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What the label lists and what reports show

Lumasiran side effects

Lumasiran's FDA label: “The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.” FAERS holds 364 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is renal transplant (49 reports).

  • No generic listed

Check it at the source: the lumasiran FDA label on DailyMed (effective December 1, 2025, Alnylam Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.

From the label: adverse reactions, continued

The most common adverse reaction (reported in ≥20% of patients) is injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alnylam Pharmaceuticals at 1-877-256-9526 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OXLUMO has been evaluated in a placebo-controlled trial and two single-arm clinical trials. Across these trials, 98 patients with PH1 have been treated with OXLUMO, including 71 pediatric patients and 15 patients on hemodialysis. Overall, 92 patients were treated for at least 6 months, 78 patients for at least 12 months, and 29 patients for at least 24 months. In the randomized, placebo-controlled, double-blind study ILLUMINATE-A in pediatric and adult patients with PH1 aged 6 to 61 years, 26 patients received OXLUMO, and 13 patients received placebo. Of these, 25 patients received ≥5 months of treatment.

Source: FDA drug label, Alnylam Pharmaceuticals, Inc., effective December 1, 2025 (SPL set 16985a31-f5e4-4557-9266-fc78d4bc5055), via openFDA; the full label on DailyMed

What do FAERS reports show?

364 reports list lumasiran among the medicines taken, each a report of something that happened, not proof the medicine caused it; 26 are coded as a death and 126 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Renal Transplant49
  • Nephrolithiasis37
  • Hospitalisation (an outcome recorded in the report)21
  • Laboratory Test Abnormal17
  • Drug Ineffective (a use or a product term, not a reaction)16
  • Urine Oxalate Increased16
  • Acute Kidney Injury13
  • Intentional Dose Omission (a use or a product term, not a reaction)13
  • Death (an outcome recorded in the report)12
  • Liver Transplant12
  • Renal And Liver Transplant12
  • Oxalosis11
  • Product Dose Omission Issue (a use or a product term, not a reaction)11
  • Dialysis10
  • Nephrocalcinosis10
  • Hyperoxalaemia9
  • End Stage Renal Disease8
  • Off Label Use (a use or a product term, not a reaction)8
  • Therapy Interrupted (a use or a product term, not a reaction)8
  • Urinary Tract Infection8
  • Diarrhoea7
  • Fatigue7
  • Injection Site Pain7
  • Infection6
  • Nephrectomy6

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Lumasiran: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions