SOTATERCEPT: 1,041 Adverse Event Reports & Safety Profile
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1,041
Total FAERS Reports
17 (1.6%)
Deaths Reported
198
Hospitalizations
1,041
As Primary/Secondary Suspect
9
Life-Threatening
3
Disabilities
First Report: 20140911 · Latest Report: 20250901
What Are the Most Common SOTATERCEPT Side Effects?
#1 Most Reported
Headache
214 reports (20.6%)
#2 Most Reported
Haemoglobin increased
151 reports (14.5%)
#3 Most Reported
Nausea
131 reports (12.6%)
All SOTATERCEPT Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Headache | 214 | 20.6% | 0 | 51 |
| Haemoglobin increased | 151 | 14.5% | 2 | 13 |
| Nausea | 131 | 12.6% | 1 | 36 |
| Diarrhoea | 130 | 12.5% | 1 | 33 |
| Epistaxis | 130 | 12.5% | 1 | 34 |
| Fatigue | 125 | 12.0% | 1 | 31 |
| Dizziness | 109 | 10.5% | 2 | 30 |
| Dyspnoea | 84 | 8.1% | 1 | 32 |
| Pericardial effusion | 65 | 6.2% | 1 | 13 |
| Vomiting | 61 | 5.9% | 1 | 24 |
| Flushing | 57 | 5.5% | 0 | 15 |
| Platelet count decreased | 57 | 5.5% | 0 | 13 |
| Cough | 52 | 5.0% | 1 | 14 |
| Dyspnoea exertional | 49 | 4.7% | 1 | 15 |
| Pain | 47 | 4.5% | 0 | 10 |
| Pain in extremity | 47 | 4.5% | 0 | 9 |
| Pain in jaw | 45 | 4.3% | 0 | 6 |
| Hypotension | 42 | 4.0% | 0 | 21 |
| Infusion site pain | 41 | 3.9% | 0 | 10 |
| Injection site pain | 40 | 3.8% | 0 | 4 |
Who Reports SOTATERCEPT Side Effects? Age & Gender Data
Gender: 76.2% female, 23.8% male. Average age: 57.5 years. Most reports from: US. View detailed demographics →
Is SOTATERCEPT Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 1 |
| 2016 | 3 | 0 | 2 |
| 2017 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 1 |
| 2019 | 1 | 0 | 1 |
| 2020 | 1 | 1 | 1 |
| 2021 | 3 | 0 | 2 |
| 2022 | 2 | 0 | 1 |
| 2023 | 13 | 0 | 6 |
| 2024 | 274 | 5 | 72 |
| 2025 | 294 | 8 | 78 |
What Is SOTATERCEPT Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 663 |
| Pulmonary arterial hypertension | 188 |
| Pulmonary hypertension | 10 |
| Heritable pulmonary arterial hypertension | 7 |
| Plasma cell myeloma | 5 |
SOTATERCEPT vs Alternatives: Which Is Safer?
SOTATERCEPT vs SOTATERCEPT-CSRK
SOTATERCEPT vs SOTORASIB
SOTATERCEPT vs SOTROVIMAB
SOTATERCEPT vs SOVALDI
SOTATERCEPT vs SOYBEAN OIL
SOTATERCEPT vs SPARSENTAN
SOTATERCEPT vs SPESOLIMAB-SBZO
SOTATERCEPT vs SPIRAMYCIN
SOTATERCEPT vs SPIRIVA
SOTATERCEPT vs SPIRONOLACTONE
Official FDA Label for SOTATERCEPT
Official prescribing information from the FDA-approved drug label.