Some ingredients in medicines can have more than the desired effect

1 AUGUST 2011

Additives in medicines, such as colours and flavours in mixtures, and fillers and coatings in tablets, can have adverse effects that range from a mild rash to a potentially life-threatening reaction in rare cases, according to Alison Haywood of Griffith University and Beverley Glass of James Cook University, writing in the August edition of Australian Prescriber.

The authors explain that these additives or excipients are included in a medicine not only for their therapeutic benefits but to facilitate the manufacture of the medicine, for easy administration to patients and for optimum storage of the medicine.

Common excipients include coatings to protect the active ingredient in the tablet, to ensure that the drug is released from the tablet in the body, and to enhance the overall safety or function of the medicine during storage and use.

“Today, medicines are available in many different forms including tablets, liquids, creams, patches, injections, implants and inhalers,” say the authors.

“Excipients are very important to ensure that these medicines are effective when used in patients. Ideally, an excipient is inactive, non-toxic, and does not interact with the active ingredient in a medicine, however they may have the potential to cause adverse effects in sensitive individuals.”

“It’s important for people to know that the side effects, which they may experience when taking a medicine, may not necessarily be due to the active ingredient but the excipient, especially if a patient has an allergy to that particular excipient, which can be identified due to its presence in another medicine they were taking or an allergy to a similar ingredient,” write the authors.

A list of the excipients included in a medicine is available in the Consumer Medicine Information (CMI) leaflet, which is often provided with the medicine or readily available online (

Anyone concerned about any suspected adverse effects should talk to their health professional. They can also phone the Adverse Medicine Events line (1300 134 237) or Medicines Line, a telephone service providing information on prescription, over-the-counter and complementary medicines (1300 MEDICINE or 1300 633 424), Monday to Friday 9am-5pm Eastern Standard Time.

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Australian Prescriber is an independent peer-reviewed journal providing critical commentary on therapeutic topics for health professionals, particularly doctors in general practice. It is published by NPS, an independent, not-for-profit organisation for quality use of medicines funded by the Australian Government Department of Health and Ageing. Australian Prescriber is published every two months, in hard copy that is distributed to health professionals free of charge, and online in full text at