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  • Jefferson Adams
    Jefferson Adams

    Is Paxlovid Gluten-Free?

    Reviewed and edited by a celiac disease expert.

    Wondering if Covid-19 drug Paxlovid is gluten free?

    Is Paxlovid Gluten-Free? - Paxlovid. Image: CC BY-SA 4.0--Kches16414
    Caption: Paxlovid. Image: CC BY-SA 4.0--Kches16414

    Celiac.com 02/21/2023 - We get numerous questions about the gluten-free status of drugs and medications, including in our forum. Lately we've been seeing a bunch of questions about Paxlovid. Mainly, is Paxlovid gluten-free and safe for people with celiac disease?

    Produced in the U.S. by Pfizer, Paxlovid is the name brand for nirmatrelvir tablets co-packaged with ritonavir tablets. Paxlovid is a drug that has been granted Emergency Use Authorisation (EUA) by the FDA for the treatment of mild-to-moderate COVID-19 in adults and children, who have had a positive SARS-CoV-2 viral test, and face a high risk for progression to severe COVID-19, including hospitalization or death.

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    Is Paxlovid gluten-free and safe for people with celiac disease? The short answer is that Paxlovid is not labeled as gluten-free, and Pfizer cannot guarantee that it is gluten-free. However, Paxlovid contains no gluten ingredients, and is naturally gluten-free. The fact that it must be manufactured in an FDA approved lab should greatly reduce any risk of cross-contamination during the manufacturing process.

    In addition to the active ingredients, Nirmatrelvir UNII:7R9A5P7H32), and Ritonavir (UNII: O3J8G9O825)...

    Paxlovid's Inactive Ingredients Include:

    • Microcrystalline Cellulose (UNII: Op1r32d61u)
    • Lactose Monohydrate (UNII: Ewq57q8i5x)
    • Croscarmellose Sodium (UNII: M28ol1hh48)
    • Silicon Dioxide (UNII: Etj7z6xbu4)
    • Sodium Stearyl Fumarate (UNII: 7cv7wjk4ui)
    • Hypromellose 2910 (10000 Mpa.S) (UNII: 0ho1h52958)
    • Titanium Dioxide (UNII: 15fix9v2jp)
    • Polyethylene Glycol, Unspecified (UNII: 3wjq0sdw1a)
    • Ferric Oxide Red (UNII: 1k09f3g675)
    • Copovidone K25-31 (UNII: D9c330md8b)
    • Anhydrous Dibasic Calcium Phosphate (UNII: L11k75p92j)
    • Sorbitan Monolaurate (UNII: 6w9ps8b71j)
    • Silicon Dioxide (UNII: Etj7z6xbu4)
    • Sodium Stearyl Fumarate (UNII: 7cv7wjk4ui)
    • Hypromellose, Unspecified (UNII: 3nxw29v3wo)
    • Titanium Dioxide (UNII: 15fix9v2jp)
    • Polyethylene Glycol 400 (UNII: B697894sgq)
    • Hydroxypropyl Cellulose (1600000 Wamw) (UNII: Rfw2et671p)
    • Talc (UNII: 7sev7j4r1u)
    • Polyethylene Glycol 3350 (UNII: G2m7p15e5p)
    • Polysorbate 80 (UNII: 6ozp39zg8h)

    If you have celiac disease or gluten intolerance, be sure to check with your doctor or pharmacist before taking Paxlovid, but it is unlikely to contain any gluten ingredients.

    Side Effects of Paxlovid

    Stop taking Paxlovid and call a health care provider right away if they experience any of the following signs of an allergic reaction:

    • Hives
    • Trouble swallowing or breathing
    • Swelling of the mouth, lips, or face
    • Throat tightness
    • Hoarseness
    • Skin rash

    Other possible side effects include:

    • Altered or impaired sense of taste
    • Diarrhea
    • Elevated blood pressure
    • Muscle aches
    • Abdominal pain
    • Nausea
    • Feeling generally unwell

    For more information, try Dailymed.nlm.nih.gov

    Read more at YaleMedicine.org

    Join our forum discussion.


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    Recommended Comments

    LovintheGFlife

    @Jefferson Adamsthanks for a great and informative article. As someone who has worked in Pharma Quality and Compliance all my life, I can attest to the fact that there is likely to be no gluten in most drug products such as tablets and capsules. While active ingredients should never contain gluten, the culprit could well be the excipients (inactive ingredients) used in a formulation. However, I know for a fact that most pharma manufacturers require the suppliers of excipients to provide an allergen declaration. In almost all instances, I have come across a statement that the material (excipient) supplied is "free from gluten" or "gluten containing ingredients". With that said, it would be more reassuring for a patient to see the "Gluten Free" label on the finished product package. I wish the FDA would mandate that.

