Generic name
Sotatercept: adverse event reports filed with FDA
1,426 reports list it as a suspect or interacting product, 2021–2026.
- 1,426
- reports as suspect product
- 0% of all reports · about 290 a year
- 660
- reports, 12 months to June 2026
- 734 in the 12 months before
- 44.4%
- marked serious by the reporter
- 57.4% across all reports
- 5%
- record death among outcomes, as reported
- 72 reports · not verified by FDA
Between August 2021 and June 2026, 1,426 adverse event reports received by FDA list sotatercept, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,540) are left out of every figure here.
In the 12 months to June 2026, 660 reports listed it, down 10% from 734 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 290 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are headache (18.1%), haemoglobin increased (13.7%) and epistaxis (12.3%). A report can list several reactions, so shares add to more than 100%; 502 different terms appear across these reports. Headache is recorded in 18.1% of these reports, against 3% of all reports in the database.
44.4% of the reports are marked serious by the reporter; 5% record death among the outcomes and 20.8% record hospitalisation, as reported. 54.1% of the reports came from consumers, and the largest patient age group is 45 to 64 (17.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Sotatercept reports recording the termall reports in the database
- Headachehead pain18.1%258
- Haemoglobin increased13.7%196
- Epistaxisnosebleed12.3%175
- Diarrhoealoose or frequent stools11.9%169
- Fatiguetiredness10.8%154
- Nauseafeeling sick9.3%132
- Dizzinesslight-headedness or unsteadiness8.8%125
- Dyspnoeashortness of breath8.3%119
- Pericardial effusionfluid around the heart7.3%104
- Coughcough4.9%70
- Vomitingbeing sick4.8%69
- Flushingsudden reddening or warmth of the skin4.6%65
- Platelet count decreasedlow platelet count4.5%64
- Dyspnoea exertional4.3%61
- Injection site painpain where the injection was given4.1%58
- Pain in jaw3.7%53
- Pain in extremitypain in an arm or leg3.6%51
- Painpain, site not specified3.5%50
- Weight decreasedweight loss3.3%47
- Weight increasedweight gain3.2%46
- Hypotensionlow blood pressure3.2%45
- Arthralgiajoint pain3.1%44
- Inappropriate schedule of product administrationthe product was taken at the wrong times3.1%44
- Product dose omission issuea dose was missed3.1%44
- Infusion site pain2.9%42
- Injection site erythemaredness where the injection was given2.9%41
- Therapy non-responderthe treatment did not work2.9%41
- Feeling abnormalfeeling odd or not right2.8%40
- Gastrointestinal haemorrhagebleeding in the stomach or bowel2.8%40
- Malaisegeneral feeling of being unwell2.7%39
Top 30 of 502 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 83.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pulmonary arterial hypertension | 349 | 24.5% |
| Heritable pulmonary arterial hypertension | 27 | 1.9% |
| Pulmonary hypertension | 26 | 1.8% |
| Langerhans' cell histiocytosis | 3 | 0.2% |
| Portopulmonary hypertension | 3 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,426 reports.
In context
| Measure | Sotatercept | All reports |
|---|---|---|
| Reports as suspect product | 1,426 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 660 | 1,332,454 |
| Marked serious | 44.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 50 | 91 |
| Hospitalisation recorded, per 1,000 reports | 208 | 213 |
| Consumer-filed share | 54.1% | 45.8% |
| Top term, share of reports | Headache 18.1% | 3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Questions about Sotatercept reports
How many adverse event reports has FDA received for Sotatercept?
1,426 reports list Sotatercept as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 660 of them arrived in the latest 12 months. Another 1,540 list it only as a concomitant medication.
What reactions are recorded in Sotatercept reports?
headache (18.1%), haemoglobin increased (13.7%), epistaxis (12.3%), diarrhoea (11.9%) and fatigue (10.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Sotatercept was responsible.
How serious are the reports?
44.4% are marked serious by the reporter. Among the outcomes recorded, 5% of reports include death and 20.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (54.1%), other health professional (24.9%) and physician (17.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sotatercept rising?
660 reports in the 12 months to June 2026, down 10% from 734 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Sotatercept was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Sotatercept?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sotatercept as a suspect or interacting product; reports listing it only as a concomitant medication (1,540) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.