Sotatercept-Csrk side effects: what 4,929 FDA adverse event reports show

Sotatercept-Csrk · 214 reaction terms · 11,377 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

4,929 reports · 57% serious · 208 with death outcome · 77% female

openFDA FAERS counts, all years, deduplication not applied

Used for

—

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Reporting / coding artifact 10Lab value / disease marker 3No label text to screen 27

What the badges mean

Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 174 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Infusion site pain	133	44.0 37.2–52.1ROR 45.2 · χ² 5,496 / p <1e-300	43.3 EB05 37.5 · IC025 +4.9 3/3 methods agree	No label text to screen	serious n=53 · 90% consumer	no trial data cached
Pericardial effusion	149	27.3 23.3–32.0ROR 28.1 · χ² 3,724 / p <1e-300	27.0 EB05 23.6 · IC025 +4.4 3/3 methods agree	No label text to screen	serious PRR 28.2	no trial data cached
Dyspnoea exertional	223	25.0 22.0–28.4ROR 26.1 · χ² 5,095 / p <1e-300	24.8 EB05 22.2 · IC025 +4.3 3/3 methods agree	No label text to screen	serious PRR 24.2	no trial data cached
Epistaxis (nosebleed)	443	24.9 22.8–27.2ROR 27.2 · χ² 10,105 / p <1e-300	24.7 EB05 22.8 · IC025 +4.4 3/3 methods agree	No label text to screen	serious PRR 18.8	no trial data cached
Pain in jaw	163	24.2 20.8–28.2ROR 25.0 · χ² 3,585 / p <1e-300	24.0 EB05 21.1 · IC025 +4.2 3/3 methods agree	No label text to screen	serious PRR 25.3 · 76% consumer	no trial data cached
Complication associated with device	73	23.2 18.5–29.2ROR 23.6 · χ² 1,523 / p <1e-300	23.0 EB05 18.9 · IC025 +3.9 3/3 methods agree	No label text to screen	serious PRR 36.9	no trial data cached
Pulmonary arterial hypertension	72	20.8 16.5–26.2ROR 21.1 · χ² 1,331 / p 1e-291	20.6 EB05 16.9 · IC025 +3.8 3/3 methods agree	No label text to screen	serious PRR 22.0	no trial data cached
Therapy change	38	16.6 12.1–22.7ROR 16.7 · χ² 538 / p 3e-119	16.3 EB05 12.3 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious n=34	no trial data cached
Pulmonary hypertension	81	16.3 13.1–20.2ROR 16.5 · χ² 1,142 / p 1e-250	16.1 EB05 13.4 · IC025 +3.5 3/3 methods agree	No label text to screen	serious PRR 16.1	no trial data cached
Dermatitis contact	43	15.9 11.8–21.4ROR 16.0 · χ² 584 / p 3e-129	15.7 EB05 12.0 · IC025 +3.3 3/3 methods agree	No label text to screen	serious n=18 · 88% consumer	no trial data cached
Decreased activity	40	15.7 11.5–21.4ROR 15.8 · χ² 533 / p 3e-118	15.4 EB05 11.7 · IC025 +3.2 3/3 methods agree	No label text to screen	serious PRR 19.5 · 79% consumer	no trial data cached
Seasonal allergy	50	14.9 11.3–19.6ROR 15.0 · χ² 631 / p 1e-139	14.7 EB05 11.5 · IC025 +3.2 3/3 methods agree	No label text to screen	serious n=24 · 86% consumer	no trial data cached
Weight fluctuation	30	12.1 8.5–17.3ROR 12.1 · χ² 293 / p 5e-66	11.5 EB05 8.2 · IC025 +2.7 3/3 methods agree	No label text to screen	serious n=22 · 79% consumer	no trial data cached
Dizziness postural	26	11.4 7.7–16.7ROR 11.4 · χ² 235 / p 3e-53	10.6 EB05 7.3 · IC025 +2.6 3/3 methods agree	No label text to screen	serious n=18 · 81% consumer	no trial data cached
Oxygen saturation decreased	150	11.3 9.6–13.2ROR 11.6 · χ² 1,395 / p <1e-300	11.2 EB05 9.7 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 11.5 · 74% consumer	no trial data cached
Device occlusion	37	11.2 8.1–15.4ROR 11.2 · χ² 331 / p 2e-74	10.7 EB05 7.9 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=23	no trial data cached
