Safety & Side Effects

Learn about BENLYSTA safety and possible BENLYSTA side effects.

This, however, is not all the safety information and does not replace talking to your healthcare provider about your medical condition
or treatment. Please see the full Prescribing Information and Patient Information for BENLYSTA for more information, or ask your healthcare provider.

What is the most important information I should know about BENLYSTA?

Possible severe side effects of 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:

  • 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 infection: fever, chills, pain or burning with urination, urinating often, coughing up mucus, or warm, red, or painful skin or sores on your body.
  • 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; or skin rash.
  • Mental health problems and suicide
    Symptoms of mental health problems can occur. Tell your healthcare provider right away if you have any of the following symptoms: thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.

BENLYSTA can cause serious side effects, including:

  • Progressive multifocal leukoencephalopathy (PML)
    PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including BENLYSTA. PML can result in death or severe disability. If you notice any new or worsening medical problems such as those below, tell your healthcare provider right away: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.
  • Cancer
    BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.

The most common side effects of BENLYSTA include:

Nausea, diarrhea, fever, stuffy or runny nose and sore throat (nasopharyngitis), persistent cough (bronchitis), trouble sleeping (insomnia), leg or arm pain, depression, headache (migraine), and pain, redness, itching, or swelling at the site of injection (when given subcutaneously).

These are not all of the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects. You may report side effects to the FDA by phone at 1-800-FDA-1088 or online at FDA.gov/medwatch. Your doctor can help determine if BENLYSTA is right for you.

The safety profile of BENLYSTA has been studied across a diverse patient population.

7,000+ patients
with lupus
included in BENLYSTA clinical trials over 11+ years(4,000+ patients received BENLYSTA + common lupus medications while other patients received a placebo + common lupus medications.)

  • Adults with lupus
  • Adults with lupus nephritis
  • Adults of Black race with lupus
  • Children 5 years and older with lupus
  • Post-marketing safety trial in adults with lupus

BENLYSTA demonstrated a consistent safety profile after being studied in more clinical trials than any other lupus medicine or medicine for lupus nephritis, including the largest clinical trial in patients with lupus nephritis. BENLYSTA was studied in 8 different clinical trials that included diverse patient populations.

There are many things to think about when considering a new lupus medication.

Your healthcare provider can help you make an informed decision about the potential risks and benefits of lupus treatment based on your individual needs.

Learn more about the impact of lupus on the body.

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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medications, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.

Who should not receive BENLYSTA?

Do not receive BENLYSTA if you are allergic to belimumab or any ingredients in BENLYSTA. See the end of the Medication Guide for a complete list of ingredients in BENLYSTA.

Before you receive BENLYSTA, tell your healthcare provider about all of your medical conditions, including if you: 

  • think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your healthcare provider tells you to. See “What is the most important information I should know about BENLYSTA?"
  • have or have had mental health problems such as depression or thoughts of suicide.
  • have recently received a vaccination or if you think you may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.
  • are allergic to other medicines.
  • are receiving other biologic medicines or monoclonal antibodies.
  • have or have had any type of cancer.
  • are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. You should talk to your healthcare provider about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA.
  • - Tell your healthcare provider right away if you become pregnant during your treatment with BENLYSTA or if you think you may be pregnant.

    - If you become pregnant while receiving BENLYSTA, talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/benlysta-belimumab/. The purpose of this registry is to collect information about the health of you and your baby.

    - If you are breastfeeding or plan to breastfeed, you and your healthcare provider should talk about whether or not you should receive BENLYSTA and breastfeed. It is not known if BENLYSTA passes into your breast milk.

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Talk with your healthcare provider today.

It's natural to have questions about your treatment options. Your doctor can help you make the most informed decision about your lupus treatment. In the meantime, here are some resources to help you learn more about BENLYSTA.

Learn more about BENLYSTATalk to your doctor about BENLYSTA