Medication Treatment
Buprenorphine Side Effects: What's Common and What Needs a Call
What Are the Side Effects of Buprenorphine?
The most common buprenorphine side effects are headache, constipation, nausea, vomiting, sweating, trouble sleeping and tiredness, and Suboxone film can also numb or redden your mouth. SAMHSA also lists tooth decay, and the FDA warns that the films and tablets can damage teeth. Serious risks include slowed breathing (especially with alcohol or sedatives), liver problems, allergic reactions and sudden withdrawal if the first dose comes too soon. The Suboxone doctors guide explains how to find a prescriber.
Buprenorphine is one of the three medications approved to treat opioid use disorder (OUD), and it’s the medicine inside Suboxone, Zubsolv, Sublocade and Brixadi. Most of its side effects are mild and familiar from other opioids: headache, constipation, nausea and sweating. A few need a call to your prescriber the same day. This page lays out both, with the numbers from the FDA label, the dental warning that most people never hear about, and the mixes that turn a safe medicine dangerous.
The Most Common Buprenorphine Side Effects
Headache, constipation, nausea, vomiting, sweating, trouble sleeping and tiredness top every official list. SAMHSA’s buprenorphine page names these common side effects:
- constipation, headache, nausea and vomiting
- dizziness, drowsiness and fatigue
- sweating and dry mouth
- tooth decay
- muscle aches and cramps
- trouble sleeping
- fever, blurred vision or wide pupils
- tremors, a pounding heartbeat (palpitations) and trouble paying attention
Tell your prescriber about any side effect that bothers you or doesn’t go away. A different dose or a different form can make treatment easier to stay on. That matters, because NIDA reports that people treated with buprenorphine or methadone are less likely to die or overdose.
How Often Each Side Effect Shows Up
The Suboxone label includes a 4-week study that compared buprenorphine with naloxone, buprenorphine alone and a placebo (a dummy pill). The placebo column matters: people coming off opioids feel rough whether or not they get medicine, so the gap between columns shows what the drug itself adds.
| Side effect | Buprenorphine + naloxone | Buprenorphine alone | Placebo |
|---|---|---|---|
| Headache | 36.4% | 29.1% | 22.4% |
| Withdrawal symptoms | 25.2% | 18.4% | 37.4% |
| Nausea | 15.0% | 13.6% | 11.2% |
| Sweating | 14.0% | 12.6% | 10.3% |
| Trouble sleeping | 14.0% | 21.4% | 15.9% |
| Constipation | 12.1% | 7.8% | 2.8% |
| Stomach pain | 11.2% | 11.7% | 6.5% |
| Vomiting | 7.5% | 7.8% | 4.7% |
Two things stand out. Headache and constipation clearly rise with the medicine. Withdrawal symptoms do the opposite: they were most common in the placebo group, because buprenorphine is what keeps withdrawal away.
The label also says restlessness was the most common problem during the first dose and the 3 days after it, so the first stretch is usually the bumpiest.
Suboxone Film, Tablets and the Monthly Shot Compared
The form you take changes which side effects you’re likely to notice. Films and tablets act in your mouth, and the injections act at the shot site.
| Film or tablet (Suboxone, Zubsolv, generics) | Injection (Sublocade, Brixadi) | |
|---|---|---|
| How it’s taken | Dissolves under the tongue or inside the cheek, once a day | Shot under the skin by a provider, weekly or monthly |
| Side effects specific to the form | Mouth numbness or redness, tongue pain, tooth decay | Pain, itching, swelling, redness or a lump at the shot site |
| Dental warning | Yes, FDA warning since 2022 | The FDA found no dental concern |
| Special rule | Don’t eat, drink or talk until it dissolves | Given only through a restricted program |
MedlinePlus lists mouth numbness or redness, tongue pain, back pain, and swelling in the hands, feet, ankles or lower legs among the common side effects of the film and tablets.
For the shots, MedlinePlus says a lump at the injection site can last several weeks and should shrink over time. In the Sublocade label, 16.5% of people in the main studies had some kind of injection-site reaction. The label’s boxed warning says the medicine turns into a solid mass in the body and can cause serious harm or death if it’s ever put into a vein, which is why only a provider gives it.
If you’re weighing a daily film against a monthly shot, or buprenorphine against methadone, the medication for opioid use disorder guide compares all three approved medicines side by side.
Buprenorphine and Your Teeth
Buprenorphine that dissolves in your mouth can damage your teeth, even if you’ve never had dental trouble. In January 2022, the FDA warned about tooth decay, cavities, mouth infections and tooth loss linked to these films and tablets. It found 305 cases, 131 of them serious, and 26 in people with no history of dental problems.
The FDA’s advice is simple:
- Let the film or tablet dissolve completely.
- Take a large sip of water, swish it gently around your teeth and gums, and swallow.
- Wait at least 1 hour before you brush your teeth.
Tell your dentist you take buprenorphine and keep up with regular checkups. MedlinePlus says to call your dentist right away about any tooth or gum problem. The FDA also said the benefits of these medicines clearly outweigh the dental risk, so don’t stop because of it. Ask about the injection if dental problems keep coming back.
Serious Side Effects: When to Call Your Doctor
Some side effects need a call to your prescriber right away, and slowed breathing needs 911. MedlinePlus lists these warning signs for the film and tablets:
- Allergic reaction: hives, rash, itching, trouble breathing or swallowing, or swelling of the face, throat, tongue, lips or eyes.
- Breathing and sedation: slowed breathing, extreme tiredness, confusion, blurred vision or slurred speech.
- Liver trouble: yellow skin or eyes, dark urine, light-colored stools, or pain in the upper right part of your stomach. The Suboxone label reports cases of hepatitis and recommends liver tests before you start.
