OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Burosumab

130 flagged reaction(s) · 7,868 total co-reports · max PRR 51.1
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 Restless Legs Syndrome 276 51.1 53.4 signal
2 Tooth Abscess 121 39.8 40.5 signal
3 Contraindicated Product Administered 190 21.0 21.7 signal
4 Inappropriate Schedule Of Product Administration 708 13.3 14.9 signal
5 Incorrect Route Of Product Administration 65 12.9 13.0 signal
6 Bone Pain 209 11.9 12.2 signal
7 Dental Caries 35 10.5 10.6 signal
8 Toothache 52 9.6 9.6 signal
9 Pharyngitis Streptococcal 31 9.5 9.6 signal
10 Knee Operation 26 8.9 8.9 signal
11 Therapy Interrupted 180 8.7 8.9 signal
12 Injection Site Pruritus 157 7.8 8.0 signal
13 Injection Site Urticaria 57 7.8 7.9 signal
14 Product Dose Omission Issue 645 7.5 8.3 signal
15 Product Dose Omission 140 7.0 7.2 signal
16 Blood Alkaline Phosphatase Increased 51 6.8 6.9 signal
17 Ear Infection 53 6.6 6.7 signal
18 Sars-cov-2 Test Positive 26 6.5 6.5 signal
19 Tooth Fracture 21 6.3 6.4 signal
20 Tooth Infection 25 6.3 6.3 signal
21 Insurance Issue 28 6.3 6.3 signal
22 Spinal Pain 21 6.0 6.0 signal
23 Hypercalcaemia 22 5.9 5.9 signal
24 Vitamin D Deficiency 17 5.8 5.8 signal
25 Injection Site Rash 48 5.3 5.3 signal
26 Injection Site Mass 58 5.2 5.3 signal
27 Laboratory Test Abnormal 46 5.2 5.2 signal
28 Gastroenteritis Viral 27 5.0 5.0 signal
29 Tooth Extraction 18 4.8 4.8 signal
30 Joint Stiffness 37 4.7 4.7 signal
31 Foot Deformity 15 4.5 4.5 signal
32 Tooth Disorder 30 4.5 4.5 signal
33 Joint Dislocation 14 4.4 4.4 signal
34 Spinal Operation 16 4.4 4.4 signal
35 Illness 123 4.1 4.1 signal
36 Pain In Extremity 353 4.0 4.2 signal
37 Injection Site Reaction 82 4.0 4.0 signal
38 Injection Site Irritation 15 3.9 3.9 signal
39 Injection Site Erythema 144 3.9 3.9 signal
40 Injection Site Swelling 87 3.8 3.9 signal
41 Incorrect Dose Administered 252 3.7 3.8 signal
42 Product Administration Error 22 3.7 3.7 signal
43 Surgery 61 3.5 3.5 signal
44 Nephrolithiasis 48 3.5 3.5 signal
45 Ligament Sprain 10 3.4 3.4 signal
46 Covid-19 179 3.4 3.4 signal
47 Therapeutic Response Shortened 31 3.2 3.2 signal
48 Injection Site Bruising 76 3.2 3.2 signal
49 Lower Limb Fracture 18 3.1 3.1 signal
50 Drug Effect Less Than Expected 13 3.1 3.1 signal
51 Arthralgia 376 3.0 3.1 signal
52 Musculoskeletal Discomfort 15 2.9 2.9 signal
53 Tenderness 9 2.9 2.9 signal
54 Seasonal Allergy 12 2.8 2.8 signal
55 Injection Site Warmth 17 2.7 2.7 signal
56 Back Pain 189 2.7 2.8 signal
57 Injection Site Pain 243 2.7 2.7 signal
58 Blood Calcium Decreased 9 2.6 2.7 signal
59 Influenza 87 2.6 2.6 signal
60 Musculoskeletal Stiffness 67 2.5 2.6 signal
61 Product Prescribing Error 18 2.5 2.5 signal
62 Fracture 14 2.5 2.5 signal
