Published March 2026
FDA Warns: Suboxone Film Causes Severe Dental Damage
In June 2022, the FDA required manufacturers of buprenorphine sublingual medicines — including Suboxone film — to add a dental warning to their labels. The warning confirmed what patients had been reporting for years: these medications cause serious dental damage. Here's everything you need to know.
The FDA's June 2022 Action
On June 21, 2022, the FDA issued a Drug Safety Communication requiring a class-wide dental warning for all buprenorphine medicines that dissolve in the mouth. The warning was required for Suboxone film, Subutex, Zubsolv, Bunavail, and all generic equivalents in sublingual or buccal dissolution form.
The FDA stated that it had received reports of "severe dental problems" in patients using these medications — including "tooth decay, cavities, oral infections, and loss of teeth." The FDA's communication confirmed that these dental problems were serious, were observed across all buprenorphine sublingual products, and occurred in patients who had no prior dental history.
What the FDA Found
- Severe dental problems including tooth decay, cavities, oral infections, and loss of teeth
- Dental problems in patients with no prior dental health issues
- Problems occurring regardless of how long patients had been using the medicine
- Issues requiring multiple extractions and significant dental treatment
- Problems described as "severe" and "life-altering" in nature
Why Did It Take So Long?
Suboxone film was approved in 2010. The FDA's dental warning came in 2022 — 12 years later. During that time, millions of patients used Suboxone film daily without any warning about dental risks.
The underlying chemistry that causes the dental damage — the film's highly acidic pH of approximately 3.4 — was not a mystery. The formulation properties were known to the manufacturer from the development stage. Post-market adverse event reports about dental problems would have been accumulating in Indivior's pharmacovigilance systems for years.
Plaintiffs in the Suboxone dental injury litigation allege that Indivior and Aquestive Therapeutics knew about the dental risk long before 2022 and failed to adequately warn patients, prescribers, or dentists.
What the Warning Means for Patients Who Were Already Harmed
For patients who used Suboxone film before 2022 and suffered dental damage, the FDA warning is both a vindication and a reference point. It officially confirms that the drug causes dental injury. It also establishes that millions of patients used the drug without proper warning for over a decade.
For statute of limitations purposes, the June 2022 FDA warning is significant. Many patients only became aware that Suboxone — not their history or oral hygiene — was responsible for their dental damage after this warning was issued. This may mean the filing deadline in many states started in June 2022 or later, not years before.
Current FDA Recommendations for Patients Still Using Suboxone
The FDA now recommends that patients using buprenorphine sublingual medicines:
- After the medicine dissolves, rinse the mouth with water and swallow
- Wait at least 1 hour before brushing teeth
- Schedule regular dental check-ups and inform dentists about Suboxone use
- Discuss dental health concerns with prescribing physicians
These are reactive measures — important for current patients, but they do nothing for the millions who suffered dental damage before the warning existed.
Do You Have a Claim?
If you used Suboxone sublingual film before the June 2022 FDA warning and suffered dental damage, you may have the right to seek compensation from the manufacturers who failed to warn you. A free case evaluation can help determine if you qualify.