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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BUROSUMAB-TWZA: 5,159 Adverse Event Reports & Safety Profile

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5,159
Total FAERS Reports
27 (0.5%)
Deaths Reported
311
Hospitalizations
5,159
As Primary/Secondary Suspect
8
Life-Threatening
16
Disabilities
Prescription
Status

FDA Application: 761068 ·

First Report: 20090101 · Latest Report: 20250914

What Are the Most Common BUROSUMAB-TWZA Side Effects?

#1 Most Reported
Inappropriate schedule of product administration
579 reports (11.2%)
#2 Most Reported
Blood phosphorus decreased
509 reports (9.9%)
#3 Most Reported
Product dose omission issue
475 reports (9.2%)

All BUROSUMAB-TWZA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Inappropriate schedule of product administration 579 11.2% 0 20
Blood phosphorus decreased 509 9.9% 0 26
Product dose omission issue 475 9.2% 1 24
Arthralgia 285 5.5% 1 16
Pain 279 5.4% 0 15
Pain in extremity 272 5.3% 0 8
Headache 226 4.4% 0 11
Restless legs syndrome 217 4.2% 1 4
Incorrect dose administered 215 4.2% 0 10
Injection site pain 205 4.0% 0 1
Fatigue 189 3.7% 0 10
Contraindicated product administered 175 3.4% 3 11
Bone pain 162 3.1% 0 2
Covid-19 148 2.9% 2 13
Back pain 146 2.8% 0 9
Pyrexia 140 2.7% 0 12
Product dose omission 137 2.7% 0 3
Injection site pruritus 132 2.6% 0 1
Injection site erythema 122 2.4% 0 1
Tooth abscess 104 2.0% 0 6

Who Reports BUROSUMAB-TWZA Side Effects? Age & Gender Data

Gender: 66.0% female, 34.0% male. Average age: 33.0 years. Most reports from: US. View detailed demographics →

Is BUROSUMAB-TWZA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 0
2010 1 0 0
2011 3 0 0
2013 2 0 0
2015 2 0 0
2016 8 0 0
2017 3 0 0
2018 200 2 9
2019 535 2 32
2020 698 3 45
2021 652 3 55
2022 475 5 38
2023 274 1 26
2024 287 2 14
2025 137 0 9

View full timeline →

What Is BUROSUMAB-TWZA Used For?

IndicationReports
Hereditary hypophosphataemic rickets 3,896
Product used for unknown indication 979
Hypophosphataemia 109
Hypophosphataemic osteomalacia 101
Phosphorus metabolism disorder 88
Osteomalacia 41
Rickets 18
Albright's disease 5
Hypopituitarism 5
Mineral metabolism disorder 5

BUROSUMAB-TWZA vs Alternatives: Which Is Safer?

BUROSUMAB-TWZA vs BUSPIRONE BUROSUMAB-TWZA vs BUSULFAN BUROSUMAB-TWZA vs BUSULFEX BUROSUMAB-TWZA vs BUTALBITAL BUROSUMAB-TWZA vs BUTENAFINE BUROSUMAB-TWZA vs BUTORPHANOL BUROSUMAB-TWZA vs BUTRANS BUROSUMAB-TWZA vs BUTYLSCOPOLAMINE BUROSUMAB-TWZA vs BYDUREON BUROSUMAB-TWZA vs BYETTA

Official FDA Label for BUROSUMAB-TWZA

Official prescribing information from the FDA-approved drug label.