ADVERSE REACTIONS
Severe/Fatal: Anaphylactic reactions have been reported with the use of iron dextran injection; on occasions these reactions have been fatal. Such reactions, which occur most often within the first several minutes of administration, have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. Because fatal anaphylactic reactions have been reported after administration of iron dextran injection, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available. (See boxed WARNING and PRECAUTIONS: General, pertaining to immediate availability of epinephrine.)
Cardiovascular: Chest pain, chest tightness, shock, cardiac arrest, hypotension, hypertension, tachycardia, bradycardia, flushing, arrhythmias. (Flushing and hypotension may occur from too rapid injections by the intravenous route.)
Dermatologic: Urticaria, pruritus, purpura, rash, cyanosis.
Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhea.
Hematologic/lymphatic: Leucocytosis, lymphadenopathy.
Musculoskeletal/soft tissue: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis - See PRECAUTIONS: General), myalgia; backache; sterile abscess, atrophy/ fibrosis (intramuscular injection site); brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites; cellulitis; swelling; inflammation; local phlebitis at or near intravenous injection site.
Neurologic: Convulsions, seizures, syncope, headache, weakness, unresponsiveness, paresthesia, febrile episodes, chills, dizziness, disorientation, numbness, unconsciousness.
Respiratory: Respiratory arrest, dyspnea, bronchospasm, wheezing.
Urologic: Hematuria.
Delayed reactions: Arthralgia, backache, chills, dizziness, fever, headache, malaise, myalgia, nausea, vomiting (See WARNINGS).
Miscellaneous: Febrile episodes, sweating, shivering, chills, malaise, altered taste.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO INFED
Below is a sample of reports where side effects / adverse reactions may be related to Infed. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Infed side effects / adverse reactions in 51 year old male
Reported by a physician from United States on 2007-01-17
Patient: 51 year old male weighing 101.0 kg (222.2 pounds)
Reactions: Chest Discomfort, Pharyngeal Oedema, Blood Pressure Systolic Increased, Pharyngolaryngeal Pain, Infusion Related Reaction
Suspect drug(s):
Infed
Possible Infed side effects / adverse reactions in 70 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-27
Patient: 70 year old female
Reactions: Hypotension, Anaphylactic Reaction, Cardiac Arrest
Adverse event resulted in: hospitalization
Suspect drug(s):
Infed
Possible Infed side effects / adverse reactions in 40 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2007-04-05
Patient: 40 year old female
Reactions: Exchange Blood Transfusion, Intravascular Haemolysis, Renal Failure Acute, Haemodialysis
Adverse event resulted in: hospitalization
Suspect drug(s):
Infed
Other drugs received by patient: Amlodipine; Sertraline; Sumatriptan Succinate
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