Benlysta Side Effects
Generic Name: belimumab
Medically reviewed by Drugs.com. Last updated on Sep 20, 2020.
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
Side effects requiring immediate medical attention
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
- swelling of the eyes, face, or inside of the nose
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- trouble breathing
- unusual tiredness or weakness
- vomiting
Less common
- Black, tarry stools
- discouragement
- fast heartbeat
- feeling sad or empty
- hoarseness
- irritability
- loss of interest or pleasure
- 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
Side effects not requiring immediate medical attention
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]
References
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. BENLYSTA (belimumab)." GlaxoSmithKline, Research Triangle Park, NC.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
More about Benlysta (belimumab)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- 41 Reviews
- Drug class: selective immunosuppressants
- FDA Approval History
Consumer resources
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.