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Soliris Side Effects

Generic Name: eculizumab

Note: This page contains side effects data for the generic drug eculizumab. It is possible that some of the dosage forms included below may not apply to the brand name Soliris.

It is possible that some side effects of Soliris may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to eculizumab: intravenous solution

As well as its needed effects, eculizumab (the active ingredient contained in Soliris) may cause unwanted side effects that 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 eculizumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 (the active ingredient contained in Soliris) detected in up to 3% of patients). Postmarketing cases of serious or fatal meningococcal infections have also been reported.[Ref]


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 (the active ingredient contained in Soliris) (up to 3%).[Ref]


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


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 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%).


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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