Benlysta (belimumab) is a brand-name injectable medication. It’s prescribed for systemic lupus erythematosus or lupus nephritis in certain adults and children. As with other drugs, Benlysta can cause side effects. These include nausea and diarrhea.

Benlysta can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Benlysta in clinical trials:

* For more information about this side effect, see “Side effect specifics.”

Mild side effects can occur with Benlysta use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Benlysta’s prescribing information.

Mild side effects that have been reported with Benlysta include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Benlysta and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics.”
† An allergic reaction is possible after using Benlysta. To learn more, see “Side effect specifics.”

Benlysta may cause serious side effects. However, serious side effects aren’t common with this medication. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Benlysta’s prescribing information.

If you develop serious side effects while taking Benlysta, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* For more information about this side effect, see “Side effect specifics.”
† An allergic reaction is possible after using Benlysta. To learn more, see “Side effect specifics.”

Benlysta is available as an intravenous (IV) infusion and as a subcutaneous (under the skin) injection. Side effects reported with the IV form of Benlysta are expected to be the same for adults and children. Examples of these side effects include:

Note: Subcutaneous injections of Benlysta are approved for children ages 5 years and older who have systemic lupus erythematosus (SLE). But they are not approved for children with active lupus nephritis (a complication of SLE).

Benlysta may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Does Benlysta cause long-term side effects?

Yes, Benlysta may cause long-term side effects. Most side effects of Benlysta will improve as you continue treatment with Benlysta. However, it’s possible for some side effects to be long term. Examples of possible long-term side effects that Benlysta may cause include:

If you have concerns about long-term side effects from taking Benlysta, talk with your doctor.

How long do side effects of Benlysta typically last?

How long Benlysta’s side effects last can depend on the specific side effect. For example, an injection site reaction, such as skin discoloration or pain, may occur right after injecting your dose of Benlysta. This side effect typically goes away within a few minutes to hours after injecting your dose.

However, other side effects, such as depression, may continue throughout your treatment with Benlysta.

If you have concerns about how long Benlysta’s side effects may last, talk with your doctor. They can help determine what to expect from taking Benlysta.

Will I experience certain side effects when stopping Benlysta?

No, you should not experience side effects from stopping Benlysta treatment. This medication is not known to cause withdrawal symptoms.

However, doctors prescribe Benlysta to treat certain types of lupus. If you stop treatment with Benlysta, it’s possible that your lupus symptoms may return.

Before stopping treatment with Benlysta, talk with your doctor. They can recommend the best treatment plan for you.

Learn more about some of the side effects that Benlysta may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Benlysta.

Depression

Benlysta may increase the risk of depression. In some cases, this may lead to suicidal thoughts or behaviors. This was a commonly reported side effect in clinical trials of Benlysta.

Due to this risk, it’s important to be aware of the symptoms of depression. Symptoms may include:

What you can do

Before starting treatment with Benlysta, tell your doctor if you have a history of depression. If you do, you may have a higher risk of this side effect.

Throughout your treatment, your doctor will monitor your condition for symptoms of depression or mood changes. If you already have risk factors for depression, your doctor may monitor your mood more frequently during treatment.

If you develop any symptoms of depression during your treatment with Benlysta, talk with your doctor right away. In some cases, they may recommend stopping Benlysta and trying a different medication to treat your lupus.

Fever

Benlysta can cause a fever. This was one of the most common side effects reported by people taking Benlysta in clinical trials.

Symptoms of a fever may include:

It’s important to note Benlysta may also cause an infection, such as pneumonia or urinary tract infection (UTI). A fever can occur due to an infection or due to Benlysta itself.

What you can do

If you develop a fever during your treatment with Benlysta, talk with your doctor. They can help determine what’s causing this side effect. They can also recommend the best ways to manage your fever. This may include staying hydrated, resting, and taking an over-the-counter medication, such as Tylenol (acetaminophen).