Gingival bleeding	31	9.5 6.7–13.5ROR 9.6 · χ² 227 / p 1e-51	8.8 EB05 6.3 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 6.2	no trial data cached
Fluid retention	110	9.1 7.5–10.9ROR 9.3 · χ² 782 / p 2e-172	8.9 EB05 7.5 · IC025 +2.8 3/3 methods agree	No label text to screen	serious PRR 11.3 · 81% consumer	no trial data cached
Blood test abnormal	30	9.0 6.3–12.8ROR 9.0 · χ² 204 / p 1e-46	8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.3	no trial data cached
Haemoptysis	54	8.1 6.2–10.6ROR 8.2 · χ² 329 / p 9e-74	7.7 EB05 6.1 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 7.2	no trial data cached
Laboratory test abnormal	56	8.0 6.1–10.3ROR 8.0 · χ² 334 / p 7e-75	7.6 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.9	no trial data cached
Internal haemorrhage	21	7.7 5.0–11.8ROR 7.7 · χ² 115 / p 3e-27	6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 7.7	no trial data cached
Therapy non-responder	80	7.5 6.1–9.4ROR 7.6 · χ² 446 / p 2e-99	7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.0 · 88% consumer	no trial data cached
Brain fog	23	6.6 4.4–9.9ROR 6.6 · χ² 104 / p 1e-24	5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree	No label text to screen	serious PRR 7.4 · ♀ 100% (drug 77%) · 78% consumer	no trial data cached
Therapy partial responder	23	6.4 4.3–9.6ROR 6.4 · χ² 99 / p 1e-23	5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8 · 91% consumer	no trial data cached
Blood iron decreased	18	6.4 4.0–10.1ROR 6.4 · χ² 77 / p 1e-18	5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 6.0	no trial data cached
Therapy interrupted	104	6.3 5.2–7.6ROR 6.4 · χ² 461 / p 1e-102	6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 14.0	no trial data cached
Product prescribing issue	30	6.2 4.3–8.8ROR 6.2 · χ² 125 / p 3e-29	5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 1.7	no trial data cached
Flushing	147	6.0 5.1–7.1ROR 6.2 · χ² 614 / p 7e-136	5.9 EB05 5.2 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 9.2 · 71% consumer	no trial data cached
Hypoxia (low oxygen)	50	6.0 4.5–7.9ROR 6.0 · χ² 202 / p 3e-46	5.7 EB05 4.5 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 6.0	no trial data cached
Device leakage	59	5.8 4.5–7.5ROR 5.9 · χ² 232 / p 1e-52	5.6 EB05 4.5 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious n=20 · 76% consumer	no trial data cached
Syringe issue	23	5.5 3.7–8.3ROR 5.5 · χ² 80 / p 2e-19	5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree	No label text to screen	serious n=3	no trial data cached
Device dislocation	56	5.4 4.2–7.0ROR 5.5 · χ² 197 / p 5e-45	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 5.6	no trial data cached
Sinus congestion	17	5.3 3.3–8.5ROR 5.3 · χ² 54 / p 8e-14	4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree	No label text to screen	serious n=10	no trial data cached
Nasal congestion (stuffy nose)	73	5.2 4.2–6.6ROR 5.3 · χ² 246 / p 1e-55	5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 6.7 · 78% consumer	no trial data cached
Gastrointestinal haemorrhage	104	5.2 4.3–6.3ROR 5.3 · χ² 348 / p 7e-78	5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 5.4	no trial data cached
Iron deficiency anaemia	11	5.0 2.8–9.1ROR 5.0 · χ² 31 / p 1e-8	4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree	No label text to screen	serious PRR 5.5	no trial data cached
Ear discomfort	12	4.9 2.8–8.6ROR 4.9 · χ² 34 / p 3e-9	4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree	No label text to screen	serious n=10	no trial data cached
Platelet count decreased	123	4.8 4.1–5.8ROR 4.9 · χ² 372 / p 3e-83	4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 3.4	no trial data cached
Injection site irritation	14	4.6 2.7–7.8ROR 4.6 · χ² 36 / p 8e-10	4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree	No label text to screen	serious n=7	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Headache	668	4.5 4.2–4.8ROR 5.0 · χ² 1,849 / p <1e-300	4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 5.2 · 71% consumer	no trial data cached
Dyspnoea (shortness of breath)	544	4.0 3.7–4.4ROR 4.4 · χ² 1,269 / p 4e-278	4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree	No label text to screen	serious PRR 4.4	no trial data cached
Diarrhoea (diarrhea)	521	3.4 3.1–3.7ROR 3.7 · χ² 904 / p 8e-199	3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree	No label text to screen	serious PRR 3.6 · 70% consumer	no trial data cached
Epistaxis (nosebleed)	443	24.9 22.8–27.2ROR 27.2 · χ² 10,105 / p <1e-300	24.7 EB05 22.8 · IC025 +4.4 3/3 methods agree	No label text to screen	serious PRR 18.8	no trial data cached
Fatigue (tiredness)	416	2.2 2.0–2.5ROR 2.4 · χ² 296 / p 1e-66	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree	No label text to screen	serious PRR 2.9	no trial data cached
Nausea	404	2.1 2.0–2.4ROR 2.2 · χ² 255 / p 1e-57	2.1 EB05 2.0 · IC025 +0.9	No label text to screen	serious PRR 2.5	no trial data cached
Dizziness	402	3.4 3.1–3.7ROR 3.6 · χ² 688 / p 7e-152	3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree	No label text to screen	serious PRR 3.9	no trial data cached
Dyspnoea exertional	223	25.0 22.0–28.4ROR 26.1 · χ² 5,095 / p <1e-300	24.8 EB05 22.2 · IC025 +4.3 3/3 methods agree	No label text to screen	serious PRR 24.2	no trial data cached
Product dose omission issue	200	2.9 2.6–3.4ROR 3.0 · χ² 258 / p 3e-58	2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1 · 79% consumer	no trial data cached
Cough	194	2.9 2.5–3.3ROR 3.0 · χ² 243 / p 4e-55	2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree	No label text to screen	serious PRR 3.0	no trial data cached
Hypotension (low blood pressure)	191	4.0 3.5–4.6ROR 4.1 · χ² 429 / p 1e-95	4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree	No label text to screen	serious PRR 4.0	no trial data cached
Pain in extremity	187	2.7 2.3–3.1ROR 2.7 · χ² 194 / p 3e-44	2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree	No label text to screen	serious PRR 3.3 · 76% consumer	no trial data cached
Weight decreased (weight loss)	183	2.7 2.4–3.2ROR 2.8 · χ² 204 / p 1e-46	2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree	No label text to screen	serious PRR 2.8	no trial data cached
Peripheral swelling	165	4.5 3.9–5.2ROR 4.6 · χ² 449 / p 6e-100	4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree	No label text to screen	serious PRR 5.1 · 78% consumer	no trial data cached
Pain in jaw	163	24.2 20.8–28.2ROR 25.0 · χ² 3,585 / p <1e-300	24.0 EB05 21.1 · IC025 +4.2 3/3 methods agree	No label text to screen	serious PRR 25.3 · 76% consumer	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Sotatercept-Csrk?

In FDA FAERS, the most frequently co-reported reaction terms for Sotatercept-Csrk are headache, dyspnoea, diarrhoea, epistaxis, fatigue, nausea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Sotatercept-Csrk have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Sotatercept-Csrk causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 214 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.