OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Idursulfase

228 flagged reaction(s) · 11,417 total co-reports · max PRR 102.0
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 Poor Venous Access 196 102.0 107.2 signal
2 Product Availability Issue 199 47.2 49.6 signal
3 Carpal Tunnel Syndrome 84 31.7 32.4 signal
4 Infusion Related Reaction 389 31.2 34.5 signal
5 Insurance Issue 78 27.8 28.3 signal
6 Device Related Infection 78 26.8 27.3 signal
7 Cyanosis 71 23.8 24.3 signal
8 Body Temperature Increased 88 22.7 23.2 signal
9 Secretion Discharge 53 22.7 23.0 signal
10 Respiratory Disorder 126 22.2 22.9 signal
11 Ear Infection 102 20.3 20.8 signal
12 Bronchospasm 55 20.3 20.6 signal
13 Respiratory Distress 106 20.3 20.8 signal
14 Complication Associated With Device 50 20.0 20.2 signal
15 Respiratory Tract Infection 95 19.3 19.8 signal
16 Pharyngitis 43 18.2 18.4 signal
17 Product Prescribing Error 76 17.0 17.3 signal
18 Body Temperature Decreased 31 16.5 16.6 signal
19 Obstructive Airways Disorder 34 16.1 16.2 signal
20 Aspiration 29 14.1 14.2 signal
21 Productive Cough 118 13.2 13.5 signal
22 Choking 48 13.1 13.2 signal
23 Inappropriate Schedule Of Product Administration 415 12.4 13.7 signal
24 Restlessness 83 12.0 12.2 signal
25 Salivary Hypersecretion 22 11.6 11.7 signal
26 Viral Infection 73 11.6 11.8 signal
27 Rhinorrhoea 141 11.6 11.9 signal
28 Pallor 59 11.4 11.6 signal
29 Tachypnoea 29 11.3 11.4 signal
30 Influenza 232 11.0 11.6 signal
31 Respiratory Tract Congestion 33 11.0 11.0 signal
32 Epilepsy 63 10.9 11.1 signal
33 Dental Caries 22 10.5 10.6 signal
34 Oxygen Saturation Decreased 111 10.5 10.8 signal
35 Seizure 217 10.0 10.5 signal
36 Treatment Noncompliance 102 9.9 10.1 signal
37 Device Occlusion 26 9.9 9.9 signal
38 Poor Quality Sleep 39 9.6 9.7 signal
39 Pyrexia 617 9.4 10.9 signal
40 Acute Respiratory Failure 34 9.4 9.4 signal
41 Gastroenteritis Viral 32 9.3 9.4 signal
42 Product Dose Omission Issue 494 9.2 10.3 signal
43 Bacteraemia 20 9.0 9.0 signal
44 Tooth Abscess 17 8.8 8.8 signal
45 Infusion Site Pain 21 8.7 8.7 signal
46 Crying 57 8.2 8.4 signal
47 Cardio-respiratory Arrest 65 8.1 8.3 signal
48 Illness 153 8.0 8.3 signal
49 Sleep Apnoea Syndrome 29 8.0 8.1 signal
50 Mitral Valve Incompetence 17 7.9 8.0 signal
51 Agitation 110 7.9 8.1 signal
52 Ear Pain 29 7.9 7.9 signal
53 Nasal Congestion 85 7.7 7.8 signal
54 Upper Respiratory Tract Infection 67 7.7 7.8 signal
55 Malnutrition 16 7.6 7.6 signal
56 Psychomotor Hyperactivity 24 7.6 7.6 signal
57 Post Procedural Complication 27 7.4 7.4 signal
58 Gastroenteritis 20 7.2 7.3 signal
59 Respiratory Failure 100 7.2 7.4 signal
60 Generalised Tonic-clonic Seizure 22 7.1 7.1 signal
61 Toothache 24 7.0 7.0 signal
62 Eating Disorder 28 6.9 7.0 signal
63 Lower Respiratory Tract Infection 59 6.9 7.0 signal
64 Pneumonia Aspiration 32 6.8 6.8 signal
65 Respiratory Arrest 35 6.6 6.7 signal
66 Scratch 13 6.6 6.6 signal
67 Peripheral Coldness 17 6.5 6.5 signal
68 Bedridden 16 6.4 6.5 signal
69 Eyelid Oedema 14 6.3 6.3 signal
70 Hernia 23 6.3 6.3 signal
71 Deafness 31 6.2 6.3 signal
