Scientific Research 42
Published, peer-reviewed research on inactive ingredients, listed newest first.
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Toxicological Effects of Tartrazine Exposure: A Review of In Vitro and Animal Studies with Human Health Implications
Visternicu M et al. Toxics. 2025;13(9):771. doi:10.3390/toxics13090771
Covers: Tartrazine (FD&C Yellow No. 5), Allura Red (Red 40), Sunset Yellow (Yellow 6)
Also at: mdpi.com
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Protecting developing brains: urgent need to regulate synthetic food dyes in children's diets
Fatima S et al. Annals of Medicine & Surgery. 2025;87(10):6918-6919. doi:10.1097/MS9.0000000000003770
Covers: FD&C dyes (incl. Red 40, Yellow 5/6, Blue 1)
Also at: DOI
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Excipients in pharmaceuticals: mechanisms of hypersensitivity and the role of global pharmacovigilance
Malkawi R, Altahrawi L. Saudi Pharmaceutical Journal. 2025;33(4):18. doi:10.1007/s44446-025-00004-8
Covers: Multiple excipients (broad)
Also at: DOI
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EFSA prohibits titanium dioxide in food- should pharmaceuticals be next?
Dand C, Bajaj A, Wairkar S. Toxicology. 2025;513:154089. doi:10.1016/j.tox.2025.154089
Covers: Titanium dioxide
Also at: DOI
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Endocrine-disrupting chemical, methylparaben, in environmentally relevant exposure promotes hazardous effects on the hypothalamus-pituitary-thyroid axis
Azeredo DBC et al. Molecular and Cellular Endocrinology. 2025;598:112444. doi:10.1016/j.mce.2024.112444
Covers: Methylparaben, propylparaben
Also at: DOI
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Never say yes to parabens? A review on paraben compounds in potential human exposure risks
Haldar S, Mukherjee S, Dey A. The Journal of Basic and Applied Zoology. 2025;86(1):13. doi:10.1186/s41936-025-00430-z
Covers: Parabens
Also at: DOI
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Excipient induced allergies in oral medications: unravelling the covert threat – a systematic review
Seth S et al. Internal Medicine Journal. 2024;55(3):353-368. doi:10.1111/imj.16605
Covers: Multiple excipients
Also at: DOI
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Industry's perspective on challenges assessing the in vivo impact of removing titanium dioxide (TiO2) from drug products
Abend A et al. Journal of Pharmaceutical Sciences. 2024;113(11):3119-3122. doi:10.1016/j.xphs.2024.08.002
Covers: Titanium dioxide (E171)
Also at: DOI
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Risks of dairy derived excipients in medications for lactose intolerant and cow milk protein allergic patients
Figueiredo A et al. Scientific Reports. 2024;14(1):15631. doi:10.1038/s41598-024-66380-8
Covers: Lactose, milk-protein contaminated lactose
Also at: DOI
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Hidden danger: maize starch excipient allergy
Lukose L et al. Medical Journal of Australia. 2024;220(4):184-185. doi:10.5694/mja2.52201
Covers: Maize / corn starch
Also at: DOI
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Role of anti-polyethylene glycol (PEG) antibodies in the allergic reactions to PEG-containing Covid-19 vaccines: Evidence for immunogenicity of PEG
Kozma GT et al. Vaccine. 2023;41(31):4561-4570. doi:10.1016/j.vaccine.2023.06.009
Covers: PEG / anti-PEG IgE
Also at: DOI
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Polyethylene Glycol and Polysorbate 80 Skin Tests in the Context of an Allergic Risk Assessment for Hypersensitivity Reactions to Anti-SARS-CoV-2 mRNA Vaccines
Nappi E et al. Vaccines. 2023;11(5):915. doi:10.3390/vaccines11050915
Covers: Polysorbate 80
Also at: DOI
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Narrative Review: The FDA's Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Events
Li W, Wertheimer A. INNOVATIONS in pharmacy. 2023;14(1):7. doi:10.24926/iip.v14i1.4989
Covers: Inactive ingredients across supplements
Also at: DOI
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New Challenges in Drug Allergy: the Resurgence of Excipients
Venturini Díaz M et al. Current Treatment Options in Allergy. 2022;9(3):273-291. doi:10.1007/s40521-022-00313-6
Covers: Multiple excipients
Also at: DOI
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Potential impacts of synthetic food dyes on activity and attention in children: a review of the human and animal evidence
Miller MD et al. Environmental Health. 2022;21(1):45. doi:10.1186/s12940-022-00849-9
Covers: FD&C Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3, Red 3
Also at: DOI
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Exposures to FD&C synthetic color additives from over-the-counter medications and vitamins in United States children and pregnant women
Thilakaratne R et al. Journal of Exposure Science & Environmental Epidemiology. 2022;33(5):787-793. doi:10.1038/s41370-022-00418-9
Covers: FD&C synthetic food dyes (Red 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2)
Also at: DOI
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The role and impact of polyethylene glycol on anaphylactic reactions to COVID-19 nano-vaccines
Bigini P et al. Nature Nanotechnology. 2021;16(11):1169-1171. doi:10.1038/s41565-021-01001-3
Covers: PEG / lipid nanoparticles
Also at: DOI
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Gluten in pharmaceutical products: a scoping review
Lizano-Díez I, Mariño EL, Modamio P. Systematic Reviews. 2021;10(1):218. doi:10.1186/s13643-021-01772-9
Covers: Wheat starch / gluten
Also at: DOI
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Hidden Dangers: Recognizing Excipients as Potential Causes of Drug and Vaccine Hypersensitivity Reactions
Caballero ML et al. The Journal of Allergy and Clinical Immunology: In Practice. 2021;9(8):2968-2982. doi:10.1016/j.jaip.2021.03.002
Covers: Multiple excipients (PEG, polysorbate, dyes, lactose, gelatin, etc.)
