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Gluten in Medications

Multiple bottles of pills on a counter. White pills are scattered across the counter.

Medications contain active ingredients—the drugs or ingredients that affect your body—and inactive ingredients—everything else, such as cornstarch to give the pill a shape or flavorings to control taste. Inactive ingredients can present a challenge to those with celiac disease because they can occasionally include gluten. However, if gluten is present, it may not be labeled clearly or prominently.

This article explores how to identify gluten in medications, the current state of labeling regulations, and practical advice for patients and caregivers seeking gluten-free options. Whether newly diagnosed or a seasoned patient, understanding how to find gluten in medication can be important to maintaining your health and peace of mind.

What Patients Need to Know

  • Manufacturers use excipients, also called inactive ingredients, which bind pills together and help deliver the medication to the patient. There are several types of excipients, and some of them may contain gluten.
  • Few medications contain gluten, but it is important to review the ingredients in your medications to be confident that they are gluten-free. If you are having trouble locating the ingredients, consider calling your doctor, pharmacist, or the manufacturer.
  • The generic form of a medication may use different excipients than the brand name drug. Even if the brand name is determined to be gluten-free, the gluten-free status of each generic must be verified.
  • There are no requirements for labeling gluten or common allergens in drug ingredients.

Ingredients to Watch for in Medications

Gluten can sometimes be found in the excipients, or inactive ingredients, used to bind medications. Many of these excipients include starches, which may be derived from gluten-containing grains such as wheat, barley, or rye. For people with celiac disease, it’s crucial to work with your doctor or pharmacist to ensure that your medications are gluten-free. You can also reach out to manufacturers for clarity about whether specific starches or other ingredients are safe for celiac patients.

Certain starch-based excipients are considered “red flags” for potential gluten content:

  • Wheat
  • Modified starch (if source unknown)
  • Pregelatinized starch (if source unknown)
  • Dextrin (if not specified as corn or potato)
  • Dextrimaltose and caramel coloring (if barley malt is used)

How to Find Gluten-Free Medications

Getting accurate information about gluten in medications can be difficult. The most reliable sources are your doctor, pharmacist, and the drug manufacturer. While some online lists exist, it’s essential to verify any claims you find on the internet with these trusted professionals to ensure your medication is truly gluten-free.

Legislation, Regulations & Advocacy Efforts

Several important legislative efforts related to gluten in medications happened between 2017 and 2019, but progress has unfortunately slowed. Here’s an overview of those efforts:

  • From 2011-2014, Beyond Celiac spearheaded a study with a grant from the FDA demonstrating that gluten in medications is a significant issue for the celiac disease community that needs to be addressed, and launched the GREAT Pharmacists training program. Read more about the study here.
  • In late 2017, the FDA released draft guidelines for labeling gluten in medications. While the efforts were a start, the action was not enough. The FDA accepted comments about the guidelines through February 12, 2018. Beyond Celiac officially responded and worked with the celiac disease community to get the most responses we could on the draft. Click here to read the letter we wrote to the FDA regarding their draft for our community members to send. We asked our community to send it in during the open comment period. Over 800 comments were received.
  • On April 3, 2019, Representative Tim Ryan introduced the Gluten in Medicine Disclosure Act of 2019 to the congressional floor. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications. Learn more about that bill.
  • On December 11, 2019, Senator Richard Blumenthal introduced S.3021, to the Senate floor. This bill is meant to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes. It will also be known as the Gluten in Medicine Disclosure Act of 2019 and uses the same language as H.R. 2074, the bill Representative Tim Ryan [D-OH] introduced to the House in April. Learn more about that bill.
  • In the years since, the Gluten in Medicine Disclosure Act has continued to gain attention with reintroductions in Congress. However, it has stalled in committees and no further progress has been made.

Although progress in Congress has slowed, Beyond Celiac and other organizations remain committed to advocating for clearer medicine labeling through public awareness campaigns and partnerships with health organizations.


FAQs about Gluten in Medications


How likely is it that a prescription or over the counter drug has gluten in its inactive ingredients?

Few medications contain gluten, but every oral medication must be checked to make sure it is gluten-free, since current labeling regulations do not require gluten to be labeled in medications. 

