Benlysta Side Effects

Generic Name: belimumab

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

In Summary

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

For the Consumer

Applies to belimumab: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by belimumab (the active ingredient contained in Benlysta). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking belimumab, check with your doctor or nurse immediately:

• 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
• shortness of breath or trouble breathing
• sneezing
• sore throat
• stuffy or runny nose
• sweating
• tightness in the chest
• unusual tiredness or weakness

• Black, tarry stools
• bloody or cloudy urine
• depression
• difficult, burning, or painful urination
• fast heartbeat
• frequent urge to urinate
• hoarseness
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• tender, swollen glands in the neck
• unusual bleeding or bruising
• voice changes

Minor Side Effects

Some of the side effects that can occur with belimumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• Arm or leg pain
• headache, severe and throbbing
• unable to sleep

• Abdominal or 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]

Not all side effects for Benlysta may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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