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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, 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 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. Cerner Multum, Inc. "Australian Product Information." O 0

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

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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