AGALSIDASE BETA

N/A

Manufactured by Genzyme Corporation

15,654 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AGALSIDASE BETA

AGALSIDASE BETA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genzyme Corporation. The most commonly reported adverse reactions for AGALSIDASE BETA include PYREXIA, PAIN, MALAISE, CHILLS, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AGALSIDASE BETA.

Top Adverse Reactions

PYREXIA507 reports
PAIN491 reports
MALAISE473 reports
CHILLS471 reports
NAUSEA451 reports
FATIGUE407 reports
DYSPNOEA403 reports
VOMITING359 reports
HEADACHE358 reports
WEIGHT DECREASED321 reports
PAIN IN EXTREMITY302 reports
INFUSION RELATED REACTION297 reports
DIZZINESS264 reports
WEIGHT INCREASED250 reports
COUGH248 reports
CONDITION AGGRAVATED246 reports
CEREBROVASCULAR ACCIDENT242 reports
CHEST PAIN240 reports
DIARRHOEA219 reports
ATRIAL FIBRILLATION203 reports
ILLNESS201 reports
PRURITUS198 reports
FALL188 reports
DRUG SPECIFIC ANTIBODY PRESENT186 reports
PARAESTHESIA176 reports
CARDIAC DISORDER171 reports
COVID 19171 reports
PRODUCT DOSE OMISSION ISSUE167 reports
URTICARIA167 reports
DEATH165 reports
TREMOR163 reports
NASOPHARYNGITIS158 reports
CHEST DISCOMFORT156 reports
ABDOMINAL PAIN145 reports
ASTHENIA144 reports
BLOOD PRESSURE INCREASED144 reports
BURNING SENSATION143 reports
GLOBOTRIAOSYLSPHINGOSINE INCREASED142 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION142 reports
TRANSIENT ISCHAEMIC ATTACK140 reports
HYPOTENSION137 reports
PNEUMONIA136 reports
RENAL FAILURE136 reports
HYPERTENSION132 reports
RASH130 reports
ARTHRALGIA128 reports
HOSPITALISATION125 reports
FEELING ABNORMAL123 reports
END STAGE RENAL DISEASE120 reports
FLUSHING119 reports
RENAL IMPAIRMENT118 reports
INFLUENZA117 reports
MYOCARDIAL INFARCTION116 reports
URINARY TRACT INFECTION113 reports
ERYTHEMA110 reports
BACK PAIN109 reports
ANXIETY108 reports
CARDIAC FAILURE107 reports
ABDOMINAL PAIN UPPER106 reports
HEART RATE INCREASED106 reports
BLOOD PRESSURE DECREASED100 reports
DISEASE PROGRESSION100 reports
HYPOAESTHESIA100 reports
LOSS OF CONSCIOUSNESS100 reports
OEDEMA PERIPHERAL100 reports
GASTROINTESTINAL DISORDER97 reports
OFF LABEL USE96 reports
SINUSITIS95 reports
PALPITATIONS94 reports
WHEEZING94 reports
EXPOSURE DURING PREGNANCY91 reports
SYNCOPE90 reports
TACHYCARDIA87 reports
DEPRESSION86 reports
RENAL FAILURE CHRONIC85 reports
RENAL TRANSPLANT85 reports
LOWER RESPIRATORY TRACT INFECTION84 reports
ARRHYTHMIA83 reports
GLOBOTRIAOSYLCERAMIDE INCREASED83 reports
HYPERSENSITIVITY83 reports
INCORRECT DOSE ADMINISTERED81 reports
POOR VENOUS ACCESS81 reports
ABDOMINAL DISCOMFORT79 reports
CARDIAC ARREST76 reports
FEELING HOT73 reports
PERIPHERAL SWELLING73 reports
BRADYCARDIA72 reports
FEELING COLD72 reports
HYPERHIDROSIS72 reports
PRODUCT USE IN UNAPPROVED INDICATION71 reports
CARDIAC FAILURE CONGESTIVE69 reports
SEPSIS69 reports
CELLULITIS67 reports
HEART RATE DECREASED67 reports
BODY TEMPERATURE INCREASED66 reports
GENERAL PHYSICAL HEALTH DETERIORATION66 reports
PROTEINURIA64 reports
RENAL DISORDER64 reports
INFUSION SITE EXTRAVASATION62 reports
SOMNOLENCE62 reports

Report Outcomes

Out of 8,831 classified reports for AGALSIDASE BETA:

Serious 52.4%Non-Serious 47.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male4,925 (60.4%)
Female3,218 (39.5%)
Unknown13 (0.2%)

Reports by Age

Age 50171 reports
Age 45169 reports
Age 53163 reports
Age 54160 reports
Age 46155 reports
Age 48154 reports
Age 51148 reports
Age 49145 reports
Age 47142 reports
Age 35137 reports
Age 41134 reports
Age 52134 reports
Age 43132 reports
Age 44132 reports
Age 40128 reports
Age 55126 reports
Age 38124 reports
Age 57122 reports
Age 56121 reports
Age 62116 reports

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 AGALSIDASE BETA?

This profile reflects 15,654 FDA FAERS reports that mention AGALSIDASE BETA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AGALSIDASE BETA?

Frequently reported terms in FAERS include PYREXIA, PAIN, MALAISE, CHILLS, NAUSEA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures AGALSIDASE BETA?

Labeling and FAERS entries often list Genzyme Corporation in connection with AGALSIDASE BETA. 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.