Generic name
Pegcetacoplan: adverse event reports filed with FDA
768 reports list it as a suspect or interacting product, 2021–2026. Class: Complement inhibitor.
- 768
- reports as suspect product
- 0% of all reports · about 154 a year
- 146
- reports, 12 months to June 2026
- 249 in the 12 months before
- 71.4%
- marked serious by the reporter
- 58.7% across the class
- 9.5%
- record death among outcomes, as reported
- 73 reports · not verified by FDA
Between July 2021 and June 2026, 768 adverse event reports received by FDA list pegcetacoplan, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (33) are left out of every figure here.
In the 12 months to June 2026, 146 reports listed it, down 41% from 249 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 154 reports a year and 0% of the 20,646,523 reports in the database, and 1.1% of the reports for the complement inhibitor class. 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 fatigue (14.5%), off label use (14.1%) and haemoglobin decreased (11.3%). A report can list several reactions, so shares add to more than 100%; 315 different terms appear across these reports. Fatigue is recorded in 14.5% of these reports, a larger share than in the median complement inhibitor drug (11.5%).
71.4% of the reports are marked serious by the reporter (58.7% across the class); 9.5% record death among the outcomes and 27.9% record hospitalisation, as reported. 47.9% of the reports came from consumers, and the largest patient age group is 18 to 44 (4.7%). 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 Pegcetacoplan reports recording the termmedian drug in complement inhibitor
- Fatiguetiredness14.5%111
- Off label useused for a purpose or in a way not on the label14.1%108
- Haemoglobin decreasedlow haemoglobin11.3%87
- Haemolysis10.4%80
- Breakthrough haemolysis7.6%58
- Headachehead pain5.7%44
- Product dose omission issuea dose was missed5.3%41
- Diarrhoealoose or frequent stools4.8%37
- Platelet count decreasedlow platelet count4.8%37
- Pyrexiafever4.8%37
- Covid-19COVID-19 infection4.7%36
- Deaththe patient died; cause not stated by this term4.7%36
- Drug ineffectivethe medicine did not work as expected4.7%36
- Dizzinesslight-headedness or unsteadiness4%31
- Injection site painpain where the injection was given4%31
- Malaisegeneral feeling of being unwell4%31
- Condition aggravatedthe condition being treated got worse3.9%30
- Nauseafeeling sick3.9%30
- Astheniaweakness or lack of energy3.6%28
- Pneumonialung infection3.6%28
- Infectionan infection, type not specified3.5%27
- Abdominal painstomach or belly pain3.4%26
- Arthralgiajoint pain3.4%26
- Pruritusitching3.4%26
- Dyspnoeashortness of breath3.1%24
- Acute kidney injurysudden loss of kidney function3%23
- Chromaturia3%23
- Injection site swellingswelling where the injection was given3%23
- Renal impairmentreduced kidney function3%23
- Thrombocytopenialow platelets3%23
Top 30 of 315 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 median share across the 6 drugs in the complement inhibitor class; 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 69,459 reports in the class. 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. 57% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Paroxysmal nocturnal haemoglobinuria | 463 | 60.3% |
| Dry age-related macular degeneration | 64 | 8.3% |
| C3 glomerulopathy | 63 | 8.2% |
| Immune-complex membranoproliferative glomerulonephritis | 8 | 1% |
| Neovascular age-related macular degeneration | 5 | 0.7% |
| Complement factor c3 | 3 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 768 reports.
In context
| Measure | Pegcetacoplan | Complement inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 768 | 69,459 | 20,646,523 |
| Share of that pool | — | 1.1% | 0% |
| Reports, latest 12 months | 146 | — | 1,332,454 |
| Marked serious | 71.4% | 58.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 95 | 97 | 91 |
| Hospitalisation recorded, per 1,000 reports | 279 | 262 | 213 |
| Consumer-filed share | 47.9% | 68.3% | 45.8% |
| Top term, share of reports | Fatigue 14.5% | median 11.5% | 3.7% |
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."
Other drugs in the complement inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Soliris | brand | 52,768 | 1,330 | 57.8% |
| Ultomiris | brand | 11,279 | 1,816 | 47.8% |
| Eculizumab | generic | 2,072 | 817 | 97.2% |
| Ravulizumab | generic | 1,919 | 1,712 | 98.9% |
| Syfovre | brand | 653 | 165 | 66.6% |
Ordered by report count for navigation only. 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." A brand and its generic are separate rows because reporters name them separately.
Questions about Pegcetacoplan reports
How many adverse event reports has FDA received for Pegcetacoplan?
768 reports list Pegcetacoplan as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 146 of them arrived in the latest 12 months. Another 33 list it only as a concomitant medication.
What reactions are recorded in Pegcetacoplan reports?
fatigue (14.5%), off label use (14.1%), haemoglobin decreased (11.3%), haemolysis (10.4%) and breakthrough haemolysis (7.6%). 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 Pegcetacoplan was responsible.
How serious are the reports?
71.4% are marked serious by the reporter. Among the outcomes recorded, 9.5% of reports include death and 27.9% 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 (47.9%), physician (31.8%) and other health professional (16.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Pegcetacoplan rising?
146 reports in the 12 months to June 2026, down 41% from 249 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 Pegcetacoplan 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 Pegcetacoplan?
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 Pegcetacoplan as a suspect or interacting product; reports listing it only as a concomitant medication (33) 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.