose)." American Regent Laboratories Inc
Frequently asked questions
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Further information
Ferric carboxymaltose 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.