Applies to iron dextran: injection solution.
Warning
Injection route (Solution)
Anaphylactic-type reactions, including fatalities, have followed the parenteral use of iron dextran. Have resuscitation equipment and personnel readily available during administration. Administer a test dose, and only administer full dose in the absence of signs or symptoms of anaphylactic-type reaction. Observe patients during administration for anaphylactic-type reaction. Use iron dextran only in patients no amenable to oral iron therapy. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic reactions.
Serious side effects of Iron dextran
Along with its needed effects, iron dextran 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 iron dextran:
Incidence not known
- Backache
- blood in the urine
- bluish color of the fingernails, lips, skin, palms, or nail beds
- blurred vision
- chest pain or discomfort
- chills
- cold, clammy skin
- confusion
- cough
- difficulty with moving
- difficulty with swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast, slow, pounding, or irregular heartbeat or pulse
- fast, weak pulse
- feeling of warmth
- fever
- headache
- hives or welts, itching, or rash
- lightheadedness, dizziness, or fainting
- muscle pain or stiffness
- nausea
- nervousness
- no blood pressure or pulse
- pain in the joints
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- redness of the skin
- seizures
- stopping of heart
- sweating
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- unconsciousness
- unusual tiredness or weakness
- vomiting
Other side effects of Iron dextran
Some side effects of iron dextran 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:
Incidence not known
- Abdominal or stomach pain
- change in taste
- diarrhea
- soreness or pain at the injection site
For Healthcare Professionals
Applies to iron dextran: injectable solution.
Hypersensitivity
Uncommon (0.1% to 1%): Anaphylactoid reactions (including dyspnea, urticaria, rashes, itching, nausea, and shivering)
Very rare (less than 0.01%): Acute severe anaphylactoid reactions (sudden onset of respiratory difficulty and/or cardiovascular collapse)
Frequency not reported: Anaphylactic reactions, fatal anaphylactic reactions[Ref]
Dermatologic
Uncommon (0.1% to 1%): Flushing, pruritus, rash
Rare (less than 0.1%): Angioedema, sweating
Frequency not reported: Urticaria, purpura[Ref]
Nervous system
Uncommon (0.1% to 1%): Numbness
Rare (less than 0.1%): Loss of consciousness, seizure, dizziness, tremor
Very rare (less than 0.01%): Headache, paresthesia
Frequency not reported: Convulsions, syncope, unresponsiveness, altered taste[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Cramps
Rare (less than 0.1%): Myalgias
Frequency not reported: Arthralgia, exacerbation of joint pain, arthritis, backache[Ref]
Other
Uncommon (0.1% to 1%): Feeling hot
Rare (0.01% to 0.1%): Fatigue, chest pain
Very rare (less than 0.01%): Transient deafness
Frequency not reported: Fever, weakness, febrile episodes, chills[Ref]
Respiratory
Uncommon (0.1% to 1%): Dyspnea
Frequency not reported: Respiratory arrest, bronchospasm, wheezing[Ref]
Ocular
Uncommon (0.1% to 1%): Blurred vision[Ref]
Gastrointestinal
Uncommon (0.1% to 1%): Nausea, emesis, abdominal pain
Rare (less than 0.1%): Diarrhea
Frequency not reported: Vomiting[Ref]
Cardiovascular
Rare (0.01 to 0.1%): Arrhythmia, tachycardia, hypotension
Very rare (less than 0.01%): Bradycardia, palpitations, hypertension
Frequency not reported: Chest tightness, shock, cyanosis, cardiac arrest[Ref]
Local
Rare (less than 0.1%): Pain and brown pigmentation at injection site
Frequency not reported: Soreness or inflammation at or near injection site, local phlebitic reaction, staining of the skin, bleeding, formation of sterile abscesses, tissue necrosis, atrophy, pain, sterile abscess, cellulitis[Ref]
Hematologic
Very rare (less than 0.01%): Hemolysis
Frequency not reported: Leukocytosis, lymphadenopathy[Ref]
Psychiatric
Rare (less than 0.1%): Restlessness, mental status changes
Frequency not reported: Disorientation[Ref]
Oncologic
Frequency not reported: Tumors at the injection site[Ref]
Genitourinary
Frequency not reported: Hematuria[Ref]
