Suboxone: Side Effects, Safety Warnings and Dental Risks
The FDA has warned that dissolvable Suboxone (buprenorphine and naloxone) films are associated with serious dental problems, including tooth loss and decay. This led to Suboxone injury lawsuits against Indivior. Common, less serious Suboxone side effects include headache, nausea and vomiting.
- Last update: July 11, 2025
What Is Suboxone and How Does It Work?
Suboxone is a prescription medication approved by the FDA in 2002 to treat opioid use disorder (OUD). It combines two active ingredients: buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist).
It’s available in tablet form or as a dissolvable film that can be placed under the tongue.
The drug works in two ways. Buprenorphine partially binds to receptors in the brain to relieve opioid withdrawal symptoms and reduce opioid cravings without causing a high. Naloxone blocks opioid receptors in the brain to help prevent Suboxone abuse by triggering withdrawal symptoms.
Indivior manufactures brand-name Suboxone, and it’s also available in generic form as buprenorphine and naloxone.
Suboxone Side Effects
The most common side effects of Suboxone include headache, nausea and vomiting. However, Suboxone also has more serious side effects, such as dental problems and life-threatening breathing problems.
Common side effects may be temporary and last for only a few days or weeks. If these don’t go away or bother you, you can talk to your medical provider.
- Headache
- Nausea
- Vomiting
- Constipation
- Pain
- Increased sweating
- Decrease in sleep (insomnia)
Serious Suboxone side effects are rarer when patients take the drug exactly as directed. However, if you experience any of the side effects listed below, you should talk to your doctor right away.
- Trouble breathing
- Don’t take Suboxone with other medicines that contain opioids, such as benzodiazepines, alcohol or other central nervous system depressants. This can cause breathing problems and may lead to coma or death. Seek help right away if you experience dizziness, blurred vision, slurred speech, breathing that’s slower than normal, confusion or trouble thinking clearly.
- Physical dependence or abuse
- It’s possible to abuse Suboxone and become dependent on it, just like other opioids. It can also cause opioid withdrawal symptoms. Call your medical provider if you experience symptoms such as shaking, excessive sweating, diarrhea, muscle aches or vomiting.
- Liver problems
- Before starting Suboxone, your medical provider should do liver function tests. Let your medical provider know right away if you experience yellowing of the skin or eyes, nausea, light colored stools, pain in the right side of your stomach, loss of appetite, dark urine or nausea.
- Allergic reaction
- Allergic reactions are a medical emergency. Call your doctor or seek emergency help if you experience a rash, face swelling, hives, wheezing or trouble breathing, low blood pressure or loss of consciousness.
- Dental problems
- Suboxone users have reported serious dental problems such as tooth loss or tooth fractures. This can happen in people with no history of poor dental health. Other dental issues include cavities, infections, fillings falling out and total tooth loss.
This isn’t a complete list of all side effects. If you experience any changes in your health or notice new symptoms, make sure you talk to your doctor right away.
Suboxone and Dental Damage
In 2022, the FDA issued a safety communication warning that it had received reports of serious dental problems with Suboxone, including “tooth decay, cavities, oral infections, and loss of teeth.” These problems can be serious and affect people with no history of dental issues.
Researchers aren’t sure exactly how Suboxone damages teeth. However, some evidence suggests that Suboxone’s acidity (pH of 3.4) is too high, causing dental problems. High acidity can alter the bacteria on teeth, increasing the risk of cavities. Patients take Suboxone about three times a day, and Suboxone film takes about five to 10 minutes to dissolve. This exposes teeth to the acidic environment multiple times a day for a prolonged period.
- Get regular dental checkups while taking Suboxone
- Gently rinse teeth and gums with water after Suboxone is dissolved
- Wait at least an hour after taking Suboxone before brushing teeth
In addition to the 2022 safety communication, the FDA required Indivior to place a warning on the drug’s label to inform the public about the dental problem reports.
