Sarilumab Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 13, 2020.
For the Consumer
Applies to sarilumab: subcutaneous solution
Subcutaneous route (Solution)
Serious infections leading to hospitalization or death including bacterial, viral, invasive fungal, and other opportunistic infections have occurred in patients receiving sarilumab.If a serious infection develops, interrupt sarilumab until the infection is controlled.Cases of tuberculosis (TB) have been reported. Prior to starting sarilumab, test for latent TB; if positive, start treatment for TB.Closely monitor patients for signs and symptoms of infection during treatment with sarilumab.
Side effects requiring immediate medical attention
Along with its needed effects, sarilumab 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 immediately if any of the following side effects occur while taking sarilumab:
- Bloody, black, or tarry stools
- lower back or side pain
- painful or difficult urination
- pale skin
- sore throat
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- Bladder pain
- bloody or cloudy urine
- body ache or pain
- difficulty breathing
- ear congestion
- frequent urge to urinate
- loss of voice
- nasal congestion
- painful cold sores or blisters on the lips
- runny nose
- Difficulty swallowing
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- severe stomach pain, cramping, or burning
- tightness in the chest
- vomiting of material that looks like coffee grounds, severe and continuing
Side effects not requiring immediate medical attention
Some side effects of sarilumab 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:
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
For Healthcare Professionals
Applies to sarilumab: subcutaneous solution
Common (1% to 10%): Neutropenia, leukopenia
Uncommon (0.1% to 1%): Decreased platelet counts
Uncommon (0.1% to 1%): Hypersensitivity reactions[Ref]
Common (1% to 10%): Serious (sometimes fatal) infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens which can be chronic or recurrent
Common (1% to 10%): Lipid abnormalities (elevated LDL, HDL, and triglycerides)[Ref]
Common (1% to 10%): Urinary tract infection[Ref]
Very common (10% or more): Elevated alanine aminotransferase (ALT) (up to 43%), elevated aspartate aminotransferase (AST) (up to 30%)[Ref]
Common (1% to 10%): Upper respiratory tract infection
The most frequent adverse reactions (occurring in at least 3% of patients treated with this drug in combination with DMARDs) were neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.[Ref]
Frequency not reported: GI perforation[Ref]
1. "Product Information. Kevzara (sarilumab)." sanofi-aventis, Bridgewater, NJ.
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More about sarilumab
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 17 Reviews
- Drug class: antirheumatics
- Patient Information
- Sarilumab Subcutaneous (Advanced Reading)
- Sarilumab Prefilled Pens
- Sarilumab Prefilled Syringes
- Other brands
Related treatment guides
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.