BUROSUMAB

N/A

Manufactured by Kyowa Kirin, Inc.

10,519 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BUROSUMAB

BUROSUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kyowa Kirin, Inc.. The most commonly reported adverse reactions for BUROSUMAB include INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION, PRODUCT DOSE OMISSION ISSUE, BLOOD PHOSPHORUS DECREASED, PAIN, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BUROSUMAB.

Top Adverse Reactions

INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION692 reports
PRODUCT DOSE OMISSION ISSUE610 reports
BLOOD PHOSPHORUS DECREASED574 reports
PAIN367 reports
ARTHRALGIA358 reports
PAIN IN EXTREMITY334 reports
RESTLESS LEGS SYNDROME270 reports
HEADACHE262 reports
INCORRECT DOSE ADMINISTERED244 reports
INJECTION SITE PAIN233 reports
FATIGUE231 reports
BONE PAIN199 reports
CONTRAINDICATED PRODUCT ADMINISTERED191 reports
BACK PAIN185 reports
COVID 19178 reports
PYREXIA166 reports
THERAPY INTERRUPTED156 reports
INJECTION SITE PRURITUS153 reports
PRODUCT DOSE OMISSION140 reports
INJECTION SITE ERYTHEMA138 reports
PRODUCT USE IN UNAPPROVED INDICATION124 reports
OFF LABEL USE123 reports
TOOTH ABSCESS120 reports
WEIGHT INCREASED120 reports
ILLNESS117 reports
CONDITION AGGRAVATED107 reports
NAUSEA107 reports
MALAISE102 reports
VITAMIN D DECREASED98 reports
VOMITING98 reports
MUSCLE SPASMS95 reports
OVERDOSE94 reports
DIZZINESS86 reports
GAIT DISTURBANCE85 reports
INJECTION SITE SWELLING85 reports
MYALGIA85 reports
HOSPITALISATION83 reports
WEIGHT DECREASED83 reports
INJECTION SITE REACTION80 reports
RASH80 reports
DRUG INEFFECTIVE79 reports
FALL78 reports
KNEE DEFORMITY77 reports
INFLUENZA76 reports
CONSTIPATION75 reports
NASOPHARYNGITIS73 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS73 reports
INJECTION SITE BRUISING72 reports
BLOOD PHOSPHORUS INCREASED68 reports
COUGH68 reports
INSOMNIA68 reports
MUSCULOSKELETAL STIFFNESS67 reports
ASTHENIA65 reports
ANXIETY62 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION61 reports
DIARRHOEA59 reports
MIGRAINE59 reports
SURGERY59 reports
INJECTION SITE MASS58 reports
INJECTION SITE URTICARIA56 reports
URTICARIA56 reports
PRURITUS55 reports
EAR INFECTION53 reports
BLOOD PARATHYROID HORMONE INCREASED52 reports
PRODUCT USE ISSUE51 reports
TOOTHACHE51 reports
BLOOD ALKALINE PHOSPHATASE INCREASED49 reports
INJECTION SITE RASH47 reports
EXPOSURE DURING PREGNANCY44 reports
LABORATORY TEST ABNORMAL44 reports
ADVERSE EVENT43 reports
LIMB OPERATION40 reports
PARAESTHESIA40 reports
ABDOMINAL PAIN UPPER39 reports
URINARY TRACT INFECTION39 reports
HYPERTENSION38 reports
NEPHROCALCINOSIS38 reports
NEPHROLITHIASIS38 reports
JOINT STIFFNESS37 reports
PNEUMONIA37 reports
PRODUCT STORAGE ERROR37 reports
DEPRESSION36 reports
DENTAL CARIES35 reports
HYPERSENSITIVITY35 reports
MUSCULAR WEAKNESS34 reports
BLOOD PHOSPHORUS ABNORMAL32 reports
CONTUSION32 reports
ABDOMINAL PAIN31 reports
HYPOAESTHESIA31 reports
NECK PAIN31 reports
SLEEP DISORDER31 reports
FEELING ABNORMAL30 reports
TOOTH DISORDER30 reports
DYSPNOEA29 reports
ALOPECIA28 reports
BLOOD 25 HYDROXYCHOLECALCIFEROL DECREASED28 reports
INSURANCE ISSUE28 reports
MOBILITY DECREASED28 reports
PHARYNGITIS STREPTOCOCCAL28 reports
THERAPEUTIC RESPONSE SHORTENED28 reports

Demographics Breakdown

Reports by Sex

Female28 (54.9%)
Male23 (45.1%)

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BUROSUMAB?

This profile reflects 10,519 FDA FAERS reports that mention BUROSUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BUROSUMAB?

Frequently reported terms in FAERS include INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION, PRODUCT DOSE OMISSION ISSUE, BLOOD PHOSPHORUS DECREASED, PAIN, ARTHRALGIA, PAIN IN EXTREMITY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BUROSUMAB?

Labeling and FAERS entries often list Kyowa Kirin, Inc. in connection with BUROSUMAB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.