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buprenorphine

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Brand names: Subutex, Sublocade

Partial Opioid Agonist Rx

Buprenorphine sublingual tablets help treat opioid dependence. It should be part of a full treatment plan with counseling and support.

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.

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.

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.

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.

Storage

Store buprenorphine sublingual tablets at room temperature (68° to 77°F) and protect them from light.

Side Effects (from patient reports)

Based on 82,069 FDA adverse event reports.

Death
13,279
Drug dependence
12,452
Overdose
10,911
Harmful effect from a substance
10,722
Pain
8,157
Withdrawal symptoms
6,860
Medicine not working
6,221
Emotional upset
5,435
Nausea
4,410
Drug abuse
3,622

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

Death-Related Reports

25,836

Hospitalization Reports

10,461

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 35,467 (56%)
Male 27,246 (43%)

Age Distribution

0–17 472
18–44 9,031
45–64 6,943
65–74 2,313
75+ 2,795

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
7 DRUG INEFFECTIVE 6,220
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

Reactions in Death Reports

DEATH 13,268
TOXICITY TO VARIOUS AGENTS 8,899
OVERDOSE 6,404
DRUG ABUSE 1,762
DRUG DEPENDENCE 1,610
OFF LABEL USE 917
ACCIDENTAL OVERDOSE 791
ARTHRALGIA 772
ASTHENIA 759
DIZZINESS 708

Reactions in Hospitalization Reports

TOXICITY TO VARIOUS AGENTS 1,763
OFF LABEL USE 1,081
DRUG ABUSE 1,069
PAIN 978
CONFUSIONAL STATE 907
OVERDOSE 861
DRUG INEFFECTIVE 857
DRUG DEPENDENCE 833
NAUSEA 825
VOMITING 824

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

moderate oxycodone

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.

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Common Questions

Can I cut or chew the tablet?
No, you must not cut, chew, or swallow the buprenorphine sublingual tablet. Place it under your tongue and let it dissolve completely.
What should I do if I feel sick after taking this medicine?
Tell your doctor if you feel sick, nauseous, or vomit after taking buprenorphine.
Can I drink alcohol while taking this medicine?
No, do not drink alcohol while taking buprenorphine. It can cause serious side effects, including breathing problems.
What if I accidentally give this medicine to my child?
Seek immediate medical attention if a child takes this medicine. It can cause severe, possibly fatal, breathing problems.
Can I take other medications with buprenorphine?
Talk to your doctor about all the medicines you take, including over-the-counter drugs and supplements. Some medicines can interact with buprenorphine.
How often will I see my doctor while taking this medicine?
Your doctor will determine how often you need to be seen. Follow their instructions carefully.
What are the signs of an overdose?
Signs of an overdose include slow or shallow breathing, extreme sleepiness, and unresponsiveness. Seek immediate medical attention if you suspect an overdose.
Can I stop taking this medicine suddenly?
No, do not stop taking this medicine suddenly. Your doctor will slowly lower your dose to prevent withdrawal symptoms.
What is naloxone and why might I need it?
Naloxone is a medicine that can reverse an opioid overdose. Your doctor may prescribe it for you in case of an emergency.
What should I do if I am going to have surgery?
Tell your doctor that you are taking buprenorphine before any surgery or medical procedure.
What are the common side effects of buprenorphine?
The most commonly reported side effects of buprenorphine include Headache, Nausea, Vomiting, Sweating, Constipation. Based on 82,069 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does buprenorphine interact with other medications?
Yes, buprenorphine has 29 known drug interactions. Notable interactions include oxycodone, trazodone, cyclobenzaprine. Always inform your doctor about all medications you are taking.
What drug class is buprenorphine?
buprenorphine belongs to the Partial Opioid Agonist drug class. It requires a prescription (Rx). This medicine treats opioid dependence.
Is buprenorphine safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 82,069 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, 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

All federal data sources used on this page