Evidence map›Paper›PMID 41995482›Full record

SynthesisMedicine2026

Safety assessment of intravenous immunoglobulins in pediatric population: A systematic review of adverse events.

Muteb Altowairqi, Naglaa M Kamal, Abdulrahman Aljaber, Abdullah M Alelyani, Mazen A Alzaedi, Saad S S Aljuaid, Abdulelah S Algethami, Mohammed A M Oshi, Ahmed S A Soliman

Abstract readSystematic Review
In one paragraph

Synthesis in Medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Comment on Wei et al.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Muteb AltowairqiPediatric Department, AlHada Armed Forces Hospital, Taif, Kingdom of Saudi Arabia.
Naglaa M KamalPediatric Department, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.
Abdulrahman AljaberPediatric Department, National Guard Hospital, Riyadh, Kingdom of Saudi Arabia.
Abdullah M AlelyaniPediatric Department, AlHada Armed Forces Hospital, Taif, Kingdom of Saudi Arabia.
Mazen A AlzaediPediatric Department, AlHada Armed Forces Hospital, Taif, Kingdom of Saudi Arabia.
Saad S S AljuaidPediatric Department, AlHada Armed Forces Hospital, Taif, Kingdom of Saudi Arabia.
Abdulelah S AlgethamiPediatric Department, AlHada Armed Forces Hospital, Taif, Kingdom of Saudi Arabia.
Mohammed A M OshiGaafar Ibnauf Specialized Hospital, Khartoum, Sudan.
Ahmed S A SolimanPediatric Department, Faculty of Medicine, Benha University, Banha, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntravenous immunoglobulin (IVIG) is a therapeutic intervention utilized in various disorders due to its antimicrobial, antiinflammatory, and immunomodulatory properties. The market offers a range of IVIG products, leading to variations in efficacy and safety profiles. This study aimed to systematically evaluate the safety profile of IVIG administration in pediatric patients.

methodsA systematic search was conducted on PubMed, Embase, and Cochrane databases using predetermined MeSH terms, covering the period from January 1, 2000, to October 15, 2022. Two independent reviewers performed relevance screening. Inclusion criteria encompassed English-language studies involving patients below 18 years of age who received IVIG treatment. Included studies were limited to peer-reviewed full-text publications with a minimum of 5 patients. A total of 8 studies met the inclusion criteria, encompassing 1088 pediatric patients.

resultsEight studies met the inclusion criteria (total 1088 pediatric patients). Five studies reported patient-level adverse event data suitable for pooling (688 patients). Among these 688 patients, 267 (38.8%) experienced adverse events (AEs). Among reported AEs, the most frequent were headache 68/267 (25.5%) and fever 47/267 (17.6%). Less common AEs included nausea 12/267 (4.5%) and fatigue 12/267 (4.5%). Four studies recorded a total of 2960 IVIG infusions, with 12.6% of infusions accompanied by AEs. The predominant AEs during infusions were headache (54.3%) and fever (29.4%). Cough (0.8%) and nausea (1.6%) were the least commonly observed AEs. Other AEs such as rash, vomiting, and abdominal pain were also reported. Of the 23 full-text articles reviewed, 8 were included. The remaining 15 were excluded due to the following reasons: 6 for duplicate data, 4 for inappropriate study design, 3 for not meeting the minimum number of patients, and 2 for incomplete adverse event reporting. These reasons are now detailed in the updated Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram.

conclusionIVIG therapy demonstrates good tolerability in pediatric patients, with an overall favorable safety profile, aside from mild AEs associated with its administration. Serious AEs were infrequent and mainly observed in high-risk patients. Headache was the most prevalent AE, which seldom required hospitalization and could be effectively managed with acetaminophen. Other AEs were generally mild systemic reactions. Notably, AEs appear to be more frequent during the initial exposure to IVIG.

Indexed as

Immunoglobulins, IntravenousImmunologic FactorsAdolescentChildFeverHeadacheHumansImmunoglobulins, IntravenousImmunologic FactorsAdverse drug eventsIntravenous ImmunoglobulinIVIGPediatrics

Identifiers

PMID41995482
PMCPMC13095261

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.