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Ofatumumab Side Effects

For the Consumer

Applies to ofatumumab: intravenous solution

Along with its needed effects, ofatumumab 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 ofatumumab:

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

Some side effects of ofatumumab 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
  • 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

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.