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.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$17.24/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
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."
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
- Feeling sick to your stomach
Feeling sick to your stomach
138 reports
- Throwing up
Throwing up
92 reports
- Reaction at the injection site
Reaction at the injection site
90 reports
- Headache
Headache
79 reports
- Problem with the medicine being substituted
Problem with the medicine being substituted
73 reports
- Withdrawal symptoms
Withdrawal symptoms
70 reports
- Abusing the medicine
Abusing the medicine
68 reports
- Poisoning from different things
Poisoning from different things
65 reports
- Withdrawal symptoms from the medicine
Withdrawal symptoms from the medicine
61 reports
- Sweating a lot 52
Sweating a lot
52 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.
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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I cut the film?
How often should I take this medicine?
What should I do if I feel like I'm going to overdose?
Can I drink alcohol while taking Suboxone?
Will I experience withdrawal symptoms if I stop taking Suboxone?
Can my child accidentally take this medicine?
What if I have liver problems?
Can I take other medications with Suboxone?
What if I am allergic to buprenorphine or naloxone?
How will I know if the medicine is working?
What are the common side effects of buprenorphine/naloxone?
Does buprenorphine/naloxone interact with other medications?
What drug class is buprenorphine/naloxone?
What pregnancy or breastfeeding source fields are listed for buprenorphine/naloxone?
Related Medications in Partial Opioid Agonist / Antagonist
Other drugs grouped near buprenorphine/naloxone - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with buprenorphine/naloxone →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with buprenorphine/naloxone →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with buprenorphine/naloxone →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with buprenorphine/naloxone →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with buprenorphine/naloxone →
Compare buprenorphine/naloxone vs acamprosate side-by-side →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: December 22, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages