Soliris Side Effects
Generic Name: eculizumab
Note: This document contains side effect information about eculizumab. Some of the dosage forms listed on this page may not apply to the brand name Soliris.
Some side effects of Soliris may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to eculizumab: intravenous solution
Along with its needed effects, eculizumab (the active ingredient contained in Soliris) 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
- difficult, burning, or painful urination
- difficulty with moving
- joint pain
- lower back or side pain
- muscle aching or cramping
- muscle pains or stiffness
- 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
- 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
- general feeling of discomfort or illness
- loss of appetite
- trouble sleeping
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 (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.
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%).
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 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%).
More about Soliris (eculizumab)
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