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Suboxone Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Suboxone (buprenorphine and naloxone) is a preparation used in the maintenance treatment of opioid addiction. Both its component drugs are opioid receptor antagonists. It 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. Side effects of Suboxone include loss of sensation in the mouth, mouth redness, and constipation.
Suboxone may interact with other drugs including benzodiazepines, erythromycin, rifampin, and HIV protease inhibitors. Buprenorphine and naloxone may dangerously increase the effects of other drugs that cause drowsiness. 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Suboxone in Detail - Patient Information: Side Effects
Buprenorphine and naloxone can cause drug dependence. This means that withdrawal symptoms may occur if you stop using the medicine too quickly. Withdrawal symptoms may also occur at the start of treatment due to dependence on another drug. Buprenorphine and naloxone is not for occasional ("as needed") use. Do not stop taking buprenorphine and naloxone without first talking to your doctor. Your doctor may want to gradually reduce the dose to avoid or minimize withdrawal symptoms.
Seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:
- an allergic reaction (difficulty breathing; closing of the throat, swelling of the lips, tongue, or face; or hives);
- slow breathing;
- dizziness or confusion; or
- liver problems such as yellowing of the skin or eyes, dark colored urine, light colored stools (bowel movements), decreased appetite for several days or longer, nausea, or lower stomach pain.
Other less serious side effects may be more likely to occur. Continue to take buprenorphine and naloxone and talk to your doctor if you experience
- problems sleeping;
- stomach pain; or
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Suboxone (Buprenorphine HCl and naloxone HCl) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Suboxone Overview - Patient Information: Side Effects
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Although this medication is used to prevent withdrawal reactions, it may rarely cause narcotic withdrawal symptoms (see also How to Use section). This is more likely to happen when you first start treatment or if you have been using long-acting narcotics such as methadone. If such symptoms occur, tell your doctor or pharmacist right away.
Severe (possibly fatal) breathing problems can occur, especially if this medication is abused, injected, or mixed with other depressants (such as alcohol, benzodiazepines including diazepam, other narcotics).
Get medical help right away if you have any very serious side effects, including: fainting, fast/irregular heartbeat, severe dizziness, mental/mood changes (such as agitation, confusion, hallucinations), slow/shallow breathing, unusual drowsiness/difficulty waking up.
This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Suboxone (Buprenorphine HCl and naloxone HCl)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Suboxone FDA Prescribing Information: Side Effects
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.
Clinical Trials Experience
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. 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 among SUBOXONE sublingual film, SUBOXONE (buprenorphine and naloxone) sublingual tablets, SUBUTEX (buprenorphine) 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.
Other adverse event data were derived from larger, controlled studies of SUBOXONE (buprenorphine and naloxone) and SUBUTEX (buprenorphine) tablets and of buprenorphine sublingual solution. In a comparative study of SUBOXONE (buprenorphine and naloxone) and SUBUTEX (buprenorphine) sublingual tablets, adverse event profiles were similar for subjects treated with 16 mg/4 mg SUBOXONE (buprenorphine and naloxone) sublingual tablets or 16 mg SUBUTEX (buprenorphine) sublingual tablets. The following adverse events were reported to occur by at least 5% of patients in a 4 week study of SUBOXONE (buprenorphine and naloxone) sublingual tablets and SUBUTEX (buprenorphine) sublingual tablets.
Table 2: Adverse Events ( ≥ 5%) by Body
System and Treatment Group in a 4 Week Study
|Body System/ Adverse Event (COSTART Terminology)||SUBOXONE (buprenorphine and naloxone) sublingual tablets 16 mg/4 mg/day
|SUBUTEX (buprenorphine) sublingual tablets 16 mg/day
|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 (COSTART Terminology)||Buprenorphine Dose|
|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:
1 mg solution would be less than a tablet dose of 2 mg
4 mg solution approximates a 6 mg tablet dose
8 mg solution approximates a 12 mg tablet 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 buprenorphineonly 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 not 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 tongue disorder.
Read the entire FDA prescribing information for Suboxone (Buprenorphine HCl and naloxone HCl) »
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