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Palivizumab Side Effects

The most commonly reported side effects of palivizumab include respiratory syncytial virus infection, pyrexia, and death, based on 15,177 FDA adverse event reports from 2004 to 2025.

Palivizumab side effects

Percentages show how often each reaction appears relative to total reports for palivizumab.

1
Respiratory Syncytial Virus Infection11.6%1,757
2
Pyrexia7.6%1,149
3
Death6.3%951
4
Bronchiolitis5.5%832
5
Cough5.0%761
6
Pneumonia4.7%719
7
Dyspnoea3.6%546
8
Vomiting3.3%507
9
Nasopharyngitis3.3%496
10
Bronchiolitis2.9%434
11
Influenza2.7%411
12
Off Label Use2.6%398
13
Product Dose Omission Issue2.6%388
14
Covid-192.4%364
15
Illness2.3%352

These are voluntary reports and do not establish that palivizumab caused these reactions.

Report severity

80.4%Serious12,200 reports
61.3%Hospitalizations9,300 reports
12.4%Fatal1,875 reports

Seriousness is determined by the reporter, not by OpenClaim.

Palivizumab drug interactions

Other drugs that appear in adverse event reports alongside palivizumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Budesonide0.6%90
2
Busulfan0.3%41
3
Omeprazole0.3%40
4
Fludarabine-phosphate0.2%35
5
Sildenafil-citrate0.2%25
6
Esomeprazole0.2%24
7
Vigabatrin0.1%21
8
Cyclophosphamide0.1%21
9
Bosentan0.1%17
10
Alemtuzumab0.1%17
11
Amoxicillin0.1%16
12
Trimethoprim0.1%16
13
Tobramycin<0.1%15
14
Spironolactone<0.1%15
15
Topiramate<0.1%14

Taken alongside

1
Furosemide4.8%736
2
Albuterol4.7%719
3
Ergocalciferol3.8%571
4
Spironolactone3.2%490
5
Omeprazole2.2%340
6
Famotidine2.1%315
7
Aspirin2.0%303
8
Ranitidine2.0%301
9
Acetaminophen2.0%296
10
Epinephrine1.9%285
11
Budesonide1.8%267
12
Fluticasone1.7%259
13
Sildenafil-citrate1.4%217
14
Ferrous-sulfate1.3%203
15
Amoxicillin1.3%200

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports palivizumab side effects

39.6% of palivizumab adverse event reports involve female patients and 51.9% involve male patients. The largest age group is infant at 83%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.6%
Male51.9%
Unknown8.4%

Age group

< 295.8%
2–113.7%
12–170.1%
18–640.3%
65+<0.1%

What is palivizumab used for

Conditions and purposes for which patients were taking palivizumab when the adverse event was reported.

Abortion SpontaneousAcquired Tracheo-oesophageal FistulaAcute EndocarditisAcute Lymphocytic LeukaemiaAcute Pulmonary OedemaAcute Respiratory Distress SyndromeAcute Respiratory FailureAdrenal InsufficiencyAdrenocortical Insufficiency NeonatalAdverse EventAnaemia NeonatalAnal AtresiaAngelman^s SyndromeAngiopathyAnkyloglossia Acquired

Showing 15 of 852 indications

Palivizumab brand names and reporting trend

Palivizumab is sold under the brand name Synagis.

Brand names

Synagis785

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking palivizumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.