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Benlysta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/29/2016

Benlysta (belimumab) is a monoclonal antibody indicated for the treatment of adult patients with active systemic lupus erythematosus (SLE). Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Common side effects of Benlysta include nausea, vomiting, diarrhea, stomach pain, pain in your arms or legs, trouble sleeping (insomnia), headache (migraine), fever, depression, urinary tract infection, decreased white blood cell count (leukopenia), and cold symptoms such as stuffy or runny nose, sneezing, cough (bronchitis), and sore throat .

The recommended dosage regimen for Benlysta is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Formal drug interaction studies have not been performed with Benlysta. Benlysta can cause serious and sometimes fatal side effects such as infections, heart problems, and mental health problems such as depression and suicide. Before you receive Benlysta, tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Benlysta will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with Benlysta. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Benlysta passes into your breast milk. You and your healthcare provider should decide if you will receive Benlysta or breastfeed. You should not do both.

Our Benlysta (belimumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Benlysta in Detail - Patient Information: Side Effects

Some people receiving a belimumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel nauseated, light-headed, itchy, or have muscle pain, severe headache, or slow heartbeats.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • new or worsening depression, anxiety, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.
  • wheezing, chest tightness, trouble breathing; or

Serious and sometimes fatal infections may occur during treatment with belimumab. Call your doctor right away if you have signs of infection such as:

  • fever, chills, flu symptoms, night sweats, weight loss;
  • increased urination, pain or burning when you urinate;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • swelling, pain, tenderness, or redness anywhere on your body; or
  • bloody diarrhea.

Less serious side effects may include:

  • nausea, diarrhea, stomach pain;
  • mild pain in your arms or legs; or
  • mild cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Benlysta (Belimumab)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Benlysta Overview - Patient Information: Side Effects

SIDE EFFECTS: See also How to Use section.

Nausea, diarrhea, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as new/worsening depression, thoughts of suicide), signs of cancer (such as fever, night sweats, unusual tiredness, unexplained weight loss, swollen glands, unusual lumps/growths).

This medication can lower your body's ability to fight an infection. You may be more likely to get serious infections such as pneumonia, urinary tract infection, and skin infections. It may also be harder to fight an infection you already have. Tell your doctor right away if you develop signs of a serious infection while using this drug, such as: fever, chills, sore throat, cough, pain or burning with urination, urinating often, bloody diarrhea, coughing up mucus.

Belimumab may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you develop any signs of PML, including: confusion, memory loss, loss of balance, difficulty talking/walking, vision changes.

Get medical help right away if you have any serious side effects, including: heart problems (such as chest/jaw/left arm pain, shortness of breath, unusual sweating, dizziness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Benlysta (Belimumab)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Benlysta FDA Prescribing Information: Side Effects
(Adverse Reactions)


Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following have been observed with BENLYSTA and are discussed in detail in the Warnings and Precautions section:

Clinical Trials Experience

The data described below reflect exposure to BENLYSTA plus standard of care compared with placebo plus standard of care in 2,133 patients in 3 controlled trials. Patients received BENLYSTA at doses of 1 mg/kg (N = 673), 4 mg/kg (N = 111; Trial 1 only), or 10 mg/kg (N = 674) or placebo (N = 675) intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days. In 2 of the trials (Trial 1 and Trial 3), treatment was given for 48 weeks, while in the other trial (Trial 2) treatment was given for 72 weeks [see Clinical Studies]. Because there was no apparent dose-related increase in the majority of adverse events observed with BENLYSTA, the safety data summarized below are presented for the 3 doses pooled, unless otherwise indicated; the adverse reaction table displays the results for the recommended dose of 10 mg/kg compared with placebo.

The population had a mean age of 39 (range: 18 to 75), 94% were female, and 52% were Caucasian. In these trials, 93% of patients treated with BENLYSTA reported an adverse reaction compared with 92% treated with placebo.

The most common serious adverse reactions were serious infections (6.0% and 5.2% in the groups receiving BENLYSTA and placebo, respectively) [see WARNINGS AND PRECAUTIONS].

The most commonly-reported adverse reactions, occurring in ≥ 5% of patients in clinical trials were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

The proportion of patients who discontinued treatment due to any adverse reaction during the controlled clinical trials was 6.2% for patients receiving BENLYSTA and 7.1% for patients receiving placebo. The most common adverse reactions resulting in discontinuation of treatment ( ≥ 1% of patients receiving BENLYSTA or placebo) were infusion reactions (1.6% BENLYSTA and 0.9% placebo), lupus nephritis (0.7% BENLYSTA and 1.2% placebo), and infections (0.7% BENLYSTA and 1.0% placebo).

Table 1 lists adverse reactions, regardless of causality, occurring in at least 3% of patients with SLE who received BENLYSTA 10 mg/kg and at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies.

Table 1: Incidence of Adverse Reactions occurring in at Least 3% of Patients Treated with BENLYSTA 10 mg/kg plus Standard of Care and at Least 1% More Frequently than in Patients receiving Placebo plus Standard of Care in 3 Controlled SLE Studies

Preferred Term BENLYSTA 10 mg/kg + Standard of Care
(n = 674) %
Placebo + Standard of Care
(n = 675) %
Nausea 15 12
Diarrhea 12 9
Pyrexia 10 8
Nasopharyngitis 9 7
Bronchitis 9 5
Insomnia 7 5
Pain in extremity 6 4
Depression 5 4
Migraine 5 4
Pharyngitis 5 3
Cystitis 4 3
Leukopenia 4 2
Gastroenteritis viral 3 1


In Trials 2 and 3, anti-belimumab antibodies were detected in 4 of 563 (0.7%) patients receiving BENLYSTA 10 mg/kg and in 27 of 559 (4.8%) patients receiving BENLYSTA 1 mg/kg. The reported frequency for the group receiving 10 mg/kg may underestimate the actual frequency due to lower assay sensitivity in the presence of high drug concentrations. Neutralizing antibodies were detected in 3 patients receiving BENLYSTA 1 mg/kg. Three patients with anti-belimumab antibodies experienced mild infusion reactions of nausea, erythematous rash, pruritus, eyelid edema, headache, and dyspnea; none of the reactions was life-threatening. The clinical relevance of the presence of anti-belimumab antibodies is not known.

The data reflect the percentage of patients whose test results were positive for antibodies to belimumab in specific assays. The observed incidence of antibody positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to belimumab with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of BENLYSTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Benlysta (Belimumab)

Benlysta - User Reviews

Benlysta User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Benlysta sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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