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Prescription medication · Partial Opioid Agonist / Antagonist

buprenorphine/naloxone

Also sold as Suboxone. Suboxone film is used to treat opioid dependence.

Data updated 2026-05-15

788
FDA reports
19
InteractionsSeveral interactions
$17.24
Brand price (NADAC)

What the data shows

buprenorphine/naloxone (Suboxone) is a prescription Partial Opioid Agonist / Antagonist, with 788 FDA adverse-event reports on file, with 19 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

buprenorphine/naloxone (Suboxone) is a prescription Partial Opioid Agonist / Antagonist. Suboxone film is used to treat opioid dependence.

Suboxone film contains buprenorphine and naloxone. It is used to treat opioid dependence as part of a complete treatment plan.

Drug Pricing (NADAC)

Brand Price

$17.24/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

Suboxone film is used to treat opioid dependence.

Common side effects

Mouth numbness, Tongue pain, Mouth redness

Key warnings

Buprenorphine can be abused, like other opioids.

The sections below are summarized in plain English from buprenorphine/naloxone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Buprenorphine is a partial opioid agonist, meaning it has some opioid effects. Naloxone is an opioid antagonist, which blocks the effects of opioids. Together, they help reduce cravings and withdrawal symptoms without causing a strong "high."

How to Take It

Take Suboxone film once a day, as directed by your doctor. Place one film under your tongue or inside your cheek. Let it dissolve completely and do not cut, chew, or swallow the film.

This is a plain-language summary of buprenorphine/naloxone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

If you are pregnant or plan to become pregnant, talk to your doctor. Using Suboxone during pregnancy can cause withdrawal symptoms in the baby after birth. Buprenorphine passes into breast milk, so talk to your doctor before breastfeeding.

This is a plain-language summary of buprenorphine/naloxone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

This is a plain-language summary of buprenorphine/naloxone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store Suboxone film at room temperature, away from heat and moisture, and in a secure place.

Side Effects (from patient reports)

Based on 788 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for buprenorphine/naloxone, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

Buprenorphine can be abused, like other opioids. Taking Suboxone with other depressants like alcohol or benzodiazepines can cause serious breathing problems, coma, or death. Keep Suboxone out of the reach of children, as it can cause severe breathing problems and death if they take it. Using opioids for a long time during pregnancy can cause withdrawal symptoms in the newborn.

Known Drug Interactions

Examples: Alcohol, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids.

Mechanism: These medicines are both sedatives that can slow down your breathing and brain activity. Using them together makes these side effects much stronger and more dangerous.

What to do: Your doctor should monitor you closely for slowed breathing or extreme sleepiness. Avoid this combination unless your doctor says it is necessary.

Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Mechanism: These drugs both increase a brain chemical called serotonin. Taking them at the same time can cause a dangerous buildup of serotonin in your body.

What to do: Tell your doctor if you feel agitated, sweaty, or have muscle twitches. Your doctor will decide if you should take both medicines.

Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Mechanism: Both of these medicines affect serotonin levels and can cause heavy sedation. This increases the risk of a serious reaction called serotonin syndrome and can make you very sleepy.

What to do: Use this combination only if your doctor says it is necessary and monitors you for serious side effects. Watch for signs of confusion or breathing problems.

Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Examples: cyclobenzaprine, metaxalone Diuretics Clinical Impact: Opioids can reduce the efficacy...

Mechanism: Both drugs can increase serotonin levels in your brain, which may cause a rare but serious reaction called serotonin syndrome.

What to do: Tell your doctor if you feel very agitated, have a fast heartbeat, or lose coordination while taking these together.

Examples: Alcohol, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), and other opioids.

Mechanism: These drugs both slow down your brain and breathing, which can make you very sleepy or cause dangerous breathing issues.

What to do: Avoid driving or using heavy machinery until you know how this combination affects you, and use the lowest dose possible.

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This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

Can I cut the film?
No, you must use the film whole.
How often should I take this medicine?
Take Suboxone film once a day.
What should I do if I feel like I'm going to overdose?
Use naloxone if you have it, and call for emergency help right away.
Can I drink alcohol while taking Suboxone?
No, drinking alcohol while taking Suboxone can cause serious side effects, including coma and death.
Will I experience withdrawal symptoms if I stop taking Suboxone?
Yes, you may experience withdrawal symptoms if you suddenly stop taking Suboxone. Talk to your doctor about slowly stopping the medicine.
Can my child accidentally take this medicine?
Yes, keep this medicine stored in a safe place out of reach of children, because it can cause breathing problems and death.
What if I have liver problems?
Tell your doctor if you have liver problems, as Suboxone may not be right for you.
Can I take other medications with Suboxone?
Some medicines can interact with Suboxone. Tell your doctor about all the medicines you take.
What if I am allergic to buprenorphine or naloxone?
You should not take this medicine if you are allergic to buprenorphine or naloxone.
How will I know if the medicine is working?
You should experience reduced cravings and withdrawal symptoms.
What are the common side effects of buprenorphine/naloxone?
The most commonly reported side effects of buprenorphine/naloxone include Mouth numbness, Tongue pain, Mouth redness, Headache, Feeling sick to your stomach. Based on 788 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does buprenorphine/naloxone interact with other medications?
Yes, buprenorphine/naloxone has 19 known drug interactions. Notable interactions include gabapentin, trazodone, tramadol. Always inform your doctor about all medications you are taking.
What drug class is buprenorphine/naloxone?
buprenorphine/naloxone belongs to the Partial Opioid Agonist / Antagonist drug class. It requires a prescription (Rx). Suboxone film is used to treat opioid dependence.
Is buprenorphine/naloxone safe during pregnancy?
If you are pregnant or plan to become pregnant, talk to your doctor. Using Suboxone during pregnancy can cause withdrawal symptoms in the baby after birth. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for buprenorphine/naloxone

The FDA label for buprenorphine/naloxone (sold under brand names such as Suboxone) classifies it as a prescription-only medication in the Partial Opioid Agonist / Antagonist class. Suboxone film is used to treat opioid dependence. Official labeling lists 12 commonly reported side effects, including Mouth numbness, Tongue pain, Mouth redness.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 788 voluntary reports. The database also lists 19 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 22, 2025

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

All federal data sources used on this page