It is important to remember that generic and brand name products containing the same active drug may contain different inactive ingredients. The source of these ingredients can be changed at any time without notice from the manufacturer. It also should be verified that the manufacturer has taken proper steps to avoid cross-contact from gluten-containing products.

The following inactive ingredients are considered “red flags,” as they may be sourced from wheat, barley or rye. The presence of red-flag ingredients indicates that there is a need for additional investigation to determine if the drug’s ingredients were derived from gluten:

  • Wheat
  • Modified starch (if source is not specified)
  • Pregelatinized starch (if source is not specified)
  • Pregelatinized modified starch (if source is not specified)
  • Dextrates (if source is not specified)
  • Dextrin (if source is not specified; the source is usually corn or potato, which are gluten-free)
  • Dextrimaltose (when barley malt is used)
  • Caramel coloring (when barley malt is used)

What should I do if I think I’m getting glutened by my medicine?

Your first step should be to call your physician to let them know that you’re experiencing symptoms. Do not stop taking prescription medicine without talking to your doctor first. 

There may be reasons aside from gluten exposure that you are experiencing symptoms, such as side effects of the prescribed medication. It is important to understand that some common side effects of medicines overlap with gluten exposure. Similarly, sugar alcohols in medications can cause significant stomach discomfort that could be easily confused with symptoms of gluten exposure. 

Beyond Celiac strongly recommends that you share your concerns and any symptoms with your doctor as soon as possible. Call the manufacturer to ask about the sources of their inactive ingredients as well as their production processes and any steps taken to prevent gluten exposure.


Who can I contact to report a suspected reaction to gluten in medication?

It is important to look into medications to find out if they contain gluten before taking the medication. However, if you think you are having a reaction to gluten in your medication, Beyond Celiac strongly suggests that you contact your doctor, explain your reaction, and call the manufacturer of the medication in question to alert them to the issue. Your pharmacist might also be able to help you figure out if your medication contains gluten. When talking to the manufacturer, you should also ask them:

  • What their production processes are
  • If their medications are made on shared equipment with gluten-containing medications
  • Whether they test their products for gluten
  • If they speak to the manufacturers of their sourced ingredients about possible gluten in their raw materials.

What types of medications are covered under the FDA’s gluten-free labeling rule?

While prescriptions and over-the-counter medications are not covered under the FDA’s gluten-free labeling rule, dietary supplements, such as vitamins and minerals, are covered, and must contain less than 20 parts per million (ppm) gluten if they are labeled gluten-free.


How should I talk about my gluten-free needs with my pharmacist?

It is important to be as thorough and clear as possible when talking about your gluten-free needs with your pharmacist. You should tell them that you are on a gluten-free diet to treat celiac disease, a serious genetic autoimmune disease. It may be helpful to tell them that you are at risk for serious health consequences, like thyroid disease, infertility, osteoporosis and even certain cancers if you continuously ingest gluten. You should also make sure to discuss hidden sources of gluten (listed above) and highlight the risks of cross-contact. Explain cross-contact to your pharmacist to help them understand the different ways you can be exposed to gluten.


What resources can I use to find safe medications?*

Below are some resources for identifying medications with and without gluten*:

  • Gluten in Medications Guide: This guide, created and developed in collaboration with American Society of Health-System Pharmacists (ASHP), can help when asking pharmacists about gluten-free prescriptions and other medication needs.
  • Gluten-Free Drugs: This list was maintained by Dr. Steven Plogsted and his pharmacy students at Columbus Children’s Hospital, Columbus, OH. It hasn’t been updated in years.
  • The Rubins: This website dedicated to senior citizens maintains a directory of drug manufacturers. Website addresses and phone numbers are provided, and may prove useful when one needs to contact a manufacturer to determine if gluten is an ingredient in a medication.

*Note: There are a few gluten-free medication lists available online, but it’s important to remember that these lists need constant updating to be correct and lists can have mistakes. Manufacturers can change their ingredients at any time and without warning. Gluten-free medication lists make a great starting point, but it is still important to talk to the manufacturer or your pharmacist to learn more about medications. Beyond Celiac is not involved in the creation or maintenance of any of these lists and is not liable for any consequences of medication ingestion.


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