Also at: DOI
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Titanium dioxide particles from the diet: involvement in the genesis of inflammatory bowel diseases and colorectal cancer
Barreau F et al. Particle and Fibre Toxicology. 2021;18(1):26. doi:10.1186/s12989-021-00421-2
Covers: Titanium dioxide (E171 / TiO2 NPs)
Also at: DOI
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Safety assessment of titanium dioxide (E171) as a food additive
EFSA Panel on Food Additives and Flavourings (Younes M, et al.). EFSA Journal. 2021;19(5):e06585. doi:10.2903/j.efsa.2021.6585
Covers: Titanium dioxide (E171)
Also at: DOI
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Polyethylene glycol (PEG) is a cause of anaphylaxis to the Pfizer/BioNTech mRNA COVID-19 vaccine
Sellaturay P et al. Clinical & Experimental Allergy. 2021;51(6):861-863. doi:10.1111/cea.13874
Covers: Polyethylene glycol (PEG / macrogol)
Also at: DOI
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Amended Safety Assessment of Parabens as Used in Cosmetics
Cherian P et al. International Journal of Toxicology. 2020;39(1_suppl):5S-97S. doi:10.1177/1091581820925001
Covers: Parabens (methyl, ethyl, propyl, butyl)
Also at: DOI
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Foodborne Titanium Dioxide Nanoparticles Induce Stronger Adverse Effects in Obese Mice than Non-Obese Mice: Gut Microbiota Dysbiosis, Colonic Inflammation, and Proteome Alterations
Cao X et al. Small. 2020;16(36):2001858. doi:10.1002/smll.202001858
Covers: Titanium dioxide (E171 vs nano-TiO2)
Also at: DOI
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Effect of Long-Term Intake of Dietary Titanium Dioxide Nanoparticles on Intestine Inflammation in Mice
Mu W et al. Journal of Agricultural and Food Chemistry. 2019;67(33):9382-9389. doi:10.1021/acs.jafc.9b02391
Covers: Titanium dioxide nanoparticles
Also at: DOI
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'Inactive' ingredients in oral medications
Reker D et al. Science Translational Medicine. 2019;11(483):eaau6753. doi:10.1126/scitranslmed.aau6753
Covers: Multiple excipients (lactose, dyes, peanut oil, gluten, etc.)
Why it matters: Researchers examined 42,052 oral medications and found that 92.8% contain at least one ingredient known to trigger allergic or adverse reactions — lactose in about 45%, food dyes in about 33%. The ingredients labelled “inactive” are not always inert for the person swallowing them.
Also at: Free full text (PMC) · DOI
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Allergic reactions to cow's milk proteins in medications in childhood
Santoro A et al. Acta Biomedica Atenei Parmensis. 2019;90(3-S):91-93. doi:10.23750/abm.v90i3-S.8169
Covers: Cow's milk proteins in medications
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Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings
Tucker J et al. JAMA Network Open. 2018;1(6):e183337. doi:10.1001/jamanetworkopen.2018.3337
Covers: Hidden pharmaceutical ingredients
Also at: DOI
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Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered
Valeur KS, Holst H, Allegaert K. Pharmaceutical Medicine. 2018;32(4):251-258. doi:10.1007/s40290-018-0243-9
Covers: Multiple excipients
Also at: DOI
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The Cumulative Daily Tolerance Levels of Potentially Toxic Excipients Ethanol and Propylene Glycol Are Commonly Exceeded in Neonates and Infants
Valeur KS et al. Basic & Clinical Pharmacology & Toxicology. 2018;122(5):523-530. doi:10.1111/bcpt.12950
Covers: Propylene glycol, benzyl alcohol
Also at: DOI
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Choosing a medication brand: Excipients, food intolerance and prescribing in older people
Page A, Etherton-Beer C. Maturitas. 2018;107:103-109. doi:10.1016/j.maturitas.2017.11.001
Covers: Multiple excipients (incl. excipients in geriatric polypharmacy)
Also at: DOI
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Safety and regulatory review of dyes commonly used as excipients in pharmaceutical and nutraceutical applications
Pérez-Ibarbia L et al. European Journal of Pharmaceutical Sciences. 2016;93:264-273. doi:10.1016/j.ejps.2016.08.026
Covers: FD&C Red 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2
Also at: DOI
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Titanium dioxide nanoparticles exacerbate DSS-induced colitis: role of the NLRP3 inflammasome
Ruiz PA et al. Gut. 2016;66(7):1216-1224. doi:10.1136/gutjnl-2015-310297
Covers: Titanium dioxide (TiO2 NPs)
Also at: DOI
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Adverse reaction to benzathine benzylpenicillin due to soy allergy: a case report
Barni S et al. Journal of Medical Case Reports. 2015;9(1):134. doi:10.1186/s13256-015-0602-z
Covers: Soy lecithin
Also at: DOI
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Hypersensitivity Reaction After Inhalation of a Lactose-Containing Dry Powder Inhaler
Robles J, Motheral L. The Journal of Pediatric Pharmacology and Therapeutics. 2014;19(3):206-211. doi:10.5863/1551-6776-19.3.206
Covers: Lactose (with milk-protein contamination)
Also at: DOI
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Propylene Glycol Toxicity in Children
Lim TY, Poole RL, Pageler NM. The Journal of Pediatric Pharmacology and Therapeutics. 2014;19(4):277-282. doi:10.5863/1551-6776-19.4.277
Covers: Propylene glycol
Also at: DOI
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Hypersensitivity reaction to human papillomavirus vaccine due to polysorbate 80
Badiu I et al. BMJ Case Reports. 2012;2012:bcr0220125797. doi:10.1136/bcr.02.2012.5797
Covers: Polysorbate 80 (Tween 80)
Also at: DOI
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Meta-Analysis of Attention-Deficit/Hyperactivity Disorder or Attention-Deficit/Hyperactivity Disorder Symptoms, Restriction Diet, and Synthetic Food Color Additives
Nigg JT et al. Journal of the American Academy of Child & Adolescent Psychiatry. 2012;51(1):86-97.e8. doi:10.1016/j.jaac.2011.10.015
Covers: Synthetic food dyes (general)
Also at: DOI
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Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates
Shehab N et al. Pediatric Critical Care Medicine. 2009;10(2):256-259. doi:10.1097/pcc.0b013e31819a383c
Covers: Benzyl alcohol, propylene glycol
Also at: DOI
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Type I Hypersensitivity in an Asthmatic Child Allergic to Peanuts: Was Soy Lecithin to Blame?
Béliveau S et al. Journal of Cutaneous Medicine and Surgery. 2008;12(1):27-30. doi:10.2310/7750.2007.00031
Covers: Soy lecithin
Also at: DOI
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Sulfites—A Food and Drug Administration Review of Recalls and Reported Adverse Events
Timbo B et al. Journal of Food Protection. 2004;67(8):1806-1811. doi:10.4315/0362-028x-67.8.1806
Covers: Sulfites
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Tartrazine exclusion for allergic asthma
Ardern KD, Ram FSF. Cochrane Database of Systematic Reviews. 2001;2017(9):CD000460. doi:10.1002/14651858.CD000460
Covers: Tartrazine (FD&C Yellow No. 5)
Also at: DOI
Government & Regulatory 6
Findings, safety alerts, and rulemaking from the FDA, EMA, and other public agencies.
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HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation's Food Supply
U.S. Department of Health & Human Services / FDA. FDA press announcement
Covers: FD&C Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3 (+ Citrus Red 2, Orange B)
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FD&C Red No. 3 — Revocation of authorization for use in food and ingested drugs
U.S. Food and Drug Administration (FDA). FDA.gov (order published in the Federal Register Jan 16, 2025)
Covers: FD&C Red No. 3 (erythrosine)
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FDA alerts health care professionals, compounders and patients of potential safety risks associated with sulfite-containing compounded drugs
U.S. Food and Drug Administration (FDA). FDA.gov — compounding safety alert
Covers: Sulfites (sodium metabisulfite, sodium bisulfite)
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Use of titanium dioxide as excipient in human and veterinary medicines and identification of alternatives — industry feedback report to EMA (Annex I)
EFPIA, AESGP, Medicines for Europe, EUCOPE, AnimalhealthEurope, Access VetMed, TiO2 Alternatives Consortium, IPEC (industry submission to the European Medicines Agency). European Medicines Agency (EMA) website
Covers: Titanium dioxide (TiO2)
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Health Effects Assessment: Potential Neurobehavioral Effects of Synthetic Food Dyes in Children
California Office of Environmental Health Hazard Assessment (OEHHA) — Miller MD, Golub M, Marty M, Steinmaus C, et al. California EPA / OEHHA
Covers: FD&C Red 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3
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Questions and answers on propylene glycol used as an excipient in medicinal products for human use (EMA/CHMP/704195/2013)
European Medicines Agency (EMA) — Committee for Medicinal Products for Human Use (CHMP). EMA scientific guideline (adopted by CHMP 15 Dec 2016)
Covers: Propylene glycol
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