FDA 2022: buprenorphine dissolved in the mouth can cause serious dental problems, and labels now say what helps
In January 2022 the FDA required a dental warning on buprenorphine that dissolves under the tongue or in the cheek. Labels now report cavities, abscesses and tooth loss, some in people with no past dental problems.
We have not finished checking this source. No judgement either way. how we score evidence
Caveat on this rating: Case reports without a rate; applies to products dissolved in the mouth only. The original FDA communication could not be read in this session.
The FDA's 2022 dental warning on buprenorphine taken by mouth, and what the label now tells people to do.
Significant findings
On 12 January 2022 the FDA notified makers of transmucosal buprenorphine products, under section 505(o)(4) of the Food, Drug, and Cosmetic Act, of "new safety information that we believe should be included in the labeling for transmucosal buprenorphine-containing products. This information pertains to the risk of dental caries." This row's anchor is FDA's June 2022 approval of the resulting Suboxone label revisions, "consistent with our January 12, 2022" letter (the same approval also covers a separate QT prolongation update).
The current Suboxone label, Warning 5.13 Dental Adverse Events: "Cases of dental caries, some severe (i.e., tooth fracture, tooth loss), have been reported following the use of transmucosal buprenorphine-containing products. Reported events include cavities, tooth decay, dental abscesses/infection, rampant caries, tooth erosion, fillings falling out, and, in some cases, total tooth loss." Treatment included extractions, root canals and dental surgery. "Multiple cases were reported in individuals without any prior history of dental problems." The label tells prescribers to refer patients for regular dental checkups and describes simple steps: after the dose has fully dissolved, gently rinse teeth and gums with water and swallow, and wait at least one hour before brushing.
The other direction
These are postmarketing case reports; the label gives no rate. The warning concerns only products dissolved in the mouth, not injections. The FDA's notice treated the medicine's benefit in opioid use disorder as the larger consideration and asked for prevention, not avoidance; the original communication is no longer online at fda.gov.
What this does not show
It does not mean buprenorphine should be stopped; stopping carries its own serious risks. It is a reason to see a dentist and follow the rinse and wait steps.
Worth asking
Can my prescriber refer me to a dentist, and is the rinse and one hour wait part of my routine?
Source
Supplement approval letter, NDA 022410/S-046 and S-047 (Suboxone sublingual film): labeling for dental caries and QT prolongation — US Food and Drug Administration, Center for Drug Evaluation and Research (2022)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- not recorded
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
We have not finished checking this source, so there is no scoring to show yet. “We have not checked this yet” and “this is disputed” are different statements, so no scored band is shown rather than a low one.
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "not yet assessed". We have not finished checking this source. No judgement either way. One caveat travels with that badge: Case reports without a rate; applies to products dissolved in the mouth only. The original FDA communication could not be read in this session. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Supplement approval letter, NDA 022410/S-046 and S-047 (Suboxone sublingual film): labeling for dental caries and QT prolongation — US Food and Drug Administration, Center for Drug Evaluation and Research (2022). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: not recorded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.