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What the label lists and what reports show

Burosumab side effects

Burosumab's FDA label: “Most common adverse reactions (≥25% in the CRYSVITA group and > Active Control) in pediatric XLH patients are: pyrexia, injection site reaction, cough, vomiting, pain in extremity, headache, tooth abscess, dental caries.” FAERS holds 6,315 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 blood phosphorus decreased (584 reports).

  • No generic listed

Check it at the source: the burosumab FDA label on DailyMed (effective April 22, 2026); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥25% in the CRYSVITA group and > Active Control) in pediatric XLH patients are: pyrexia, injection site reaction, cough, vomiting, pain in extremity, headache, tooth abscess, dental caries.

Table 6: Adverse Reactions Reported in 10% or More of CRYSVITA-Treated Pediatric Patients and with Higher Frequency Than the Active Control Group in Study 1

Adverse ReactionCRYSVITA (N=29) n (%)Active Control (N=32) n (%)
Pyrexia16 (55)6 (19)
Injection site reaction Injection site reaction includes: injection site reaction,…15 (52)0 (0)
Cough Cough includes: cough and productive cough15 (52)6 (19)
Vomiting12 (41)8 (25)
Pain in extremity11 (38)10 (31)
Headache10 (34)6 (19)
Tooth abscess Tooth abscess includes: tooth abscess, tooth infection, toothache10 (34)4 (13)
Dental caries9 (31)2 (6)
Diarrhea7 (24)2 (6)
Vitamin D decreased Vitamin D decreased includes: vitamin D deficiency, blood…7 (24)1 (3)
Constipation5 (17)0 (0)
Rash Rash includes: rash, rash pruritic, rash maculopapular, rash erythematous, rash…4 (14)2 (6)
Nausea3 (10)1 (3)

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are described below and elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hyperphosphatemia and Risk of Nephrocalcinosis [see Warnings and Precautions (5.2) ] Hypercalcemia [see Warnings and Precautions (5.3) Injection Site Reactions [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥25% in the CRYSVITA group and > Active Control) in pediatric XLH patients are: pyrexia, injection site reaction, cough, vomiting, pain in extremity, headache, tooth abscess, dental caries. ( 6.1 ) Most common adverse reactions (>5% and in at least 2 patients more than placebo) in adult XLH patients are: back pain, headache, tooth infection, restless legs syndrome, vitamin D decreased, dizziness, constipation, muscle spasms, blood phosphorus increased. ( 6.1 ) Most common adverse reactions (>10%) in TIO patients are: tooth abscess, muscle spasms, dizziness, constipation, injection site reaction, rash, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, 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?

6,315 reports list burosumab among the medicines taken, 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. Of the 18 reactions below, 9 are 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.

Reports received each year

The 25 most reported reactions

  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)708
  • Product Dose Omission Issue (a use or a product term, not a reaction)645
  • Blood Phosphorus Decreased584
  • Pain391
  • Arthralgia376
  • Pain In Extremity (named in the label)353
  • Restless Legs Syndrome (named in the label)276
  • Headache (named in the label)273
  • Fatigue252
  • Incorrect Dose Administered (a use or a product term, not a reaction)252
  • Injection Site Pain (named in the label)243
  • Bone Pain209
  • Contraindicated Product Administered190
  • Back Pain (named in the label)189
  • Pyrexia (named in the label)182
  • Therapy Interrupted (a use or a product term, not a reaction)180
  • Covid-19179
  • Injection Site Pruritus (named in the label)157
  • Injection Site Erythema (named in the label)144
  • Product Dose Omission (a use or a product term, not a reaction)140
  • Off Label Use (a use or a product term, not a reaction)134
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)125
  • Weight Increased124
  • Illness123
  • Tooth Abscess (named in the label)121

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

What next?

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