Boxed warning

The most serious risks.

FDA Boxed Warning — Buprenorphine

Risks from misuse and from combining with other depressants.

Buprenorphine is an opioid. It exposes users to risks of opioid misuse, dependence, and overdose, which can lead to death. Your physician will assess your risk before prescribing and monitor you over time.

Combining buprenorphine with benzodiazepines, alcohol, or other CNS depressants is dangerous. The combination can cause profound sedation, slowed breathing, coma, and death. Tell your physician about all medications, including alcohol, sleep aids, and benzodiazepines (Xanax, Klonopin, Valium, Ativan).

Accidental exposure of children to even one dose can be fatal. Store buprenorphine securely, out of reach of children. If a child ingests buprenorphine, call 911 immediately.

Who should not take buprenorphine

Contraindications.

Do not take buprenorphine if you have had a serious allergic reaction (anaphylaxis or angioedema) to buprenorphine or to naloxone. Tell your physician about any prior medication reactions.

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.

Respiratory depression. Buprenorphine can slow breathing, especially in opioid-naive patients, when doses are increased, or when combined with CNS depressants. Risk is higher with intravenous misuse or with alcohol or benzodiazepines.

Neonatal opioid withdrawal syndrome (NOWS). Babies born to people taking opioids during pregnancy may have withdrawal symptoms (NOWS). NOWS is treatable but requires monitoring and may require care in a hospital. Pregnancy care is specialized — see Suboxone and pregnancy.

Hepatic effects. Cases of hepatitis (liver inflammation) have 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.

QT prolongation. Buprenorphine can affect heart rhythm. Tell your physician about heart conditions or any other medications you take that affect heart rhythm.

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

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 CNS depressants — serious risk. This includes alcohol, sleep aids (zolpidem, eszopiclone), benzodiazepines (Xanax, Klonopin, Valium, Ativan), gabapentin/pregabalin, muscle relaxants, and other opioids. Combining these with buprenorphine can cause profound sedation, slowed breathing, coma, and death.

CYP3A4 inhibitors (such as ketoconazole, certain HIV medications, certain antibiotics like clarithromycin) can raise buprenorphine levels. Your physician may need to adjust your dose.

CYP3A4 inducers (such as rifampin, phenytoin, carbamazepine, St. John’s wort) can lower buprenorphine levels and trigger withdrawal.

Serotonergic medications (some antidepressants, triptans for migraine, MDMA) may rarely cause serotonin syndrome — a serious condition with confusion, fever, sweating, fast heart rate, and muscle stiffness.

MAO inhibitors are generally not used with opioids.

Methadone, full opioid agonists, and concentrated 7-OH products can cause precipitated withdrawal if buprenorphine is started too soon. Your physician will discuss timing.

Use in specific populations

Pregnancy, breastfeeding, and other situations.

Pregnancy. Buprenorphine is used during pregnancy in patients with opioid use disorder, with coordination between addiction and obstetric providers. Untreated opioid use disorder in pregnancy carries serious risks. Care during pregnancy 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. Monitor the infant for sleepiness or feeding difficulty. Discuss with your physician.

Pediatric patients. Buprenorphine is FDA-approved for opioid use disorder treatment in patients age 16 and older. Use in younger patients is not established.

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

Liver impairment. If you have liver disease, your physician may need to lower your dose and monitor liver function.

Other medical conditions. Tell your physician about heart, lung, or kidney disease, head injury, seizures, urinary or biliary problems, mental health conditions, and any history of substance use.

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.