72 Covid-19 207 6.2 6.5 signal
73 Generalised Oedema 14 6.0 6.0 signal
74 Irritability 67 5.9 6.0 signal
75 Cough 311 5.9 6.3 signal
76 Blood Pressure Abnormal 22 5.9 5.9 signal
77 Pharyngitis Streptococcal 12 5.8 5.9 signal
78 Aggression 54 5.7 5.7 signal
79 Pulmonary Congestion 14 5.6 5.6 signal
80 Dermatitis Contact 12 5.6 5.6 signal
81 Body Height Decreased 11 5.4 5.4 signal
82 Head Injury 32 5.3 5.4 signal
83 Nasopharyngitis 185 5.3 5.5 signal
84 Urticaria 165 5.2 5.4 signal
85 Dermatitis Allergic 12 5.1 5.1 signal
86 Weight Fluctuation 10 5.1 5.1 signal
87 Nervous System Disorder 30 5.1 5.1 signal
88 Pneumonia 300 4.9 5.2 signal
89 Accident 11 4.9 4.9 signal
90 Tachycardia 82 4.9 4.9 signal
91 Laryngitis 10 4.9 4.9 signal
92 Tooth Infection 12 4.8 4.8 signal
93 Bronchitis 67 4.7 4.8 signal
94 Tooth Disorder 20 4.7 4.7 signal
95 Incorrect Product Administration Duration 18 4.7 4.7 signal
96 Device Issue 76 4.6 4.7 signal
97 Weight Increased 192 4.5 4.7 signal
98 Bacterial Infection 16 4.5 4.6 signal
99 Grand Mal Convulsion 8 4.5 4.5 signal
100 Heart Rate Decreased 30 4.5 4.5 signal
101 Skin Discolouration 39 4.5 4.5 signal
102 Convulsion 48 4.4 4.4 signal
103 Face Oedema 14 4.4 4.4 signal
104 Hepatomegaly 8 4.3 4.3 signal
105 Hypothermia 8 4.2 4.2 signal
106 Gait Inability 26 4.1 4.2 signal
107 Staphylococcal Infection 26 4.1 4.2 signal
108 Chills 92 4.1 4.2 signal
109 Circumstance Or Information Capable Of Leading To Medication Error 26 4.1 4.1 signal
110 Conjunctivitis 14 4.0 4.0 signal
111 Wheezing 45 4.0 4.0 signal
112 Cardiac Arrest 63 4.0 4.1 signal
113 Incontinence 8 4.0 4.0 signal
114 Appendicitis 7 4.0 4.0 signal
115 Surgery 43 3.9 3.9 signal
116 Tooth Fracture 8 3.8 3.8 signal
117 Joint Stiffness 19 3.8 3.8 signal
118 Incorrect Dose Administered 157 3.7 3.8 signal
119 Dysphagia 66 3.7 3.7 signal
120 Heart Rate Increased 69 3.7 3.7 signal
121 Product Prescribing Issue 14 3.6 3.6 signal
122 Hypoxia 24 3.6 3.6 signal
123 Abnormal Behaviour 27 3.6 3.6 signal
124 Myoclonus 8 3.5 3.5 signal
125 Sneezing 15 3.5 3.5 signal
126 Oropharyngeal Pain 62 3.5 3.6 signal
127 Limb Injury 18 3.5 3.5 signal
128 Anaphylactic Reaction 36 3.5 3.5 signal
129 Product Use Complaint 10 3.4 3.4 signal
130 Cardiomegaly 8 3.4 3.4 signal
131 Seasonal Allergy 9 3.4 3.4 signal
132 Muscle Atrophy 8 3.4 3.4 signal
133 Rash Macular 22 3.3 3.3 signal
134 Influenza Like Illness 52 3.3 3.3 signal
135 General Physical Health Deterioration 72 3.3 3.3 signal
136 Movement Disorder 20 3.3 3.3 signal
137 Hypokinesia 9 3.3 3.3 signal
138 Blood Pressure Systolic Increased 12 3.2 3.2 signal
139 Ligament Sprain 6 3.2 3.2 signal
140 Inflammation 31 3.2 3.2 signal
141 Lip Swelling 20 3.2 3.2 signal
142 Mobility Decreased 43 3.2 3.2 signal
143 Post Procedural Haemorrhage 7 3.2 3.2 signal
144 Covid-19 Pneumonia 7 3.1 3.1 signal
145 Ear Discomfort 6 3.1 3.1 signal
146 Petechiae 6 3.0 3.0 signal
147 Lower Limb Fracture 11 3.0 3.0 signal
148 Disease Progression 67 3.0 3.0 signal
149 Acute Respiratory Distress Syndrome 10 3.0 3.0 signal
150 Retching 12 3.0 3.0 signal
