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Anifrolumab Side Effects

The most commonly reported side effects of anifrolumab include systemic lupus erythematosus, fatigue, and arthralgia, based on 2,110 FDA adverse event reports from 2014 to 2025. 4.6% of reports found the drug to be ineffective.

Anifrolumab side effects

Percentages show how often each reaction appears relative to total reports for anifrolumab.

1
Systemic Lupus Erythematosus8.2%174
2
Fatigue6.8%143
3
Arthralgia5.2%110
4
Headache5.0%106
5
Nausea4.8%101
6
Drug Ineffective4.6%98
7
Off Label Use4.5%95
8
Pain3.9%82
9
Herpes Zoster3.8%81
10
Rash3.6%76
11
Covid-193.3%69
12
Product Dose Omission Issue3.0%63
13
Dizziness2.9%62
14
Condition Aggravated2.9%62
15
Pyrexia2.8%60

These are voluntary reports and do not establish that anifrolumab caused these reactions.

Report severity

63.8%Serious1,346 reports
20.7%Hospitalizations436 reports
4.2%Fatal89 reports

Seriousness is determined by the reporter, not by OpenClaim.

Anifrolumab drug interactions

Other drugs that appear in adverse event reports alongside anifrolumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Hydroxychloroquine-sulfate4.4%92
2
Belimumab4.2%89
3
Mycophenolate3.7%78
4
Methotrexate2.7%57
5
Prednisone2.2%46
6
Azathioprine2.2%46
7
Prednisolone2.1%44
8
Rituximab2.0%43
9
Voclosporin1.2%26
10
Corticotropin0.8%17
11
Treprostinil0.8%16
12
Tacrolimus0.7%14
13
Tofacitinib0.6%13
14
Methylprednisolone0.5%11
15
Cyclosporine0.5%11

Taken alongside

1
Hydroxychloroquine-sulfate11.7%247
2
Prednisone7.6%160
3
Mycophenolate4.5%95
4
Methotrexate3.4%72
5
Prednisolone3.3%70
6
Aspirin2.6%55
7
Azathioprine2.5%52
8
Folic-acid2.1%45
9
Belimumab2.0%42
10
Ergocalciferol1.9%40
11
Tacrolimus1.8%39
12
Methylprednisolone1.8%37
13
Levothyroxine-sodium1.7%35
14
Pantoprazole-sodium1.4%29
15
Acetaminophen1.3%28

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports anifrolumab side effects

69.4% of anifrolumab adverse event reports involve female patients and 7.8% involve male patients. The largest age group is adult at 86%. These figures reflect who reports side effects, not underlying risk.

Sex

Female69.4%
Male7.8%
Unknown22.8%

Age group

< 20.1%
2–110.4%
12–171.2%
18–6485.9%
65+12.3%

What is anifrolumab used for

Conditions and purposes for which patients were taking anifrolumab when the adverse event was reported.

Acute Cutaneous Lupus ErythematosusAdverse ReactionAlopeciaAntibody Test PositiveAntiinflammatory TherapyAntiphospholipid AntibodiesAntiphospholipid SyndromeArthritisArthropathyAutoantibody PositiveAutoinflammatory DiseaseCandle SyndromeCentral Nervous System LupusChronic Cutaneous Lupus ErythematosusConnective Tissue Disorder

Showing 15 of 60 indications

Anifrolumab brand names and reporting trend

Anifrolumab is sold under the brand name Saphnelo.

Brand names

Saphnelo703

Quarterly reports (20142025)

202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking anifrolumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.