63 Exposure During Pregnancy 45 2.4 2.4 signal
64 Tooth Loss 15 2.4 2.4 signal
65 Weight Fluctuation 7 2.2 2.2 no signal
66 Therapy Partial Responder 10 2.2 2.2 signal
67 Hip Arthroplasty 10 2.2 2.2 signal
68 Pain 391 2.1 2.2 signal
69 Migraine 60 2.1 2.1 signal
70 Limb Discomfort 19 2.0 2.0 signal
71 Gout 11 2.0 2.0 signal
72 Deafness 16 2.0 2.0 signal
73 Hospitalisation 88 1.9 1.9 no signal
74 Neck Pain 32 1.9 1.9 no signal
75 Weight Increased 124 1.8 1.9 no signal
76 Muscle Spasms 101 1.8 1.8 no signal
77 Myalgia 89 1.7 1.7 no signal
78 Crying 19 1.7 1.7 no signal
79 Product Use In Unapproved Indication 125 1.7 1.7 no signal
80 Osteomyelitis 9 1.7 1.7 no signal
81 Glomerular Filtration Rate Decreased 6 1.6 1.6 no signal
82 Sluggishness 5 1.6 1.6 no signal
83 Injection Site Discomfort 5 1.6 1.6 no signal
84 Femur Fracture 15 1.6 1.6 no signal
85 Brain Fog 7 1.6 1.6 no signal
86 Foot Fracture 9 1.6 1.6 no signal
87 Adverse Event 43 1.5 1.6 no signal
88 Mobility Decreased 33 1.5 1.5 no signal
89 Pain In Jaw 13 1.5 1.5 no signal
90 Bedridden 6 1.5 1.5 no signal
91 Injection Site Nodule 5 1.5 1.5 no signal
92 Overdose 97 1.5 1.5 no signal
93 Product Availability Issue 10 1.5 1.5 no signal
94 Treatment Noncompliance 24 1.5 1.5 no signal
95 Conjunctivitis 8 1.4 1.4 no signal
96 Muscle Tightness 7 1.4 1.4 no signal
97 Muscle Twitching 10 1.4 1.4 no signal
98 Knee Arthroplasty 9 1.4 1.4 no signal
99 Product Storage Error 37 1.4 1.4 no signal
100 Blood Test Abnormal 6 1.4 1.4 no signal
101 Spinal Disorder 4 1.4 1.4 no signal
102 Accident 5 1.4 1.4 no signal
103 Nasopharyngitis 76 1.4 1.4 no signal
104 Coeliac Disease 4 1.4 1.4 no signal
105 Injection Site Extravasation 5 1.3 1.3 no signal
106 Tendonitis 6 1.3 1.3 no signal
107 Abscess 6 1.2 1.2 no signal
108 Wrong Technique In Product Usage Process 75 1.2 1.2 no signal
109 Intestinal Perforation 4 1.2 1.2 no signal
110 Upper Limb Fracture 7 1.2 1.2 no signal
111 Neoplasm 4 1.2 1.2 no signal
112 Anosmia 5 1.1 1.1 no signal
113 Underdose 24 1.1 1.1 no signal
114 Product Packaging Issue 3 1.1 1.1 no signal
115 Adverse Reaction 4 1.0 1.0 no signal
116 Blood Glucose Fluctuation 3 0.9 0.9 no signal
117 Abortion Spontaneous 10 0.8 0.8 no signal
118 Injection Site Discolouration 3 0.8 0.8 no signal
119 Multiple Fractures 4 0.8 0.8 no signal
120 Abnormal Weight Gain 3 0.8 0.8 no signal
121 Amenorrhoea 4 0.8 0.8 no signal
122 Product Dispensing Error 5 0.8 0.8 no signal
123 Dysmenorrhoea 3 0.8 0.8 no signal
124 Syringe Issue 4 0.8 0.8 no signal
125 Menstruation Irregular 6 0.8 0.8 no signal
126 Hair Texture Abnormal 3 0.7 0.7 no signal
127 Drug Effective For Unapproved Indication 5 0.6 0.6 no signal
128 Acne 12 0.5 0.5 no signal
129 Intentional Self-injury 3 0.5 0.5 no signal
130 Injection Site Haemorrhage 7 0.3 0.3 no signal