Prescription medicine
Burosumab Brand names: Crysvita
Burosumab (Crysvita) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the burosumab FDA label on DailyMed (effective April 22, 2026); every burosumab label on DailyMed.
Highlights of the record
FDA label of April 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
Forms and strengths
- 10 mg/ml
- 20 mg/ml
- 30 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,315 through July 30, 2026
What is burosumab used for?
From the label: indications and usageCRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. ( 1.1 ) The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. […]
Source: FDA drug label (CRYSVITA), Kyowa Kirin, Inc., effective April 22, 2026 (SPL set 102f96a0-6e3a-4fc1-b204-34d604683af6), via openFDA; the full label on DailyMed
Is there a generic for burosumab (Crysvita)?
No generic burosumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the burosumab label say about other medicines?
The burosumab label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Calcifediol | contraindications | CONTRAINDICATIONS CRYSVITA is contraindicated: In concomitant use with oral phosphate and/or active vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia [see Warnings and Precautions (5.2) and Drug Interactions (7.1) ]. |
| Calcitriol | contraindications | CONTRAINDICATIONS CRYSVITA is contraindicated: In concomitant use with oral phosphate and/or active vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia [see Warnings and Precautions (5.2) and Drug Interactions (7.1) ]. |
| Doxercalciferol | contraindications | CONTRAINDICATIONS CRYSVITA is contraindicated: In concomitant use with oral phosphate and/or active vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia [see Warnings and Precautions (5.2) and Drug Interactions (7.1) ]. |
| Paricalcitol | contraindications | CONTRAINDICATIONS CRYSVITA is contraindicated: In concomitant use with oral phosphate and/or active vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia [see Warnings and Precautions (5.2) and Drug Interactions (7.1) ]. |
Source: FDA drug label (CRYSVITA), Kyowa Kirin, Inc., effective April 22, 2026 (SPL set 102f96a0-6e3a-4fc1-b204-34d604683af6), via openFDA; the full label on DailyMed
What do FAERS reports show for burosumab?
The FDA Adverse Event Reporting System holds 6,315 reports that list burosumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 42 are coded as a death and 463 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Burosumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other