Prescription medicine
Ravulizumab Brand names: Ultomiris
Ravulizumab (Ultomiris) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ravulizumab FDA label on DailyMed (effective October 9, 2025); every ravulizumab label on DailyMed.
Highlights of the record
FDA label of October 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS MENINGOCOCCAL INFECTIONS ULTOMIRIS,.
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 ULTOMIRIS, unless the risks of delaying therapy with ULTOMIRIS 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 ULTOMIRIS 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 usageULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH).
Forms and strengths
- 300 mg/30ml
- 300 mg/3ml
- 1100 mg/11ml
Solution (concentrate).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 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)
- No recall recorded
- FAERS reports
- 13,435 through July 30, 2026
What is ravulizumab used for?
From the label: indications and usageULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). ( 1.2 ) Limitations of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. […]
FDA pharmacologic class: Complement Inhibitor.
Source: FDA drug label (Ultomiris), Alexion Pharmaceuticals Inc., effective October 9, 2025 (SPL set a9a590d9-0217-43c7-908d-e62a71279791), via openFDA; the full label on DailyMed
What does the patient leaflet for ravulizumab 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 ULTOMIRIS?ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS may lower the ability of your immune system to fight infections. ULTOMIRIS 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 ULTOMIRIS. If you have not completed your meningococcal vaccines and ULTOMIRIS must be started right away, you should receive the required vaccine(s) as soon as possible. If you have not been vaccinated and ULTOMIRIS 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 ULTOMIRIS. 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 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 8 months after your last dose of ULTOMIRIS. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. […]
Source: FDA drug label (Ultomiris), Alexion Pharmaceuticals Inc., effective October 9, 2025 (SPL set a9a590d9-0217-43c7-908d-e62a71279791), via openFDA; the full label on DailyMed
Is there a generic for ravulizumab (Ultomiris)?
No generic ravulizumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ravulizumab label say about other medicines?
The ravulizumab label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name ravulizumab. 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 |
|---|---|---|
| Eculizumab | boxed warning | Because of the risk of serious meningococcal infections, ULTOMIRIS 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 ravulizumab
Source: FDA drug label (Ultomiris), Alexion Pharmaceuticals Inc., effective October 9, 2025 (SPL set a9a590d9-0217-43c7-908d-e62a71279791), via openFDA; the full label on DailyMed
What do FAERS reports show for ravulizumab?
The FDA Adverse Event Reporting System holds 13,435 reports that list ravulizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 941 are coded as a death and 2,634 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 rose sharply in 2024 (4,318, against a median of 434 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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
- Ravulizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other