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Synagis (Palivizumab) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Synagis (Palivizumab) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (1079)
Death (146)
Life Threatening Events (54)
Disability (1)

Reports by Reaction Type

Pyrexia (206)Dyspnoea (173)Cough (162)Bronchiolitis (112)Nasopharyngitis (109)Pneumonia (91)Vomiting (81)Death (78)Viral Infection (65)Hypophagia (62)Respiratory Tract Infection (60)Crying (59)

Below are a few examples of reports where side effects / adverse reactions may be related to Synagis (Palivizumab). For a complete list or a specific selection of reports, please use the links above.

Possible Synagis side effects in 7 month old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 7 month old female, weighing 4.8 kg (10.6 pounds)

Reactions: Productive Cough, Dyspnoea, Stridor, General Physical Health Deterioration, Bronchial Obstruction, Respiratory Failure, Cyanosis, Mechanical Ventilation Complication, Oedema, Hypoalbuminaemia, Use of Accessory Respiratory Muscles, Withdrawal Syndrome, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis
    Start date: 2012-06-18
    End date: 2012-06-18

Synagis
    Indication: Antiviral Prophylaxis
    Start date: 2012-05-17
    End date: 2012-05-17



Possible Synagis side effects in 12 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 12 month old male, weighing 7.3 kg (16.1 pounds)

Reactions: Viral Infection, Gastroenteritis Rotavirus, Conjunctivitis, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Ampicillin and Sulbactam; Ipratropium Bromide; Albuterol Sulate; Sodium Chloride



Possible Synagis side effects in 12 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 12 month old male, weighing 7.3 kg (16.1 pounds)

Reactions: Viral Infection, Gastroenteritis Rotavirus, Conjunctivitis, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Ampicillin and Sulbactam; Ipratropium Bromide; Albuterol Sulate; Sodium Chloride



Possible Synagis side effects in male

Reported by a physician from Ireland on 2012-08-14

Patient: male, weighing 9.0 kg (19.8 pounds)

Reactions: Nasopharyngitis, Respiratory Tract Infection, Cough

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Ferrous Sulfate TAB; Kapsovit



Possible Synagis side effects in male

Reported by a physician from Ireland on 2012-08-13

Patient: male, weighing 9.0 kg (19.8 pounds)

Reactions: Nasopharyngitis, Respiratory Tract Infection, Cough

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Ferrous Sulfate TAB; Kapsovit



Possible Synagis side effects in 1 month old female

Reported by a physician from Australia on 2012-08-09

Patient: 1 month old female

Reactions: Nasopharyngitis, Restlessness, Nasal Congestion, Pyrexia, Respiratory Distress

Drug(s) suspected as cause:
Prevenar 13
    Dosage: one dose unpecified one time
    Administration route: Oral
    Indication: Immunisation
    Start date: 2011-08-29
    End date: 2011-08-29

Rotateq
    Dosage: one dose unspecified one time
    Indication: Immunisation
    Start date: 2011-08-29
    End date: 2011-08-29

Synagis
    Dosage: one dose unpecified one time
    Indication: Immunisation
    Start date: 2011-08-29
    End date: 2011-08-29

Other drugs received by patient: Infantrix Hexa



Possible Synagis side effects in male

Reported by a physician from Ireland on 2012-08-08

Patient: male, weighing 9.0 kg (19.8 pounds)

Reactions: Nasopharyngitis, Lobar Pneumonia, Respiratory Tract Infection, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Ferrous Sulfate TAB; Kapsovit



Possible Synagis side effects in 11 month old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 11 month old female, weighing 6.0 kg (13.2 pounds)

Reactions: Viral Infection, Vomiting, Nasopharyngitis, Pyrexia, Diarrhoea, Dehydration, Gastroenteritis, Fluid Intake Reduced

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis
    Indication: Premature Baby
    Start date: 2011-09-26
    End date: 2011-09-26

Synagis
    Start date: 2012-03-13
    End date: 2012-03-13

Synagis
    Start date: 2012-02-16
    End date: 2012-02-16

Other drugs received by patient: Vaccination



Possible Synagis side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male, weighing 9.2 kg (20.2 pounds)

Reactions: Cerebral Disorder, Nasopharyngitis, Urinary Tract Infection, Cough, Infantile Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Kapsovit; Ferrous Sulfate TAB; Vigabatrin; Baclofen; Lactulose; Lansoprazole



Possible Synagis side effects in male

Reported by a physician from Ireland on 2012-08-06

Patient: male, weighing 9.0 kg (19.8 pounds)

Reactions: Nasopharyngitis, Respiratory Tract Infection, Lobar Pneumonia, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Kapsovit; Ferrous Sulfate TAB



Possible Synagis side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-06

Patient: female

Reactions: Mechanical Ventilation, Respiratory Syncytial Virus Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: male, weighing 10.4 kg (22.9 pounds)

Reactions: Pneumonia, Organ Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Albuterol; Saline; Singulair; Symbicort; Nystatin; Atrovent; Zyrtec; Albuterol; Antibiotics; Calcium Carbonate; Pulmicort; Xylitol



Possible Synagis side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-06

Patient: male

Reactions: Mechanical Ventilation, Respiratory Syncytial Virus Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: male, weighing 10.4 kg (22.9 pounds)

