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

In addition to its needed effects, some unwanted effects may be caused by eculizumab. 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 eculizumab, check with your doctor or nurse immediately:

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 of the side effects that can occur with eculizumab 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
  • Difficulty having a bowel movement (stool)
  • pain in the arms or legs

For Healthcare Professionals

Applies to eculizumab: intravenous solution

Immunologic

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.[Ref]

Respiratory

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%).[Ref]

Musculoskeletal

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%).[Ref]

Gastrointestinal

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%).[Ref]

Hematologic

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

Cardiovascular

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%).[Ref]

General

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

Psychiatric

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

Genitourinary

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

References

1. "Product Information. Soliris (eculizumab)." Alexion Pharmaceuticals Inc, Cheshire, CT.

2. Hillmen P, Young NS, Schubert J, et al. "The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria." N Engl J Med 355 (2006): 1233-43

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