PALIVIZUMAB

N/A

Manufactured by Swedish Orphan Biovitrum AB (publ)

24,586 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PALIVIZUMAB

PALIVIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Swedish Orphan Biovitrum AB (publ). The most commonly reported adverse reactions for PALIVIZUMAB include RESPIRATORY SYNCYTIAL VIRUS INFECTION, PYREXIA, BRONCHIOLITIS, DEATH, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PALIVIZUMAB.

Top Adverse Reactions

RESPIRATORY SYNCYTIAL VIRUS INFECTION2,083 reports
PYREXIA1,437 reports
BRONCHIOLITIS1,267 reports
DEATH1,063 reports
COUGH1,017 reports
PNEUMONIA939 reports
DYSPNOEA777 reports
VOMITING651 reports
NASOPHARYNGITIS635 reports
INFLUENZA493 reports
BRONCHITIS417 reports
OFF LABEL USE397 reports
DIARRHOEA396 reports
PRODUCT DOSE OMISSION ISSUE388 reports
COVID 19363 reports
NASAL CONGESTION361 reports
ILLNESS351 reports
MALAISE348 reports
RHINORRHOEA345 reports
OXYGEN SATURATION DECREASED341 reports
WEIGHT DECREASED341 reports
WHEEZING322 reports
VIRAL INFECTION310 reports
RESPIRATORY SYNCYTIAL VIRUS TEST POSITIVE308 reports
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS292 reports
RESPIRATORY DISTRESS282 reports
APNOEA281 reports
RASH276 reports
RESPIRATORY TRACT INFECTION259 reports
CYANOSIS258 reports
RHINOVIRUS INFECTION258 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION249 reports
RESPIRATORY FAILURE244 reports
RESPIRATORY DISORDER225 reports
CRYING216 reports
EAR INFECTION205 reports
SEIZURE200 reports
DRUG INEFFECTIVE197 reports
CARDIAC DISORDER184 reports
GASTROOESOPHAGEAL REFLUX DISEASE172 reports
HOSPITALISATION166 reports
IRRITABILITY163 reports
DEHYDRATION158 reports
INFECTION158 reports
LOWER RESPIRATORY TRACT INFECTION153 reports
PALLOR141 reports
UPPER RESPIRATORY TRACT INFECTION131 reports
FATIGUE129 reports
URINARY TRACT INFECTION128 reports
ASTHMA122 reports
ILL DEFINED DISORDER116 reports
PRODUCTIVE COUGH114 reports
CARDIAC ARREST113 reports
HYPOPHAGIA113 reports
LUNG DISORDER111 reports
CARDIAC OPERATION109 reports
URTICARIA109 reports
DECREASED APPETITE107 reports
RESPIRATORY ARREST105 reports
INGUINAL HERNIA100 reports
ANAEMIA97 reports
GASTROENTERITIS97 reports
BRADYCARDIA91 reports
CONVULSION89 reports
HYPOXIA89 reports
GENERAL PHYSICAL HEALTH DETERIORATION86 reports
CARDIO RESPIRATORY ARREST85 reports
ERYTHEMA83 reports
ASPIRATION82 reports
CARDIAC FAILURE81 reports
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL81 reports
BRONCHOPULMONARY DYSPLASIA78 reports
FLUID INTAKE REDUCED77 reports
HYPERSENSITIVITY77 reports
SECRETION DISCHARGE77 reports
FEEDING DISORDER76 reports
PAIN75 reports
PRODUCT DOSE OMISSION74 reports
SEPSIS74 reports
UNEVALUABLE EVENT74 reports
CONDITION AGGRAVATED73 reports
SARS COV 2 TEST POSITIVE73 reports
PULMONARY HYPERTENSION72 reports
RESPIRATORY TRACT CONGESTION70 reports
GASTROINTESTINAL DISORDER69 reports
RESTLESSNESS66 reports
CONSTIPATION65 reports
PRODUCT USE IN UNAPPROVED INDICATION64 reports
SOMNOLENCE63 reports
HAEMATOCHEZIA62 reports
POOR FEEDING INFANT61 reports
RHINITIS60 reports
RESPIRATORY RATE INCREASED59 reports
HYPOTONIA58 reports
TACHYPNOEA58 reports
RESPIRATORY TRACT INFECTION VIRAL57 reports
ATELECTASIS55 reports
INCREASED BRONCHIAL SECRETION55 reports
PRODUCT USE ISSUE55 reports
BODY TEMPERATURE INCREASED54 reports

Report Outcomes

Out of 15,163 classified reports for PALIVIZUMAB:

Serious 80.4%Non-Serious 19.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male7,877 (56.2%)
Female6,004 (42.8%)
Unknown143 (1.0%)

Reports by Age

Age 01,057 reports
Age 1924 reports
Age 3564 reports
Age 4491 reports
Age 2480 reports
Age 5426 reports
Age 6378 reports
Age 7363 reports
Age 9286 reports
Age 8276 reports
Age 10241 reports
Age 11188 reports
Age 12161 reports
Age 1393 reports
Age 1468 reports
Age 1568 reports
Age 1753 reports
Age 1644 reports
Age 1841 reports
Age 1936 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with PALIVIZUMAB?

This profile reflects 24,586 FDA FAERS reports that mention PALIVIZUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PALIVIZUMAB?

Frequently reported terms in FAERS include RESPIRATORY SYNCYTIAL VIRUS INFECTION, PYREXIA, BRONCHIOLITIS, DEATH, COUGH, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PALIVIZUMAB?

Labeling and FAERS entries often list Swedish Orphan Biovitrum AB (publ) in connection with PALIVIZUMAB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.