Reactions: Pneumonia, Organ Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Albuterol; Singulair; Symbicort; Xylitol; Atrovent; Antibiotics; Albuterol; Calcium Carbonate; Saline; Pulmicort; Zyrtec; Nystatin



Possible Synagis side effects in 8 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: 8 month old male, weighing 7.8 kg (17.2 pounds)

Reactions: Abdominal Pain, Urinary Tract Infection, Feeling Abnormal, Kidney Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis
    Start date: 2012-04-17
    End date: 2012-04-17

Synagis
    Start date: 2012-03-26
    End date: 2012-03-26

Synagis
    Indication: Heart Disease Congenital
    Start date: 2011-11-25
    End date: 2011-11-25

Other drugs received by patient: Nitrazepam; Ranitidine Hydrochloride; Domperidone; Vigabatrin; Polyethylene Glycol



Possible Synagis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in 8 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: 8 month old male, weighing 7.4 kg (16.3 pounds)

Reactions: Productive Cough, Nasopharyngitis, Upper Respiratory Tract Infection, Insomnia, Hypophagia, Pyrexia, Cough

Drug(s) suspected as cause:
Synagis
    Start date: 2012-01-19
    End date: 2012-01-19

Synagis
    End date: 2012-04-23

Synagis
    Indication: Premature Baby
    Start date: 2011-10-27
    End date: 2011-10-27

Synagis
    Start date: 2012-02-16
    End date: 2012-02-16

Other drugs received by patient: Albuterol Sulate



Possible Synagis side effects in 2 month old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: 2 month old female, weighing 4.4 kg (9.7 pounds)

Reactions: Respiratory Arrest, Pyrexia, Apnoea

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Synagis
    Start date: 2012-01-31
    End date: 2012-01-31

Synagis
    Indication: Premature Baby
    Start date: 2012-01-04
    End date: 2012-01-04

Other drugs received by patient: Theofyliline; Lactulose; Tetanus Vaccination; Diphtheria Vaccination; Ferrofumarate; Poliomyelitis Vaccination; Whooping Cough Vaccination



Possible Synagis side effects in

Reported by a physician from United States on 2012-08-02

Patient:

Reactions: Cyanosis, Hypotonia, Immediate Post-Injection Reaction, Pallor, Cardiovascular Disorder

Drug(s) suspected as cause:
Synagis

Other drugs received by patient: Lasix; Keflex



Possible Synagis side effects in

Reported by a physician from United States on 2012-07-31

Patient:

Reactions: Aspiration

Adverse event resulted in: death

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Pneumonia Bacterial

Adverse event resulted in: death

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient:

Reactions: Convulsion

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in 7 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: 7 month old male

Reactions: Respiratory Rate Increased, Dyspnoea, Enteral Nutrition, Wheezing, Respiratory Tract Infection Viral, Rhinorrhoea, Bronchiolitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis
    Start date: 2012-03-12
    End date: 2012-03-12

Synagis
    Start date: 2012-04-10
    End date: 2012-04-10

Synagis
    Start date: 2011-11-04
    End date: 2011-11-04

Synagis
    Start date: 2011-10-06
    End date: 2011-10-06

Synagis
    Indication: Premature Baby
    Start date: 2011-09-08
    End date: 2011-09-08



Possible Synagis side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: female, weighing 6.8 kg (15.0 pounds)

Reactions: Teething, Upper Respiratory Tract Infection, Sneezing, Rhinorrhoea, Respiratory Syncytial Virus Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis
    Start date: 2012-03-19

Synagis
    Start date: 2012-02-20
    End date: 2012-02-20

Synagis
    Start date: 2011-11-21
    End date: 2012-01-16

Other drugs received by patient: Prilosec Suspension



Possible Synagis side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-18

Patient: male, weighing 5.9 kg (13.0 pounds)

Reactions: Pyrexia, Respiratory Distress, Cough, Respiratory Syncytial Virus Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Synagis
    Indication: Antiviral Prophylaxis
    Start date: 2012-05-15
    End date: 2012-05-15

Synagis
    Start date: 2012-06-15
    End date: 2012-06-15

Other drugs received by patient: Viternum Vitamin; Vitamin A C D; Ferrous Sulfate TAB; Losec Mups HP; Albuterol Sulfate Autohaler; Fluticasone Propionate



Possible Synagis side effects in female

Reported by a health professional (non-physician/pharmacist) from South Africa on 2012-07-16

Patient: female, weighing 2.2 kg (4.8 pounds)

Reactions: Respiratory Syncytial Virus Infection, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Synagis
    Indication: Antiviral Prophylaxis
    Start date: 2012-05-04
    End date: 2012-05-04

Synagis
    Start date: 2012-06-04
    End date: 2012-06-04

Synagis
    Start date: 2012-06-04
    End date: 2012-06-04

Synagis
    Indication: Premature Baby
    Start date: 2012-05-04
    End date: 2012-05-04



Possible Synagis side effects in male

Reported by a physician from United States on 2012-07-16

Patient: male, weighing 4.5 kg (9.9 pounds)

Reactions: Respiratory Failure, Septic Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Synagis



Possible Synagis side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient: male, weighing 5.9 kg (13.0 pounds)

Reactions: Pyrexia, Respiratory Distress, Cough, Respiratory Syncytial Virus Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Synagis

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