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.

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: 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:

• 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

• 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:

• Arm or leg pain
• headache, severe and throbbing

• Stomach pain
• weakness

For Healthcare Professionals

Applies to belimumab: intravenous powder for injection

General

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

Immunologic

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]

Hypersensitivity

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]

Respiratory

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

Musculoskeletal

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

Gastrointestinal

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

Genitourinary

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

Other

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

Psychiatric

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

Hematologic

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

Oncologic

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

Dermatologic

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

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.

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