SYNAGIS: 265 Adverse Event Reports & Safety Profile
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265
Total FAERS Reports
45 (17.0%)
Deaths Reported
212
Hospitalizations
265
As Primary/Secondary Suspect
14
Life-Threatening
3
Disabilities
First Report: 20100112 · Latest Report: 20140604
What Are the Most Common SYNAGIS Side Effects?
#1 Most Reported
Cough
43 reports (16.2%)
#2 Most Reported
Dyspnoea
33 reports (12.5%)
#3 Most Reported
Bronchiolitis
32 reports (12.1%)
All SYNAGIS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Cough | 43 | 16.2% | 1 | 38 |
| Dyspnoea | 33 | 12.5% | 2 | 31 |
| Bronchiolitis | 32 | 12.1% | 0 | 31 |
| Pyrexia | 29 | 10.9% | 0 | 25 |
| Respiratory syncytial virus infection | 23 | 8.7% | 4 | 21 |
| Vomiting | 23 | 8.7% | 0 | 22 |
| Death | 21 | 7.9% | 21 | 5 |
| Pneumonia | 20 | 7.6% | 1 | 19 |
| Diarrhoea | 17 | 6.4% | 0 | 17 |
| Respiratory syncytial virus bronchiolitis | 14 | 5.3% | 2 | 13 |
| Respiratory syncytial virus test positive | 14 | 5.3% | 1 | 14 |
| Wheezing | 14 | 5.3% | 0 | 13 |
| Nasopharyngitis | 11 | 4.2% | 1 | 11 |
| Oxygen saturation decreased | 11 | 4.2% | 2 | 10 |
| Rhinorrhoea | 11 | 4.2% | 1 | 9 |
| Cyanosis | 9 | 3.4% | 3 | 8 |
| Respiratory tract congestion | 9 | 3.4% | 0 | 9 |
| Viral infection | 9 | 3.4% | 0 | 9 |
| Malaise | 8 | 3.0% | 0 | 8 |
| Bronchitis | 7 | 2.6% | 0 | 7 |
Who Reports SYNAGIS Side Effects? Age & Gender Data
Average age: 1.0 years. Most reports from: IE. View detailed demographics →
Is SYNAGIS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 1 | 1 |
| 2012 | 1 | 0 | 1 |
| 2013 | 71 | 5 | 60 |
| 2014 | 137 | 23 | 114 |
What Is SYNAGIS Used For?
| Indication | Reports |
|---|---|
| Antiviral prophylaxis | 88 |
| Premature baby | 51 |
| Product used for unknown indication | 34 |
| Heart disease congenital | 28 |
| Lung disorder | 11 |
| Bronchopulmonary dysplasia | 8 |
| Trisomy 21 | 5 |
SYNAGIS vs Alternatives: Which Is Safer?
SYNAGIS vs SYNTHROID
SYNAGIS vs TACROLIMUS
SYNAGIS vs TACROLIMUS\TACROLIMUS ANHYDROUS
SYNAGIS vs TADALAFIL
SYNAGIS vs TAFAMIDIS
SYNAGIS vs TAFAMIDIS MEGLUMINE
SYNAGIS vs TAFASITAMAB
SYNAGIS vs TAFASITAMAB-CXIX
SYNAGIS vs TAFINLAR
SYNAGIS vs TAFLUPROST
Official FDA Label for SYNAGIS
Official prescribing information from the FDA-approved drug label.