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Benlysta Side Effects

Generic Name: belimumab

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.

For the Consumer

Applies to belimumab: intravenous powder for 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.[Ref]


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[Ref]


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[Ref]

-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.[Ref]

Nervous system

Very common (10% or more): Headache (21.1%)
Common (1% to 10%): Migraine, fatigue[Ref]


Very common (10% or more): Upper respiratory tract infection (17.5%)
Common (1% to 10%): Nasopharyngitis, bronchitis[Ref]


Very common (10% or more): Arthralgia (16.2%)
Common (1% to 10%): Pain in extremity[Ref]


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


Very common (10% or more): Urinary tract infection
Common (1% to 10%): Cystitis[Ref]


Very common (10% or more): Pyrexia (10%)
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Death[Ref]


Common (1% to 10%): Insomnia, depression, anxiety
Uncommon (0.1% to 1%): Serious depression, suicide[Ref]


Common (1% to 10%): Leukopenia[Ref]


Uncommon (0.1% to 1%): Malignancies[Ref]


Uncommon (0.1% to 1%): Rash, urticaria[Ref]


1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. BENLYSTA (belimumab)." GlaxoSmithKline, Research Triangle Park, NC.

Some side effects of Benlysta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.