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

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. Continue reading for a comprehensive list of adverse effects.

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:

More common

• Bladder pain
• 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
• bloody or cloudy urine
• body aches or pain
• chest pain or tightness
• chills
• cough
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• difficulty with breathing or swallowing
• dizziness
• ear congestion
• fever
• frequent urge to urinate
• headache, severe and throbbing
• hives, skin rash
• 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
• pain or tenderness around the eyes and cheekbones
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sneezing
• sore throat
• stuffy or runny nose
• sweating
• swelling of the eyes, face, or inside of the nose
• trouble breathing
• unusual tiredness or weakness
• vomiting

Less common

• Black, tarry stools
• blood in the urine or stools
• discouragement
• fast heartbeat
• feeling sad or empty
• hoarseness
• irritability
• loss of interest or pleasure
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sores, ulcers, or white spots on the lips or in the mouth
• tender, swollen glands in the neck
• trouble concentrating
• trouble sleeping
• unusual bleeding or bruising
• voice changes

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:

More common

• Arm or leg pain

Less common

• Stomach pain

For Healthcare Professionals

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

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%)

Common (1% to 10%): Migraine, fatigue^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (18%)

Common (1% to 10%): Nasopharyngitis, bronchitis^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (16%)

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]