Safety and Efficacy of Intravenous Ferric Carboxymaltose (750 mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials
Table 2
Incidence of treatment-emergent adverse events occurring in ≥2% of subjects.
Single-dose study
value
FCM
SMC
≥1 event
132 (36.0)
128 (34.6)
Nausea
15 (4.1)
18 (4.9)
0.722
Headache
11 (3.0)
5 (1.4)
0.138
Diarrhea
10 (2.7)
8 (2.2)
0.642
Fatigue
10 (2.7)
7 (1.9)
0.474
Constipation
7 (1.9)
13 (3.5)
0.257
Vomiting
4 (1.1)
14 (3.8)
0.029*
Abdominal pain
2 (<1)
8 (2.2)
0.107
Urinary tract infection
1 (<1)
8 (2.2)
0.038*
Multidose study
FCM
SMC
≥1 event
185 (54.4)
198 (55.0)
Decreased blood phosphorous
25 (7.3)
0
<0.001**
Headache
16 (4.7)
18 (5.0)
0.862
Nausea
14 (4.1)
27 (7.5)
0.055
Constipation
12 (3.5)
26 (7.2)
0.031*
Diarrhea
10 (2.9)
14 (3.9)
0.537
Dizziness
10 (2.9)
17 (4.7)
0.242
Upper respiratory tract infection
9 (2.6)
6 (1.7)
0.440
Arthralgia
8 (2.3)
8 (2.2)
1.000
Myalgia
8 (2.3)
2 (0.06)
0.058
Pain in extremity
9 (2.6)
4 (1.1)
0.167
Fatigue
9 (2.6)
5 (1.4)
0.287
Increased alanine aminotrasferase
7 (2.0)
5 (1/4)
0.570
Back pain
7 (2.0)
6 (1.7)
0.784
Nasopharyngitis
7 (2.0)
6 (1.7)
0.784
Urinary tract infection
7 (2.0)
6 (1.7)
0.784
Vomiting
6 (1.7)
13 (3.6)
0.164
Peripheral edema
3 (<1)
8 (2.2)
0.224
Cough
2 (<1)
8 (2.2)
0.108
Values are expressed as number of subjects (percentage). FCM: ferric carboxymaltose; SMC: standard medical care.
*Statistically significant at 0.05 level.
**Statistically significant at 0.001 level.