However, Suboxone had been on the market since 2002 without warnings, potentially exposing many patients to tooth damage. Some people who experienced dental problems after using Suboxone films filed lawsuits.
Dental Side Effects Can Be Devastating
One Suboxone patient shared her experience with us under the initials D.S. to protect her privacy. She suffered dental problems for years and didn’t know it was Suboxone until recent research came out. She felt the manufacturer withheld information about the risk from consumers.
She’s had multiple cavities, several teeth pulled and multiple root canals. It’s affected her self-esteem and quality of life.
“I don’t have the first clue how I will ever afford getting new teeth because I can’t go on like this. I am in constant pain, and I cannot even properly eat. It’s unfair and devastating. And the worst part is that this is not a medication that can abruptly be stopped and involves a lengthy weaning process,” D.S. told Drugwatch.
Suboxone Withdrawal and Dependence
While people use Suboxone to treat opioid dependence, it can also be addictive and cause withdrawal symptoms if patients stop taking the drug too quickly.
- Anxiety
- Chills
- Concentration difficulties
- Depression
- Digestive distress
- Drug cravings
- Fever
- Headaches
- Insomnia
- Irritability
- Lethargy
- Muscle aches/body aches
- Nausea
- Vomiting
The severity of symptoms varies and depends on the strength of the dose and how long a patient has been on the drug. Symptoms may last for as long as a month. Most physical withdrawal symptoms occur within the first 72 hours.
-
72 hours
Physical symptoms
-
1 week
Symptoms include insomnia, mood swings, body aches and pains
-
2 weeks
Psychological symptoms, such as depression
-
1 month
Depression continues, cravings and psychological dependence
To prevent these symptoms, avoid stopping Suboxone abruptly. Be sure to get professional guidance to gradually taper off the medication.
Suboxone Safety in Special Populations
Suboxone isn’t for everyone and has varying levels of safety in pregnant people, children and older adults.
- Pregnancy: Babies born to mothers taking Suboxone may suffer from opioid withdrawal. Symptoms include irritability, hyperactivity, vomiting, diarrhea and failure to gain weight.
- Men and women of reproductive age: Infertility may occur after taking opioids, including Suboxone, and researchers don't know if it's reversible.
- Breastfeeding: Suboxone can pass into breast milk. Monitor babies for increased sleepiness, drowsiness and trouble breathing.
- Children:Suboxone’s safety hasn’t been tested in pediatric patients.
- Older adults: Suboxone hasn’t been tested in enough adults over age 65 to determine its safety for older people. Elders should use Suboxone cautiously because of its potential to affect the heart and kidneys.
Before taking Suboxone, make sure you tell your medical provider about any drugs you’re taking and any health conditions you have.
What To Do if You're Experiencing Side Effects
If you experience any Suboxone side effects, make sure you tell your medical provider right away. If you are having dental problems, talk to your dentist.
Talk to your medical provider about Suboxone alternatives or if you can taper off the drug safely.
The FDA encourages people to submit reports about side effects to its MedWatch Program.
If you’re considering taking legal action against Indivior for severe dental damage, make sure you get your medical and dental records. Keep any receipts or prescription notes about your history of using Suboxone.
Suboxone and Legal Action
If you’ve used Suboxone films (sublingual films) and suffered dental problems, it’s not your fault, and you may be able to pursue legal action against Indivior.
“There’s already the stigma attached to the fact that somebody is struggling with addiction issues. So that is crushing. Someone’s self-confidence and self-worth are obviously affected. Then just add to that this condition with serious dental issues and it makes it exponentially worse than it already was,” Suboxone lawyer Trent Miracle told Drugwatch.
Suboxone lawsuits accuse Indivior of failing to warn health care providers and patients about the risks of severe dental problems. Injuries in lawsuits include oral infections, tooth decay, cavities and tooth loss.
You can sign up for a free Suboxone case review on Drugwatch, and there’s never any pressure to pursue a claim. We’ll match you with a lawyer for your specific situation, and you can change your mind at any time.
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