Injectafer Side Effects

Generic Name: ferric carboxymaltose

Note: This page contains information about the side effects of ferric carboxymaltose. Some of the dosage forms included on this document may not apply to the brand name Injectafer.

For the Consumer

Applies to ferric carboxymaltose: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by ferric carboxymaltose (the active ingredient contained in Injectafer). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking ferric carboxymaltose, check with your doctor or nurse immediately:

• Blurred vision
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• headache
• nervousness
• pounding in the ears
• redness of the face, neck, arms, and occasionally, upper chest
• slow or fast heartbeat
• sweating
• unusual tiredness or weakness

• Chest discomfort
• chills
• cough
• difficult or labored breathing
• difficulty swallowing
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• hives
• itching
• 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
• skin rash
• tightness in the chest

Minor Side Effects

Some of the side effects that can occur with ferric carboxymaltose may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• Nausea

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

• Abdominal or stomach pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• diarrhea
• difficulty having a bowel movement (stool)
• pain or irritation at the injection site
• sneezing

• Back pain
• difficulty with moving
• hives or welts
• 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

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]

Not all side effects for Injectafer may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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