Eculizumab: uses, dosing, side effects & brands

Eculizumab is a complement inhibitor sold in the U.S. under one brand, for paroxysmal hemoglobinuria, myasthenia gravis and atypical hemolytic uremic syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Complement Inhibitor
Treats: Paroxysmal Hemoglobinuria, Myasthenia Gravis and Atypical Hemolytic Uremic Syndrome
Available as: Injectable
Sold as: Soliris
Prescription?: Prescription only
Generic available?: Not in our catalog
Boxed warning: Boxed warning

How eculizumab is dosed

From the FDA label for Soliris (application BLA125166). Other eculizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

For intravenous infusion only; recommended dosage for: PNH: ( 2.2 ) aHUS, gMG, and NMOSD in adults: ( 2.3 ) aHUS and gMG in pediatric patients: ( 2.4 ) 2.1 Recommended Vaccination and Prophylaxis for Meningococcal Infection Vaccinate patients against meningococcal infection (serogroups A, C, W, Y and B) according to current ACIP recommendations at least 2 weeks prior to initiation of SOLIRIS [see Warnings and Precautions (5.1) ] . If urgent SOLIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. Healthcare providers who prescribe SOLIRIS must enroll in the ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2) ] . 2.2 Recommended Dosage for Adults – PNH The recommended dosage of SOLIRIS for the treatment of PNH in patients 18 years of age and older is administered as an intravenous infusion [see Dosage and Administration (2.7) ] as follows: 600 mg weekly for the first 4 weeks, followed by 900 mg for the fifth dose 1 week later, then 900 mg every 2 weeks thereafter. Administer SOLIRIS at the recommended dosage regimen time points, or within two days of these time points [see Warnings and Precautions (5.4) ] . 2.3 Recommended Dosage for Adults – aHUS, gMG, and NMOSD The recommended dosage of…

Eculizumab side effects

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Serious Meningococcal Infections [see Warnings and Precautions (5.1) ] Other Infections [see Warnings and Precautions (5.3) ] Monitoring Disease Manifestations after SOLIRIS Discontinuation [see Warnings and Precautions (5.4) ] Thrombosis Prevention and Management [see Warnings and Precautions (5.5) ] Infusion-Related Reactions [see Warnings and Precautions (5.6) ] The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea. ( 6.1 ) The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia. ( 6.1 ) The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) in adult patients is musculoskeletal pain. ( 6.1 ) The most frequently reported adverse reactions in the NMOSD placebo- controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals,…

Who shouldn’t take eculizumab

SOLIRIS is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection [see Warnings and Precautions (5.1) ] . SOLIRIS is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection. ( 4 )

Eculizumab drug interactions

7.1 Plasmapheresis, Plasma Exchange, Fresh Frozen Plasma Infusion or IVIg Concomitant use of SOLIRIS with plasma exchange (PE), plasmapheresis (PP) , fresh frozen plasma infusion (PE/PI), or in patients with gMG on concomitant IVIg treatment can reduce serum eculizumab concentrations and requires a supplemental dose of SOLIRIS [see Dosage and Administration (2.5) ]. 7.2 Neonatal Fc Receptor Blockers Concomitant use of SOLIRIS with neonatal Fc receptor (FcRn) blockers may lower systemic exposures and reduce effectiveness of SOLIRIS. Closely monitor for reduced effectiveness of SOLIRIS.

Every eculizumab product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Soliris.

How long eculizumab keeps

No eculizumab label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does eculizumab expire? The in-use limits and storage rules from its labels

Eculizumab and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Maternal dosages of eculizumab usually produce undetectable levels in breastmilk. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. No adverse effects attributable to eculizumab have been reported in infants who were breastfed during maternal therapy. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.

Full LactMed record for eculizumab: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised February 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about eculizumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,256 reports naming eculizumab, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

thrombotic microangiopathy166 reports
maternal exposure during pregnancy93 reports
renal impairment87 reports
cytomegalovirus infection70 reports
acute kidney injury68 reports
pyrexia65 reports
covid-1964 reports
infection61 reports

Read these as a signal, not a rate. A report does not mean eculizumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is eculizumab?

Soliris (Eculizumab) is a complement inhibitor used to treat Paroxysmal Hemoglobinuria, Myasthenia Gravis, Atypical Hemolytic Uremic Syndrome.

What kind of drug is eculizumab?

The FDA classifies eculizumab as a complement inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take eculizumab with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run eculizumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does eculizumab come in?

Across the brands we track, eculizumab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic eculizumab?

We do not currently list a generic-labelled eculizumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page

APA: pharmaranks. (2026, July 24). Eculizumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/eculizumab
MLA: “Eculizumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/eculizumab.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for eculizumab on DailyMed (NIH) ↗ — including its boxed warning in full.