Table 3.

Number (proportion) of adverse events by randomization arm (reported in 10% or more in either group)

Adverse EventFerric Citrate, n (%)Ferrous Sulfate, n (%)
Total N3030
Weight loss3 (10)7 (24)
Weight gain5 (17)8 (27)
Fatigue6 (20)3 (10)
Infection5 (17)1 (4)
Eye pain2 (7)5 (17)
Vision changes4 (14)1 (4)
Nasal congestion3 (10)4 (14)
Shortness of breath2 (7)5 (16)
Cough3 (10)1 (4)
Nausea6 (20)5 (16)
Diarrhea9 (30)5 (16)
Constipation9 (30)11 (36)
Change in stool color16 (53)8 (27)
Anorexia2 (7)8 (27)
GERD3 (10)1 (4)
Frequency2 (7)5 (16)
Muscle pain3 (10)2 (7)
Edema04 (14)
Headache2 (7)6 (20)
Change smell/taste3 (10)2 (7)
  • GERD, gastroesophageal reflux disease.