Eculizumab Side Effects

Not all side effects for eculizumab 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 eculizumab: intravenous solution

Along with its needed effects, eculizumab 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 eculizumab:

More common
  • Back pain
  • black, tarry stools
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning or stinging of the skin
  • chest pain
  • cough
  • difficult, burning, or painful urination
  • difficulty with moving
  • dizziness
  • fever
  • headache
  • joint pain
  • lower back or side pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • nausea
  • nervousness
  • pain or tenderness around the eyes and cheekbones
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pale skin
  • pounding in the ears
  • shortness of breath or troubled breathing
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on lips or in the mouth
  • stuffy or runny nose
  • swollen glands
  • swollen joints
  • tightness of the chest or wheezing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Chills
  • diarrhea
  • general feeling of discomfort or illness
  • loss of appetite
  • shivering
  • sweating
  • trouble sleeping
  • vomiting

Some side effects of eculizumab 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
  • Difficulty having a bowel movement (stool)
  • pain in the arms or legs

For Healthcare Professionals

Applies to eculizumab: intravenous solution


Immunologic side effects have included herpes simplex infections (up to 7%), influenza-like illness (up to 5%), and immunogenicity (antibodies to eculizumab detected in up to 3% of patients). Postmarketing cases of serious or fatal meningococcal infections have also been reported.


Respiratory side effects have included upper respiratory tract infection (up to 35%), nasopharyngitis (up to 23%), cough ( up to 14%), pharyngolaryngeal pain (up to 14%), sinusitis (up to 7%), and low titers of antibodies to eculizumab (up to 3%).


Musculoskeletal side effects have included back pain (up to 19%), pain in extremity (up to 11%), arthralgia (up to 7%), and myalgia (up to 7%).


Gastrointestinal side effects have included diarrhea (up to 32%), vomiting (up to 22%), nausea (up to 19%), abdominal pain (up to 11%), and constipation (up to 7%).


Hematologic side effects have included anemia (up to 24%), and leukopenia (up to 16%).


Cardiovascular side effects have included hypertension (up to 35%).

Nervous system

Nervous system side effects have included headache (up to 44%), vertigo (up to 11%), and dizziness (up to 5%).


General side effects have included fatigue (up to 12%), peripheral edema (up to 11%), and pyrexia (up to 11%).


Psychiatric side effects have included insomnia (up to 14%).


Genitourinary side effects have included urinary tract infection (up to 16%).

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