ReviewSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2025
Excipients in pharmaceuticals: mechanisms of hypersensitivity and the role of global pharmacovigilance.
Review in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
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.
Who cites it
3 citing papers in PubMed.
- Advances in Camptothecin-Class Compounds Nanomedicines: A Comprehensive Review of Antitumor Strategies.Pharmaceutics · 2026Review
- Understanding Biologics in CRSwNP: Related Events and Insights.Current allergy and asthma reports · 2026Review
- All things are active … new approach methods for excipient safety.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Excipients are important inactive components in drug formulations that ensure stability, bioavailability, and patient compliance. However, emerging evidence suggests that certain excipients, once considered inert, can cause hypersensitivity reactions in certain individuals. Such reactions include mild erythema due to systemic anaphylaxis and create clinical challenges that are difficult to handle. This review presents a systematic review of the existing literature on excipient hypersensitivity, with specific attention paid to commonly implicated excipients such as polyethylene glycol (PEG), parabens, and tartrazine. Hypersensitivity mechanisms (immune-mediated [IgE, T-cell] and non-immune) are discussed, along with their clinical features and diagnostic challenges. In addition, geographic variations in reporting are discussed, which in turn focus on the role of pharmacovigilance in the reduction of risk. Geographic variations in excipient hypersensitivity reporting are also discussed, highlighting disparities in pharmacovigilance efforts across different regions. This review also discusses recent work, regulatory issues, and desensitization protocols for the control of hypersensitivity reactions. Persistent surveillance and individual strategies are needed to enhance patient safety in the context of excipient-induced hypersensitivity.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.