Table 2.

Organ systems potentially affected by ferumoxytol related AEs, and their severity based classification using FDA and CTCAE guidelines.

FDA	Adverse Events			Serious Adverse Events
CTCAE	Grade 1 (mild)	Grade 2 (moderate)	Grade 3 (severe)	Grade 4 (anaphylaxis)	Grade 5 (death)
Cardiac	Hypertension	Chest tightness, tachycardia	Hypotension*	Shock	Cardiac arrest
Skin	Injection site pain, itching erythema; Asymptomatic transient flush, rush, macular/papular eruption; Mild or localized pruritus, hyperpigmentation	Injection site pain or swelling with inflammation or phlebitis; Symptomatic flush, urticaria, macular/papular eruptions covering <50% BSA; Generalized pruritus, hyperpigmentation	Injection site ulceration/necrosis; Intense, widespread pruritus interfering with ADL; Severe, generalized macular/papular/vesicular eruption covering >50% BSA	Generalized exfoliative, ulcerative or bullous dermatitis
Gastrointestinal	Constipation, diarrhea, GERD, nausea, vomiting, taste alteration	Constipation (treatment indicated), diarrhea or vomiting (IV fluids indicated)
Musculoskeletal	Transient myalgia, arthralgia**	Pain (treatment required)
Neurology	Transient headache***	Headache (treatment required)	Loss of consciousness
Constitutional	Fatigue
Ocular/Visual	Red eye
Respiratory	Cough	Cough (narcotic medication needed), dyspnea, wheezing	Stridor, symptomatic bronchospasm	Life-threating bronchospasm	Death
Vascular	Asymptomatic vein injury	Symptomatic vein injury	Vein injury, repair or revision indicated

^*Systolic blood pressure of less than 90 mmHg or greater than 30% decrease from that patient’s baseline

^**Myalgias, arthralgias (e.g. back pain, chest discomfort) are called Fishbane reactions. These are transient, mild infusion reactions (not HSR) and usually they don’t require any treatment.

^***A transient, mild headache can be a normal reaction to iron infusion.

ADL=activities of daily living BSA=body surface area