Allergic reaction

As with most drugs, Benlysta can cause an allergic reaction in some people. In clinical trials, this side effect was common.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Benlysta. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Help is out there

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

  • Call or text the 988 Lifeline at 988 or chat at 988lifeline.org. Caring counselors are available to listen and provide free and confidential support 24/7.
  • Text HOME to the Crisis Text Line at 741741 to connect with a volunteer crisis counselor for free and confidential support 24/7.
  • Not in the United States? Find a helpline in your country with Befrienders Worldwide.
  • Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you’re not in the same household, stay on the phone with them until help arrives.

Be sure to talk with your doctor about your health history before you take Benlysta. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Infection: Tell your doctor if you have an infection before taking Benlysta. This medication may increase your risk of infection, such as pneumonia or urinary tract infection (UTI). If you already have an infection, taking Benlysta may worsen your condition. For this reason, your doctor will likely recommend treating your infection before you start taking Benlysta.

Depression or other mental health conditions: Tell your doctor if you have a history of depression or another mental health condition. It’s possible for Benlysta to cause depression, which can lead to suicidal thoughts or behaviors. If you have a history of these conditions, you may have a higher risk of these side effects. In this case, your doctor may monitor your mental health more often during treatment with Benlysta. In some cases, they may recommend a different treatment option for your condition.

Allergic reaction: If you’ve had an allergic reaction to Benlysta or any of its ingredients, your doctor will likely not prescribe Benlysta. Ask your doctor what other medications may be better options for you.

Recent vaccination: Tell your doctor about any recent vaccinations you have had. Benlysta may weaken your immune system. For this reason, it is important not to receive any live-attenuated vaccines during treatment or up to 30 days before starting Benlysta.

Since live vaccines contain some of the live virus, they aren’t recommended for people with weakened immune systems. Due to this risk, your doctor will typically recommend waiting at least 30 days after the vaccination before you start taking Benlysta.

Cancer: If you have cancer or have had it in the past, tell your doctor before starting Benlysta. Benlysta may weaken your immune system. It’s possible for drugs that weaken your immune system to also increase your risk of cancer. However, it’s not known whether Benlysta may increase your risk of cancer. If you have a history of cancer, your doctor may monitor your condition more often during treatment with Benlysta.

Taking other biologic drugs: If you currently take a biologic drug, such as a monoclonal antibody, talk with your doctor before they prescribe Benlysta. Benlysta is also a biologic drug. It’s not known whether it’s safe to receive Benlysta in combination with other biologics. In this case, your doctor can recommend the best treatment plan for you.

Pregnancy or breastfeeding: If you’re pregnant, planning to become pregnant, or breastfeeding, talk with your doctor before starting Benlysta. This drug may not be safe for you to take. At this time, it’s not known whether Benlysta may harm a developing fetus. It’s also not known whether the drug is present in breast milk or how it may affect a child who is breastfed. Your doctor may recommend using birth control during your treatment and for at least 4 months after your last dose of Benlysta.

If you become pregnant during treatment, tell your doctor right away. They may recommend that you stop treatment with Benlysta. Or they may recommend signing up for Benlysta’s pregnancy registry. A pregnancy registry is a collection of information about the risks of receiving a specific medication during pregnancy. You can sign up for the registry by calling 877-311-8972, or you can sign up online.

Alcohol consumption: If you drink alcohol, Benlysta is likely safe for you to use. There are no known interactions between Benlysta and alcohol. However, doctors prescribe Benlysta in combination with other medications to treat lupus. It’s possible that another medication you’re taking may interact with alcohol. If you drink alcohol, talk with your doctor about how much, if any, is safe to drink during treatment with your prescribed medications.

Benlysta may cause side effects, but most side effects from this medication are mild. If you’d like to learn more about Benlysta side effects, talk with your doctor or pharmacist.

To learn more about Benlysta, see these articles:

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.