FDA: Transmucosal Buprenorphine Medications Linked to Dental Issues

The FDA has identified 305 cases of dental problems with buprenorphine-containing medicines dissolved in the mouth.

Buprenorphine medications that dissolve in the mouth have been linked to dental problems, including tooth decay, cavities, infections, and tooth loss in some patients, according to a recent Food and Drug Administration (FDA) safety communication.

Transmucosal buprenorphine-containing medications are available as sublingual tablets and films for the treatment of opioid use disorder, and as buccal films for treating pain. Since the approval of buprenorphine in 2002, the FDA has identified 305 cases of dental problems associated with buprenorphine medicines that dissolve in the mouth; 131 of these cases were classified as serious.

In some cases, dental problems occurred as early as 2 weeks after starting treatment; the median time to diagnosis was reported to be approximately 2 years after treatment initiation. A number of these cases occurred in patients without prior history of dental problems. Tooth extraction/removal was the most common treatment and was reported in 71 cases.

Based on these findings, the FDA is requiring that the prescribing information for all transmucosal buprenorphine-containing medicines be updated with a warning about potential dental issues. Prior to initiating treatment, patients should be screened for oral disease and a referral to a dentist is recommended for a baseline dental evaluation.

It is also recommended that patients be counseled on maintaining oral health while on treatment. After the medication has fully dissolved in the oral mucosa, patients should gently rinse their teeth and gums with water and then swallow. Brushing should be avoided for at least an hour after using the medication.  

Despite the potential for dental problems, the FDA continues to believe the benefits of buprenorphine-containing medicines clearly outweigh the risks.


FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain. News release. US Food and Drug Administration. Accessed January 12, 2022. .https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorder.