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Sotatercept Side Effects

The most commonly reported side effects of sotatercept include headache, diarrhoea, and dyspnoea, based on 5,532 FDA adverse event reports from 2013 to 2025.

Sotatercept side effects

Percentages show how often each reaction appears relative to total reports for sotatercept.

1
Headache15.2%842
2
Diarrhoea11.5%638
3
Dyspnoea9.9%550
4
Nausea9.6%529
5
Fatigue9.0%499
6
Dizziness8.4%467
7
Epistaxis8.1%450
8
Haemoglobin Increased6.3%346
9
Vomiting4.9%270
10
Infusion Site Pain4.7%262
11
Dyspnoea Exertional4.2%231
12
Cough4.0%224
13
Pain4.0%219
14
Hypotension4.0%219
15
Flushing3.8%211

These are voluntary reports and do not establish that sotatercept caused these reactions.

Report severity

48.0%Serious2,653 reports
32.9%Hospitalizations1,821 reports
3.3%Fatal180 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sotatercept drug interactions

Other drugs that appear in adverse event reports alongside sotatercept. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Treprostinil66.4%3,671
2
Macitentan5.1%282
3
Tadalafil4.4%243
4
Ambrisentan4.2%233
5
Riociguat4.2%230
6
Selexipag3.3%185
7
Acetaminophen1.6%86
8
Epoprostenol-sodium1.4%76
9
Sildenafil-citrate1.2%67
10
Loperamide-hydrochloride1.0%57
11
Apixaban0.8%43
12
Furosemide0.6%34
13
Ibuprofen0.5%26
14
Nintedanib0.5%26
15
Dupilumab0.5%25

Taken alongside

1
Oxygen38.9%2,152
2
Macitentan32.1%1,778
3
Furosemide27.8%1,539
4
Tadalafil26.6%1,470
5
Acetaminophen25.7%1,419
6
Spironolactone24.1%1,335
7
Potassium-chloride23.3%1,287
8
Sildenafil-citrate22.0%1,216
9
Ergocalciferol20.0%1,107
10
Ambrisentan18.4%1,018
11
Albuterol17.0%939
12
Gabapentin15.1%834
13
Fluticasone15.0%829
14
Aspirin13.9%771
15
Sodium-chloride13.9%769

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sotatercept side effects

74.7% of sotatercept adverse event reports involve female patients and 21.5% involve male patients. The largest age group is adult at 59%. These figures reflect who reports side effects, not underlying risk.

Sex

Female74.7%
Male21.5%
Unknown3.7%

Age group

< 20.2%
2–111.9%
12–172.8%
18–6459.2%
65+35.9%

What is sotatercept used for

Conditions and purposes for which patients were taking sotatercept when the adverse event was reported.

Adverse Drug ReactionAntisynthetase SyndromeCongenital Aplastic AnaemiaConnective Tissue Disease-associated Interstitial Lung DiseaseConnective Tissue DisorderCor TriatriatumDyspnoeaHiv InfectionHeritable Pulmonary Arterial HypertensionHypertensionIdiopathic Pulmonary FibrosisMixed Connective Tissue DiseaseParoxysmal Sympathetic HyperactivityPortopulmonary HypertensionProduct Used For Unknown Indication

Showing 15 of 25 indications

Sotatercept brand names and reporting trend

Sotatercept is sold under the brand name Winrevair.

Brand names

Winrevair4,495

Quarterly reports (20132025)

201320242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sotatercept with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.