OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Sotatercept-csrk

214 flagged reaction(s) · 11,377 total co-reports · max PRR 44.0
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 Infusion Site Pain 133 44.0 45.2 signal
2 Pericardial Effusion 149 27.3 28.1 signal
3 Dyspnoea Exertional 223 25.0 26.1 signal
4 Epistaxis 443 24.9 27.2 signal
5 Pain In Jaw 163 24.2 25.0 signal
6 Complication Associated With Device 73 23.2 23.6 signal
7 Pulmonary Arterial Hypertension 72 20.8 21.1 signal
8 Therapy Change 38 16.6 16.7 signal
9 Pulmonary Hypertension 81 16.3 16.5 signal
10 Dermatitis Contact 43 15.9 16.0 signal
11 Decreased Activity 40 15.7 15.8 signal
12 Seasonal Allergy 50 14.9 15.0 signal
13 Weight Fluctuation 30 12.1 12.1 signal
14 Dizziness Postural 26 11.4 11.4 signal
15 Oxygen Saturation Decreased 150 11.3 11.6 signal
16 Device Occlusion 37 11.2 11.2 signal
17 Gingival Bleeding 31 9.5 9.6 signal
18 Fluid Retention 110 9.1 9.3 signal
19 Blood Test Abnormal 30 9.0 9.0 signal
20 Haemoptysis 54 8.1 8.2 signal
21 Laboratory Test Abnormal 56 8.0 8.0 signal
22 Internal Haemorrhage 21 7.7 7.7 signal
23 Therapy Non-responder 80 7.5 7.6 signal
24 Brain Fog 23 6.6 6.6 signal
25 Therapy Partial Responder 23 6.4 6.4 signal
26 Blood Iron Decreased 18 6.4 6.4 signal
27 Therapy Interrupted 104 6.3 6.4 signal
28 Product Prescribing Issue 30 6.2 6.2 signal
29 Flushing 147 6.0 6.2 signal
30 Hypoxia 50 6.0 6.0 signal
31 Device Leakage 59 5.8 5.9 signal
32 Syringe Issue 23 5.5 5.5 signal
33 Device Dislocation 56 5.4 5.5 signal
34 Sinus Congestion 17 5.3 5.3 signal
35 Nasal Congestion 73 5.2 5.3 signal
36 Gastrointestinal Haemorrhage 104 5.2 5.3 signal
37 Iron Deficiency Anaemia 11 5.0 5.0 signal
38 Ear Discomfort 12 4.9 4.9 signal
39 Platelet Count Decreased 123 4.8 4.9 signal
40 Injection Site Irritation 14 4.6 4.6 signal
41 Head Discomfort 19 4.5 4.5 signal
42 Appendicitis 10 4.5 4.5 signal
43 Peripheral Swelling 165 4.5 4.6 signal
44 Presyncope 26 4.5 4.5 signal
45 Headache 668 4.5 5.0 signal
46 Exposure Via Skin Contact 23 4.3 4.3 signal
47 Hospice Care 10 4.3 4.3 signal
48 Device Related Infection 15 4.1 4.1 signal
49 Hospitalisation 148 4.1 4.2 signal
50 Dyspnoea 544 4.0 4.4 signal
51 Blood Pressure Abnormal 19 4.0 4.0 signal
52 Hypotension 191 4.0 4.1 signal
53 Respiratory Tract Congestion 15 3.9 4.0 signal
54 Syncope 94 3.9 4.0 signal
55 Blood Pressure Decreased 62 3.9 4.0 signal
56 Skin Laceration 10 3.9 3.9 signal
57 Throat Irritation 40 3.7 3.8 signal
58 Productive Cough 42 3.7 3.7 signal
59 Intentional Dose Omission 24 3.7 3.7 signal
60 Product Preparation Error 18 3.6 3.6 signal
61 Rectal Haemorrhage 37 3.6 3.6 signal
62 Chest Pain 159 3.6 3.7 signal
63 Illness 86 3.6 3.6 signal
64 Sputum Discoloured 8 3.5 3.5 signal
65 Therapy Cessation 43 3.5 3.5 signal
66 Acute Respiratory Failure 16 3.5 3.5 signal
67 Migraine 79 3.5 3.5 signal
68 Oedema 45 3.5 3.5 signal
69 Gastrointestinal Pain 9 3.4 3.4 signal
70 Diarrhoea 521 3.4 3.7 signal
71 Malnutrition 9 3.4 3.4 signal
