Applies to ferric derisomaltose: intravenous solution.
Serious side effects
Along with its needed effects, ferric derisomaltose 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 derisomaltose:
Rare
- Blurred vision
- confusion
- cough
- difficulty swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- hives, itching, rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sweating
- tightness in the chest
- troubled breathing
- unusual tiredness or weakness
Incidence not known
- Chest pain
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- headache
- loss of consciousness
- nervousness
- pounding in the ears
- seizures
- slow heartbeat
Other side effects
Some side effects of ferric derisomaltose 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:
Less common
- Nausea
- rash
Incidence not known
- Abdominal or stomach pain
- anxiety
- back pain
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
- change or loss of taste
- constipation
- diarrhea
- joint or muscle pain
- muscle spasms
- vomiting
For Healthcare Professionals
Applies to ferric derisomaltose: intravenous solution.
Metabolic
Common (1% to 10%): Hypophosphatemia (serum phosphate under 2 mg/dL)
Frequency not reported: Iron overload[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Serious or severe hypersensitivity
Postmarketing reports: Anaphylactic/anaphylactoid reaction, hypersensitivity[Ref]
Dermatologic
Common (1% to 10%): Rash
Postmarketing reports: Erythema, urticaria, discoloration skin, pruritus, sweating[Ref]
Gastrointestinal
Common (1% to 10%): Nausea
Postmarketing reports: Abdominal pain, nausea and vomiting, constipation, diarrhea[Ref]
Cardiovascular
Postmarketing reports: Tachycardia, hypertension, hypotension, flushing, phlebitis[Ref]
Local
Postmarketing reports: Extravasation, injection site reactions, long lasting brown discoloration at injection site[Ref]
Musculoskeletal
Postmarketing reports: Back pain, muscle spasms, arthralgia, myalgia[Ref]
Nervous system
Postmarketing reports: Dizziness, headache, paresthesia, dysgeusia, seizure, loss of consciousness, syncope[Ref]
Other
Postmarketing reports: Fatigue, pyrexia, chest pain, chills, Fishbane reactions, influenza like symptoms[Ref]
Hepatic
Postmarketing reports: Hepatic enzymes increased[Ref]
Respiratory
Postmarketing reports: Dyspnea, cough[Ref]
Psychiatric
Postmarketing reports: Anxiety[Ref]
