Acetaminophen, also known as paracetamol, is one of the most commonly used medications for treating pain and fever. It is found in many over-the-counter drugs like Tylenol, Excedrin, and Theraflu. Acetaminophen is generally considered safe for most people when taken as directed, but some individuals with celiac disease or gluten sensitivity wonder if it contains gluten.
What is Acetaminophen?
Acetaminophen is a medication that works by inhibiting prostaglandin production and blocking pain signals in the brain. It has analgesic (pain-relieving) and antipyretic (fever-reducing) effects. Acetaminophen is used to temporarily relieve minor aches, pains, headaches, colds, flu symptoms, sore throats, arthritis, and fevers. It is one of the most popular over-the-counter medications in the United States and around the world.
Acetaminophen has been used medically for over 50 years. It was initially approved by the U.S. Food and Drug Administration (FDA) in 1951 and became available over-the-counter in the 1980s. Today, acetaminophen is the active ingredient in hundreds of prescription and OTC medicines for adults and children. Some of the most common brand names include Tylenol, Mapap, Panadol, Anacin-3, and Ofirmev.
Is Acetaminophen Gluten-Free?
The simple answer is yes, acetaminophen itself does not contain gluten. Acetaminophen is made of chemicals – it does not contain any food proteins. Therefore, pure or generic acetaminophen products do not pose a problem for those with celiac disease or non-celiac gluten sensitivity.
However, it’s important to note that medications often contain other inactive ingredients in addition to the active drug. These additional ingredients, like binders, colors, flavors, preservatives, and coatings, could potentially introduce trace amounts of gluten. Acetaminophen pills, caplets, or tablets may have starch, wheat starch, or pregelatinized starch in the ingredients.
How Acetaminophen is Made
Acetaminophen is a synthetic chemical called N-acetyl-para-aminophenol. It is made through chemical reactions in a laboratory setting, not derived from a grain or plant source that could contain gluten. The pure active drug does not contain protein. Therefore, there is no possibility of gluten contamination in purified acetaminophen itself.
Inactive Ingredients in Medications
While the active ingredient acetaminophen does not contain gluten, inactive ingredients in medications could be problematic for gluten-sensitive individuals. Drug products contain both active and inactive components:
- Active ingredients – chemicals that produce the desired therapeutic effect
- Inactive ingredients – additional components like fillers, binders, coatings, colors, flavors, preservatives, etc.
Manufacturers use inactive ingredients to create the desired drug formulation, appearance, taste, consistency, solubility, shelf life, etc. These additional ingredients are listed on the product label and packaging.
Inactive ingredients, like excipients, binders, fillers, and coatings, could potentially contain gluten. Common problematic sources include:
- Starch (wheat, barley)
- Pregelatinized starch
- Maltodextrin
- Dextrin
- Dextrates
- Caramel color (made from barley malt)
Gluten-containing ingredients may be used as fillers, binders, or coatings in acetaminophen products. Always thoroughly read the Drug Facts label and inactive ingredient list.
Cross-Contamination Risks
Shared manufacturing equipment could potentially lead to gluten cross-contamination in medications:
- Facilities that make gluten-containing drugs may also produce gluten-free products, using the same equipment
- Trace amounts of gluten could be introduced during the manufacturing process
Drug companies generally do not test products or label medications as gluten-free. Individuals with celiac disease or gluten sensitivity should look for acetaminophen products from facilities that do not process wheat, barley, rye, or gluten.
Is Acetaminophen Gluten-Free? The Verdict
Pure acetaminophen does not naturally contain gluten. However, there is a chance for cross-contamination or gluten exposure from additional inactive ingredients added to medications. The safest options include:
- Seeking acetaminophen products labeled gluten-free
- Checking product websites for manufacturing details
- Contacting the drug manufacturer directly to inquire about gluten-free status
- Choosing products made without gluten-based inactive ingredients
Individuals with celiac disease or gluten intolerance should carefully inspect acetaminophen product labels and avoid formulations containing wheat starch, maltodextrin, dextrin, caramel color and other suspicious ingredients. Generic or store brand acetaminophen tablets or caplets may have fewer problematic additives than name brands. With proper precautions, acetaminophen can be considered gluten-free for most gluten-sensitive consumers.
