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Generic Name: belimumab (be LIM ue mab)
Brand Names: Benlysta
Benlysta (belimumab) is used in to treat active systemic lupus erythematosus (SLE). Includes Benlysta side effects, interactions and indications.
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Drug Information:
Benlysta (belimumab) is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage. Benlysta is used to treat active systemic lupus erythematosus (SLE) in adults and children aged five years and above. Benlysta is not for use in people who have severe kidney problems caused by SLE, or have active SLE that affects the central nervous system (brain, nerves, and spinal cord). Learn more

Benlysta Side Effects

Benlysta Side Effects

Note: This document contains side effect information about belimumab. Some of the dosage forms listed on this page may not apply to the brand name Benlysta.

In Summary

Common side effects of Benlysta include: infection, serious infection, hypersensitivity reaction, mental disorders, and nausea. Other side effects include: bronchitis, leukopenia, depression, insomnia, and nasopharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to belimumab: powder for solution, solution

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:

More common

  • Bleeding, blistering, burning, coldness, skin discoloration, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • body aches or pain
  • chest congestion
  • chills
  • cough
  • diarrhea
  • difficulty with breathing or swallowing
  • dizziness
  • ear congestion
  • fever
  • headache
  • hives
  • itching, pain, redness, swelling, tenderness, or warmth of the skin
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle aches and pains
  • nausea or vomiting
  • pain or tenderness around the eyes and cheekbones
  • swelling of the eyes, face, or inside of the nose
  • sneezing
  • sore throat
  • stuffy or runny nose
  • sweating
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness

Less common

  • Black, tarry stools
  • bloody or cloudy urine
  • discouragement
  • difficult, burning, or painful urination
  • fast heartbeat
  • feeling sad or empty
  • frequent urge to urinate
  • hoarseness
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tender, swollen glands in the neck
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unusual bleeding or bruising
  • voice changes

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:

More common

  • Arm or leg pain
  • headache, severe and throbbing

Less common

  • Stomach pain
  • weakness

For Healthcare Professionals

Applies to belimumab: intravenous powder for injection, subcutaneous solution


The most common adverse events were infections, headache, infusion reactions, arthralgia, nausea, hypersensitivity reactions, diarrhea, urinary tract infection, and pyrexia.


Very common (10% or more): Infections (non-opportunistic) (70%)

Common (1% to 10%): Serious infections, pharyngitis, cystitis, gastroenteritis viral, anti-belimumab (the active ingredient contained in Benlysta) antibodies

Uncommon (0.1% to 1%): Infections resulting in death

Frequency not reported: Progressive multifocal leukoencephalopathy


Very common (10% or more): Infusion-related reactions (17%), hypersensitivity reactions (13%)

Uncommon (0.1% to 1%): Serious infusion reaction, anaphylaxis, angioedema

Rare (less than 0.1%): Delayed-type non-acute hypersensitivity reactions

Postmarketing reports: Fatal anaphylaxis

-Hypersensitivity reaction covers a group of terms, including anaphylaxis, and symptoms including hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea.

-Infusion-related reaction covers a group of terms including bradycardia, myalgia, headache, rash, urticaria, pyrexia, hypotension, hypertension, dizziness, and arthralgia.

-Delayed-type, non- acute hypersensitivity reactions included rash, nausea, fatigue, myalgia, headache, and facial edema.

Nervous system

Very common (10% or more): Headache (21.1%)

Common (1% to 10%): Migraine, fatigue


Very common (10% or more): Upper respiratory tract infection (17.5%)

Common (1% to 10%): Nasopharyngitis, bronchitis


Very common (10% or more): Arthralgia (16.2%)

Common (1% to 10%): Pain in extremity


Very common (10% or more): Nausea (15%), diarrhea (12%)


Very common (10% or more): Urinary tract infection

Common (1% to 10%): Cystitis


Very common (10% or more): Pyrexia (10%)

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Death


Common (1% to 10%): Insomnia, depression, anxiety

Uncommon (0.1% to 1%): Serious depression, suicide


Common (1% to 10%): Leukopenia


Uncommon (0.1% to 1%): Malignancies


Uncommon (0.1% to 1%): Rash, urticaria

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Benlysta