Medical Editor: John P. Cunha, DO, FACOEP
What Is Suboxone?
Suboxone (buprenorphine and naloxone) is a combination of two opioid receptor antagonists used in the maintenance treatment of opioid addiction.
What Are Side Effects for Suboxone?
Suboxone may cause serious side effects including:
- weak or shallow breathing,
- breathing that stops during sleep,
- loss of coordination,
- extreme weakness,
- blurred vision,
- slurred speech,
- upper stomach pain,
- loss of appetite,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- worsening tiredness or weakness,
- goose bumps,
- increased sweating,
- feeling hot or cold,
- runny nose,
- watery eyes,
- diarrhea, and
- muscle pain
Get medical help right away, if you have any of the symptoms listed above.
Side effects of Suboxone include:
- mouth numbness,
- mouth redness,
- mouth pain,
- numbness or tingling,
- sleep problems (insomnia),
- stomach pain,
- feeling drunk, or
- trouble concentrating.
Get medical help right away if you have serious side effects of Suboxone including:
- fast or irregular heartbeat,
- severe dizziness,
- mental/mood changes (such as agitation, confusion, hallucinations),
- slow or shallow breathing,
- unusual drowsiness, or
- difficulty waking up.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Suboxone
Suboxone is intended for sublingual administration and is available in two dosage strengths:
- 2 mg buprenorphine with 0.5 mg naloxone, and
- 8 mg buprenorphine with 2 mg naloxone
What Drugs, Substances, or Supplements Interact with Suboxone?
Suboxone may interact with other drugs including:
- rifampin, and
- HIV protease inhibitors
Buprenorphine and naloxone may dangerously increase the effects of other drugs that cause drowsiness.
Suboxone During Pregnancy and Breastfeeding
Neonatal withdrawal has been reported in the infants of women treated with buprenorphine during pregnancy. Breastfeeding is not advised in mothers treated with buprenorphine products as it is known to pass into breast milk.
Our Suboxone Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once or seek emergency medical attention if you have:
- weak or shallow breathing, breathing that stops during sleep;
- a light-headed feeling, like you might pass out;
- confusion, loss of coordination, extreme weakness;
- blurred vision, slurred speech;
- liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
- low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
- opioid withdrawal symptoms--shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.
Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.
Common side effects may include:
- dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
- withdrawal symptoms;
- tongue pain, redness or numbness inside your mouth;
- nausea, vomiting, constipation;
- headache, back pain;
- fast or pounding heartbeats, increased sweating; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described elsewhere in the labeling:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Respiratory and CNS Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Opioid Withdrawal [see WARNINGS AND PRECAUTIONS]
- Hepatitis, Hepatic Events [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Elevation of Cerebrospinal Fluid Pressure [see WARNINGS AND PRECAUTIONS]
- Elevation of Intracholedochal Pressure [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of SUBOXONE sublingual film is supported by clinical trials using SUBUTEX® (buprenorphine) sublingual tablets and SUBOXONE (buprenorphine and naloxone) sublingual tablets, and other trials using buprenorphine sublingual solutions, as well as an open-label study in 194 patients treated with SUBOXONE sublingual film administered sublingually and 188 patients treated with the film administered buccally. In total, safety data from clinical studies are available from over 3000 opioid-dependent subjects exposed to buprenorphine at doses in the range used in the treatment of opioid dependence. Few differences in the adverse event profile were noted with regard to sublingually and bucally administered SUBOXONE sublingual film, SUBOXONE sublingual tablets, SUBUTEX sublingual tablets and a buprenorphine ethanolic sublingual solution.
The most common adverse event (> 1%) associated with the sublingual administration of the SUBOXONE sublingual film was oral hypoesthesia. Other adverse events were constipation, glossodynia, oral mucosal erythema, vomiting, intoxication, disturbance in attention, palpitations, insomnia, withdrawal syndrome, hyperhidrosis, and blurred vision.
The most common adverse events associated with the buccal administration were similar to those observed with sublingual administration of the film.
Other adverse event data were derived from larger, controlled studies of SUBOXONE sublingual tablets and SUBUTEX sublingual tablets and of buprenorphine sublingual solution. In a comparative study of SUBOXONE sublingual tablets and SUBUTEX sublingual tablets, adverse event profiles were similar for subjects treated with 16 mg/4 mg SUBOXONE sublingual tablets or 16 mg SUBUTEX sublingual tablets. The following adverse events were reported to occur by at least 5% of patients in a 4 week study of SUBOXONE sublingual tablets and SUBUTEX sublingual tablets.
