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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.

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

Minor Side Effects

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

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.

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.

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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