Soliriseculizumab
According to the FDA label: SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. ( 1.2 ) Limitation of Use SOLIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
53,305 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Soliris in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Fatigue 5,845 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 4,658 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Haemoglobin Decreased 3,904 reports
A blood test result showing a low level of haemoglobin, the protein in red blood cells that carries oxygen. This is closely related to anaemia. Also spelled hemoglobin in American English.
Full definition in the glossary →Headache 3,463 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Death 2,621 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Pyrexia 2,398 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 2,162 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthenia 2,006 reports
Physical weakness or lack of strength.
Full definition in the glossary →Nausea 1,983 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 1,906 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Haemolysis 1,854 reports
Platelet Count Decreased 1,820 reports
A blood test result showing a low level of platelets, the cells that help blood clot. This is the lab-measurement version of thrombocytopenia.
Full definition in the glossary →Malaise 1,785 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →- Blood Lactate Dehydrogenase Increased 1,581 reports
Abdominal Pain 1,537 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 25,216 |
| Male | 16,977 |
| Unknown | 766 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,141 |
| 18-34 | 3,231 |
| 35-49 | 2,729 |
| 50-64 | 2,665 |
| 65-74 | 1,716 |
| 75+ | 1,160 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Soliris. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 25,079 |
| Non-Serious | 21,632 |
| Hospitalization | 15,075 |
| Death | 5,459 |
| Life-Threatening | 1,003 |
| Disability | 280 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Soliris. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2007 | 4 |
| 2008 | 10 |
| 2009 | 1,259 |
| 2010 | 800 |
| 2011 | 1,550 |
| 2012 | 1,360 |
| 2013 | 1,451 |
| 2014 | 5,560 |
| 2015 | 2,869 |
| 2016 | 5,450 |
| 2017 | 5,589 |
| 2018 | 6,298 |
| 2019 | 6,652 |
| 2020 | 2,347 |
| 2021 | 2,051 |
| 2022 | 2,079 |
| 2023 | 2,750 |
| 2024 | 2,744 |
| 2025 | 2,008 |
| 2026 (partial) | 474 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Soliris
In FDA adverse event reports that mention Soliris, these medications appeared most often in the same report.
- Folic Acid (2,551 reports)
- Prednisone (2,512 reports)
- Mycophenolate Mofetil (1,316 reports)
- Ravulizumab (1,273 reports)
- Tacrolimus (1,242 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026