- Hormone problems: nausea, vomiting, loss of appetite, weakness or dizziness that won’t quit, or trouble getting or keeping an erection, low sex drive or irregular periods. SAMHSA lists adrenal insufficiency, a shortage of stress hormones, among the serious side effects.
- Serotonin syndrome: agitation, hallucinations, fever, sweating, a fast heartbeat, shivering, stiff or twitching muscles, or loss of coordination. This can happen with some antidepressants and other medicines, so give your prescriber a full list, including St. John’s wort.
If someone on buprenorphine is very hard to wake or is breathing slowly, call 911 and give naloxone if you have it. The naloxone guide shows the signs of an overdose and how to respond.
Precipitated Withdrawal: The Side Effect of Starting Too Soon
If you take your first dose while other opioids are still active in your body, buprenorphine can throw you into sudden, intense withdrawal. This is called precipitated withdrawal. Buprenorphine is a partial agonist, meaning it switches on opioid receptors only partway, so it can push out a stronger opioid and leave you worse off in minutes.
SAMHSA says you need to go at least 12 to 24 hours without opioids and be in early withdrawal before your first dose. The Suboxone label adds that the naloxone in the film can trigger withdrawal if it’s given before the other opioid’s effects wear off. Tell your prescriber exactly what you’ve been using and when, so they can time the first dose.
The withdrawal guide explains what opioid withdrawal feels like and how long it lasts. If you can’t start right away, a detox program can manage withdrawal safely in the meantime.
Alcohol, Benzodiazepines and Other Dangerous Mixes
Mixing buprenorphine with alcohol, benzodiazepines such as Xanax or Valium, sleeping pills or other sedatives is the most common way it turns deadly. SAMHSA warns against drinking or taking sedatives, tranquilizers or anything else that slows breathing, because the combination can lead to overdose or death. MedlinePlus says the same about alcohol and street drugs.
Don’t stop a benzodiazepine on your own to get into treatment, either. The FDA warns that stopping benzodiazepines suddenly or cutting the dose too fast can cause seizures that can be life-threatening, so any change needs a plan with your health care professional. The Suboxone label says treatment shouldn’t be refused just because you take one, and that your prescribers should coordinate your care. Tell every doctor, dentist and pharmacist that you take buprenorphine.
Keep your medicine out of reach of children and pets and never share it. Even a small amount can seriously harm a child or someone who doesn’t use opioids.
Pregnancy and Stopping Buprenorphine
You don’t have to stop buprenorphine if you become pregnant. SAMHSA calls buprenorphine and methadone the treatments of choice for OUD during pregnancy and breastfeeding. Babies can have withdrawal after birth, called neonatal opioid withdrawal syndrome, and the Suboxone label describes it as expected and treatable. Plan for it with your prescriber and your baby’s doctor.
When it’s time to stop, do it slowly with your prescriber. MedlinePlus says your doctor will probably lower your dose gradually, and the FDA says not to stop suddenly. Treatment length is up to you and your prescriber, and SAMHSA notes it can be indefinite.
Stopping also lowers your tolerance, so a dose of another opioid you once handled can now cause an overdose. Keep naloxone at home either way.
If Side Effects Are Making You Want to Quit
Talk to your prescriber before you stop. Most side effects can be eased by adjusting the dose, switching between the film, tablet and shot, or changing to a different medicine. Methadone, given daily at an opioid treatment program, is the main alternative, and the methadone clinics guide explains how those programs work. Naltrexone is a non-opioid option, and the naltrexone for alcohol post covers how it works and its own side effects.
If you need a new prescriber, the Suboxone doctors guide explains who can prescribe buprenorphine and how telehealth starts work. Use the treatment finder to search for programs near you that offer buprenorphine, and the insurance coverage guide to check what your plan pays.
Frequently Asked Questions
How Addictive Is Buprenorphine?
Buprenorphine is a partial opioid agonist, so its effects are weaker than full opioids like heroin or oxycodone. You can become physically dependent on it, and SAMHSA notes it can be misused, mostly by people without opioid dependence. NIDA says that taken as prescribed, it prevents cravings and withdrawal without the intense high, and dependence can be managed by lowering the dose slowly.
What Is Suboxone?
Suboxone is a brand of buprenorphine combined with naloxone, sold as a film that dissolves under the tongue or inside the cheek. The naloxone is there to discourage misuse. The Suboxone doctors guide covers who can prescribe it and how telehealth starts work.
How Do You Take Suboxone Film?
MedlinePlus says to take it once a day at about the same time, placed under the tongue or between the gum and cheek. Don't chew or swallow it, and don't eat, drink or talk until it has fully dissolved. Then rinse with water to protect your teeth.
Do Buprenorphine Side Effects Go Away?
Some are tied to starting treatment. The Suboxone label says restlessness was the most common problem during the first dose and the 3 days after. Tell your prescriber about any side effect that bothers you or doesn't go away, since a dose change can help.
Can Buprenorphine Cause Erectile Dysfunction?
MedlinePlus lists trouble getting or keeping an erection, decreased sexual desire and irregular periods among the side effects to report to your doctor. They can point to a hormone problem your prescriber should check.
Guides on This Topic
More From the Blog
This post explains treatment options in plain language from official sources. It isn't medical advice; a clinician can assess what care fits your situation.
Sources
- SAMHSA: Buprenorphine
- MedlinePlus: Buprenorphine and Naloxone Sublingual and Buccal
- MedlinePlus: Buprenorphine Injection (Opioid Dependence)
- FDA: Dental Problems With Buprenorphine Medicines Dissolved in the Mouth
- DailyMed: Suboxone Sublingual Film Label
- DailyMed: Sublocade Extended-Release Injection Label
- FDA: Boxed Warning Updated for Benzodiazepines
- NIDA: Medications for Opioid Use Disorder