Highest-priority safety risks

What matters most before starting buprenorphine.

Buprenorphine — key safety risks

Misuse, respiratory depression, drug interactions, and product-specific warnings.

Buprenorphine is a partial opioid agonist. It is a Schedule III controlled substance. It can cause misuse, physical dependence, slowed breathing, overdose, and death. Risk goes up when buprenorphine is misused or combined with:

Alcohol
Benzodiazepines (Xanax, Klonopin, Valium, Ativan)
Sleep medications (zolpidem, eszopiclone)
Muscle relaxants
Gabapentin or pregabalin
Other opioids
Other sedatives

Safety warnings differ by product.

Suboxone and generic buprenorphine/naloxone (taken under the tongue or inside the cheek) carry warnings for misuse, slowed breathing, accidental exposure of children, newborn opioid withdrawal, liver effects, dental problems, and drug interactions.
Sublocade and Brixadi (long-acting injections) carry boxed warnings and REMS restrictions. Serious harm or death can occur if the depot medication is injected into a vein.

Accidental exposure to children can be fatal — even one dose. Store buprenorphine locked away, out of reach. If a child swallows buprenorphine, call 911 right away.

Keep an opioid overdose reversal medication on hand. Your physician may recommend naloxone or another reversal medication. If you suspect an overdose:

Give naloxone if available.
Call 911.
Stay with the person.

Buprenorphine lasts a long time and binds tightly to opioid receptors. Repeated or higher doses of a reversal medication may be needed. Emergency care is still required.

Who should not take buprenorphine

Contraindications.

Do not take buprenorphine if you have had a serious allergic reaction to buprenorphine or any ingredient in your specific product.

Do not take Suboxone or another buprenorphine/naloxone product if you have had a serious allergic reaction to naloxone.

Sublocade, Brixadi, and buprenorphine-only products do not all contain naloxone. The contraindication is product-specific.

Tell your physician about any prior medication reactions before you start.

Warnings & precautions

What to know before and during treatment.

Precipitated withdrawal during induction. Starting buprenorphine too soon after a recent opioid dose can cause sudden, intense withdrawal. Your physician will discuss timing with you, especially if you have been using fentanyl, methadone, or long-acting opioids. Do not start buprenorphine without your physician’s guidance on timing.

Slowed breathing (respiratory depression). Buprenorphine can slow breathing. Risk is higher in patients new to opioids, when doses go up, or when buprenorphine is combined with alcohol, benzodiazepines, or other sedatives. Risk is also higher with intravenous misuse.

Newborn opioid withdrawal (NOWS). Babies exposed to opioids in the womb may have withdrawal symptoms after birth. This is called neonatal opioid withdrawal syndrome, or NOWS. It is treatable but requires monitoring. Some babies need hospital care. Pregnancy care is specialized — see Suboxone and pregnancy.

Liver effects (hepatic effects). Hepatitis (liver inflammation) has been reported. Tell your physician about any history of liver disease or hepatitis. Your physician may order blood tests.

Allergic reactions. Stop the medication and call 911 or go to the emergency room if you have signs of a serious allergic reaction: rash, hives, swelling of the face or tongue, difficulty breathing, or low blood pressure.

Adrenal insufficiency. Long-term opioid use, including buprenorphine, can rarely cause low cortisol. Symptoms include nausea, vomiting, fatigue, low blood pressure, and dizziness. Tell your physician about new persistent symptoms.

Driving and machinery. Buprenorphine may impair your ability to drive or operate machinery, especially when starting treatment, when the dose is changed, or when combined with other sedating medications or alcohol.

Orthostatic hypotension (low blood pressure standing up). Buprenorphine can lower blood pressure, particularly when standing. Stand up slowly until you know how the medication affects you.

QTc / heart rhythm. Buprenorphine can cause small QTc changes in some settings. For most patients without risk factors, this is not expected to cause a dangerous rhythm problem by itself. Tell your physician if you have a history of long QT syndrome, fainting, serious heart rhythm problems, low potassium or magnesium, or if you take other QT-prolonging medications.

Stopping the medication suddenly. Abruptly stopping buprenorphine can cause withdrawal symptoms. Discuss any plan to stop or reduce treatment with your physician.

Dental problems with mouth-dissolving products. Buprenorphine that dissolves under the tongue or inside the cheek (Suboxone film, Suboxone tablets, generic buprenorphine/naloxone) has been linked to dental problems. These include cavities, infections, tooth fracture, and tooth loss (per FDA labeling). After the medication dissolves:

Take a sip of water.
Gently swish it around your teeth and gums.
Swallow.
Wait at least 1 hour before brushing your teeth.

Tell your dentist that you take buprenorphine. Get regular dental care.

Long-acting injections: Sublocade and Brixadi. Sublocade and Brixadi are given by a healthcare professional under REMS restrictions. They are not dispensed for self-injection.

These products must never be injected into a vein, muscle, or the skin layer. Intravenous injection can cause serious tissue damage, embolism, overdose, or death.

After the injection you may have site pain, itching, redness, swelling, nodules, or irritation. Follow the clinic’s instructions. For Sublocade: do not rub or massage the injection site.

Common side effects

What patients commonly report.

The most common side effects of buprenorphine include:

Headache
Nausea, vomiting, constipation
Insomnia (trouble sleeping)
Sweating
Numbness, tingling, or pain in the mouth (with sublingual film/tablet)
Withdrawal symptoms during induction or dose changes
Pain at the injection site (with Sublocade or Brixadi)

Most side effects improve over the first few weeks. Tell your physician about any side effects that are bothering you or that don’t go away.

Drug interactions

Medications and substances that interact.

Tell your physician about all medications, supplements, and substances you use. Important interactions include:

Benzodiazepines and other sedatives — serious risk. This group includes:

Alcohol
Sleep aids (zolpidem, eszopiclone)
Benzodiazepines (Xanax, Klonopin, Valium, Ativan)
Gabapentin or pregabalin
Muscle relaxants
Other opioids

Combining any of these with buprenorphine can cause deep sedation, slowed breathing, coma, and death.

That said: FDA labeling and SAMHSA guidance both say patients should not be automatically denied buprenorphine just because they use benzodiazepines or other sedatives. Untreated opioid use disorder can be more dangerous than the combination. The risk should be managed clinically — with careful medication review, patient education, dose monitoring, and coordination with other prescribers.

CYP3A4 inhibitors can raise buprenorphine levels in the blood. Examples: ketoconazole, certain HIV medications, and some antibiotics like clarithromycin. Your physician may need to adjust your dose.

CYP3A4 inducers can lower buprenorphine levels and trigger withdrawal. Examples: rifampin, phenytoin, carbamazepine, St. John’s wort.

Serotonergic medications may rarely cause serotonin syndrome when combined with buprenorphine. Examples include some antidepressants, triptans for migraine, and MDMA. Serotonin syndrome is a serious condition. Signs include confusion, fever, sweating, fast heart rate, and muscle stiffness.

MAO inhibitors are generally not used with opioids.

Recent opioid or opioid-like substance use. Methadone, fentanyl, oxycodone, heroin, other full opioids, and some kratom or 7-OH products can affect induction timing. Starting buprenorphine too soon after opioids can cause sudden, intense withdrawal. Your physician will choose the right timing based on:

What you used
When you last used it
How severe your withdrawal is
Your overall clinical risk

Use in specific populations

Pregnancy, breastfeeding, and other situations.

Pregnancy. Buprenorphine is used in pregnancy for patients with opioid use disorder, when clinically appropriate. Care is coordinated between addiction and obstetric providers. Untreated opioid use disorder in pregnancy carries serious risks.

Do not stop buprenorphine suddenly during pregnancy. Withdrawal and return to opioid use can be dangerous for both the pregnant patient and the fetus.

Babies exposed to opioids in the womb may have newborn opioid withdrawal. This is treatable but requires monitoring.

Pregnancy care is specialized and outside the scope of MyStreetHealth’s telehealth practice. See Suboxone and pregnancy for guidance on finding care.

Breastfeeding. Small amounts of buprenorphine pass into breast milk. In stable patients, breastfeeding may be considered after discussion with the treating clinician and pediatrician. Watch the infant for:

Increased sleepiness
Breathing problems
Limpness
Feeding difficulty

Seek medical care right away if any of these occur.

Pediatric patients. Use in minors requires specialized care. It depends on the specific product, the indication, and clinician judgment. The current Suboxone film label states that safety and effectiveness have not been established in pediatric patients. MyStreetHealth has its own age policy — ask the practice.

Older adults. Older patients may need closer monitoring. Doses may need to be lower or adjusted more carefully.

Liver problems. Tell your physician if you have hepatitis, cirrhosis, abnormal liver tests, or any history of liver disease. Your physician may check liver tests before and during treatment.

Some buprenorphine/naloxone products are not recommended in severe liver impairment.
Some may not be recommended for induction in moderate liver impairment.
Long-acting injections may not be appropriate in moderate or severe liver impairment, because the medication cannot be quickly removed once injected.

Other medical conditions to tell your physician about:

COPD, asthma, sleep apnea, or other breathing problems
Head injury or increased pressure in the brain
Seizures
Liver disease
Gallbladder or bile duct disease
Pancreatitis
Adrenal problems
Low blood pressure
Urinary problems
Severe constipation or bowel blockage
Heart rhythm problems
Dental problems
Mental health conditions
All substance use history

Storage and disposal

Keep buprenorphine secure.

Do not share, sell, or give buprenorphine to anyone else.

Store it locked.
Keep it out of sight and reach of children, pets, and other adults.
Keep films, tablets, and injection records secure.
Dispose of unused medication per your pharmacist’s instructions or the product label.

Even one accidental dose can be fatal to a child.

When to seek emergency care

Call 911 or go to the emergency room.

Get emergency help right away if you experience:

Slow, shallow, or stopped breathing
Severe drowsiness, inability to stay awake
Cold, clammy skin; bluish lips or fingertips
Seizure
Signs of allergic reaction: rash, swelling of the face or tongue, difficulty breathing, low blood pressure
Severe abdominal pain, yellowing of the skin or eyes (possible liver problem)
Confusion, fever, sweating, fast heart rate, muscle stiffness (possible serotonin syndrome)

If a child accidentally takes buprenorphine, call 911 immediately. Naloxone (Narcan) can be used to reverse opioid overdose — see naloxone and naltrexone.

Reporting side effects

How to report a side effect.

Tell your physician about any side effect, especially serious ones. You can also report side effects directly to the FDA at FDA MedWatch or by calling 1-800-FDA-1088.

Full prescribing information

Where to read the complete label.

This page is a summary written for patients. The complete FDA-approved prescribing information for buprenorphine products contains additional detail on dosing, pharmacology, clinical studies, and all known risks. Links below.

Medical sources

Medical note. This page is for education only. It is not a complete substitute for the FDA-approved prescribing information or your physician’s instructions. Always follow the directions your physician provides. For medical emergencies, call 911 or go to the emergency room.

Important Safety Information for Buprenorphine.