Skip to main content

Saphnelo Side Effects

Generic name: anifrolumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jul 12, 2022.

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

  • Back pain
  • chest tightness
  • chills
  • cough or hoarseness
  • cough producing mucus
  • fever
  • flushing
  • headache
  • lower back or side pain
  • nausea and vomiting
  • painful blisters on the trunk of the body
  • painful or difficult urination
  • trouble breathing
  • weakness

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

  • Body aches or pain
  • ear congestion
  • loss of voice
  • muscle aches
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tender, swollen glands in the neck

For Healthcare Professionals

Applies to anifrolumab: intravenous solution.

Respiratory

Very common (10% or more): Upper respiratory tract infections, including nasopharyngitis, and pharyngitis (34%), bronchitis, including tracheobronchitis (11%)

Common (1% to 10%): Cough, respiratory tract infection

Frequency not reported: Pneumonia[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Uncommon (0.1% to 1%): Serious hypersensitivity reactions, including angioedema[Ref]

Immunologic

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

Local

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

Oncologic

Common (1% to 10%): Malignant neoplasm, including non-melanoma skin cancers[Ref]

General

The most frequent serious infection was pneumonia. Fatal infections occurred in 0.4%. The most common infusion related reactions were headache, nausea, vomiting, fatigue, and dizziness.[Ref]

Other

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

Common (1% to 10%): Herpes Zoster, serious infections[Ref]

Frequently asked questions

References

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.