ASFOTASE ALFA

N/A

Manufactured by Alexion Pharmaceuticals, Inc.

17,151 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ASFOTASE ALFA

ASFOTASE ALFA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alexion Pharmaceuticals, Inc.. The most commonly reported adverse reactions for ASFOTASE ALFA include INJECTION SITE PAIN, INJECTION SITE ERYTHEMA, FATIGUE, PAIN, INJECTION SITE REACTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ASFOTASE ALFA.

Top Adverse Reactions

INJECTION SITE PAIN1,254 reports
INJECTION SITE ERYTHEMA833 reports
FATIGUE809 reports
PAIN705 reports
INJECTION SITE REACTION674 reports
ARTHRALGIA569 reports
PAIN IN EXTREMITY487 reports
INJECTION SITE BRUISING470 reports
INJECTION SITE SWELLING422 reports
HEADACHE344 reports
INJECTION SITE PRURITUS320 reports
BLOOD ALKALINE PHOSPHATASE INCREASED284 reports
INJECTION SITE MASS284 reports
NAUSEA275 reports
MALAISE274 reports
BONE PAIN255 reports
INJECTION SITE DISCOLOURATION248 reports
WEIGHT INCREASED239 reports
BACK PAIN237 reports
DRUG INEFFECTIVE235 reports
PYREXIA208 reports
FALL205 reports
WEIGHT DECREASED204 reports
DIZZINESS196 reports
ASTHENIA187 reports
MYALGIA176 reports
ANXIETY163 reports
FEELING ABNORMAL163 reports
INJECTION SITE WARMTH156 reports
GAIT DISTURBANCE152 reports
VOMITING151 reports
INJECTION SITE ATROPHY149 reports
DYSPNOEA148 reports
INJECTION SITE RASH145 reports
INCORRECT DOSE ADMINISTERED142 reports
INSOMNIA142 reports
INJECTION SITE URTICARIA138 reports
VITAMIN B6 DECREASED135 reports
NASOPHARYNGITIS126 reports
RASH117 reports
COUGH112 reports
CONTUSION111 reports
ILLNESS111 reports
INFLUENZA111 reports
MUSCLE SPASMS110 reports
MUSCULAR WEAKNESS110 reports
CONDITION AGGRAVATED108 reports
DEPRESSION107 reports
FOOT FRACTURE107 reports
OFF LABEL USE107 reports
MIGRAINE103 reports
HYPERSENSITIVITY101 reports
PERIPHERAL SWELLING101 reports
PNEUMONIA101 reports
INJECTION SITE HAEMORRHAGE100 reports
BLOOD ALKALINE PHOSPHATASE DECREASED98 reports
TOOTH LOSS94 reports
NEPHROLITHIASIS93 reports
SEIZURE92 reports
CHILLS89 reports
DIARRHOEA89 reports
ERYTHEMA85 reports
INJECTION SITE INDURATION85 reports
PARAESTHESIA84 reports
COVID 1983 reports
MUSCULOSKELETAL STIFFNESS82 reports
PRURITUS81 reports
URTICARIA78 reports
VITAMIN D DECREASED78 reports
INJECTION SITE DISCOMFORT77 reports
HYPOAESTHESIA76 reports
SOMNOLENCE76 reports
VITAMIN B6 INCREASED76 reports
TREMOR75 reports
PRODUCT DOSE OMISSION ISSUE73 reports
LIPODYSTROPHY ACQUIRED71 reports
ARTHRITIS70 reports
BLOOD PHOSPHORUS INCREASED68 reports
OSTEOPOROSIS68 reports
JOINT SWELLING67 reports
NECK PAIN65 reports
NEUROPATHY PERIPHERAL64 reports
CALCINOSIS63 reports
BRAIN FOG61 reports
ABDOMINAL PAIN UPPER59 reports
SINUSITIS59 reports
LABORATORY TEST ABNORMAL58 reports
INJECTION SITE IRRITATION57 reports
BONE DENSITY DECREASED56 reports
CONSTIPATION55 reports
SWELLING55 reports
ABDOMINAL PAIN53 reports
DECREASED APPETITE53 reports
EAR INFECTION53 reports
FRACTURE53 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION53 reports
TOOTH DISORDER52 reports
BRONCHITIS51 reports
CHEST PAIN51 reports
DRUG HYPERSENSITIVITY51 reports

Report Outcomes

Out of 9,084 classified reports for ASFOTASE ALFA:

Serious 26.5%Non-Serious 73.5%

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

Female5,697 (72.5%)
Male2,166 (27.5%)

Reports by Age

Age 1155 reports
Age 447 reports
Age 541 reports
Age 338 reports
Age 237 reports
Age 637 reports
Age 5137 reports
Age 4136 reports
Age 5036 reports
Age 6836 reports
Age 6936 reports
Age 834 reports
Age 1234 reports
Age 1434 reports
Age 5934 reports
Age 4333 reports
Age 4933 reports
Age 5433 reports
Age 132 reports
Age 932 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 ASFOTASE ALFA?

This profile reflects 17,151 FDA FAERS reports that mention ASFOTASE ALFA. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ASFOTASE ALFA?

Frequently reported terms in FAERS include INJECTION SITE PAIN, INJECTION SITE ERYTHEMA, FATIGUE, PAIN, INJECTION SITE REACTION, ARTHRALGIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ASFOTASE ALFA?

Labeling and FAERS entries often list Alexion Pharmaceuticals, Inc. in connection with ASFOTASE ALFA. 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.