Drug · FAERS side-effect profile with label screen
Palivizumab side effects: what 599 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
599 reports · 99% serious · 92 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Lab value / disease marker 2No label text to screen 38
What the badges mean
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 886 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Respiratory syncytial virus test positive | 309 | 1,081.0 931.6–1,254.3ROR 1,103.3 · χ² 184,791 / p <1e-300 | 579.8 EB05 527.5 · IC025 +8.1 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Respiratory syncytial virus bronchiolitis | 293 | 819.6 709.5–946.7ROR 835.6 · χ² 148,715 / p <1e-300 | 494.3 EB05 448.6 · IC025 +7.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Bronchiolitis | 1,274 | 775.2 725.0–828.9ROR 845.7 · χ² 626,004 / p <1e-300 | 489.7 EB05 467.5 · IC025 +8.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Respiratory syncytial virus infection | 2,105 | 442.6 422.4–463.7ROR 513.2 · χ² 698,912 / p <1e-300 | 332.8 EB05 321.0 · IC025 +8.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Respiratory syncytial virus bronchitis | 31 | 419.7 280.6–627.7ROR 420.5 · χ² 9,567 / p <1e-300 | 267.7 EB05 197.6 · IC025 +5.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Infantile spitting up | 53 | 156.0 117.4–207.2ROR 156.5 · χ² 7,180 / p <1e-300 | 133.3 EB05 105.8 · IC025 +5.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Pneumonia respiratory syncytial viral | 82 | 151.5 120.6–190.2ROR 152.3 · χ² 10,888 / p <1e-300 | 132.2 EB05 109.9 · IC025 +5.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Sudden infant death syndrome | 49 | 150.1 111.8–201.5ROR 150.6 · χ² 6,399 / p <1e-300 | 128.5 EB05 101.1 · IC025 +5.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Bronchopulmonary dysplasia | 78 | 147.9 117.1–186.7ROR 148.7 · χ² 10,128 / p <1e-300 | 129.3 EB05 106.9 · IC025 +5.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Fontanelle bulging | 11 | 144.6 77.7–269.2ROR 144.7 · χ² 1,290 / p 7e-283 | 107.0 EB05 63.8 · IC025 +3.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Human metapneumovirus test positive | 11 | 140.5 75.5–261.3ROR 140.6 · χ² 1,257 / p 1e-275 | 104.8 EB05 62.4 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Feeding disorder of infancy or early childhood | 15 | 137.2 80.7–233.3ROR 137.3 · χ² 1,720 / p <1e-300 | 107.9 EB05 69.4 · IC025 +3.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Oligodipsia | 17 | 109.6 66.9–179.6ROR 109.7 · χ² 1,593 / p <1e-300 | 91.3 EB05 60.4 · IC025 +3.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Use of accessory respiratory muscles | 28 | 101.9 69.4–149.6ROR 102.1 · χ² 2,509 / p <1e-300 | 89.2 EB05 64.8 · IC025 +4.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Rhinovirus infection | 259 | 100.4 88.6–113.8ROR 102.2 · χ² 23,650 / p <1e-300 | 93.0 EB05 83.8 · IC025 +6.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Rotavirus infection | 38 | 98.4 70.8–136.7ROR 98.6 · χ² 3,324 / p <1e-300 | 87.8 EB05 66.8 · IC025 +4.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Gastroenteritis rotavirus | 19 | 90.3 56.7–143.6ROR 90.4 · χ² 1,490 / p <1e-300 | 78.3 EB05 52.9 · IC025 +4.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Croup infectious | 46 | 86.7 64.4–116.8ROR 87.0 · χ² 3,584 / p <1e-300 | 79.0 EB05 61.6 · IC025 +5.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Poor feeding infant | 62 | 84.5 65.4–109.2ROR 84.9 · χ² 4,739 / p <1e-300 | 77.8 EB05 62.8 · IC025 +5.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Teething | 16 | 77.6 46.9–128.5ROR 77.7 · χ² 1,073 / p 1e-235 | 67.8 EB05 44.2 · IC025 +3.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Chronic respiratory disease | 18 | 74.5 46.4–119.7ROR 74.6 · χ² 1,169 / p 2e-256 | 66.0 EB05 44.1 · IC025 +3.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Metapneumovirus infection | 37 | 70.4 50.6–97.9ROR 70.5 · χ² 2,339 / p <1e-300 | 64.8 EB05 49.1 · IC025 +4.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Corona virus infection | 19 | 62.6 39.5–99.1ROR 62.7 · χ² 1,042 / p 5e-229 | 56.6 EB05 38.3 · IC025 +3.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Breath holding | 15 | 59.2 35.3–99.3ROR 59.3 · χ² 768 / p 3e-169 | 53.2 EB05 34.2 · IC025 +3.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Apnoeic attack | 23 | 58.1 38.3–88.2ROR 58.2 · χ² 1,183 / p 1e-259 | 53.4 EB05 37.5 · IC025 +4.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Enterovirus infection | 33 | 55.1 38.9–78.0ROR 55.2 · χ² 1,632 / p <1e-300 | 51.5 EB05 38.4 · IC025 +4.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Apnoea | 282 | 51.2 45.5–57.6ROR 52.2 · χ² 13,341 / p <1e-300 | 49.3 EB05 44.6 · IC025 +5.