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Suboxone

Last reviewed on RxList: 11/11/2019
Suboxone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/11/2019

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?

Side effects of Suboxone include:

  • mouth numbness,
  • mouth redness,
  • mouth pain,
  • headache,
  • dizziness,
  • numbness or tingling,
  • drowsiness,
  • sleep problems (insomnia),
  • stomach pain,
  • vomiting,
  • constipation,
  • feeling drunk, or
  • trouble concentrating.

Get medical help right away if you have serious side effects of Suboxone including:

  • fainting,
  • fast or irregular heartbeat,
  • severe dizziness,
  • mental/mood changes (such as agitation, confusion, hallucinations),
  • slow or shallow breathing,
  • unusual drowsiness, or
  • difficulty waking up.

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:

  • benzodiazepines,
  • erythromycin,
  • 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.

    Additional Information

    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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Suboxone Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, buprenorphine and naloxone can slow your breathing. Death may occur if breathing becomes too weak. 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);
  • 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.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

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.

Read the entire detailed patient monograph for Suboxone (Buprenorphine HCl and naloxone HCl)

Suboxone Professional Information

SIDE EFFECTS

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 (COSTART Terminology) SUBOXONE sublingual tablets 16 mg/4 mg/day
N=107
n (%)
SUBUTEX sublingual tablets 16 mg/day
N=103
n (%)
Placebo
N=107
n (%)
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%)
Cardiovascular System
Vasodilation 10 (9.3%) 4 (3.9%) 7 (6.5%)
Digestive System
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%)
Nervous System
Insomnia 15 (14.0%) 22 (21.4%) 17 (15.9%)
Respiratory System
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
Very Low*
N=184
n (%)
Low*
N=180
n (%)
Moderate*
N=186
n (%)
High*
N=181
n (%)
Total*
N=731
n (%)
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%)
Digestive System
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%)
Nervous System
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%)
Respiratory System
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%)
Special Senses
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.

Postmarketing Experience

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.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis

Anaphylaxis has been reported with ingredients contained in SUBOXONE sublingual film.

Androgen Deficiency

Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Local Reactions

glossodynia, glossitis, oral mucosal erythema, oral hypoesthesia, and stomatitis

Read the entire FDA prescribing information for Suboxone (Buprenorphine HCl and naloxone HCl)

Related Resources for Suboxone

Related Health

Read the Suboxone User Reviews »

© 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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