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Synagis Adverse Events Reported to the FDA Over Time

How are Synagis adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Synagis, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Synagis is flagged as the suspect drug causing the adverse event.

Most Common Synagis Adverse Events Reported to the FDA

What are the most common Synagis adverse events reported to the FDA?

Pyrexia
871 (4.34%)
Bronchiolitis
863 (4.3%)
Cough
775 (3.86%)
Dyspnoea
684 (3.4%)
Respiratory Syncytial Virus Infecti...
578 (2.88%)
Pneumonia
542 (2.7%)
Nasopharyngitis
463 (2.3%)
Vomiting
402 (2%)
Wheezing
305 (1.52%)
Respiratory Tract Infection
290 (1.44%)
Oxygen Saturation Decreased
277 (1.38%)
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Diarrhoea
261 (1.3%)
Cyanosis
254 (1.26%)
Death
250 (1.24%)
Viral Infection
240 (1.19%)
Rhinorrhoea
229 (1.14%)
Apnoea
228 (1.13%)
Bronchitis
215 (1.07%)
Hypophagia
199 (.99%)
Malaise
189 (.94%)
Respiratory Disorder
176 (.88%)
Fatigue
174 (.87%)
Convulsion
173 (.86%)
Influenza
170 (.85%)
Respiratory Syncytial Virus Test Po...
162 (.81%)
Respiratory Failure
158 (.79%)
Crying
154 (.77%)
Infantile Spitting Up
153 (.76%)
Pallor
144 (.72%)
Dehydration
142 (.71%)
Respiratory Arrest
136 (.68%)
Asthma
133 (.66%)
Weight Decreased
129 (.64%)
Fluid Intake Reduced
126 (.63%)
Gastrooesophageal Reflux Disease
125 (.62%)
Respiratory Distress
125 (.62%)
Respiratory Syncytial Virus Bronchi...
124 (.62%)
Increased Bronchial Secretion
123 (.61%)
Lower Respiratory Tract Infection
110 (.55%)
Cardiac Arrest
101 (.5%)
Sense Of Oppression
97 (.48%)
Decreased Appetite
95 (.47%)
Gastroenteritis
94 (.47%)
Infection
93 (.46%)
Nasal Congestion
88 (.44%)
Upper Respiratory Tract Infection
86 (.43%)
Drug Ineffective
85 (.42%)
Urinary Tract Infection
84 (.42%)
General Physical Health Deteriorati...
83 (.41%)
Anaemia
79 (.39%)
Lung Disorder
79 (.39%)
Hypoventilation
78 (.39%)
Rhinovirus Infection
76 (.38%)
Sepsis
76 (.38%)
Bronchopneumonia
72 (.36%)
Irritability
68 (.34%)
Feeding Disorder
67 (.33%)
Bradycardia
65 (.32%)
Asthenia
64 (.32%)
Cardiac Failure
64 (.32%)
Cardio-respiratory Arrest
63 (.31%)
Tachypnoea
63 (.31%)
Rhinitis
58 (.29%)
Bronchospasm
57 (.28%)
Ear Infection
57 (.28%)
Aspiration
56 (.28%)
Epilepsy
56 (.28%)
Ill-defined Disorder
56 (.28%)
Respiratory Tract Infection Viral
56 (.28%)
Oligodipsia
55 (.27%)
Rash
55 (.27%)
Increased Upper Airway Secretion
54 (.27%)
Inguinal Hernia
54 (.27%)
Pulmonary Hypertension
54 (.27%)
Bronchopulmonary Dysplasia
53 (.26%)
Adverse Event
51 (.25%)
Respiratory Rate Increased
51 (.25%)
Hypotonia
50 (.25%)
Rotavirus Infection
50 (.25%)
Skin Discolouration
47 (.23%)
Sudden Infant Death Syndrome
47 (.23%)
Productive Cough
46 (.23%)
Cardiac Disorder
45 (.22%)
Laryngitis
45 (.22%)
Obstructive Airways Disorder
45 (.22%)
Constipation
44 (.22%)
Restlessness
43 (.21%)
Somnolence
43 (.21%)
Cardiac Operation
41 (.2%)
Condition Aggravated
40 (.2%)
Abdominal Distension
39 (.19%)
Hospitalisation
39 (.19%)
Body Temperature Increased
38 (.19%)
Pain
38 (.19%)
Pneumonia Respiratory Syncytial Vir...
38 (.19%)
Growth Retardation
36 (.18%)
Haemoglobin Decreased
36 (.18%)
Respiration Abnormal
36 (.18%)
Shock
36 (.18%)
Stridor
36 (.18%)
Lethargy
35 (.17%)

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This graph shows the top adverse events submitted to the FDA for Synagis, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Synagis is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Synagis

What are the most common Synagis adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Synagis, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Synagis is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Synagis According to Those Reporting Adverse Events

Why are people taking Synagis, according to those reporting adverse events to the FDA?

Antiviral Prophylaxis
1505
Premature Baby
347
Bronchopulmonary Dysplasia
259
Heart Disease Congenital
145
Respiratory Syncytial Virus Infecti...
119
Cardiac Disorder
91
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Prophylaxis
68
Immunisation
38
Drug Use For Unknown Indication
32
Respiratory Disorder
25
Cardiomyopathy
21
Product Used For Unknown Indication
11
Spinal Muscular Atrophy
9
Infection Prophylaxis
8
Ventricular Septal Defect
8
Bronchiolitis
7
Tracheostomy
7
Lung Disorder
7
Pulmonary Hypertension
7
Pneumonia
6
Neonatal Respiratory Distress Syndr...
6
Canavan Disease
5
Lower Respiratory Tract Infection
5
Tracheomalacia
5
Atrial Septal Defect
5
Cleft Lip And Palate
4
Osteogenesis Imperfecta
4
Bronchomalacia
4
Hydrocephalus
4
Tracheo-oesophageal Fistula
3
Respiratory Distress
3
Charge Syndrome
3
Pulmonary Artery Atresia
3
Tracheal Stenosis
3
Fundoscopy
3
Oxygen Supplementation
2
Overcrowded Housing
2
Congenital Cardiovascular Anomaly
2
Chronic Obstructive Pulmonary Disea...
2
Refsums Disease
2
Metabolic Disorder
2
Trisomy 21
2
Multiple Pregnancy
2
Myopathy
2
Chronic Respiratory Disease
2
Atrioventricular Septal Defect
2
Exomphalos
1
Twin Pregnancy
1
Hypoplastic Left Heart Syndrome
1
Beckwith-wiedemann Syndrome
1
Infection
1

Drug Labels

LabelLabelerEffective
SynagisMedImmune, LLC15-APR-13

Synagis Case Reports

What Synagis safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Synagis. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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