OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Elosulfase Alfa

107 flagged reaction(s) · 5,293 total co-reports · max PRR 29.9
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 Knee Operation 74 29.9 30.3 signal
2 Poor Venous Access 60 22.8 23.0 signal
3 Ear Infection 86 12.7 12.9 signal
4 Oxygen Saturation Decreased 153 10.7 11.0 signal
5 Body Temperature Increased 55 10.5 10.6 signal
6 Gastroenteritis Viral 48 10.4 10.4 signal
7 Cyanosis 40 9.9 10.0 signal
8 Respiratory Distress 65 9.2 9.3 signal
9 Product Dose Omission 155 9.1 9.4 signal
10 Pharyngitis Streptococcal 25 9.0 9.1 signal
11 Spinal Operation 27 8.7 8.7 signal
12 Nasal Congestion 129 8.6 8.8 signal
13 Pyrexia 726 8.2 9.3 signal
14 Joint Dislocation 20 7.4 7.4 signal
15 Secretion Discharge 23 7.3 7.3 signal
16 Ear Pain 35 7.0 7.1 signal
17 Sleep Apnoea Syndrome 33 6.7 6.8 signal
18 Pallor 46 6.6 6.6 signal
19 Bronchospasm 24 6.5 6.6 signal
20 Device Related Infection 25 6.3 6.3 signal
21 Spinal Disorder 15 6.2 6.2 signal
22 Respiratory Disorder 45 5.9 5.9 signal
23 Sars-cov-2 Test Positive 20 5.8 5.9 signal
24 Oropharyngeal Pain 134 5.6 5.8 signal
25 Upper Respiratory Tract Infection 64 5.4 5.5 signal
26 Deafness 36 5.4 5.4 signal
27 Infusion Site Pain 17 5.2 5.2 signal
28 Foot Deformity 14 4.9 4.9 signal
29 Cough 344 4.8 5.1 signal
30 Device Occlusion 17 4.8 4.8 signal
31 Infusion Related Reaction 80 4.7 4.8 signal
32 Respiratory Tract Congestion 19 4.7 4.7 signal
33 Respiratory Tract Infection 31 4.7 4.7 signal
34 Viral Infection 39 4.6 4.6 signal
35 Influenza 125 4.4 4.4 signal
36 Spinal Pain 13 4.3 4.3 signal
37 Tachypnoea 15 4.3 4.3 signal
38 Rhinorrhoea 70 4.2 4.3 signal
39 Nasopharyngitis 193 4.1 4.2 signal
40 Atelectasis 10 4.0 4.0 signal
41 Productive Cough 48 4.0 4.0 signal
42 Tachycardia 87 3.8 3.9 signal
43 Heart Rate Increased 95 3.7 3.8 signal
44 Gait Inability 28 3.3 3.3 signal
45 Sinus Congestion 11 3.2 3.2 signal
46 Obstructive Airways Disorder 9 3.1 3.1 signal
47 Cyst 10 3.1 3.1 signal
48 Mitral Valve Incompetence 9 3.1 3.1 signal
49 Toothache 14 3.0 3.0 signal
50 Complication Associated With Device 10 2.9 3.0 signal
51 Body Height Decreased 8 2.9 2.9 signal
52 Hip Arthroplasty 11 2.8 2.8 signal
53 Hypoacusis 31 2.8 2.8 signal
54 Urticaria 119 2.8 2.8 signal
55 Ligament Sprain 7 2.8 2.8 signal
56 Retching 15 2.7 2.8 signal
57 Vomiting 329 2.7 2.8 signal
58 Ear Discomfort 7 2.7 2.7 signal
59 Pulmonary Congestion 9 2.7 2.7 signal
60 Influenza Like Illness 55 2.6 2.6 signal
61 Chills 77 2.6 2.6 signal
62 Procedural Pain 18 2.5 2.5 signal
63 Malaise 286 2.5 2.6 signal
64 Aspiration 7 2.5 2.5 signal
65 Gastroenteritis 9 2.4 2.4 signal
66 Dermatitis Contact 7 2.4 2.4 signal
67 Mobility Decreased 43 2.3 2.4 signal
68 Eyelid Oedema 7 2.3 2.3 signal
69 Feeling Cold 16 2.2 2.2 signal
70 Mass 8 2.2 2.2 signal
71 Pharyngitis 7 2.2 2.2 no signal
72 Neck Pain 31 2.2 2.2 signal
73 Bedridden 7 2.1 2.1 no signal
74 Device Issue 46 2.1 2.1 signal
75 Throat Irritation 23 2.0 2.0 signal
76 Joint Injury 11 2.0 2.0 signal
77 Covid-19 91 2.0 2.0 signal
78 Wheezing 30 2.0 2.0 no signal
79 Discomfort 30 1.9 1.9 no signal
80 Abdominal Pain Upper 98 1.9 1.9 no signal
81 Pain In Extremity 140 1.8 1.9 no signal
82 Hypertensive Crisis 5 1.7 1.7 no signal
83 Throat Tightness 12 1.7 1.7 no signal
84 Flushing 45 1.7 1.7 no signal
85 Panic Attack 16 1.7 1.7 no signal
86 Nerve Compression 4 1.7 1.7 no signal
87 Accident 5 1.6 1.6 no signal
88 Hypokinesia 6 1.6 1.6 no signal
89 Salivary Hypersecretion 4 1.6 1.6 no signal
90 Hypotonia 4 1.6 1.6 no signal
91 Cold Sweat 7 1.5 1.5 no signal
92 Hand Deformity 5 1.5 1.5 no signal
93 Rash Generalised 10 1.5 1.5 no signal
94 Sneezing 8 1.4 1.4 no signal
95 Crying 13 1.4 1.4 no signal
96 Tooth Extraction 4 1.3 1.3 no signal
97 Surgery 17 1.1 1.1 no signal
98 Injection Site Discomfort 3 1.1 1.1 no signal
99 Knee Arthroplasty 6 1.1 1.1 no signal
100 Intentional Self-injury 5 1.0 1.0 no signal
101 Product Preparation Error 5 0.9 0.9 no signal
102 Injection Site Rash 6 0.8 0.8 no signal
103 Drug Administration Error 6 0.8 0.8 no signal
104 Incorrect Drug Administration Duration 5 0.7 0.7 no signal
105 Device Dislocation 6 0.5 0.5 no signal
106 Drug Dose Omission 23 0.5 0.5 no signal
107 Device Malfunction 9 0.5 0.5 no signal