72 Oedema Peripheral 99 3.4 3.4 signal
73 Dizziness 402 3.4 3.6 signal
74 Skin Infection 9 3.4 3.4 signal
75 Injection Site Rash 24 3.3 3.3 signal
76 No Adverse Event 140 3.3 3.4 signal
77 Haemoglobin Decreased 81 3.3 3.3 signal
78 Gastric Haemorrhage 9 3.3 3.3 signal
79 Scratch 8 3.2 3.2 signal
80 Platelet Count Increased 10 3.2 3.2 signal
81 Renal Pain 8 3.2 3.2 signal
82 Eye Haemorrhage 10 3.1 3.1 signal
83 Device Issue 65 3.1 3.1 signal
84 Gout 13 3.0 3.0 signal
85 Sinus Disorder 14 3.0 3.0 signal
86 Product Dose Omission Issue 200 2.9 3.0 signal
87 Sciatica 11 2.9 2.9 signal
88 Cough 194 2.9 3.0 signal
89 Clostridium Difficile Infection 15 2.9 2.9 signal
90 Haematochezia 38 2.9 2.9 signal
91 Sluggishness 7 2.9 2.9 signal
92 Unintentional Medical Device Removal 8 2.9 2.9 signal
93 Ascites 20 2.8 2.9 signal
94 General Physical Health Deterioration 77 2.8 2.8 signal
95 Full Blood Count Abnormal 7 2.8 2.8 signal
96 Weight Decreased 183 2.7 2.8 signal
97 Increased Tendency To Bruise 6 2.7 2.7 signal
98 Device Use Error 22 2.7 2.7 signal
99 Pulmonary Thrombosis 7 2.7 2.7 signal
100 Injection Site Nodule 7 2.7 2.7 signal
101 Heart Rate Increased 63 2.7 2.7 signal
102 Device Use Issue 11 2.7 2.7 signal
103 Cyanosis 10 2.7 2.7 signal
104 Pain In Extremity 187 2.7 2.7 signal
105 Pneumothorax 10 2.6 2.6 signal
106 Cardiogenic Shock 9 2.6 2.6 signal
107 Subdural Haematoma 9 2.6 2.6 signal
108 Skin Haemorrhage 9 2.6 2.6 signal
109 Dyspepsia 60 2.6 2.6 signal
110 Insurance Issue 9 2.5 2.5 signal
111 Pulmonary Oedema 27 2.5 2.5 signal
112 Injection Site Pruritus 40 2.5 2.5 signal
113 Faeces Discoloured 13 2.5 2.5 signal
114 Blood Potassium Decreased 18 2.5 2.5 signal
115 Hypersomnia 17 2.5 2.5 signal
116 Haemorrhage 62 2.5 2.5 signal
117 Dry Throat 6 2.5 2.5 no signal
118 Weight Increased 131 2.5 2.5 signal
119 Subarachnoid Haemorrhage 6 2.5 2.5 no signal
120 Injection Site Bruising 46 2.4 2.5 signal
121 Product Use Complaint 9 2.4 2.4 signal
122 Injection Site Erythema 71 2.4 2.4 signal
123 Heart Rate Decreased 20 2.4 2.4 signal
124 Secretion Discharge 7 2.4 2.4 signal
125 Joint Swelling 68 2.4 2.4 signal
126 Pharyngitis Streptococcal 6 2.3 2.3 no signal
127 Ocular Discomfort 6 2.3 2.3 no signal
128 Mood Altered 15 2.3 2.3 signal
129 Device Malfunction 37 2.3 2.3 signal
130 Inappropriate Schedule Of Product Administration 97 2.3 2.3 signal
131 Rash Macular 19 2.3 2.3 signal
132 Influenza 61 2.3 2.3 signal
133 Nerve Injury 6 2.3 2.3 no signal
134 Rash Pruritic 29 2.3 2.3 signal
135 Systemic Lupus Erythematosus 19 2.2 2.3 signal
136 Fatigue 416 2.2 2.4 signal
137 Incorrect Route Of Product Administration 9 2.2 2.2 signal
138 Respiratory Disorder 16 2.2 2.2 signal
139 Chest Discomfort 54 2.2 2.2 signal
140 Abdominal Discomfort 88 2.2 2.2 signal
141 Blood Urine Present 10 2.2 2.2 signal
142 Limb Injury 14 2.2 2.2 signal
143 Post Procedural Haemorrhage 6 2.2 2.2 no signal
144 Nausea 404 2.1 2.2 signal
145 Viral Infection 17 2.1 2.1 signal
146 Contusion 49 2.1 2.1 signal
