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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.

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
  • cough
  • difficult, burning, or painful urination
  • difficulty with moving
  • dizziness
  • fever
  • headache
  • joint pain
  • lower back or side pain
  • muscle ache, cramp, pain, 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
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stuffy or runny nose
  • swollen glands or joints
  • tightness of the chest
  • troubled breathing with or without 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
  • pain in the arms or legs

For Healthcare Professionals

Applies to eculizumab: intravenous solution

Immunologic

Common (1% to 10%): Meningococcal sepsis, aspergillus infection, arthritis bacterial, oral herpes, viral infection

Uncommon (0.1% to 1%): Meningococcal meningitis, neisseria infection, sepsis, septic shock, pneumonia, fungal infection, Haemophilus influenza infection, abscess, cellulitis, influenza, cystitis, gingival infection, impetigo, tooth infection[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, bronchitis, dyspnea, cough, nasal congestion, pharyngolaryngeal pain, rhinorrhea

Uncommon (0.1% to 1%): Lower respiratory tract infection, sinusitis, epistaxis, throat irritation[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, muscle spasms, bone pain, back pain, neck pain, pain in extremity

Uncommon (0.1% to 1%): Trismus, joint swelling[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, vomiting, nausea, abdominal pain, constipation, dyspepsia

Uncommon (0.1% to 1%): Gastrointestinal infection, peritonitis, gastroesophageal reflux disease, abdominal distension, gingival pain[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia, leukopenia, hemolysis

Uncommon (0.1% to 1%): Coagulopathy, red blood cell agglutination, abnormal clotting factor, anemia, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hematocrit decreased, hemoglobin decreased[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 35%)

Common (1% to 10%): Hypotension

Uncommon (0.1% to 1%): Palpitation, accelerated hypertension, hematoma, hot flush, vein disorder[Ref]

Nervous system

Very common (10% or more): Headache (up to 44%)

Common (1% to 10%): Dizziness, dysgeusia

Uncommon (0.1% to 1%): Syncope, tremor, paresthesia[Ref]

General

The most common adverse reaction was headache (occurred mostly in the initial phase), and the most serious adverse reaction was meningococcal sepsis.[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, anxiety, insomnia, sleep disorder, abnormal dreams, mood swings[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Spontaneous penile erection, menstrual disorder[Ref]

Dermatologic

Common (1% to 10%): Rash, alopecia, pruritus

Uncommon (0.1% to 1%): Urticaria, dermatitis, erythema, petechiae, skin depigmentation, hyperhidrosis, dry skin[Ref]

Endocrine

Uncommon (0.1% to 1%): Grave's disease[Ref]

Hepatic

Uncommon (0.1% to 1%): Jaundice[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylactic reaction

Uncommon (0.1% to 1%): Hypersensitivity[Ref]

Local

Uncommon (0.1% to 1%): Infusion site paresthesia, infusion site pain, extravasation[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Uncommon (0.1% to 1%): Anorexia[Ref]

Ocular

Uncommon (0.1% to 1%): Vision blurred, conjunctival irritation[Ref]

Oncologic

Uncommon (0.1% to 1%): Malignant melanoma, myelodysplastic syndrome[Ref]

Other

Common (1% to 10%): Edema, chest discomfort, pyrexia, chills, fatigue, asthenia, influenza like illness

Uncommon (0.1% to 1%): Tinnitus, vertigo, feeling hot[Ref]

Renal

Uncommon (0.1% to 1%): Renal impairment, hematuria, dysuria[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

3. Cerner Multum, Inc. "Australian Product Information." 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.

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