Palivizumab: uses, dosing, side effects & brands
Palivizumab is a respiratory syncytial virus anti-f protein monoclonal antibody sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
- Available as
- Injectable
- Sold as
- Synagis
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How palivizumab is dosed
From the FDA label for Synagis (application BLA103770). Other palivizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
15 mg per kg of body weight, administered intramuscularly prior to commencement of the RSV season and remaining doses administered monthly throughout the RSV season. ( 2.1 ) Children undergoing cardio-pulmonary bypass should receive an additional dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly as scheduled. ( 2.1 , 12.3 ) 2.1 Dosing Information The recommended dose of Synagis is 15 mg per kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season. In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities. Synagis serum levels are decreased after cardio-pulmonary bypass [see Clinical Pharmacology ( 12.3 ) ]. Children undergoing cardio-pulmonary bypass should receive an additional dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly as…
Palivizumab side effects
The most serious adverse reactions occurring with Synagis are anaphylaxis and other acute hypersensitivity reactions [see Warnings and Precautions ( 5.1 ) ]. Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Synagis (n=1639) compared with placebo (n=1143) in children 3 days to 24.1 months of age at high risk of RSV-related hospitalization in two clinical trials. Trial 1 was conducted during a single RSV season and studied a total of 1502 children less than or equal to 24 months of age with BPD or infants with premature birth (less than or equal to 35 weeks gestation) who were less than or equal to 6 months of age at study entry. Trial 2 was conducted over four consecutive seasons among a total of 1287 children less than or equal to 24 months of age with hemodynamically significant congenital heart disease. In Trials 1 and 2 combined, fever and rash were…
Who shouldn’t take palivizumab
Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis [see Warnings and Precautions ( 5.1 ) ]. Previous significant hypersensitivity reaction to Synagis. ( 4 )
Palivizumab drug interactions
No formal drug-drug interaction studies were conducted. In Trial 1, the proportions of children in the placebo and Synagis groups who received routine childhood vaccines, influenza vaccine, bronchodilators, or corticosteroids were similar and no incremental increase in adverse reactions was observed among children receiving these agents.
Every palivizumab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Synagis.
Palivizumab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for palivizumab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of palivizumab during breastfeeding. Because palivizumab is a large protein molecule with a molecular weight of about 148,000 Da, the amount in milk is likely to be very low. Palivizumab appears to be degraded in the infant’s gastrointestinal tract by about 20% after 1 hour and up to 36% at 2 hours in one study and 50 to 62% in others. Normal maternal milk antibodies against respiratory syncytial virus are not degraded under the same conditions. Absorption of the undigested antibodies by the infant is probably minimal.
National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about palivizumab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 609 reports naming palivizumab, and the FDA flagged 99% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- bronchiolitis81 reports
- cough53 reports
- pneumonia53 reports
- pyrexia48 reports
- respiratory syncytial virus infection44 reports
- influenza37 reports
- dyspnoea36 reports
- vomiting32 reports
Read these as a signal, not a rate. A report does not mean palivizumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is palivizumab?
Synagis (Palivizumab) is a respiratory syncytial virus anti-f protein monoclonal antibody.
What kind of drug is palivizumab?
The FDA classifies palivizumab as a respiratory syncytial virus anti-f protein monoclonal antibody. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take palivizumab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run palivizumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does palivizumab come in?
Across the brands we track, palivizumab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic palivizumab?
We do not currently list a generic-labelled palivizumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Palivizumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/palivizumab
- MLA
- “Palivizumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/palivizumab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for palivizumab on DailyMed (NIH) ↗.