Applies to ferric carboxymaltose: intravenous solution.

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

• 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

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

• Nausea

Less common

• Change in taste
• discoloration at the injection site
• loss of taste
• vomiting

Rare

• 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

For Healthcare Professionals

Applies to ferric carboxymaltose: intravenous solution.

Cardiovascular

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

Injection site reactions include infusion site burning, -pain, -bruising, -discoloration, -extravasation, -irritation, and -paresthesia.^[Ref]

Common (1% to 10%): Injection site reactions^[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]