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Arzerra Side Effects

Generic Name: ofatumumab

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

For the Consumer

Applies to ofatumumab: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by ofatumumab (the active ingredient contained in Arzerra). 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 ofatumumab, check with your doctor or nurse immediately:

More common:
  • Black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • body aches or pain
  • chest pain
  • chills
  • confusion
  • cough or hoarseness
  • cough producing mucus
  • difficult or labored breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • ear congestion
  • facial swelling
  • fainting
  • fast heartbeat
  • feeling of warmth
  • headache
  • hives or welts, itching, or skin rash
  • increased sweating
  • lightheadedness
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea or vomiting
  • painful blisters on the trunk of the body
  • painful or difficult urination
  • pale skin
  • rapid weight gain
  • rapid, shallow breathing
  • redness of the face, neck, arms, and occasionally, upper chest
  • runny nose
  • sneezing
  • sore throat
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness
Less common:
  • Fast, pounding, or irregular heartbeat or pulse
  • nervousness
  • pounding in the ears
  • slow heartbeat
Incidence not known:
  • Blistering, peeling, or loosening of the skin
  • dark urine
  • diarrhea
  • fluid-filled skin blisters
  • joint or muscle pain
  • light-colored stools
  • no blood pressure or pulse
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sensitivity to the sun
  • skin thinness
  • stopping of heart
  • unconsciousness
  • yellow eyes or skin

Minor Side Effects

Some of the side effects that can occur with ofatumumab 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:

More common:
  • Back pain
  • muscle aches
  • redness of the skin
  • trouble sleeping
Less common:
  • Bleeding, blistering, burning, coldness, discoloration of the skin, 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
  • muscle spasms
  • pain or tenderness around the eyes and cheekbones

For Healthcare Professionals

Applies to ofatumumab: intravenous solution


Very common (10% or more): Neutropenia (up to 27%), anemia (up to 18%)
Common (1% to 10%): Leukopenia, febrile neutropenia, thrombocytopenia
Uncommon (0.1% to 1%): Agranulocytosis, coagulopathy, red cell aplasia, lymphopenia[Ref]


Very common (10% or more): Upper respiratory tract infection (up to 19%), pneumonia (up to 23%), cough (up to 19%), dyspnea (up to 14%), bronchitis (up to 11%), lower respiratory tract infection
Common (1% to 10%): Sinusitis, nasopharyngitis, bronchospasm, hypoxia, dyspnea, chest discomfort, pharyngolaryngeal pain, nasal congestion
Uncommon (0.1% to 1%): Pulmonary edema[Ref]


Very common (10% or more): Diarrhea (up to 18%), nausea (up to 11%)
Common (1% to 10%): Upper abdominal pain
Uncommon (0.1% to 1%): Small bowel obstruction[Ref]


Very common (10% or more): Rash (e.g., rash, rash macular, rash vesicular) (up to 14%)
Common (1% to 10%): Urticaria, hyperhidrosis, erythema, pruritus
Uncommon (0.1% to 1%): Coagulopathy, red cell aplasia
Postmarketing reports: Stevens-Johnson syndrome, porphyria cutanea tarda[Ref]


Common (1% to 10%): Arthralgia, back pain, chills, muscle spasms, rigors[Ref]


Common (1% to 10%): Insomnia[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]


Common (1% to 10%): Hypertension, hypotension, tachycardia
Uncommon (0.1% to 1%): Bradycardia
Postmarketing reports: Cardiac arrest (infusion related)[Ref]


Common (1% to 10%): Urinary tract infection[Ref]


Rare (less than 0.1%): Hepatitis B infection and reactivation[Ref]


Common (1% to 10%): Anaphylactoid reactions, hypersensitivity
Uncommon (0.1% to 1%): Anaphylactic shock, cytokine release syndrome[Ref]


Common (1% to 10%): Herpes simplex (e.g., oral herpes, herpes, herpes virus infection, genital herpes), influenza, herpes zoster, hypogammaglobulinemia, bacterial infections, viral infections, fungal infections, sepsis (e.g., sepsis, neutropenic sepsis, bacteremia, septic shock)
Uncommon (0.1% to 1%): Immunogenicity[Ref]


Very common (10% or more):
Common (1% to 10%): Peripheral edema
Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]


Very common (10% or more): Pyrexia (up to 20%), fatigue (up to 15%)[Ref]


1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

2. "Product Information. Arzerra (ofatumumab)." GlaxoSmithKline, Research Triangle Park, NC.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.