147 Carpal Tunnel Syndrome 7 2.1 2.1 no signal
148 Localised Infection 12 2.1 2.1 signal
149 Sneezing 11 2.1 2.1 signal
150 Gastrointestinal Disorder 43 2.0 2.0 signal
151 Abnormal Weight Gain 6 2.0 2.0 no signal
152 Increased Appetite 9 2.0 2.0 no signal
153 Palpitations 55 2.0 2.0 no signal
154 Blood Pressure Fluctuation 11 1.9 1.9 no signal
155 Melaena 10 1.9 1.9 no signal
156 Cardiac Disorder 42 1.9 1.9 no signal
157 Gallbladder Disorder 8 1.9 1.9 no signal
158 Eye Infection 5 1.9 1.9 no signal
159 Head Injury 14 1.9 1.9 no signal
160 Hypoacusis 19 1.9 1.9 no signal
161 Heart Rate Irregular 10 1.8 1.8 no signal
162 Injection Site Warmth 9 1.8 1.8 no signal
163 Product Use Issue 81 1.8 1.8 no signal
164 Eye Swelling 16 1.8 1.8 no signal
165 Device Breakage 17 1.8 1.8 no signal
166 Aphonia 6 1.8 1.8 no signal
167 Diarrhoea Haemorrhagic 4 1.8 1.8 no signal
168 Drug Effect Less Than Expected 6 1.8 1.8 no signal
169 Injection Site Swelling 32 1.8 1.8 no signal
170 Amenorrhoea 7 1.8 1.8 no signal
171 Cardiac Failure 33 1.7 1.7 no signal
172 Dermatitis Allergic 5 1.7 1.7 no signal
173 Feeling Abnormal 95 1.7 1.7 no signal
174 Erythema 81 1.7 1.7 no signal
175 Device Adhesion Issue 6 1.7 1.7 no signal
176 Wrong Technique In Device Usage Process 18 1.6 1.7 no signal
177 Device Difficult To Use 26 1.6 1.7 no signal
178 Cerebral Haemorrhage 14 1.6 1.6 no signal
179 Thyroid Disorder 6 1.6 1.6 no signal
180 Adverse Drug Reaction 34 1.6 1.6 no signal
181 Injection Site Pain 114 1.6 1.6 no signal
182 Hunger 5 1.6 1.6 no signal
183 Pericarditis 6 1.5 1.5 no signal
184 Adverse Event 32 1.5 1.5 no signal
185 Full Blood Count Decreased 7 1.5 1.5 no signal
186 Hot Flush 26 1.4 1.4 no signal
187 Injection Site Haemorrhage 27 1.4 1.4 no signal
188 Product Dose Omission In Error 9 1.4 1.4 no signal
189 Haemorrhage Intracranial 5 1.4 1.4 no signal
190 Product Physical Issue 6 1.3 1.3 no signal
191 Injection Site Discomfort 3 1.2 1.2 no signal
192 Coronary Artery Occlusion 4 1.2 1.2 no signal
193 Needle Issue 8 1.2 1.2 no signal
194 Incorrect Dose Administered 56 1.0 1.0 no signal
195 Injection Site Mass 9 1.0 1.0 no signal
196 Skin Irritation 11 1.0 1.0 no signal
197 Poisoning 3 1.0 1.0 no signal
198 Acne 18 1.0 1.0 no signal
199 Accidental Exposure To Product 23 1.0 1.0 no signal
200 Device Delivery System Issue 6 1.0 1.0 no signal
201 Application Site Rash 3 0.9 0.9 no signal
202 Device Failure 3 0.8 0.8 no signal
203 Product Storage Error 16 0.8 0.8 no signal
204 Application Site Pain 4 0.8 0.8 no signal
205 Application Site Pruritus 4 0.7 0.7 no signal
206 Extra Dose Administered 7 0.7 0.7 no signal
207 Injection Site Urticaria 4 0.7 0.7 no signal
208 Vaginal Haemorrhage 7 0.7 0.7 no signal
209 Therapeutic Response Shortened 5 0.7 0.7 no signal
210 Application Site Erythema 4 0.6 0.6 no signal
211 Injury Associated With Device 3 0.6 0.6 no signal
212 Skin Burning Sensation 10 0.6 0.6 no signal
213 Incorrect Dose Administered By Device 3 0.5 0.5 no signal
214 Drug Dose Omission By Device 3 0.2 0.2 no signal