Prescription medication · Partial Opioid Agonist
buprenorphine
Also sold as Subutex, Sublocade. This medicine treats opioid dependence.
Data updated 2026-05-15
- 90,121
- FDA reportsOften reported
- 29
- InteractionsSeveral interactions
- 1
- Recall record
What the data shows
buprenorphine (Subutex) is a prescription Partial Opioid Agonist, more reported than most tracked drugs (90,121 FDA reports), with 29 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 (Subutex) is a prescription Partial Opioid Agonist. This medicine treats opioid dependence.
Buprenorphine sublingual tablets help treat opioid dependence. It should be part of a full treatment plan with counseling and support.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$28.84/unit
Generic Available
Yes (32 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats opioid dependence.
Common side effects
Headache, Nausea, Vomiting
Key warnings
Buprenorphine can be abused, like other opioids.
The sections below are summarized in plain English from buprenorphine'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. This means it binds to the same receptors in the brain as opioids, but it does not activate them as strongly. This helps to reduce cravings and withdrawal symptoms without causing the same high as other opioids.
How to Take It
Take buprenorphine sublingual tablets under your tongue once a day. Do not cut, chew, or swallow the tablet. Let it dissolve completely under your tongue. When stopping treatment, your doctor will slowly lower your dose to prevent withdrawal symptoms.
This is a plain-language summary of buprenorphine'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 this medicine during pregnancy can cause withdrawal symptoms in your baby after birth. Buprenorphine can pass into breast milk.
This is a plain-language summary of buprenorphine'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 take your next dose at the regular time.
This is a plain-language summary of buprenorphine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store buprenorphine sublingual tablets at room temperature (68° to 77°F) and protect them from light.
Side Effects (from patient reports)
Based on 90,121 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for buprenorphine, by number of reports
- Death
Death
13,279 reports
- Drug dependence
Drug dependence
12,452 reports
- Overdose
Overdose
10,911 reports
- Harmful effect from a substance
Harmful effect from a substance
10,722 reports
- Pain
Pain
8,157 reports
- Withdrawal symptoms
Withdrawal symptoms
6,860 reports
- Emotional upset
Emotional upset
5,435 reports
- Nausea 4,410
Nausea
4,410 reports
- Drug abuse 3,622
Drug abuse
3,622 reports
- Tablet sticking in mouth 3,292
Tablet sticking in mouth
3,292 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.
Reports over time
Adverse-event reports filed for buprenorphine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where buprenorphine sits
buprenorphine has more FDA adverse-event reports than 84% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is buprenorphine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 90,121 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
90,121
Reports Mentioning Death
25,836
28.7% of reports — not proof of cause
Hospitalization Reports
10,461
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DEATH | 13,278 |
| 2 | DRUG DEPENDENCE | 12,452 |
| 3 | OVERDOSE | 10,911 |
| 4 | TOXICITY TO VARIOUS AGENTS | 10,722 |
| 5 | PAIN | 8,157 |
| 6 | DRUG WITHDRAWAL SYNDROME | 6,860 |
| 8 | EMOTIONAL DISTRESS | 5,436 |
| 9 | NAUSEA | 4,411 |
| 10 | DRUG ABUSE | 3,622 |
| 11 | PRODUCT ADHESION ISSUE | 3,292 |
| 12 | APPLICATION SITE RASH | 3,042 |
| 13 | INADEQUATE ANALGESIA | 3,028 |
| 14 | DIZZINESS | 2,578 |
| 15 | RASH | 2,501 |
| 16 | APPLICATION SITE PRURITUS | 2,341 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Buprenorphine can be abused, like other opioids. Taking buprenorphine with benzodiazepines or other depressants can cause serious breathing problems, coma, or death. Keep this medicine out of the reach of children, as it can cause severe breathing problems and death. Using opioids for a long time during pregnancy can cause withdrawal symptoms in the newborn.
Known Drug Interactions
Intervention: Avoid concomitant use Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Mechanism: Oxycodone can make the muscle-weakening effects of other drugs stronger and can cause your breathing to slow down significantly. This combination can be very dangerous for your lungs and muscles.
What to do: You should avoid using these two medications together to prevent serious breathing or muscle 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).
Mechanism: Both of these medications increase the amount of a brain chemical called serotonin. Taking them at the same time can cause serotonin levels to become dangerously high.
What to do: Watch for signs like confusion, fast heartbeat, or shivering, and seek medical help if they occur.
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 drugs increase serotonin levels in the brain, which can cause a serious and potentially dangerous reaction.
What to do: Talk to your doctor about the risks and watch for symptoms like confusion, shivering, or a fast heartbeat.
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 medications both affect the serotonin system, and taking them together can lead to a dangerous buildup of this chemical in your body.
What to do: Your healthcare provider should monitor you closely for signs of serotonin syndrome if these drugs are used together.
ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inducers can decrease the plasma concentration of buprenorphine [see Clinical Pharmacology (12.3)] , potentially resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to buprenorphine.
Mechanism: Ketoconazole interferes with the enzymes that break down buprenorphine, which can change the amount of medicine that stays in your blood.
What to do: Your doctor may need to adjust your dose and monitor you for increased side effects or signs of withdrawal.
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 or chew the tablet?
What should I do if I feel sick after taking this medicine?
Can I drink alcohol while taking this medicine?
What if I accidentally give this medicine to my child?
Can I take other medications with buprenorphine?
How often will I see my doctor while taking this medicine?
What are the signs of an overdose?
Can I stop taking this medicine suddenly?
What is naloxone and why might I need it?
What should I do if I am going to have surgery?
What are the common side effects of buprenorphine?
Does buprenorphine interact with other medications?
What drug class is buprenorphine?
Is buprenorphine safe during pregnancy?
Has buprenorphine been recalled?
Active Recalls
Crystallization; identified as Buprenorphine free base
ENDO USA, Inc.
Related Medications in Partial Opioid Agonist
Other drugs grouped near buprenorphine - same-class peers and common alternatives.
acamprosate
Campral
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alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
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amitriptyline
Elavil
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for buprenorphine
The FDA label for buprenorphine (sold under brand names such as Subutex, Sublocade) classifies it as a prescription-only medication in the Partial Opioid Agonist class. This medicine treats opioid dependence. Official labeling lists 11 commonly reported side effects, including Headache, Nausea, Vomiting.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 90,121 voluntary reports. The database also lists 29 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $28.84.
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 (currently 1 recall record on file), 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: February 3, 2025
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 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
- 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