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Drug

Ferric Carboxymaltose

118 flagged reaction(s) · 8,180 total co-reports · max PRR 43.8
Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
Reaction Co-reports (a) PRR ROR Signal
1 Anhedonia 254 43.8 46.3 signal
2 Infusion Site Pain 37 13.2 13.2 signal
3 Product Quality Issue 325 10.9 11.7 signal
4 Blood Iron Decreased 27 10.4 10.4 signal
5 Injection Site Discolouration 27 9.9 9.9 signal
6 Emotional Distress 258 9.6 10.1 signal
7 Skin Discolouration 96 9.5 9.7 signal
8 Ill-defined Disorder 117 8.7 8.9 signal
9 Infusion Related Reaction 126 8.6 8.9 signal
10 Urticaria 287 7.8 8.3 signal
11 Flushing 173 7.7 7.9 signal
12 Vitamin D Deficiency 16 7.4 7.5 signal
13 Throat Tightness 44 7.4 7.4 signal
14 Chest Discomfort 162 7.2 7.4 signal
15 Hypocalcaemia 28 6.7 6.8 signal
16 Anaphylactic Reaction 78 6.4 6.5 signal
17 Iron Deficiency Anaemia 13 6.4 6.4 signal
18 Throat Irritation 62 6.3 6.4 signal
19 Injection Site Extravasation 17 6.2 6.2 signal
20 Bone Pain 79 6.1 6.2 signal
21 Myalgia 203 5.4 5.6 signal
22 Palpitations 127 4.9 5.0 signal
23 Presyncope 25 4.7 4.7 signal
24 Chest Pain 191 4.7 4.8 signal
25 Anxiety 292 4.6 4.9 signal
26 Adverse Reaction 13 4.4 4.4 signal
27 Paraesthesia Oral 14 4.4 4.4 signal
28 Maternal Exposure During Pregnancy 85 4.4 4.4 signal
29 Dental Caries 10 4.1 4.1 signal
30 Tachycardia 77 3.9 4.0 signal
31 Stress 60 3.8 3.8 signal
32 Back Pain 187 3.6 3.8 signal
33 Muscle Tightness 13 3.6 3.6 signal
34 Polyneuropathy 9 3.4 3.4 signal
35 Premature Delivery 12 3.4 3.4 signal
36 Flank Pain 7 3.4 3.4 signal
37 Eye Haemorrhage 10 3.4 3.4 signal
38 Dyspnoea Exertional 28 3.4 3.4 signal
39 Pain 429 3.2 3.4 signal
40 Nausea 550 3.2 3.4 signal
41 Dyspnoea 393 3.1 3.3 signal
42 Paraesthesia 109 3.1 3.2 signal
43 Muscle Spasms 126 3.1 3.2 signal
44 Vasculitis 8 3.1 3.1 signal
45 Brain Fog 10 3.1 3.1 signal
46 Ear Discomfort 7 3.1 3.1 signal
47 Head Discomfort 12 3.1 3.1 signal
48 Neck Pain 38 3.1 3.1 signal
49 Pruritus 253 3.0 3.1 signal
50 Arthralgia 277 3.0 3.2 signal
51 Unresponsive To Stimuli 17 3.0 3.0 signal
52 Feeling Hot 40 3.0 3.0 signal
53 Muscle Twitching 15 2.9 2.9 signal
54 Hypomagnesaemia 9 2.9 2.9 signal
55 Chills 76 2.9 3.0 signal
56 Sinus Tachycardia 9 2.9 2.9 signal
57 Pharyngeal Swelling 6 2.8 2.8 signal
58 Sneezing 14 2.8 2.8 signal
59 Blood Calcium Decreased 7 2.8 2.8 signal
60 Dizziness 308 2.8 2.9 signal
61 Loss Of Personal Independence In Daily Activities 29 2.8 2.8 signal
62 Bedridden 8 2.8 2.8 signal
63 Influenza Like Illness 50 2.7 2.8 signal
64 Hypersensitivity 112 2.7 2.8 signal
65 Joint Range Of Motion Decreased 8 2.7 2.7 signal
66 Premature Baby 18 2.7 2.7 signal
67 Headache 365 2.6 2.8 signal
68 Asthenia 215 2.6 2.7 signal
69 Cold Sweat 10 2.6 2.6 signal
70 Toothache 10 2.5 2.5 signal
71 Arrhythmia 26 2.5 2.5 signal
72 Hypoaesthesia 81 2.4 2.5 signal
73 Fibromyalgia 13 2.4 2.4 signal
74 Hypoaesthesia Oral 8 2.4 2.4 signal
75 Blood Pressure Decreased 35 2.4 2.4 signal
76 Lethargy 30 2.4 2.4 signal
77 Burning Sensation 35 2.3 2.3 signal
78 Glomerular Filtration Rate Decreased 6 2.2 2.2 no signal
79 Gait Inability 16 2.2 2.2 signal
80 Blood Pressure Increased 74 2.2 2.2 signal
81 Tubulointerstitial Nephritis 9 2.2 2.2 signal
82 Muscle Atrophy 6 2.2 2.2 no signal
83 Pain In Extremity 140 2.1 2.2 signal
84 Rash 203 2.1 2.2 signal
85 Bone Loss 7 2.1 2.1 no signal
86 Blood Pressure Systolic Increased 9 2.1 2.1 signal
87 Joint Stiffness 12 2.1 2.1 signal
88 Gastrointestinal Pain 5 2.1 2.1 no signal
89 Eye Infection 5 2.0 2.0 no signal
90 Restless Legs Syndrome 8 2.0 2.0 no signal
91 Impaired Driving Ability 5 2.0 2.0 no signal
92 Anaphylactic Shock 11 1.9 1.9 no signal
93 Diarrhoea Haemorrhagic 4 1.9 1.9 no signal
94 Feeling Abnormal 102 1.9 1.9 no signal
95 Fracture 8 1.9 1.9 no signal
96 Limb Discomfort 13 1.9 1.9 no signal
97 Impaired Quality Of Life 6 1.9 1.9 no signal
98 Swollen Tongue 13 1.9 1.9 no signal
99 Heart Rate Irregular 9 1.8 1.8 no signal
100 Pelvic Pain 7 1.7 1.7 no signal
101 Hot Flush 29 1.7 1.7 no signal
102 Impaired Work Ability 8 1.7 1.7 no signal
103 Nephropathy Toxic 4 1.6 1.6 no signal
104 Menorrhagia 7 1.6 1.6 no signal
105 Rash Generalised 9 1.6 1.6 no signal
106 Post Procedural Haemorrhage 4 1.6 1.6 no signal
107 Exposure During Pregnancy 21 1.5 1.5 no signal
108 Toxic Skin Eruption 3 1.3 1.3 no signal
109 Osteonecrosis 9 1.2 1.2 no signal
110 Colon Cancer 4 1.2 1.2 no signal
111 Multiple Fractures 4 1.1 1.1 no signal
112 Tooth Loss 5 1.1 1.1 no signal
113 Foetal Exposure During Pregnancy 18 1.0 1.0 no signal
114 Injection Site Rash 5 0.7 0.7 no signal
115 Injection Site Urticaria 3 0.6 0.6 no signal
116 Hepatic Cancer 3 0.6 0.6 no signal
117 Injection Site Pruritus 8 0.5 0.5 no signal
118 Menstruation Irregular 3 0.5 0.5 no signal