Ultomiris Side Effects
Generic name: ravulizumab
Note: This document provides detailed information about Ultomiris Side Effects associated with ravulizumab. Some dosage forms listed on this page may not apply specifically to the brand name Ultomiris.
Applies to ravulizumab: solution.
Serious side effects of Ultomiris
Along with its needed effects, ravulizumab (the active ingredient contained in Ultomiris) 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 ravulizumab:
More common side effects
- bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chills
- confusion
- cough
- decreased urine
- difficult, burning, or painful urination
- difficulty with breathing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- ear congestion
- extremely high fever or body temperature
- fast, shallow breathing
- fast, weak heartbeat
- fever
- frequent urge to urinate
- headache
- increased thirst
- irregular heartbeat
- loss of appetite
- loss of voice
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea or vomiting
- nervousness
- numbness or tingling in hands, feet, or lips
- pale, clammy skin
- pounding in the ears
- rapid weight gain
- runny or stuffy nose
- sneezing
- slow or fast heartbeat
- sore throat
- sweating
- swollen glands
- thirst
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- chest tightness
- difficulty swallowing
- hives, itching, or skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Other side effects of Ultomiris
Some side effects of ravulizumab 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 side effects
- back pain
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- diarrhea
- difficulty having a bowel movement (stool)
- difficulty with moving
- fear
- hair loss or thinning of the hair
- joint pain
- muscle pain, stiffness ,or spasms
- nausea or vomiting
- pain in the arms or legs
- stomach pain
For healthcare professionals
Applies to ravulizumab: intravenous solution.
General adverse events
The most frequent adverse drug reactions (greater than 10%) with are upper respiratory tract infection and headache.[Ref]
Local
- Rare (0.01% to 0.1%): Infusion reactions (e.g., lower back pain, drop in blood pressure, infusion-related pain)[Ref]
Musculoskeletal
- Common (1% to 10%): Pain in extremity, arthralgia[Ref]
Respiratory
- Very common (10% or more): Upper respiratory tract infection (e.g., nasopharyngitis, upper respiratory tract infection, oropharyngeal pain, viral
upper respiratory tract infection, rhinitis, respiratory tract infection, rhinorrhea, pharyngitis, upper respiratory tract inflammation) (39%)[Ref]
Other
- Common (1% to 10%): Hyperthermia, pyrexia[Ref]
Immunologic
- Frequency not reported: Immunogenicity, increased susceptibility to encapsulated bacterial infections (especially infections caused by Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae), life-threatening meningococcal infections (e.g., septicemia and/or meningitis)[Ref]
Nervous system
- Very common (10% or more): Headache (32%)
- Common (1% to 10%): Dizziness[Ref]
Gastrointestinal
- Common (1% to 10%): Diarrhea, nausea, abdominal pain[Ref]
References
1. (2019) "Product Information. Ultomiris (ravulizumab)." Alexion Pharmaceuticals Inc
Frequently asked questions
- How does Ultomiris compare to Soliris for PNH?
- How long does an Ultomiris infusion take?
- How long does it take for Ultomiris to work?
- How does Ultomiris work for myasthenia gravis?
More about Ultomiris (ravulizumab)
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- Reviews (7)
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- Dosage information
- During pregnancy
- FDA approval history
- Drug class: selective immunosuppressants
- Breastfeeding
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Further information
Ultomiris side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.
