Skip to main content

Saphnelo Side Effects

Generic name: anifrolumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 20, 2024.

Note: This document contains side effect information about anifrolumab. Some dosage forms listed on this page may not apply to the brand name Saphnelo.

Applies to anifrolumab: intravenous solution.

Serious side effects of Saphnelo

Along with its needed effects, anifrolumab (the active ingredient contained in Saphnelo) 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 anifrolumab:

More common

Less common

Other side effects of Saphnelo

Some side effects of anifrolumab 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

For Healthcare Professionals

Applies to anifrolumab: intravenous solution.


The most common adverse drug reactions with an incidence of 5% or greater were nasopharyngitis, upper respiratory tract infections, urinary tract infection, bronchitis, infusion related reactions, herpes zoster, headache, back pain, sinusitis, and cough.[Ref]


Common (1% to 10%): Diarrhea, nausea, oral herpes, vomiting


Very common (10% or more): Urinary tract infection (12%)


Common (1% to 10%): Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction[Ref]

-Serious hypersensitivity reactions were reported in 0.6% of patients.[Ref]


Common (1% to 10%): Antibody development[Ref]


Common (1% to 10%): Infusion-related reactions[Ref]

-The most common infusion-related reaction symptoms were headache, nausea, vomiting, fatigue, and dizziness.[Ref]


Common (1% to 10%): Back pain, arthralgia

Nervous system

Common (1% to 10%): Headache


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

-Malignant neoplasms, included non-melanoma skin cancers, were reported in 1.3% of patients.

-Malignancies that were reported in more than one patient included breast cancer and squamous cell carcinoma.[Ref]


Very common (10% or more): Infections (69.7%)

Common (1% to 10%): Herpes zoster, serious Infections[Ref]

-The most frequent serious infection was pneumonia.

-Fatal infections occurred in 0.4% of patients.[Ref]


Very common (10% or more): Bronchitis (11%), upper respiratory tract infection (34%), nasopharyngitis (16.3)

Common (1% to 10%): Cough, respiratory tract infection, sinusitis, cough, pharyngitis, pneumonia[Ref]

-Upper respiratory tract infections included nasopharyngitis and pharyngitis.

-Bronchitis included viral bronchitis and tracheobronchitis.

-Respiratory tract infection included viral respiratory tract infection and bacterial respiratory tract infection.[Ref]

Frequently asked questions


1. Product Information. Saphnelo (anifrolumab). Astra-Zeneca Pharmaceuticals. 2021.

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.