Popular Acetaminophen Brands and Gluten
Here is some additional information on the gluten-free status of common acetaminophen brands:
Tylenol
Tylenol is one of the most well-known acetaminophen brands. According to the gluten-free watchdog site GlutenFreeDrugs.com, most Tylenol products do not currently contain gluten. However, Tylenol Sinus Congestion & Pain caplets contain wheat starch.
Excedrin
Excedrin tablets and caplets contain acetaminophen, aspirin, and caffeine. According to Excedrin’s parent company GlaxoSmithKline, these products are gluten-free. However, Excedrin Migraine formulations contain gluten.
Mapap, Equate, Up & Up
These acetaminophen store brands sold at Walmart, CVS, Walgreens, etc. do not contain gluten, based on their ingredient lists. They contain ingredients like powdered cellulose, pregelatinized starch, and sodium starch glycolate. These are gluten-free starches derived from sources like potatoes or corn.
Ofirmev
Ofirmev is an intravenous (IV) form of acetaminophen. According to the manufacturer Mallinckrodt Pharmaceuticals, Ofirmev intravenous solution does not contain gluten. However, the company cannot guarantee the product is completely gluten-free due to potential cross-contamination risks.
Acetaminophen for Gluten-Sensitive Children
Acetaminophen in children’s pain and fever relievers may also be labeled gluten-free, but inactive ingredients should be checked carefully. Common kids’ brands like Children’s Tylenol, Little Remedies, Pediacare, and Up & Up children’s suspensions generally do not contain gluten. Liquid forms often contain gluten-free thickeners like xanthan gum or guar gum instead of wheat starch.
Other Pain Relievers Without Gluten
In addition to acetaminophen, other over-the-counter pain medications are typically gluten-free, but inactive ingredients should still be verified:
- Ibuprofen (Advil, Motrin)
- Naproxen sodium (Aleve)
- Aspirin
Popular brands of these pain relievers currently do not contain gluten. As always, double check labels to be safe.
Risks of Gluten Exposure
While trace gluten exposure from medications is typically minimal, individuals with celiac disease or wheat allergy should avoid even small amounts of gluten:
- Celiac disease – Gluten triggers an autoimmune reaction that damages the small intestine
- Non-celiac gluten sensitivity – Gluten causes abdominal pain, bloating, fatigue, and other symptoms
- Wheat allergy – Even tiny gluten exposures can provoke allergy symptoms
For those with gluten intolerance, look for acetaminophen capsules and tablets made without gluten-containing inactive ingredients. Consult your pharmacist or doctor if you have any concerns about the gluten content of a medication.
Signs of a Gluten Exposure Reaction
Those with celiac disease or gluten sensitivity should watch for potential symptoms after taking acetaminophen or other medications. Possible signs of an adverse reaction to gluten include:
- Digestive issues – Diarrhea, abdominal pain, cramping, bloating
- Fatigue and weakness
- Skin rash or irritation
- Joint pain
- Headaches
- Dizziness
- Tingling or numbness
Severe allergic reactions to gluten are rare but require immediate medical care. Anaphylaxis symptoms include breathing difficulty, swelling of the face, lips, tongue and throat, rapid heart rate, dizziness and loss of consciousness.
Precautions for Gluten-Sensitive Individuals
People with celiac disease, non-celiac gluten sensitivity or wheat allergy should take the following precautions with acetaminophen products:
- Read all medication labels carefully
- Call the manufacturer with any questions or concerns
- Look for pills without gluten-based inactive ingredients like wheat starch
- Seek store brand acetaminophen tablets without unnecessary additives
- Start with a low dose to test tolerance if uncertain about gluten content
- Consult a pharmacist about finding gluten-free medications
Being diligent about label reading, contacting drug makers, and purchasing only known gluten-free products can help reduce risks. Speak to a doctor or pharmacist for guidance identifying safe medications.
The Bottom Line
Pure acetaminophen does not contain gluten. However, inactive ingredients added to drug products could potentially introduce small amounts of gluten. Checking labels carefully and contacting manufacturers directly provides the most reliable information. With appropriate precautions, most people with gluten intolerance should be able to safely take acetaminophen for pain relief and fever reduction.
