FDA — authorised 1 May 2012
- Application: BLA022458
- Marketing authorisation holder: PFIZER
- Local brand name: ELELYSO
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Elelyso in United States
FDA authorised Elelyso on 1 May 2012 · 362 US adverse-event reports
Marketing authorisation
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 362
Most-reported reactions
- Fatigue — 58 reports (16.02%)
- Malaise — 39 reports (10.77%)
- Off Label Use — 39 reports (10.77%)
- Inappropriate Schedule Of Product Administration — 38 reports (10.5%)
- Arthralgia — 35 reports (9.67%)
- Pyrexia — 33 reports (9.12%)
- Pain In Extremity — 32 reports (8.84%)
- Pain — 31 reports (8.56%)
- Headache — 29 reports (8.01%)
- Covid-19 — 28 reports (7.73%)
Pricing & reimbursement
- annual_list: USD 200000.00 per year
Elelyso in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Elelyso approved in United States?
Yes. FDA authorised it on 1 May 2012.
Who is the marketing authorisation holder for Elelyso in United States?
PFIZER holds the US marketing authorisation.
What does Elelyso cost in United States?
annual_list: USD 200000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.