• Yogesh R
• DR Senthil Rajan
• Newshiya JS
• Rajeswari D

Pharmaceutical excipients, such as co-solvents, preservatives, colorants, surfactants, or sweeteners, are essential components in the drug formulation process. They provide benefits such as solubilization, stabilization, delivery enhancement, and formulation preservation. However, few excipients are covered by regulatory guidelines, and some manufacturers include them in new package inserts. The Drug Standards Division of the United States Pharmacopoeia has attempted to implement obligatory labelling. Excipients can also cause adverse reactions in patients, ranging from mild rash to potentially life-threatening reactions. Adverse reactions have been reported for a small proportion of over 1300 excipients used by pharmaceutical manufacturers. The true prevalence of these reactions in the general population is impossible to predict due to lack of controls, inadequate testing, and changes in excipient formulations. In this present review, we are going to discuss about the excipient origin, functions, types and also we have included the information on adverse reaction to the major excipients in the pharmaceutical dosage form.

Pharmaceutical excipients, USP, Labelling, Adverse reactions, Pharmaceutical dosage form.

"A Review On: “Pharmaceutical Excipients And Its Adverse Effects’’", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 3, page no.e650-e656, March-2025, Available :http://www.jetir.org/papers/JETIR2503488.pdf

"A Review On: “Pharmaceutical Excipients And Its Adverse Effects’’", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 3, page no. ppe650-e656, March-2025, Available at : http://www.jetir.org/papers/JETIR2503488.pdf