Table 2. Adverse Events (≥ 5%) by Body System and Treatment Group in a 4 Week Study
|Body System/ Adverse Event
|SUBOXONE sublingual tablets 16 mg/4 mg/day
N = 107
|SUBUTEX sublingual tablets 16 mg/day
N = 103
N = 107
|Body as a Whole|
|Asthenia||7 (6.5%)||5 (4.9%)||7 (6.5%)|
|Chills||8 (7.5%)||8 (7.8%)||8 (7.5%)|
|Headache||39 (36.4%)||30 (29.1%)||24 (22.4%)|
|Infection||6 (5.6%)||12 (11.7%)||7 (6.5%)|
|Pain||24 (22.4%)||19 (18.4%)||20 (18.7%)|
|Pain abdomen||12 (11.2%)||12 (11.7%)||7 (6.5%)|
|Pain back||4 (3.7%)||8 (7.8%)||12 (11.2%)|
|Withdrawal syndrome||27 (25.2%)||19 (18.4%)||40 (37.4%)|
|Vasodilation||10 (9.3%)||4 (3.9%)||7 (6.5%)|
|Constipation||13 (12.1%)||8 (7.8%)||3 (2.8%)|
|Diarrhea||4 (3.7%)||5 (4.9%)||16 (15.0%)|
|Nausea||16 (15.0%)||14 (13.6%)||12 (11.2%)|
|Vomiting||8 (7.5%)||8 (7.8%)||5 (4.7%)|
|Insomnia||15 (14.0%)||22 (21.4%)||17 (15.9%)|
|Rhinitis||5 (4.7%)||10 (9.7%)||14 (13.1%)|
|Skin And Appendages|
|Sweating||15 (14.0%)||13 (12.6%)||11 (10.3%)|
|Abbreviations: COSTART = Coding Symbols for Thesaurus of Adverse Reaction Terms.|
The adverse event profile of buprenorphine was also characterized in the dose-controlled study of a buprenorphine ethanolic solution, over a range of doses in four months of treatment. Table 3 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled trial.
Table 3. Adverse Events (≥ 5%) by Body System and Treatment Group in a 16 Week Study
|Body System/ Adverse Event
N = 184
N = 180
N = 186
N = 181
N = 731
|Body as a Whole|
|Abscess||9 (5%)||2 (1%)||3 (2%)||2 (1%)||16 (2%)|
|Asthenia||26 (14%)||28 (16%)||26 (14%)||24 (13%)||104 (14%)|
|Chills||11 (6%)||12 (7%)||9 (5%)||10 (6%)||42 (6%)|
|Fever||7 (4%)||2 (1%)||2 (1%)||10 (6%)||21 (3%)|
|Flu syndrome||4 (2%)||13 (7%)||19 (10%)||8 (4%)||44 (6%)|
|Headache||51 (28%)||62 (34%)||54 (29%)||53 (29%)||220 (30%)|
|Infection||32 (17%)||39 (22%)||38 (20%)||40 (22%)||149 (20%)|
|Injury accidental||5 (3%)||10 (6%)||5 (3%)||5 (3%)||25 (3%)|
|Pain||47 (26%)||37 (21%)||49 (26%)||44 (24%)||177 (24%)|
|Pain back||18 (10%)||29 (16%)||28 (15%)||27 (15%)||102 (14%)|
|Withdrawal syndrome||45 (24%)||40 (22%)||41 (22%)||36 (20%)||162 (22%)|
|Constipation||10 (5%)||23 (13%)||23 (12%)||26 (14%)||82 (11%)|
|Diarrhea||19 (10%)||8 (4%)||9 (5%)||4 (2%)||40 (5%)|
|Dyspepsia||6 (3%)||10 (6%)||4 (2%)||4 (2%)||24 (3%)|
|Nausea||12 (7%)||22 (12%)||23 (12%)||18 (10%)||75 (10%)|
|Vomiting||8 (4%)||6 (3%)||10 (5%)||14 (8%)||38 (5%)|
|Anxiety||22 (12%)||24 (13%)||20 (11%)||25 (14%)||91 (12%)|
|Depression||24 (13%)||16 (9%)||25 (13%)||18 (10%)||83 (11%)|
|Dizziness||4 (2%)||9 (5%)||7 (4%)||11 (6%)||31 (4%)|
|Insomnia||42 (23%)||50 (28%)||43 (23%)||51 (28%)||186 (25%)|
|Nervousness||12 (7%)||11 (6%)||10 (5%)||13 (7%)||46 (6%)|
|Somnolence||5 (3%)||13 (7%)||9 (5%)||11 (6%)||38 (5%)|
|Cough increase||5 (3%)||11 (6%)||6 (3%)||4 (2%)||26 (4%)|
|Pharyngitis||6 (3%)||7 (4%)||6 (3%)||9 (5%)||28 (4%)|
|Rhinitis||27 (15%)||16 (9%)||15 (8%)||21 (12%)||79 (11%)|
|Skin and Appendages|
|Sweat||23 (13%)||21 (12%)||20 (11%)||23 (13%)||87 (12%)|
|Runny eyes||13 (7%)||9 (5%)||6 (3%)||6 (3%)||34 (5%)|
|*Sublingual solution. Doses in this table cannot necessarily be delivered in tablet form, but for comparison purposes:
"Very low" dose (1 mg solution) would be less than a tablet dose of 2 mg
"Low" dose (4 mg solution) approximates a 6 mg tablet dose
"Moderate" dose (8 mg solution) approximates a 12 mg tablet dose
"High" dose (16 mg solution) approximates a 24 mg tablet dose
The safety of SUBOXONE sublingual film during treatment induction is supported by a clinical trial using 16 patients treated with SUBOXONE sublingual film and 18 treated with a buprenorphine-only sublingual film. Few differences in the adverse event profiles were noted between SUBOXONE sublingual film and the buprenorphine-only sublingual film.
The most common adverse event occurring during treatment induction and the 3 days following induction using SUBOXONE sublingual film was restlessness. Other adverse events were anxiety, piloerection, stomach discomfort, irritability, headache, rhinorrhea, cold sweat, arthralgia, and lacrimation increased.
Four subjects left the study early on the first day of sublingual film administration. However, there was no evidence to suggest that any of the four subjects experienced precipitated withdrawal secondary to the administration of buprenorphine or buprenorphine/naloxone sublingual films.
The following adverse reactions have been identified during post-approval use of SUBOXONE sublingual film. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most frequently reported postmarketing adverse events were peripheral edema, stomatitis, glossitis, and blistering and ulceration of the mouth or tongue.
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis has been reported with ingredients contained in SUBOXONE sublingual film.
Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
Dental decay (including caries, tooth fracture, and tooth loss), glossodynia, glossitis, oral mucosal erythema, oral hypoesthesia, and stomatitis
Table 4 Includes clinically significant drug interactions with SUBOXONE.
Table 4. Clinically Significant Drug Interactions
|Benzodiazepines and Other Central Nervous System (CNS) Depressants|
|Clinical Impact:||Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death.|
|Intervention:||Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate.|
|Before co−prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non−pharmacologic treatments [see WARNINGS AND PRECAUTIONS].|
|If concomitant use is warranted, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all patients in treatment for opioid use disorder [see WARNINGS AND PRECAUTIONS].|
|Examples:||Alcohol, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids.|
|Inhibitors of CYP3A4|
|Clinical Impact:||The concomitant use of buprenorphine and CYP3A4 inhibitors can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of SUBOXONE sublingual film is achieved.|
|After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the buprenorphine plasma concentration will decrease [see CLINICAL PHARMACOLOGY], potentially resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to buprenorphine.|
|Intervention:||If concomitant use is necessary, consider dosage reduction of SUBOXONE sublingual film until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.|
|If a CYP3A4 inhibitor is discontinued, consider increasing the SUBOXONE sublingual film dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.|
|Examples:||Macrolide antibiotics (e.g., erythromycin), azole−antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir)|
|Clinical Impact:||The concomitant use of buprenorphine and CYP3A4 inducers can decrease the plasma concentration of buprenorphine [see CLINICAL PHARMACOLOGY], potentially resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to buprenorphine.|
|After stopping a CYP3A4 inducer, as the effects of the inducer decline, the buprenorphine plasma concentration will increase [see CLINICAL PHARMACOLOGY], which could increase or prolong both therapeutic effects and adverse reactions and may cause serious respiratory depression.|
|Intervention:||If concomitant use is necessary, consider increasing the SUBOXONE sublingual film dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.|
|If a CYP3A4 inducer is discontinued, consider SUBOXONE sublingual film dosage reduction and monitor for signs of respiratory depression.|
|Examples:||Rifampin, carbamazepine, phenytoin|
|Antiretrovirals: Non−nucleoside reverse transcriptase inhibitors (NNRTIs)|
|Clinical Impact:||Non−nucleoside reverse transcriptase inhibitors (NNRTIs) are metabolized principally by CYP3A4. Efavirenz, nevirapine, and etravirine are known CYP3A inducers, whereas delavirdine is a CYP3A inhibitor. Significant pharmacokinetic interactions between NNRTIs (e.g., efavirenz and delavirdine) and buprenorphine have been shown in clinical studies, but these pharmacokinetic interactions did not result in any significant pharmacodynamic effects.|
|Intervention:||Patients who are on chronic SUBOXONE sublingual film treatment should have their dose monitored if NNRTIs are added to their treatment regimen.|
|Examples:||efavirenz, nevirapine, etravirine, delavirdine|
|Antiretrovirals: Protease inhibitors (PIs)|
