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 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 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 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 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 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 2012-08-03
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 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 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
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
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 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 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 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 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
|