151 Blood Pressure Decreased 37 2.9 3.0 signal
152 Subdural Haematoma 8 2.9 2.9 signal
153 Skin Laceration 6 2.9 2.9 signal
154 Brain Oedema 7 2.9 2.9 signal
155 Osteomyelitis 10 2.9 2.9 signal
156 Feeding Disorder 11 2.9 2.9 signal
157 Product Administration Error 11 2.9 2.9 signal
158 Gastrointestinal Pain 6 2.9 2.9 signal
159 Foot Deformity 6 2.8 2.9 signal
160 Therapy Interrupted 37 2.8 2.8 signal
161 Device Dislocation 23 2.8 2.8 signal
162 Tremor 88 2.8 2.8 signal
163 Discomfort 32 2.8 2.8 signal
164 Sars-cov-2 Test Positive 7 2.8 2.8 signal
165 Femur Fracture 16 2.7 2.7 signal
166 Spinal Pain 6 2.7 2.7 signal
167 Inability To Afford Medication 5 2.7 2.7 no signal
168 Product Use Issue 95 2.7 2.7 signal
169 Gait Disturbance 97 2.7 2.7 signal
170 Muscle Rigidity 6 2.6 2.6 signal
171 Mass 7 2.6 2.6 signal
172 Hypotonia 5 2.6 2.6 no signal
173 Cognitive Disorder 23 2.6 2.6 signal
174 Hypersomnia 14 2.6 2.6 signal
175 Hypoacusis 21 2.6 2.6 signal
176 Tooth Extraction 6 2.5 2.5 signal
177 Skin Lesion 13 2.5 2.5 signal
178 Hand Deformity 6 2.4 2.4 no signal
179 Rash Generalised 12 2.4 2.4 signal
180 Localised Infection 11 2.4 2.4 signal
181 Drug Eruption 8 2.4 2.4 signal
182 Malaise 199 2.4 2.5 signal
183 Intentional Self-injury 9 2.4 2.4 signal
184 Bone Disorder 8 2.3 2.3 signal
185 Muscle Twitching 10 2.3 2.3 signal
186 Swelling Face 28 2.3 2.3 signal
187 Inappropriate Schedule Of Drug Administration 31 2.3 2.3 signal
188 Eye Inflammation 4 2.2 2.2 no signal
189 Cardiac Failure 34 2.2 2.2 signal
190 Needle Issue 12 2.2 2.2 signal
191 Dyskinesia 17 2.2 2.2 signal
192 Affect Lability 4 2.2 2.2 no signal
193 Knee Operation 4 2.2 2.2 no signal
194 Flushing 42 2.2 2.2 signal
195 Decreased Immune Responsiveness 4 2.2 2.2 no signal
196 Device Use Issue 7 2.1 2.1 no signal
197 Muscle Spasticity 5 2.1 2.1 no signal
198 Erythema 82 2.1 2.1 signal
199 Sluggishness 4 2.1 2.1 no signal
200 Haematoma 10 2.0 2.0 signal
201 Sudden Death 4 2.0 2.0 no signal
202 Device Malfunction 25 2.0 2.0 no signal
203 Product Dispensing Error 8 1.9 1.9 no signal
204 Abasia 9 1.9 1.9 no signal
205 Eye Swelling 13 1.9 1.9 no signal
206 Anaphylactic Shock 9 1.9 1.9 no signal
207 Nervousness 18 1.8 1.8 no signal
208 Hospitalisation 52 1.8 1.8 no signal
209 Angioedema 15 1.8 1.8 no signal
210 No Adverse Event 58 1.7 1.7 no signal
211 Brain Neoplasm 3 1.7 1.7 no signal
212 Procedural Pain 9 1.7 1.7 no signal
213 Death 271 1.7 1.7 no signal
214 Coeliac Disease 3 1.6 1.6 no signal
215 Adverse Reaction 4 1.6 1.6 no signal
216 Cardiac Disorder 28 1.6 1.6 no signal
217 Product Preparation Error 6 1.5 1.5 no signal
218 Product Storage Error 24 1.5 1.5 no signal
219 Drug Dose Omission 46 1.4 1.5 no signal
220 Device Breakage 10 1.3 1.3 no signal
221 Application Site Rash 3 1.1 1.1 no signal
222 Dystonia 4 1.1 1.1 no signal
223 Device Leakage 8 1.0 1.0 no signal
224 Acne 14 1.0 1.0 no signal
225 Skin Irritation 8 0.9 0.9 no signal
226 Application Site Pruritus 3 0.7 0.7 no signal
227 Injection Site Urticaria 3 0.7 0.7 no signal
228 Device Difficult To Use 3 0.2 0.2 no signal