Table 1. Rates of adverse reaction and intolerance to IV iron agents

Iron AgentAuthorStudy Design 1Patients (n)Previous Exposure (Y/N)Doses (n)Dose Size (mg)IV Rate (mg/min)Serious ADE Rate (%)Nonserious ADE Rate (%)Intolerance Rate (%)Notes
Per PatientPer ExposurePer PatientPer Exposure
a IV, intravenous; ADE, adverse drug event; IM, intramuscular; PD, peritoneal dialysis; HD, hemodialysis; CKD, chronic kidney disease; SFGC, sodium ferric gluconate complex.
Free ironHeath et al. (57)P178–80IM100Ferric ammonium citrate (IM)
Friend et al. (58)P211010Ferrous ascorbate
Goetsch et al. (59)P1415608–10232.1–8.6100Colloidal ferric hydroxide
Iron dextranMarchasin and Wallerstein (60)R37100–300010–30002.7Safety information is limited
Wallerstein (61)R2396500–300050–1001.42Review
Hamstra et al. (47)R/P4812099100–250050–2500.60.110.43.1ADE rate increased at doses >250 mg
Auerbach et al. (62)P87871200–23002 vs 63.53.546463.5Infusion rate, premedication showed no effect
St. Peter et al. (63)P10401003.3 vs 502050No difference between rates
Fishbane et al. (64)R5730.75.23.8
Sloand et al. (48)P2020100061010ADE in PD patients weighing <50 kg
McCarthy et al. (65)R254N35783005–100.80.0612.20.871.6570% of ADE occurred in incident patients
Barton et al. (66)R1352855002.8–4.200130All patients were premedicated
Fletes et al. (67)RNA841,2521000.02
Prakash et al. (12)34675001.7–2.12.91.414.77.41PD patients
Walters and Van Wyck (68)R48,5091,066,0990.0350.0350.69Incident
Sloand et al. (48)P11N1110005.600910Randomized, controlled, efficacy trial
Ferric gluconatePascual et al. (69)R63N1254.84.8
Hallak et al. (70)R261Intolerance after test dose
Navarro et al. (71)P2716262.52.100000
Nissenson et al. (72)P88N62.5–1252.13.410.23.41/88 intolerant to 25-mg test dose
Kosch et al. (73)P2872062.512.500Parallel group trial in HD patients
Panesar and Agarwal (74)R582401250.52–8.333.41.7Non-dialysis-dependent CKD
Michael et al. (75)P2,534N251412512.50.60.63.93.90.4Single-dose, placebo-controlled trial
Jain and Bastani (76)R40792501.0–4.25.05.1Hospitalized patients
Bastani et al. (77)R13202501.0–1.410
5001.730
Folkert et al. (78)P144Y5712504.24.20.70.69Rates varied; 4.2 mg/min = “most”
Michael et al. (79)P1321Y13,151125–250<5–1250.13.90.60.4Patients from Michael et al. (75))
Includes patients from Folkert et al. (78))
Iron sucroseChandler et al. (49)P892001.700Dose-finding study in HD, PD, and non–dialysis-dependent CKD
1893002.50
354003.36
225004.236
Kosch et al. (73)P277202504.200000Parallel-group trial in HD patients
Van Wyck et al. (80)P22N22310020009.00.140Previous iron-dextran–intolerant patients
Charytan et al. (81)P77N75710020005.00.50
Prakash et al. (12)23N465001.7–2.14.32.28.74.30
Charytan et al. (82,83)P48N2292005000HD patients
Blaustein et al. (84)P107N2665003.21.82.6Nondialysis CKD patients
Furuland et al. (11)P25510020000HD, PD, and nondialysis CKD
Charytan et al. (82)P130N100–20050–100005.70Patients with previous intolerance to iron dextran or SFGC
Aronoff et al. (10)P665N858310050004.40.340HD patients
PlaceboMichael et al. (75)P2514251400000.1Placebo arm of SFGC trial, above
Sloand et al. (2)P1414000057Placebo arm of iron dextran trial