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FDA warns of oral health problems linked to transmucosal buprenorphine

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January 13, 2022

2 min read

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The FDA is warning patients and health care professionals that transmucosal buprenorphine products may cause tooth decay, cavities, oral infections and tooth loss, even in patients with no prior history of dental issues.

“Despite these risks, buprenorphine is an important treatment option for opioid use disorder and pain, and the benefits of these medicines clearly outweigh the risks,” the FDA said in a drug safety communication issued Jan. 12.

Older man experiencing what appears to be mouth pain

The FDA said it is aware of 305 cases of individuals who took certain transmucosal buprenorphine products and later experienced one of several oral health issues.  
Photo source: Adobe stock

In the nearly 2 decades since the FDA first approved buprenorphine, the agency said it has identified 305 cases of dental problems that were associated with buprenorphine tablets and films that dissolve under the tongue or against the inside of the cheek. The average age of the patients was 42 years; however, some were as young as 18 years. Of the cases that the FDA identified, 131 were classified as serious. In 26 of the cases, the patient had no previous history of dental problems.

The dental problems were reported from 2 weeks to 2 years after initiating buprenorphine treatment, according to the FDA. The agency said it is unable to assess how likely it is that a person who takes transmucosal buprenorphine will experience oral health complications.

The FDA is requiring updates to the prescribing information and medication guide for transmucosal buprenorphine products to include information about the risk for dental issues.

The agency also encouraged health care professionals to ask patients about their oral health history before they prescribe transmucosal buprenorphine and to advise patients with opioid use disorder to continue taking their buprenorphine as prescribed. Health care professionals should refer patients to a dentist as quickly as possible after starting the treatment and encourage them to “gently rinse their teeth and gums with water and then swallow” after the product has been fully dissolved and to wait at least 1 hour before brushing their teeth, the FDA said.


FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorder. Published Jan. 12, 2022. Accessed Jan. 13, 2022.

FDA warns about risks of dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-risks-dental-problems-associated-buprenorphine-medicines-dissolved-mouth-treat?utm_medium=email&utm_source=govdelivery. Published Jan. 12, 2022. Accessed Jan. 13, 2022.