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    Plola

    So, while this was great info, my experience with taking paxlovid would indicate that there is something in the medicine that flares up celiac symptoms.  

    One of the main side effects of taking paxlovid is diarrhea.  Anyone with celiac is going to give a long pause on this. We all know the difference between sickness diarrhea and what I refer to as celiac poop (is there a proper name for this? I just make it up as I go along). 

    I take the first dose. 2 hrs later, I'm living on the toilet. I take the second dose. Same results. By the third dose, I am praying for death. 

    The last thing I want to deal with on top of trying to get over having covid is having to deal with my celiac being out of control. The pharmacist recommended NOT taking any other medication while taking paxlovid so I couldn't even take an antidiareheal to stop or slow down the madness. 

    This is a current result of my experience with paxlovid. I took my last dose this morning so I am still suffering the affects of all this.

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    Wheatwacked
    1 hour ago, Plola said:

    celiac poop

    I believe it is poor fat digestion from not absorbing choline or simply not eating enough. Gall bladder needs choline to make bile.  Most of the western countries have low choline intake (liver, eggs, beef) from misguided attempt to control cholesterol in the '70s and the Paxlovid somehow compounds it?

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    Wheatwacked

    By the way, do you know your vitamin D blood plasma?

    Vitamin D and the Immune System  There have been multiple cross-sectional studies associating lower levels of vitamin D with increased infection. 

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    Scott Adams
    2 hours ago, Plola said:

    So, while this was great info, my experience with taking paxlovid would indicate that there is something in the medicine that flares up celiac symptoms.  

    One of the main side effects of taking paxlovid is diarrhea.  Anyone with celiac is going to give a long pause on this. We all know the difference between sickness diarrhea and what I refer to as celiac poop (is there a proper name for this? I just make it up as I go along). 

    I take the first dose. 2 hrs later, I'm living on the toilet. I take the second dose. Same results. By the third dose, I am praying for death. 

    The last thing I want to deal with on top of trying to get over having covid is having to deal with my celiac being out of control. The pharmacist recommended NOT taking any other medication while taking paxlovid so I couldn't even take an antidiareheal to stop or slow down the madness. 

    This is a current result of my experience with paxlovid. I took my last dose this morning so I am still suffering the affects of all this.

    Diarrhea is a listed side-effect of the medication, so even those without celiac disease may experience it.

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    Plola
    3 minutes ago, Scott Adams said:

    Diarrhea is a listed side-effect of the medication, so even those without celiac disease may experience it.

    Agreed and I noted that originally.  The point I was attempting to make was that what I experienced would not be considered "normal" diarrhea but definitely a "celiac-type" diarrhea. There is a definite difference between the two. 

    If I was experiencing just normal diarrhea, we would not be having this conversation. If there is something in the medicine makes celiac symptoms flare up then we need to know so we can not take it and seek alternatives. 

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    Plola

    Had my gallbladder removed years ago but i haven't been able to eat much for the past 5 days. 

    Don't know what my vit d levels are but they historically have been low. Definitely need to get that checked. Thanks 😊 

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    trents

    I am a celiac dx'd 20 years ago. I took paxlovid last summer and had no issues. I realize that there is a great range of sensitivities in the celiac community to gluten and I am not particularly sensitive, insofar as immediate symptoms are concerned.

    I question whether or not a person can distinguish gluten-induced diarrhea or celiac-related diarrhea from other causes of diarrhea. There is a sense in which diarrhea is diarrhea. And I also acknowledge that you, Plola, are not saying that gluten in the paxlovid is necessarily the culprit.

    Edited by trents
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    knitty kitty

    @Plola,

    You're not alone!  I understand!  It's a dumping, mass evacuation type diarrhea. 

    Propylene Glycol is an ingredient, generally recognized as safe, but diarrhea is one of the side effects. 

    Propylene Glycol causes water from body fluids to influx into the intestines and colon which results in that mass evacuation.

    Propylene Glycol has been used as a colon cleanser in preparation for colonoscopy.  Definitely mass evacuation there.

    I bought a calcium supplement with propylene glycol and the same mass evacuation happened. 

    I hope you feel better! Try some slow cooked tender meat and veggies cooked in the crock pot or the oven.  Eat small amounts every two hours or so.  It does help keeping something in the stomach.  

     

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    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University. His articles, essays, poems, stories and book reviews have appeared in numerous magazines, journals, and websites, including North American Project, Antioch Review, Caliban, Mississippi Review, Slate, and more. He is the author of more than 2,500 articles on celiac disease. His university coursework includes studies in science, scientific methodology, biology, anatomy, physiology, medicine, logic, and advanced research. He previously devised health and medical content for Colgate, Dove, Pfizer, Sharecare, Walgreens, and more. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of numerous books, including "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

    >VIEW ALL ARTICLES BY JEFFERSON ADAMS

     


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