Suboxone (buprenorphine and naloxone) is one of the most effective and well-studied medications for treating opioid use disorder, but like any medication, it can cause side effects. Understanding what's common, what's a dental red flag, and what's a medical emergency can help you feel more confident in your treatment and know when to reach out to your care team.
Common Side Effects
The side effects below are the ones most frequently reported in clinical studies of Suboxone sublingual film. They tend to be mild to moderate and often ease as your body adjusts to the medication. Taking your dose correctly (letting the film or tablet fully dissolve under your tongue rather than swallowing it) can also help minimize some of these effects.
| Side Effect | What to Know |
|---|---|
| Oral hypoesthesia | A numb or "sleepy" feeling in the mouth where the film dissolves. Usually temporary and resolves after the dose is fully absorbed. |
| Tongue pain (glossodynia) | A burning or aching sensation on the tongue, most noticeable during the dissolving process. |
| Mouth redness (oral mucosal erythema) | Mild irritation or redness where the film sits against the inside of the mouth. |
| Headache | One of the most commonly reported side effects, typically mild and manageable with rest and hydration. |
| Nausea | Can occur, especially early in treatment or after dose changes; often improves over time. |
| Vomiting | Less common than nausea but can happen, particularly during the first days of treatment. |
| Sweating (hyperhidrosis) | Excessive sweating unrelated to heat or exercise; a known effect of buprenorphine. |
| Constipation | A common opioid-related effect. Staying hydrated, eating fiber, and staying active can help. |
| Withdrawal-like symptoms | Can occur if a dose is taken too soon after opioid use, or during dose adjustments. Your provider can help you time doses correctly. |
| Insomnia | Some people notice trouble falling or staying asleep, particularly when starting treatment. |
| General pain | Some patients report body aches or generalized pain unrelated to a specific injury. |
| Peripheral edema | Mild swelling in the hands, ankles, or feet has been reported in some patients. |
Dental Health Warning
The FDA has issued a specific safety warning about dental problems associated with buprenorphine medicines that dissolve in the mouth, including Suboxone film and tablets. Reported issues include tooth decay, cavities, oral infections, and in some cases tooth loss. This appears to be related to the acidity of the dissolved medication and its prolonged contact with tooth surfaces and gums, even in patients with no prior history of dental problems.
You can lower this risk with a few simple habits: rinse your mouth gently with water after your dose has fully dissolved (swallow the water, don't spit, since the medication is still absorbing), wait at least an hour before brushing your teeth, and keep up with routine dental checkups. Be sure to tell your dentist that you're taking Suboxone so they can monitor your oral health accordingly.
Serious Risks and Warnings
Beyond the common side effects above, Suboxone carries several serious risks that are important to understand, even though they are far less common than the mild effects listed earlier.
The most important of these is life-threatening respiratory and central nervous system depression, meaning breathing can become dangerously slow or stop altogether. This risk rises sharply when Suboxone is combined with benzodiazepines (such as Xanax, Valium, or Klonopin), alcohol, or other central nervous system depressants like sedatives or sleep medications. This is one of the most serious safety concerns associated with buprenorphine, and you should never combine Suboxone with these substances without your provider's explicit guidance. Always tell your care team about every medication and substance you use.
Suboxone has also been associated with liver problems, including hepatitis and hepatotoxicity (liver injury). Your provider may check liver function through bloodwork, particularly if you have a history of liver disease.
If Suboxone is used during pregnancy, babies can be born with neonatal opioid withdrawal syndrome, a treatable but medically monitored condition. If you are pregnant or planning to become pregnant, your provider will talk through the risks and benefits with you directly, since untreated opioid use disorder carries its own significant risks in pregnancy.
Finally, like other medications used to treat opioid use disorder, Suboxone causes physical dependence. Stopping abruptly can trigger withdrawal symptoms. If you and your provider decide it's time to discontinue treatment, it should be done through a gradual, supervised taper rather than stopping suddenly.
According to the FDA-approved prescribing information for Suboxone sublingual film, the most commonly reported adverse reactions include oral numbness, tongue pain, mouth redness, headache, nausea, vomiting, sweating, constipation, withdrawal symptoms, insomnia, pain, and peripheral swelling. The label also carries serious warnings about life-threatening respiratory depression when combined with benzodiazepines or other CNS depressants, liver injury, neonatal opioid withdrawal syndrome, and physical dependence. Separately, the FDA has warned about dental problems, including tooth decay and infection, linked to buprenorphine medicines that dissolve in the mouth.
Side Effects That Need Medical Attention
Contact your provider promptly if you notice signs of a liver problem, such as yellowing of the skin or eyes, unusually dark urine, or severe stomach pain. Reach out as well if you have questions about a persistent or worsening side effect, or if a dose adjustment seems needed.
Seek emergency care immediately (call 911) if you experience signs of a severe allergic reaction (swelling of the face, lips, tongue, or throat, hives, or difficulty breathing), extreme drowsiness, confusion, or trouble waking up, or slowed, shallow, or stopped breathing. These can be signs of a medical emergency, particularly if Suboxone was combined with alcohol, benzodiazepines, or other sedating substances.
This article is for general educational purposes and isn't a substitute for individualized medical advice. Your treatment plan should be developed with your own provider based on your specific health history. If you are experiencing a medical emergency, call 911.