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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.

NIRSEVIMAB-ALIP: 783 Adverse Event Reports & Safety Profile

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783
Total FAERS Reports
32 (4.1%)
Deaths Reported
281
Hospitalizations
783
As Primary/Secondary Suspect
34
Life-Threatening
5
Disabilities
Prescription
Status

FDA Application: 761328 ·

First Report: 20230101 · Latest Report: 20250923

What Are the Most Common NIRSEVIMAB-ALIP Side Effects?

#1 Most Reported
Drug ineffective
173 reports (22.1%)
#2 Most Reported
Respiratory syncytial virus bronchiolitis
135 reports (17.2%)
#3 Most Reported
Bronchiolitis
83 reports (10.6%)

All NIRSEVIMAB-ALIP Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 173 22.1% 1 127
Respiratory syncytial virus bronchiolitis 135 17.2% 1 72
Bronchiolitis 83 10.6% 0 65
Incorrect dose administered 80 10.2% 0 2
Respiratory syncytial virus infection 76 9.7% 2 54
Pyrexia 54 6.9% 0 29
Cough 45 5.8% 0 25
Respiratory syncytial virus test positive 36 4.6% 1 30
Extra dose administered 30 3.8% 0 0
Product storage error 30 3.8% 0 0
Rash 25 3.2% 0 6
Oxygen therapy 22 2.8% 0 22
Product administered to patient of inappropriate age 20 2.6% 0 0
Respiratory distress 17 2.2% 0 14
Urticaria 17 2.2% 0 4
Wrong product administered 16 2.0% 0 0
Dyspnoea 13 1.7% 0 9
Product dispensing error 12 1.5% 0 0
Vomiting 12 1.5% 1 5
Wheezing 12 1.5% 0 5

Who Reports NIRSEVIMAB-ALIP Side Effects? Age & Gender Data

Gender: 46.3% female, 53.7% male. Average age: 3.3 years. Most reports from: US. View detailed demographics →

Is NIRSEVIMAB-ALIP Getting Safer? Reports by Year

YearReportsDeathsHosp.
2023 242 8 129
2024 257 11 62
2025 109 3 41

View full timeline →

What Is NIRSEVIMAB-ALIP Used For?

IndicationReports
Respiratory syncytial virus immunisation 170
Antiviral prophylaxis 137
Immunisation 107
Prophylaxis 26
Respiratory syncytial virus infection 22
Product used for unknown indication 16

NIRSEVIMAB-ALIP vs Alternatives: Which Is Safer?

NIRSEVIMAB-ALIP vs NITAZOXANIDE NIRSEVIMAB-ALIP vs NITISINONE NIRSEVIMAB-ALIP vs NITRAZEPAM NIRSEVIMAB-ALIP vs NITRENDIPINE NIRSEVIMAB-ALIP vs NITRIC NIRSEVIMAB-ALIP vs NITROFURANTOIN NIRSEVIMAB-ALIP vs NITROFURANTOIN\NITROFURANTOIN NIRSEVIMAB-ALIP vs NITROFURAZONE NIRSEVIMAB-ALIP vs NITROGLYCERIN NIRSEVIMAB-ALIP vs NITROUS

Official FDA Label for NIRSEVIMAB-ALIP

Official prescribing information from the FDA-approved drug label.