Benlysta Side Effects

Generic name: belimumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 16, 2024.

Note: This document provides detailed information about Benlysta Side Effects associated with belimumab. Some dosage forms listed on this page may not apply specifically to the brand name Benlysta.

Applies to belimumab: powder for solution, solution.

Serious side effects of Benlysta

Along with its needed effects, belimumab (the active ingredient contained in Benlysta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking belimumab:

Other side effects of Benlysta

Some side effects of belimumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Precautions

It is very important that your doctor check your or your child's progress closely and at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

You should not receive this medicine if you are also using other biologic treatments or cyclophosphamide (Cytoxan®). Using these medicines together may increase your chance for more serious side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for at least 4 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious infections (eg, pneumonia, urinary tract infections, cellulitis, and bronchitis). Check with your doctor right away if you have bladder pain, bloody or cloudy urine, chest pain, cough, cough producing mucus, difficult, burning, or painful urination, fever or chills, frequent urge to urinate, itching, pain, redness, swelling, tenderness, or warmth of the skin, lower back or side pain, sneezing, sore throat, trouble breathing, or tightness in the chest.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy (PML). Avoid being near people who are sick and wash your hands often. Check with your doctor right away if you have a fever, chills, a cough that won't go away, flu-like symptoms, a headache, night sweats, or weight loss. Tell your doctor if you have balance problems, confusion, difficulty talking or walking, dizziness, memory loss, or vision changes.

Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.

Belimumab may cause infusion reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting, after receiving this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

While you are being treated with belimumab, and 30 days before starting treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Belimumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who are receiving live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Tell your doctor if you are African-American or have African ancestry. This medicine may not work the same way and may require caution in African-American patients receiving belimumab. Talk to your doctor if you have concerns.

For healthcare professionals

Applies to belimumab: intravenous powder for injection, subcutaneous solution.

General adverse events

The most common adverse events were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection-site reactions (subcutaneous administration).^[Ref]

Dermatologic

• Common (1% to 10%): Skin reactions, rash, urticaria, acne
• Uncommon (0.1% to 1%): Angioedema
• Frequency not reported: Cellulitis

Gastrointestinal

• Very common (10% or more): Nausea (up to 15%), diarrhea (up to 12%)
• Common (1% to 10%): Viral gastroenteritis, upper abdominal pain
• Frequency not reported: Vomiting

Obese patients (body mass index [BMI] greater than 30 kg/m2) with SLE treated with this drug administered IV reported higher rates of nausea, vomiting, and diarrhea compared with normal-weight patients (BMI 18.5 to 30 kg/m2); none of these gastrointestinal events in obese patients were serious.

Genitourinary

• Very common (10% or more): Urinary tract infection (UTI; up to 19.2%)
• Common (1% to 10%): Cystitis, bacterial UTI

Hematologic

• Common (1% to 10%): Leukopenia
• Frequency not reported: Myelosuppression

Cases of myelosuppression (including febrile neutropenia, leukopenia, and pancytopenia) were observed in patients who received induction therapy with cyclophosphamide followed by maintenance therapy with azathioprine, or mycophenolate.

Hypersensitivity

• Very common (10% or more): Hypersensitivity reactions (up to 13%)
• Uncommon (0.1% to 1%): Anaphylactic reaction
• Rare (0.01% to 0.1%): Delayed-type nonacute hypersensitivity reaction
• Postmarketing reports: Fatal anaphylaxis

In clinical trials of this drug administered IV in patients with systemic lupus erythematosus (SLE), hypersensitivity reactions (occurring on the same day of infusion) and anaphylaxis were reported in 13% and 0.6% of patients receiving this drug, respectively. Manifestations included hypotension, angioedema, urticaria/other rash, pruritus, and dyspnea.

Delayed-type, nonacute hypersensitivity reactions included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial edema.

Local

• Common (1% to 10%): Injection-site reactions (subcutaneous formulations only)

In clinical trials of this drug administered subcutaneously in patients with SLE, injection-site reactions were reported in 6.1% of patients receiving this drug (plus standard therapy). These injection site reactions (most commonly pain, erythema, hematoma, pruritus, and induration) were mild to moderate in severity and most (94%) did not require discontinuation of therapy.

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 16.2%)
• Common (1% to 10%): Pain in extremity, muscle spasms

Nervous system

• Very common (10% or more): Headache (up to 21.1%)
• Common (1% to 10%): Migraine

Oncologic

• Uncommon (0.1% to 1%): Malignancies (including nonmelanoma skin cancers)

Other

• Very common (10% or more): Infections (up to 82%), infusion-related events (up to 17%), serious infections (up to 14%), bacterial infections (e.g., bronchitis, UTI)
• Common (1% to 10%): Pyrexia, fatigue, infusion-/injection-related systemic reactions, postinjection systemic reactions, herpes zoster, death
• Uncommon (0.1% to 1%): Fatal infections, all-cause mortality, serious infusion reactions, serious opportunistic infections

In clinical trials of this drug administered IV in patients with SLE, infusion-related events (occurring on the same day of infusion) were reported in 17% of patients receiving this drug. Serious infusion reactions (excluding hypersensitivity reactions) were reported in 0.5% of patients receiving this drug and included bradycardia, myalgia, headache, rash, urticaria, and hypotension. The most common infusion reactions were headache, nausea, and skin reactions.

Infusion- or injection-related systemic reactions included a group of terms and manifested as a range of symptoms (including bradycardia, myalgia, headache, rash, urticaria, pyrexia, hypotension, hypertension, dizziness, and arthralgia); due to overlap in signs/symptoms, it was not possible to distinguish between hypersensitivity reactions and infusion- or injection-related systemic reactions in all cases.

Psychiatric

• Very common (10% or more): Psychiatric events (up to 16%)
• Common (1% to 10%): Insomnia, depression, depression-related events, anxiety, suicidal ideation/behavior, serious psychiatric events
• Uncommon (0.1% to 1%): Serious depression, serious suicidal ideation/behavior/self-injury without suicidal intent, suicidal ideation, suicidal behavior, suicide

Respiratory

• Very common (10% or more): Upper respiratory tract infection (up to 17.5%), cough (up to 12.5%)
• Common (1% to 10%): Nasopharyngitis, bronchitis, pharyngitis, sinusitis, influenza, viral upper respiratory tract infection
• Frequency not reported: Pneumonia

See also:

Frequently asked questions

• What is the difference between Benlysta and Saphnelo?
• What's the difference between Lupkynis and Benlysta?
• Does Benlysta cause weight gain?
• Where do you inject Benlysta?
• How long does it take for Benlysta injections to work?
• Can Benlysta cause an allergic reaction?
• How does Benlysta help lupus?
• How long does a Benlysta infusion take?
• Does Benlysta cause hair loss?

Further information

Benlysta side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer