U.S. Food and Drug Administration (FDA) Warns of Dental Problems With Buprenorphine Dissolved in the Mouth (2022)

Table of Contents

1. What the U.S. Food and Drug Administration Announced on January 12, 2022
2. Which Medicines the Warning Covers
3. What the New Labeling Adds
4. What the U.S. Food and Drug Administration Found: 305 Reported Cases
5. What the Case Count Can and Cannot Show
6. The U.S. Food and Drug Administration’s Statement on Benefits and Risks
7. What the U.S. Food and Drug Administration Told Patients and Health Care Professionals
8. What the Warning Does Not Do
9. Dates and Legal Status as of October 18, 2026
10. How It Fits Other U.S. Food and Drug Administration Opioid Actions
11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What the U.S. Food and Drug Administration Announced on January 12, 2022

The announcement was a U.S. Food and Drug Administration Drug Safety Communication, a safety announcement with separate sections for patients and caregivers and for health care professionals. Dated January 12, 2022, it carries the title “U.S. Food and Drug Administration warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain,” with the subtitle “Benefits for use outweigh these risks and oral care can help.” It is not a Federal Register rule and lists no Federal Register docket.

The communication opens with the safety concern in the U.S. Food and Drug Administration’s words: dental problems “including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.”

Under the heading “What is U.S. Food and Drug Administration doing?” the agency states that it is “requiring a new warning about the risk of dental problems be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth.” The prescribing information is the detailed label written for prescribers; the Medication Guide is the leaflet handed to patients with each prescription. The U.S. Food and Drug Administration adds that both will include “strategies to maintain or improve oral health while undergoing treatment with these medicines.”

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2. Which Medicines the Warning Covers

The communication explains that buprenorphine is an opioid that “works by changing the way the brain and nervous system respond to pain,” and that at proper doses it “decreases the pleasurable effects of other opioids, making misuse of them less appealing.” It gives this history: buprenorphine was approved in 2002 as a tablet placed under the tongue to treat opioid use disorder (OUD), and in 2015 as a film placed inside the cheek to treat pain.

The warning applies to the forms that dissolve in the mouth. The U.S. Food and Drug Administration describes them as:

• tablets and films dissolved under the tongue (sublingual) or placed against the inside of the cheek (buccal), kept there until completely dissolved;
• both single-ingredient products and products that combine buprenorphine with naloxone;
• both brand-name and generic versions.

The U.S. Food and Drug Administration’s health-professional section calls these “transmucosal” products, meaning they are absorbed through the lining of the mouth. The communication notes that most of these medicines are approved to treat OUD and one product is approved to treat pain.

Other forms are outside the warning. The U.S. Food and Drug Administration states that there are also buprenorphine products for pain and OUD “delivered by other routes such as a skin patch and injection, but U.S. Food and Drug Administration has not identified a concern for dental health related to these other forms.”

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3. What the New Labeling Adds

According to the communication, the new prescribing and patient information includes strategies for oral health. As the U.S. Food and Drug Administration describes them, these strategies include prescribers referring patients to dental care services and encouraging regular checkups while they take these products. The U.S. Food and Drug Administration’s patient and professional sections describe these oral-care measures:

• Rinsing after the dose. After the medicine is completely dissolved, taking a large sip of water, swishing it gently around the teeth and gums, and swallowing.
• Waiting to brush. Waiting at least 1 hour before brushing the teeth. The U.S. Food and Drug Administration’s professional section gives the reason: to let the mouth “gradually return to oral homeostasis” (its natural state) and to prevent mechanical damage that brushing might cause.
• A dental visit early in treatment. Seeing a dentist soon after starting the medicine, telling the dentist about the buprenorphine, and having regular dental checkups while taking it.
• Dental history. Telling the prescriber about any history of tooth problems, including cavities.

For dentists, the U.S. Food and Drug Administration describes a baseline dental evaluation, a caries risk assessment (caries is the clinical term for tooth decay), a preventive plan against decay, and regular checkups.

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4. What the U.S. Food and Drug Administration Found: 305 Reported Cases

The communication’s Data Summary describes a review of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), the agency’s database of reports of side effects sent in by health professionals, patients and manufacturers, together with the medical literature, through December 31, 2018. The U.S. Food and Drug Administration reports:

• 305 cases of dental problems with buprenorphine dissolved in the mouth, 131 of them classified as serious.
• An average age of 41.8 years (range 18 to 71).
• Most cases in people using the medicines for OUD; 28 cases in people using a pain-only product or treated for pain.
• 26 cases in people with no reported prior history of dental problems.
• A median time to diagnosis of 24.25 months (about 2 years) after starting treatment, with a range of 0.5 to 182 months; some cases reported problems as soon as 2 weeks after treatment began.
• 113 cases mentioning two or more teeth; some mentioned 11 to 12 or more teeth, and 11 cases involved all teeth.
• Of the 151 cases that reported a treatment, tooth extraction was the most common, in 71 cases; others required root canals, dental surgery, or restorative work such as crowns and implants.

The professional section lists the reported events as cavities and tooth decay, including rampant caries; dental abscesses and infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss. The U.S. Food and Drug Administration notes that many cases were reported by health care professionals and documented extensive dental damage, in phrases such as “all upper,” “all lower,” “multiple teeth” and “rampant decay.”

The Data Summary adds context: people with OUD “may have a higher incidence of poor dental health,” and the U.S. Food and Drug Administration cites a 2020 systematic review on dental caries and gum disease among people who use drugs (listed below under Key Research Papers). It then states that many cases nonetheless described severe dental problems in people with no reported prior dental history.

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5. What the Case Count Can and Cannot Show

The 305 cases are reports, not a measured rate. The U.S. Food and Drug Administration states that the count includes only cases “reported to U.S. Food and Drug Administration or published in the medical literature, so there may be additional cases about which we are unaware.”

Under the heading “What is my risk?” the communication explains that people respond differently to medicines depending on their health, other medicines, other diseases, genetic factors and other reasons, and concludes: “As a result, we cannot determine how likely it is that someone will experience these side effects when taking buprenorphine medicines that dissolve in the mouth.”

The communication also gives a measure of how many people take these medicines. It reports that the estimated number of prescriptions for buprenorphine medicines dissolved in the mouth, dispensed from U.S. outpatient retail and mail-order pharmacies, rose from 11 million in 2014 to 16 million in 2020. It lists the common side effects of buprenorphine as headache, nausea, vomiting, constipation, pain, increased sweating and insomnia.

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6. The U.S. Food and Drug Administration’s Statement on Benefits and Risks

The communication pairs the warning with a statement of benefit, repeated in several sections: buprenorphine “is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.”

The U.S. Food and Drug Administration describes what the medicine does in OUD: regular use “reduces withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse.” It describes buprenorphine combined with counseling and other behavioral therapies as medication-assisted treatment (MAT), and calls this approach “often one of the most effective ways to treat OUD,” one that “can help sustain recovery and prevent or reduce opioid overdose.”

The communication also cites the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), stating that according to SAMHSA, MAT “has been shown to be effective in improving patient survival, decreasing opioid use, and allowing patients to live a self-directed life, including the ability to gain and maintain employment.”

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7. What the U.S. Food and Drug Administration Told Patients and Health Care Professionals

The communication contains separate lists for patients and caregivers and for health care professionals. These are the U.S. Food and Drug Administration’s statements, reported here as the agency gave them.

To patients and caregivers, the U.S. Food and Drug Administration:

• advised continuing buprenorphine as prescribed and not stopping it suddenly without first talking to a health care professional. The agency explained that suddenly stopping could cause withdrawal symptoms, “because your body has become used to the buprenorphine medicine,” or a relapse to opioid misuse “that could result in overdose and death”;
• described the rinsing and 1-hour brushing measures in section 3, a dental visit soon after starting, and regular checkups;
• advised notifying both the health care professional and the dentist immediately about any problems with the teeth or gums;
• pointed to the Medication Guide, which it said “will be updated with this new or other important information,” and to reporting side effects to the U.S. Food and Drug Administration’s MedWatch program.

To health care professionals, the U.S. Food and Drug Administration:

• restated that the benefits of buprenorphine clearly outweigh the risks and that it is an important tool to treat OUD;
• described screening patients for oral disease and asking about oral health history before starting a transmucosal buprenorphine medicine;
• described referring patients to a dentist as soon as possible after starting, counseling them about the reported dental problems and the rinse-and-wait measures, and encouraging them to read the Medication Guide;
• described counseling OUD patients about the serious consequences of stopping, including relapse, misuse of other opioids, overdose and death.

Decisions about a person’s own medicines belong with the clinician who prescribes them.

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8. What the Warning Does Not Do

• It does not restrict buprenorphine. The U.S. Food and Drug Administration states that the benefits clearly outweigh the risks, and the communication describes sudden stopping as carrying a risk of withdrawal or relapse to opioid misuse.
• It does not cover skin patches or injections. The U.S. Food and Drug Administration states it has not identified a dental-health concern with those forms.
• It does not give a rate. The U.S. Food and Drug Administration states that it cannot determine how likely it is that a person will experience these side effects; the 305 cases are reports, and there may be cases the agency does not know of.
• It is a labeling action. What the U.S. Food and Drug Administration required is a new warning and oral-care information in the prescribing information and the Medication Guide.
• It does not name one cause. The communication reports the cases and the measures in the labeling; it does not state a mechanism for the dental damage.

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9. Dates and Legal Status as of October 18, 2026

• 2002: buprenorphine first approved, as a tablet placed under the tongue to treat OUD (as the communication states).
• 2015: a buprenorphine film placed inside the cheek approved to treat pain.
• December 31, 2018: end of the period covered by the U.S. Food and Drug Administration’s case review.
• January 12, 2022: the U.S. Food and Drug Administration issues the Drug Safety Communication and requires the new warning (the U.S. Food and Drug Administration page shows its content current as of January 21, 2022).
• December 27, 2024: the U.S. Food and Drug Administration publishes a separate Federal Register notice on the dosage statements in the labeling of buprenorphine products for opioid dependence (89 FR 105613; Docket No. FDA-2024-N-5381; see section 10).

Status as of October 18, 2026: the warning is in effect. A query of the Federal Register for U.S. Food and Drug Administration documents mentioning buprenorphine from January 1, 2022 through October 18, 2026 found no document withdrawing or changing the dental warning. The date on which the updated labels themselves were approved was not found in the documents read for this page and is not given here.

A Federal Register docket is the public file for an action, where its documents and public comments are kept on regulations.gov.

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10. How It Fits Other U.S. Food and Drug Administration Opioid Actions

The dental warning is one of several U.S. Food and Drug Administration labeling actions on opioid medicines in these years:

• January 12, 2022. The dental-problems warning for buprenorphine dissolved in the mouth (this page). The communication’s related-information list points to the shared risk program for buprenorphine products for opioid dependence and to the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy).
• 2023. The U.S. Food and Drug Administration required new safety labeling for all opioid pain medicines, reported on the page U.S. Food and Drug Administration Requires New Safety Labeling for All Opioid Pain Medicines (2023). The same year it approved the first over-the-counter naloxone nasal spray, an opioid overdose reversal medicine, reported on U.S. Food and Drug Administration Approves the First Over-the-Counter Naloxone Nasal Spray (2023).
• December 27, 2024. In a Federal Register notice, the U.S. Food and Drug Administration concluded that certain statements in the labeling of buprenorphine products for opioid dependence, on the recommended maintenance dosage and on dosage adjustments during pregnancy, “can be modified,” because the labeling “may be misinterpreted by some as establishing a maximum dosage when none exists.” The U.S. Food and Drug Administration said it was concerned that this misreading “may be adversely impacting patients’ access” to these products, and it encouraged the holders of approved applications to submit labeling supplements. This is a different labeling issue from the dental warning and does not reverse it.

Other U.S. Food and Drug Administration actions of 2022 are listed on the U.S. Food and Drug Administration Actions of 2022 hub, among them two other labeling and approval decisions on medicines: the emergency contraceptive label update and the tirzepatide approval for type 2 diabetes.

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11. Primary Documents

1. U.S. Food and Drug Administration (2022). U.S. Food and Drug Administration warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain. Drug Safety Communication, January 12, 2022; content current as of January 21, 2022. No Federal Register docket — fda.gov Drug Safety Communication
2. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2024). Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence. Notice. Federal Register 89 FR 105613, December 27, 2024. Docket No. FDA-2024-N-5381 — FR Doc. 2024-30776
3. Public docket FDA-2024-N-5381 — regulations.gov FDA-2024-N-5381

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Key Research Papers

1. Suzuki J, Park EM (2012). Buprenorphine/naloxone and dental caries: a case report. The American Journal on Addictions 21(5):494-495 — PubMed PMID: 22882403
2. Suzuki J, Mittal L, Woo SB (2013). Sublingual buprenorphine and dental problems: a case series. The Primary Care Companion for CNS Disorders 15(5):PCC.13l01533 — PubMed PMID: 24511440
3. Yazdanian M, Armoon B, Noroozi A, Mohammadi R, Bayat AH, Ahounbar E, Higgs P, Nasab HS, Bayani A, Hemmat M (2020). Dental caries and periodontal disease among people who use drugs: a systematic review and meta-analysis. BMC Oral Health 20(1):44 — PubMed PMID: 32041585
4. Etminan M, Rezaeianzadeh R, Kezouh A, Aminzadeh K (2022). Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease. JAMA 328(22):2269-2271 — PubMed PMID: 36511932
5. Barus R, Montastruc F, de Canecaude C, Bagheri H, Sommet A, Lapeyre-Mestre M (2023). Sublingual/Buccal buprenorphine and dental problems: a pharmacovigilance study. Expert Opinion on Drug Safety 22(12):1283-1287 — PubMed PMID: 37584264
6. Zheng Z, Chen J, Srinual S, Tumbas Šaponjac V, Yin T, Wang BY, Sun R, Hu M (2025). Buprenorphine Salivary Gland Accumulation Sustaining High Oral Fluid Exposure and Increasing the Risk of Streptococcus mutans Biofilm Formation. Journal of Addiction Medicine 19(5):520-528 — PubMed PMID: 39621545
7. Tuan WJ, Clebak KT, Jawadi E, Snyder J, Zgierska AE (2025). Risk of Oral Health Problems in Adults With Opioid Use Disorder Treated With Transmucosal Buprenorphine. Journal of Addiction Medicine 19(5):529-535 — PubMed PMID: 40062592

The first two papers, a case report and a case series, are the two literature references the U.S. Food and Drug Administration cites for its case review; the third is the systematic review the U.S. Food and Drug Administration cites on dental health among people who use drugs. The fourth, published in December 2022, is a study of the association between sublingual buprenorphine-naloxone and dental disease. The fifth is a pharmacovigilance study of reported dental problems with sublingual and buccal buprenorphine. The last two, from 2025, study a possible mechanism through saliva and oral bacteria, and the risk of oral health problems in adults with OUD treated with transmucosal buprenorphine.

PubMed Topic Searches

1. PubMed: buprenorphine and dental caries
2. PubMed: transmucosal buprenorphine and oral health
3. PubMed: opioid use disorder and oral health

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Connections

• U.S. Food and Drug Administration Actions of 2022
• U.S. Food and Drug Administration and Regulation
• Addiction
• Opioid Overdose
• Dentistry & Oral Health
• Periodontitis (Gum Disease)
• New Safety Labeling for Opioid Pain Medicines (2023)
• Over-the-Counter Naloxone Nasal Spray (2023)
• Emergency Contraceptive Label Update (2022)
• Tirzepatide Approval for Type 2 Diabetes (2022)

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