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Febrile convulsion | 40 | 46.7 34.1–64.0ROR 46.8 · χ² 1,685 / p <1e-300 | 44.3 EB05 33.9 · IC025 +4.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Restrictive cardiomyopathy | 10 | 46.4 24.7–87.1ROR 46.4 · χ² 386 / p 3e-86 | 41.6 EB05 24.1 · IC025 +2.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Laryngomalacia | 11 | 46.1 25.3–84.1ROR 46.1 · χ² 427 / p 4e-95 | 41.6 EB05 24.8 · IC025 +2.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Poor sucking reflex | 13 | 45.8 26.4–79.6ROR 45.9 · χ² 509 / p 5e-113 | 41.9 EB05 26.0 · IC025 +3.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Infantile spasms | 22 | 43.5 28.5–66.6ROR 43.6 · χ² 845 / p 4e-186 | 40.8 EB05 28.4 · IC025 +3.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Dermatitis diaper | 21 | 42.4 27.5–65.4ROR 42.4 · χ² 783 / p 1e-172 | 39.8 EB05 27.4 · IC025 +3.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Feeding intolerance | 13 | 41.3 23.8–71.7ROR 41.3 · χ² 458 / p 7e-102 | 38.1 EB05 23.7 · IC025 +3.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Tracheitis | 22 | 40.9 26.8–62.5ROR 41.0 · χ² 793 / p 8e-175 | 38.5 EB05 26.8 · IC025 +3.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Dependence on respirator | 11 | 39.3 21.6–71.5ROR 39.3 · χ² 363 / p 4e-81 | 36.0 EB05 21.4 · IC025 +2.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Pertussis | 28 | 37.6 25.9–54.8ROR 37.7 · χ² 936 / p 6e-206 | 35.8 EB05 26.0 · IC025 +3.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Respiratory tract infection viral | 57 | 34.6 26.6–44.9ROR 34.7 · χ² 1,780 / p <1e-300 | 33.4 EB05 26.7 · IC025 +4.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Apparent life threatening event | 10 | 32.7 17.5–61.2ROR 32.7 · χ² 270 / p 6e-61 | 30.2 EB05 17.4 · IC025 +2.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Parainfluenzae virus infection | 36 | 32.7 23.5–45.4ROR 32.7 · χ² 1,048 / p 3e-230 | 31.4 EB05 23.7 · IC025 +3.9 3/3 methods agree | No label text to screen | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Respiratory syncytial virus infection | 2,105 | 442.6 422.4–463.7ROR 513.2 · χ² 698,912 / p <1e-300 | 332.8 EB05 321.0 · IC025 +8.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Pyrexia (fever) | 1,450 | 5.8 5.5–6.1ROR 6.3 · χ² 5,785 / p <1e-300 | 5.7 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Bronchiolitis | 1,274 | 775.2 725.0–828.9ROR 845.7 · χ² 626,004 / p <1e-300 | 489.7 EB05 467.5 · IC025 +8.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Death | 1,068 | 1.7 1.6–1.8ROR 1.8 · χ² 322 / p 2e-72 | 1.7 EB05 1.6 · IC025 +0.7 | Outcome field, not a reaction | – | no trial data cached |
| Cough | 1,028 | 5.1 4.8–5.4ROR 5.4 · χ² 3,377 / p <1e-300 | 5.0 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Pneumonia (lung infection) | 948 | 4.0 3.8–4.3ROR 4.2 · χ² 2,189 / p <1e-300 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Dyspnoea (shortness of breath) | 785 | 1.9 1.8–2.0ROR 2.0 · χ² 347 / p 1e-77 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen | – | no trial data cached |
| Vomiting | 655 | 1.9 1.8–2.1ROR 2.0 · χ² 294 / p 4e-66 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen | – | no trial data cached |
| Nasopharyngitis (common cold) | 640 | 4.8 4.4–5.1ROR 4.9 · χ² 1,913 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Influenza | 506 | 6.2 5.7–6.8ROR 6.4 · χ² 2,221 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Bronchitis | 421 | 7.8 7.1–8.6ROR 8.0 · χ² 2,487 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Off label use (used outside approved label) | 398 | 0.6 0.6–0.7ROR 0.6 · χ² 90 / p 1e-21 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | no trial data cached |
| Diarrhoea (diarrhea) | 397 | 0.8 0.8–0.9ROR 0.8 · χ² 11 / p 4e-4 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | No label text to screen | – | no trial data cached |
| Product dose omission issue | 391 | 1.9 1.7–2.1ROR 1.9 · χ² 164 / p 7e-38 | 1.9 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | – | no trial data cached |
| Covid-19 | 363 | 2.8 2.5–3.1ROR 2.9 · χ² 427 / p 3e-95 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen | – | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Palivizumab?
In FDA FAERS, the most frequently co-reported reaction terms for Palivizumab are respiratory syncytial virus infection, pyrexia, bronchiolitis, cough, pneumonia, dyspnoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Palivizumab have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Palivizumab causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 926 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.