Drug
Anifrolumab-fnia
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Systemic Lupus Erythematosus | 149 | 50.8 | 55.5 | signal |
| 2 | Insurance Issue | 29 | 23.5 | 23.9 | signal |
| 3 | Pericarditis | 32 | 23.1 | 23.5 | signal |
| 4 | Herpes Zoster | 66 | 13.8 | 14.3 | signal |
| 5 | Proteinuria | 20 | 12.8 | 12.9 | signal |
| 6 | Brain Fog | 13 | 10.7 | 10.8 | signal |
| 7 | Vasculitis | 10 | 10.3 | 10.4 | signal |
| 8 | Infusion Site Pain | 9 | 8.5 | 8.5 | signal |
| 9 | Pharyngeal Swelling | 6 | 7.5 | 7.6 | signal |
| 10 | Myocarditis | 7 | 7.4 | 7.5 | signal |
| 11 | Immune System Disorder | 7 | 6.4 | 6.4 | signal |
| 12 | Drug Effect Less Than Expected | 7 | 6.0 | 6.0 | signal |
| 13 | Hepatic Cytolysis | 6 | 5.9 | 5.9 | signal |
| 14 | Photosensitivity Reaction | 8 | 5.8 | 5.9 | signal |
| 15 | Hyperbilirubinaemia | 5 | 5.8 | 5.8 | signal |
| 16 | Infusion Related Reaction | 30 | 5.5 | 5.5 | signal |
| 17 | Illness | 44 | 5.3 | 5.4 | signal |
| 18 | Bronchospasm | 6 | 5.0 | 5.1 | signal |
| 19 | Paraesthesia Oral | 6 | 5.0 | 5.0 | signal |
| 20 | Tuberculosis | 5 | 4.7 | 4.7 | signal |
| 21 | Lip Swelling | 12 | 4.3 | 4.4 | signal |
| 22 | Oral Herpes | 7 | 4.3 | 4.3 | signal |
| 23 | Skin Reaction | 5 | 4.3 | 4.3 | signal |
| 24 | Increased Tendency To Bruise | 3 | 3.9 | 3.9 | no signal |
| 25 | Therapy Change | 3 | 3.7 | 3.7 | no signal |
| 26 | Pneumocystis Jirovecii Pneumonia | 3 | 3.6 | 3.6 | no signal |
| 27 | Poor Venous Access | 3 | 3.5 | 3.5 | no signal |
| 28 | Blindness Unilateral | 4 | 3.4 | 3.4 | signal |
| 29 | Complication Associated With Device | 3 | 2.7 | 2.7 | no signal |
| 30 | Uveitis | 3 | 2.7 | 2.7 | no signal |
| 31 | Synovitis | 4 | 2.7 | 2.7 | no signal |
| 32 | Therapeutic Response Shortened | 7 | 2.6 | 2.6 | signal |
| 33 | Wrong Technique In Device Usage Process | 3 | 0.8 | 0.8 | no signal |