Prescription medicine
Belimumab Brand names: Benlysta
Belimumab (Benlysta) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the belimumab FDA label on DailyMed (effective August 21, 2026); the BLA 125370 record on Drugs@FDA; every belimumab label on DailyMed.
Highlights of the record
FDA label of August 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBENLYSTA is indicated for the treatment of patients 5 years of age and older with:
Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and
Active lupus nephritis who are receiving standard therapy.
Forms and strengths
- 120 mg/1.5ml
- 200 mg/ml
- 400 mg/5ml
Injection (powder) (lyophilized) for solution; solution.
On the market
- Earliest approval on file
- March 9, 2011 Benlysta, Human Genome Sciences Inc.; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- 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)
- 1 since 2025 0 Class I among all firms' recalls; latest April 21, 2025
- FAERS reports
- 31,474 through July 30, 2026
What is belimumab used for?
From the label: indications and usageBENLYSTA is indicated for the treatment of patients 5 years of age and older with:
Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and
Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation. BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients 5 years of age and older with:
Active systemic lupus erythematosus (SLE) who are receiving standard therapy; ( 1 )
Active lupus nephritis who are receiving standard therapy. […]
FDA pharmacologic class: B Lymphocyte Stimulator-specific Inhibitor.
Source: FDA drug label (BENLYSTA), GlaxoSmithKline LLC, effective August 21, 2026 (SPL set 2fa3c528-1777-4628-8a55-a69dae2381a3), via openFDA; the full label on DailyMed
What does the patient leaflet for belimumab 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 BENLYSTA?Immunosuppressive agents, including BENLYSTA can cause serious side effects. Some of these side effects may cause death. The following are serious adverse reactions that have occurred in patients receiving BENLYSTA: 1. Infections. Infections could be serious, leading to hospitalization or death. Tell your healthcare provider right away if you have any of the following symptoms of an infection: • fever • chills • pain or burning with urination • urinating often • coughing up mucus • warm, red, or painful skin or sores on your body 2. Allergic (hypersensitivity) reactions. Serious allergic reactions can happen on the day of, or in the days after, receiving BENLYSTA and may cause death. Your healthcare provider will watch you closely while you are receiving BENLYSTA given in a vein (intravenous infusion) and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed. Tell your healthcare provider right away if you have any of the following symptoms of an allergic reaction following use of BENLYSTA: • itching • swelling of the face, lips, mouth, tongue, or throat • trouble breathing • anxiousness • low blood pressure • dizziness or fainting • headache • nausea • skin rash 3. Severe skin reactions. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, can occur with BENLYSTA. Stop using BENLYSTA right away and tell your healthcare provider if you develop any of the signs and/or symptoms of a severe skin reaction listed below. These may sometimes begin with fever and flu-like symptoms. […]
From the patient leaflet: How should I store BENLYSTA?Store autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. • Keep BENLYSTA autoinjectors and prefilled syringes in the original package until time of use to protect from light. • Do not shake. Keep away from heat and sunlight. • Do not use and do not place back in the refrigerator if left out at room temperature for more than 12 hours. • Safely throw away medicine that is out of date or no longer needed. Keep BENLYSTA and all medicines out of the reach of children.
Source: FDA drug label (BENLYSTA), GlaxoSmithKline LLC, effective August 21, 2026 (SPL set 2fa3c528-1777-4628-8a55-a69dae2381a3), via openFDA; the full label on DailyMed
Is there a generic for belimumab (Benlysta)?
No generic belimumab is approved (Drugs@FDA, October 8, 2026).
- 2011 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has belimumab been recalled?
The FDA's Enforcement Report lists 1 recall naming belimumab since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 21, 2025 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | CGMP Deviations; potential temperature excursions due to transit delays |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the belimumab label say about other medicines?
The belimumab label names 4 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Azathioprine | drug interactions | In clinical trials, BENLYSTA was administered concomitantly with other drugs, including corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (including azathioprine, cyclophosphamide, methotrexate, and mycophenolate), angiotensin pathway antihypertensives, HMG‑CoA reductase inhibitors … |
| Cyclophosphamide | drug interactions | In clinical trials, BENLYSTA was administered concomitantly with other drugs, including corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (including azathioprine, cyclophosphamide, methotrexate, and mycophenolate), angiotensin pathway antihypertensives, HMG‑CoA reductase inhibitors … |
| Methotrexate | drug interactions | In clinical trials, BENLYSTA was administered concomitantly with other drugs, including corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (including azathioprine, cyclophosphamide, methotrexate, and mycophenolate), angiotensin pathway antihypertensives, HMG‑CoA reductase inhibitors … |
| Rituximab | warnings and precautions | An increased incidence of serious infections and post-injection systemic reactions in subjects receiving BENLYSTA concomitantly with rituximab compared to subjects receiving BENLYSTA alone has been observed [see Adverse Reactions ( 6.1 )]. |
Source: FDA drug label (BENLYSTA), GlaxoSmithKline LLC, effective August 21, 2026 (SPL set 2fa3c528-1777-4628-8a55-a69dae2381a3), via openFDA; the full label on DailyMed
What do FAERS reports show for belimumab?
The FDA Adverse Event Reporting System holds 31,474 reports that list belimumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 893 are coded as a death and 4,627 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?
- Belimumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other