|Clinical Impact:||Studies have shown some antiretroviral protease inhibitors (PIs) with CYP3A4 inhibitory activity (nelfinavir, lopinavir/ritonavir, ritonavir) have little effect on buprenorphine pharmacokinetic and no significant pharmacodynamic effects. Other PIs with CYP3A4 inhibitory activity (atazanavir and atazanavir/ritonavir) resulted in elevated levels of buprenorphine and norbuprenorphine, and patients in one study reported increased sedation. Symptoms of opioid excess have been found in post−marketing reports of patients receiving buprenorphine and atazanavir with and without ritonavir concomitantly.|
|Intervention:||Monitor patients taking SUBOXONE sublingual film and atazanavir with and without ritonavir, and reduce dose of SUBOXONE sublingual film if warranted.|
|Antiretrovirals: Nucleoside reverse transcriptase inhibitors (NRTIs)|
|Clinical Impact:||Nucleoside reverse transcriptase inhibitors (NRTIs) do not appear to induce or inhibit the P450 enzyme pathway, thus no interactions with buprenorphine are expected.|
|Clinical Impact:||The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.|
|Intervention:||If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue SUBOXONE sublingual film sublingual film if serotonin syndrome is suspected.|
|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).|
|Monoamine Oxidase Inhibitors (MAOIs)|
|Clinical Impact:||MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma).|
|Intervention:||The use of SUBOXONE sublingual film is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.|
|Examples:||phenelzine, tranylcypromine, linezolid|
|Clinical Impact:||Buprenorphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.|
|Intervention:||Monitor patients receiving muscle relaxants and SUBOXONE sublingual film for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of SUBOXONE sublingual film and/or the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, strongly consider prescribing naloxone for the emergency treatment of opioid overdose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.|
|Intervention:||Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.|
|Clinical Impact:||The concomitant use of anticholinergic drugs may increase the risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.|
|Intervention:||Monitor patients for signs of urinary retention or reduced gastric motility when SUBOXONE sublingual film is used concomitantly with anticholinergic drugs.|
Drug Abuse And Dependence
SUBOXONE sublingual film contains buprenorphine, a Schedule III controlled substance under the Controlled Substances Act.
Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
Buprenorphine, like morphine and other opioids, has the potential for being abused and is subject to criminal diversion. This should be considered when prescribing or dispensing buprenorphine in situations when the clinician is concerned about an increased risk of misuse, abuse, or diversion. Healthcare professionals should contact their state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with or referred for more intensive and structured treatment.
Abuse of buprenorphine poses a risk of overdose and death. This risk is increased with the abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.
The healthcare provider may be able to more easily detect misuse or diversion by maintaining records of medication prescribed including date, dose, quantity, frequency of refills, and renewal requests of medication prescribed.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper handling and storage of the medication are appropriate measures that help to limit abuse of opioid drugs.
Buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces physical dependence of the opioid type, characterized by moderate withdrawal signs and symptoms upon abrupt discontinuation or rapid taper. The withdrawal syndrome is typically milder than seen with full agonists and may be delayed in onset [see WARNINGS AND PRECAUTIONS].
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Suboxone (Buprenorphine HCl and naloxone HCl)
© Suboxone Patient Information is supplied by Cerner Multum, Inc. and Suboxone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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