Prescription medicine
Eculizumab Brand names: Soliris, Bkemv, Epysqli
Eculizumab (Epysqli) is a prescription medicine with an FDA approval on record since 2007. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the eculizumab FDA label on DailyMed (effective July 8, 2026, Alexion Pharmaceuticals Inc.); the BLA 125166 record on Drugs@FDA; every eculizumab label on DailyMed.
Highlights of the record
FDA label of July 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS MENINGOCOCCAL INFECTIONS SOLIRIS,.
a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ]. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying therapy with SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving SOLIRIS are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. […]
Used for
From the label: indications and usageSOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
Forms and strengths
- 300 mg/30ml
Injection (solution) (concentrate); injection (solution).
On the market
- Earliest approval on file
- March 16, 2007 Soliris, Alexion Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 2 Class I among all firms' recalls; latest June 2, 2014
- FAERS reports
- 54,046 through July 30, 2026
What is eculizumab used for?
From the label: indications and usageSOLIRIS 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). the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive. […]
FDA pharmacologic class: Complement Inhibitor.
Source: FDA drug label (SOLIRIS), Alexion Pharmaceuticals Inc., effective July 8, 2026 (SPL set ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722), via openFDA; the full label on DailyMed
What does the patient leaflet for eculizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SOLIRIS?SOLIRIS is a medicine that affects your immune system. SOLIRIS may lower the ability of your immune system to fight infections. SOLIRIS increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria. Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early. You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of SOLIRIS. If you have not completed your meningococcal vaccines and SOLIRIS must be started right away, you should receive the required vaccine(s) as soon as possible. If you have not been vaccinated and SOLIRIS must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you. If you had a meningococcal vaccine in the past, you might need additional vaccines before starting SOLIRIS. Your healthcare provider will decide if you need additional meningococcal vaccines. Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection: fever fever with high heart rate headache and fever confusion muscle aches with flu-like symptoms fever and a rash headache with nausea or vomiting headache with a stiff neck or stiff back eyes sensitive to light Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of SOLIRIS. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. […]
Source: FDA drug label (SOLIRIS), Alexion Pharmaceuticals Inc., effective July 8, 2026 (SPL set ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722), via openFDA; the full label on DailyMed
Is there a generic for eculizumab (Epysqli)?
No generic eculizumab is approved (Drugs@FDA, October 8, 2026).
- 2007 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has eculizumab been recalled?
The FDA's Enforcement Report lists 2 recalls naming eculizumab since 2013: 2 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 2, 2014 | Class I | Alexion Pharmaceuticals, Inc. | Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. |
| November 4, 2013 | Class I | Alexion Pharmaceuticals, Inc. | Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the eculizumab label say about other medicines?
The eculizumab label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name eculizumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ravulizumab | boxed warning | Because of the risk of serious meningococcal infections, SOLIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2) ]. |
Other labels that name eculizumab
Source: FDA drug label (SOLIRIS), Alexion Pharmaceuticals Inc., effective July 8, 2026 (SPL set ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722), via openFDA; the full label on DailyMed
What do FAERS reports show for eculizumab?
The FDA Adverse Event Reporting System holds 54,046 reports that list eculizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,614 are coded as a death and 15,307 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other complement inhibitors
- the pharmacologic class, with prices and generics
- Eculizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other