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.

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.

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

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
  • unable to sleep
Less common
  • Abdominal or stomach pain
  • weakness

For Healthcare Professionals

Applies to belimumab: intravenous powder for injection


Hypersensitivity side effects have included anaphylaxis. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea. Due to overlap in signs and symptoms, it was not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases. Postmarketing reports have included fatal anaphylaxis.


General side effects have included increased mortality, malignancy and serious, sometimes fatal infections.


Immunologic side effects have included bradycardia, myalgia, headache, rash, urticaria, and hypotension. The most common infusion reactions were headache, nausea, and skin reactions.


Psychiatric side effects have included new or worsening depression, suicidal thoughts, and other mood changes.


Gastrointestinal side effects have included nausea, diarrhea and gastroenteritis viral.


Respiratory side effects have included nasopharyngitis, bronchitis and pharyngitis.

Nervous system

Nervous system side effects have included insomnia, migraine and pain in extremity.


Hematologic side effects have included leukopenia.


Genitourinary side effects have included cystitis.

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